Chemistry Reference Manual - Beckman Coulter Chemistry ACTM ALB ALP Methodology Immuno-Turbidimetry BCP KineticRate ReactionType a Rate-1 EP-2 Rate-1 AnalyticalWavelength 340nm 600nm

Chemistry Reference Manual

For In Vitro Diagnostic Use

This manual is intended for use withUniCel DxC 600UniCel DxC 600iUniCel DxC 660iUniCel DxC 680iUniCel DxC 800UniCel DxC 860iUniCel DxC 880i

PN A45586AP (December 2016)

Chemistry Reference ManualPN A45586AP (December 2016)

Copyright © 2016 Beckman Coulter, Inc.

Revision HistoryRevision AP, December 2016

Serum Index

Added sentence to Specimen Handling

Added reference to Further Reading

Revision AN, June 2015

Synchron Chemistry Abstracts - Cartridge

Corrected typo "CRPH"

Chemistry Supplies - Reagent Information

Added correct part no. 475000

Added Total Protein

Removed obsolete 467915 and 467935

Calibration Information

Removed HbA1c and Hba1c2

Solution Information

Added new part number for NO FOAM

Remove Obsolete 465121-LIWA

Serum Index

Corrected values in Lipemia column for ALT, ASO, AST and BUN.

Added UREA, Ref 442820

Added headers for Table 6.0 and 7.0

Operator Tips

Added troubleshoot comment/direction to table 4.0 for Lipase

Added Visual Aid to BUNm or UREAm, CREm, and PHOSm

A45586 AP Revision HistoryDECEMBER 2016 Page 1 of 1

Table of Content• Revision History, 1/1

• CHEMISTRY ABSTRACTS, 1/48

• Chemistry Supplies, 1/4

• CALIBRATION INFORMATION, 1/2

• CONTROL INFORMATION, 1/2

• SOLUTION INFORMATION, 1/1

• Serum Index, 1/7

• Operator Tips, 1/34

Refer to the Beckman Coulter website (www.beckmancoulter.com) for the most recent version of individual ChemistryInformation Sheets. For more detailed information on the Synchron Systems, refer to the appropriate Synchron manual.

A45586 AP Table of ContentDECEMBER 2016 Page 1 of 1

SYNCHRON CHEMISTRY ABSTRACTSTable 1.0 Modular Reagents

Chemistry ALBm BUNm CALC

Measurement Type Endpoint Timed rate Endpoint

Measurement Principle Colorimetry (600 nm) Conductivity Indirect ISE

Chemical Principle BCP Urease Ca ionophore membrane

Sample Type Serum/Plasma Serum/Plasma/Urine Serum/Plasma/Urine

Sample Volume

Serum/Plasma 5 µL 10 µL 40 µL

Urine NAa 10 µL (10 fold dil.) 40 µL

CSF NA NA NA

ORDAC NA 5 µL NA

Reagent

1.3 mL ISE Electrolyte BufferVolume per test 0.570 mL 0.765 mL

3.3 mL ISE Electrolyte Reference

On-Instrument Stability 60 days 15 days 30 days

Storage Room Teperature +2°C to +8°C Room Temperature

Measurement Time 11.5 to 11.9 sec. 11.3 to 14.6 sec. 17.8 to 18.7 sec.

Temperature

Set-point +36°C to +38°C +36°C to +38°C 18°C to 32°C

Regulation ±0.2°C ±0.2°C NA

Stirrer

Size Small (grey) Large (orange) NA

Speed (RPM) 720 900 NA

Calibration Frequency 14 days 72 hrs. 24 hrs.

Analytical Range

Serum/Plasma 1.0–7.0 g/dL (10–70 g/L) 1–150 mg/dL (0.4–53.6 mmol/L) 2–20.0 mg/dL (0.5–5.0 mmol/L)

ORDAC NA 130–300 mg/dL (46.4–107.1 mmol/L) NA

Urine NA 10–1500 mg/dL (3.57–535.7 mmol/L)b 2–30.0 mg/dL (0.5–7.5 mmol/L)

ORDAC NA 1300–3000 mg/dL (464.3–1071.4

mmol/L)bNA

CSF NA NA NA

ORDAC NA NA NA

Reference Interval

Serum/Plasma 3.5–4.8 g/dL (35–48 g/L) 8–20 mg/dL (2.9–7.1 mmol/L) 8.9–10.3 mg/dL (2.23–2.58 mmol/L)

Urine NA 12–20 g/24 hrs. (0.43–0.71 mol/24

hrs.)c100–300 mg/24 hrs. (25–75 mmol/24

hrs.)

CSF NA NA NA

Precision Specication (Use the

greater number)

Serum/Plasma 2% or 0.2 g/dL (2.0 g/L) 3% or 1.5 mg/dL (0.5 mmol/L) 2% or 0.2 mg/dL (0.05 mmol/L)

Urine NA 3% or 3.0 mg/dL (1.1 mmol/L) 3% or 0.3 mg/dL (0.08 mmol/L)

CSF NA NA NA

A45586 AP SYNCHRON CHEMISTRY ABSTRACTSDECEMBER 2016 Page 1 of 48

Table 1.0 Modular ReagentsChemistry ALBm BUNm CALC

ORDAC NA 5 % NA

Comment NA NA NA

a NA = Not applicable.b Range for 10 fold dilution.c Taken from literature, refer to Chemistry Information Sheet for source.

SYNCHRON CHEMISTRY ABSTRACTS A45586 APPage 2 of 48 DECEMBER 2016

Table 2.0 Modular Reagents

Chemistry CL CO2 CREm

Measurement Type Endpoint Peak rate Timed rate

Measurement Principle Indirect ISE Differential rate pH Colorimetry (520 nm)

Chemical Principle Ag/AgCI pellet Acid liberation CO2 Gas Alkaline picrate

Sample Type Serum/Plasma/Urine/CSF Serum/Plasma Serum/Plasma/Urine

Sample Volume

Serum/Plasma 40 µL 40 µL 16.5 µL

Urine 40 µL NAa 5.5 µL

CSF 40 µL NA NA

ORDAC NA NA NA

Reagent

1.3 mL ISE Electrolyte Buffer 1.3 mL ISE Electrolyte Buffer


2.5 mL Acid Reagent

Volume per test


Alkaline Buffer

0.570 mL


Storage Room temperature Room temperature Room temperature

Measurement Time 17.8 to 18.7 sec. 7 to 12.7 sec. 20.5 to 26.4 sec.

Temperature

Set-point 18°C to 32°C 18°C to 32°C +40°C to +42°C

Regulation NA NA ±0.2°C

Stirrer

Size NA NA Small (grey)

Speed (RPM) NA NA 720

Calibration Frequency 24 hrs. 24 hrs. 72 hrs.

Analytical Range

Serum/Plasma 50–200 mmol/L 5–50 mmol/L 0.1–25 mg/dL (8.84–2210 µmol/L)

ORDAC NA NA NA

Urine 15–300 mmol/L NA 10–400 mg/dL (0.88–35.36 mmol/L)

ORDAC NA NA NA

CSF 50–200 mmol/L NA NA

ORDAC NA NA NA

Reference Interval

M 0.9–1.3 mg/dL (80–115 µmol/L)Serum/Plasma 101–111 mmol/L 22–32 mmol/L

F 0.6–1.1 mg/dL (53–97 µmol/L)

M 800–2000mg/24 hrs.b (7.1–17.7

mmol/24 hrs.)bUrine 110–250 mmol/24 hrs.b NA

F 600–1800 mg/24 hrs.b (5.3–15.9

mmol/24 hrs.)b

CSF 118–132 mmol/Lb NA NA


greater number)

Serum/Plasma 2% or 2 mmol/L 3% or 1 mmol/L 3% or 0.1 mg/dL (9 µmol/L)

Urine 3% or 3 mmol/L NA 3% or 2.0 mg/dL (177 µmol/L)


Table 2.0 Modular ReagentsChemistry CL CO2 CREm

CSF 2% or 2 mmol/L NA NA

ORDAC NA NA NA

Comment NA NA NA

a NA = Not applicable.b Taken from literature, refer to Chemistry Information Sheet for source.



Chemistry GLUCm K NA

Measurement Type Timed-peak rate Endpoint Endpoint

Measurement Principle O2 depletion Indirect ISE Indirect ISE

Chemical Principle Glucose oxidase Valinomycin membrane LAS glass membrane

Sample Type Serum/Plasma/Urine/CSF Serum/Plasma/Urine Serum/Plasma/Urine

Sample Volume


Urine 10 µL 40 µL 40 µL

CSF 10 µL NAa NA

ORDAC 5 µL NA NA

Reagent

1.3 mL ISE Electrolyte Buffer 1.3 mL ISE Electrolyte BufferVolume per test 0.765 mL

3.3 mL ISE Electrolyte Reference 3.3 mL ISE Electrolyte Reference


Storage +2°C to +8°C Room temperature Room temperature


Temperature

Set-point +36°C to +38°C 18°C to 32°C 18°C to 32°C

Regulation ±0.2°C NA NA

Stirrer

Size Large (orange) NA NA

Speed (RPM) 900 NA NA

Calibration Frequency 48 hrs. 24 hrs. 24 hrs.

Analytical Range

Serum/Plasma 3–600 mg/dL (0.2–33.3 mmol/L) 1–15.0 mmol/L 100–200 mmol/L

ORDAC 300–1200 mg/dL (16.7–66.7 mmol/L) NA NA

Urine 3–600 mg/dL (0.2–33.3 mmol/L) 2–300 mmol/L 10–300 mmol/L


CSF 3–600 mg/dL (0.2–33.3 mmol/L) NA NA


Reference Interval

Serum/Plasma 74–118 mg/dL (4.1–6.6 mmol/L) 3.6–5.1 mmol/L 136–144 mmol/L

Urine 1–15 mg/dL (0.06–0.83 mmol/L)b 25–125 mmol/24 hrs.b 40–220 mmol/24 hrs.b

CSF 40–70 mg/dL (2.2–3.9 mmol/L)b NA NA


greater number)

Serum/Plasma 2% or 2 mg/dL (0.1 mmol/L) 2% or 0.1 mmol/L 1% or 1 mmol/L

Urine 2% or 2 mg/dL (0.1 mmol/L) 4% or 2 mmol/L 4% or 2 mmol/L

CSF 2% or 2 mg/dL (0.1 mmol/L) NA NA

ORDAC 5% NA NA

Comment NA NA NA

a NA = Not applicable.b Taken from literature, refer to Chemistry Information Sheet for source.



Chemistry PHOSm TPm UREAm

Measurement Type Timed rate Timed rate Timed rate

Measurement Principle Colorimetry (365 nm) Colorimetry (545 nm) Conductivity

Chemical Principle Phosphomolybdate-UV Biuret Urease

Sample Type Serum/Plasma/Urine Serum/Plasma/CSF Serum/Plasma/Urine

Sample Volume


Urine 8 µL (10 fold dil.) NAa 10 µL (10 fold dil.)

CSF NA 60 µL NA

ORDAC NA NA 5 µL

Reagent

Volume per test 0.570 mL 0.630 mL 0.765 mL


Storage Room temperature Room teperature +2°C to +8°C


Temperature

Set-point +36°C to +38°C +36°C to +38°C +36°C to +38°C

Regulation ±0.2°C ±0.2°C ±0.2°C

Stirrer

Size Small (grey) Small (grey) Large (orange)

Speed (RPM) 720 720 900

Calibration Frequency 72 hrs. 14 days 72 hrs.

Analytical Range

Serum/Plasma 0.5–12 mg/dL (0.2–3.9 mmol/L) 1.0–12.0 g/dL (10–120 g/L) 0.4–53.6 mmol/L

ORDAC NA NA 46.4–107.1 mmol/L

Urine 5–140 mg/dL (1.6–45.5 mmol/L)b NA 3.57–535.7 mmol/Lb

ORDAC NA NA 464.3–1071.4 mmol/Lb

CSF NA 10–1500 mg/dL (100–15,000 mg/L) NA

ORDAC NA NA NA

Reference Interval

Serum/Plasma 2.4–4.7 mg/dL (0.78–1.53 mmol/L) 6.1–7.9 g/dL (61–79 g/L) 2.9–7.1 mmol/L

Urine 0.4–1.3 g/24 hrs. (12.9–42.0 mmol/24

hrs.)cNA 0.43–0.71 mol/24 hrs.c

CSF NA 15–45 mg/dL (150–450 mg/L)c NA


greater number)

Serum/Plasma 2% or 0.15 mg/dL (0.05 mmol/L) 2% or 0.2 g/dL (2.0 g/L) 3% or .54 mmol/L

Urine 2% or 2.0 mg/dL (0.60 mmol/L) NA 3% or 1.0 mmol/L

CSF NA 5% or 5 mg/dL (50 mg/L) NA

ORDAC NA NA 5%

Comment NA NA NA

a NA = Not applicable.b Range for 10 fold dilution.c Taken from literature, refer to Chemistry Information Sheet for source.


Table 5.0 Cartridge

Chemistry ACTM ALB ALP

Methodology Immuno-Turbidimetry BCP Kinetic Rate

Reaction Typea Rate-1 EP-2 Rate-1

Analytical Wavelength 340 nm 600 nm 410 nm

Sample Type Serum/Plasma Serum/Plasma Serum/Plasma

Sample Volume


Urine NAb NA NA

CSF NA NA NA

ORDAC NA NA 3 µL

Reagent Volume 302 µL 300 µL 250 µL

Cartridge Volume

A 230 µL 300 µL 228 µL

B 40 µL NA 22 µL

C 32 µL NA NA

Storage +2°C to +8°C Room Temperature +2°C to +8°C


Tests per Cartridge 100 300 200 or 400

Reaction Time Window

Start 112 sec. 75 sec. 128 sec.

Stop 160 sec. 105 sec. 280 sec.

Default Unit µg/mL g/dL IU/L

Calibration Frequency 14 days 14 days NA

Within-lot Cal. Freq. 60 days 90 days NA

Analytical Range

Serum/Plasma 10–300 µg/mL (66–1986 µmol/L) 1–7 g/dL (10–70 g/L) 5–1000 IU/L (0.1–16.7 µkat/L)

Urine NA NA NA

CSF NA NA NA

ORDAC Range NA NA 800–1650 IU/L (13.3–27.5 µkat/L)

Reference Interval

Serum/Plasma See Chemistry Information Sheet 3.5–5.0 g/dL (35–50 g/L) 38–126 IU/L (0.65–2.14 µkat/L)c

Urine NA NA NA

CSF NA NA NA


greater number)

Serum/Plasma 2.0 µg/mL (13.2 µmol/L) or 4.0% 0.2 g/dL (2.0 g/L) or 3.0% 3.0 IU/L (0.05 µkat/L) or 3.5%

Urine NA NA NA

CSF NA NA NA

ORDAC NA NA 10%

Comment NA NA NA

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b NA = Not applicable.c Taken from literature, refer to Chemistry Information Sheet for source.


Table 6.0 Cartridge

Chemistry ALP (IFCC/DGKCh) ALT ALT-

Methodology Kinetic Rate Henry P5P activated

Reaction Typea RATE-1 RATE-1 RATE-1



Sample Volume


Urine NAb NA NA

CSF NA NA NA

ORDAC 3 µL 3 µL 3 µL


Cartridge Volume

A 228 µL 242 µL 250 µL

B 22 µL 8 µL 8 µL

C NA NA NA

Storage +2°C to +8°C +2°C to +8°C +2°C to +8°C


Tests per Cartridge 200 or 400 200 or 400 100 or 300




Default Unit IU/L IU/L IU/L

Calibration Frequency 10 days NA 5 days

Within-lot Cal. Freq. 30 days NA 30 days

Analytical Range

5–1000 IU/L 5–400 IU/L 5–400 IU/LSerum/Plasma

(0.1–16.7 µkat/L) (0.09–6.80 µkat/L) (0.09–6.80 µkat/L)

Urine NA NA NA

CSF NA NA NA

ORDAC Range 800–1650 IU/L (13.3–27.5 µkat/L) 350–2600 IU/L (5.95–44.20 µkat/L) 350–2600 IU/L (5.8–43.0 µkat/L)

Reference Interval

M 17–63 IU/L (0.29–1.07 µkat/L) M 45 IU/L (0.74 µkat/L)cSerum/Plasma See Chemistry Information Sheet

F 14–54 IU/L (0.24–0.92 µkat/L) F 34 IU/L (0.56 µkat/L)c

Urine NA NA NA

CSF NA NA NA


greater number)

Serum/Plasma 3.0 IU/L (0.05 µkat/L) or 3.5% 3.0 IU/L (0.05 µkat/L) or 3.5% 3.0 IU/L (0.05 µkat/L) or 3.5%

Urine NA NA NA

CSF NA NA NA

ORDAC 10% 10% NA


Table 6.0 CartridgeChemistry ALP (IFCC/DGKCh) ALT ALT-

Comment Calibration required. Mix C into A. (for 200 tests) Mix C into A. Calibration required.

Mix ALT (A-reagent) into A (for 400

tests)

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b NA = Not applicable.c Serum values.


Table 7.0 Cartridge

AMM

Chemistry Software Version < 2.0 Software Version > 2.0 AMPH

Methodology Enzymatic Enzymatic EIA

Reaction Typea EP-2 EP-2 RATE-1


Sample Type Plasma Plasma Urine

Sample Volume

Serum/Plasma 25 µL 40 µL NA

Urine NAb NA 20 µL

CSF NA NA NA

ORDAC NA NA NA


Cartridge Volume

A 180 µL 180 µL 200 µL

B 40 µL 40 µL 50 µL

C 6 µL 6 µL NA


Tests per Cartridge 25 25 250





Default Unit µmol/L µmol/L m/Abs/min

Calibration Frequency 5 days 5 days 14 days

Within-lot Cal. Freq. NA NA 90 days

Analytical Range

5–1000 µL 9–1000 µmol/L NASerum/Plasma

(9–1700 µg/dL)c 16–1700 µg/dLc NA

Urine NA NA NA

CSF NA NA NA

ORDAC Range NA NA NA

Reference Interval

19–60 µLd 19–60 µLd NASerum/Plasma

(11 – 35 µmol/L)d (11 – 35 µmol/L)d NA

Urine NA NA NA

CSF NA NA NA

Precision Specication (Use the greater number)

Serum/Plasma 5 µmol/L (8.5 µg/dL) or 2.0%c 5 µmol/L (8.5 µg/dL) or 2.0%c NA

Urine NA NA 2.0%

CSF NA NA NA

ORDAC NA NA NA

Comment NA NA Qualitative, POS/NEG

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b NA = Not applicable.


Table 7.0 Cartridgec Plasma values.d Taken from literature, refer to Chemistry Information Sheet for source.


Table 8.0 Cartridge

Chemistry AMY7 ApoA ApoB

Methodology Enzymatic-G7 Immuno-Turbidimetry Immuno-Turbidimetry

Reaction Typea RATE-1 EP-2 EP-2


Sample Type Serum/Plasma/Urine Serum/Plasma Serum/Plasma

Sample Volume

Serum/Plasma 7 µL 15 µLb 15 µLb

Urine 7 µL NAc NA

CSF NA NA NA

ORDAC 3 µL NA NA


Cartridge Volume

A 175 µL 200 µL 200 µL

B 3.5 µL NA NA

C NA 30 µL 30 µL







Default Unit U/L mg/dL mg/dL

Calibration Frequency NA 14 days 14 days

Within-lot Cal. Freq. NA 30 days 30 days

Analytical Range

Serum/Plasma 5–1200 U/L (0.08–20.00 µkat/L) 25–300 mg/dL (0.25–3.00 g/L) 35–300 mg/dL (0.35–3.00 g/L)

Urine 5–1200 U/L (0.08–20.00 µkat/L) NA NA

CSF NA NA NA

ORDAC Range 1000–2000 U/L (16.67–33.34 µkat/L) NA NA

Reference Interval

M 95–176 mg/dL (0.95–1.76 g/L) M 51–153 mg/dL (0.51–1.53 g/L)Serum/Plasma See Chemistry Information Sheet

F 119–228 mg/dL (1.19–2.28 g/L) F 51–165 mg/dL (0.51–1.65 g/L)

Urine See Chemistry Information Sheet NA NA

CSF NA NA NA


greater number)

Serum/Plasma 3.0 U/L (0.03 µkat/L) or 3.5% 5 mg/dL (0.05 g/L) or 5.0% 5 mg/dL (0.05 g/L) or 5.0%

Urine 3.0 U/L (0.03 µkat/L) or 3.5% NA NA

CSF NA NA NA

ORDAC 10% NA NA

Comment NA DIL1 required for Sample dilution. DIL1 required for Sample dilution.

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b Refer to Chemistry Information Sheet for details.c NA = Not applicable.


Table 9.0 Cartridge

Chemistry ASO- AST AST-

Methodology Immuno-Turbidimetry Henry P5P activated


Analytical Wavelength 340 nm 340nm 340 nm


Sample Volume


Urine NAb NA NA

CSF NA NA NA



Cartridge Volume

A 250 µL 242 µL 250 µL

B 50 µL 8 µL 8 µL

C NA NA NA



Tests per Cartridge 100 200 or 400 100 or 300




Default Unit IU/mL IU/L IU/L



Analytical Range

Serum/Plasma 25–800 IU/mL 5–400 IU/L (0.1–6.7 µkat/L) 10–400 IU/L (0.2–6.7 µkat/L)

Urine NA NA NA

CSF NA NA NA

ORDAC Range 640–1600 IU/mL 350–2600 IU/L (5.8–43.3 µkat/L) 350–2600 IU/L (5.8–43.3 µkat/L)

Reference Interval

M 35 IU/L (0.58 µkat/L)cSerum/Plasma <145 IU/mL 15–41 IU/L (0.3–0.7 µkat/L)

F 31 IU/L (0.52 µkat/L)c

Urine NA NA NA

CSF NA NA NA


greater number)

Serum/Plasma 10 IU/mL or 4% 3.0 IU/L (0.05 µkat/L) or 3.5% 3.0 IU/L (0.05 µkat/L) or 3.5%

Urine NA NA NA

CSF NA NA NA

ORDAC 4.0% 10% 10%

Comment NA Mix C into A (for 200 tests) Mix C into A. Calibration required.

Mix AST (A-reagent) into A (for 400

tests)

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.


Table 9.0 Cartridgeb NA = Not applicable.c Serum values.


Table 10.0 Cartridge

Chemistry BARB BNZG BUN

Methodology EIA EIA Enzymatic



Sample Type Urine Urine Serum/Plasma/Urine

Sample Volume

Serum/Plasma NAb NA 3 µL

Urine 10 µL 20 µL 3 µL (10 fold dil.)c

CSF NA NA NA

ORDAC NA NA NA


Cartridge Volume

A 200 µL 200 µL 285 µL

B 50 µL 50 µL 15 µL

C NA 10 µL NA







Default Unit mAbs/min mAbs/mon mg/dL

Calibration Frequency 14 days 14 days 24 hrs.

Within-lot Cal. Freq. 90 days 60 days 30 days

Analytical Range

Serum/Plasma NA NA 5–100 mg/dL (1.8–35.7 mmol/L)

Urine NA NA 50–1000 mg/dL (17.9–357.0 mmol/L)

CSF NA NA NA


Reference Interval

Serum/Plasma NA NA 8–26 mg/dL (2.9–9.3 mmol/L)

Urine NA NA 12–20 g/24 hrs. (0.43–0.71 mol/24

hrs.)d

CSF NA NA NA


greater number)

Serum/Plasma NA NA 2 mg/dL (0.71 mmol/L) or 3.0%

Urine 2.0% 2.0% 3 mg/dL (1.07 mmol/L) or 3.0%

CSF NA NA NA

ORDAC NA NA NA

Comment Qualitative, POS/NEG Qualitative, POS/NEG Urine Samples require DIL1.

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b NA = Not applicable.c Reaction volume, actual required sample volume differs due to on-board dilution. Refer to Chemistry Information Sheet for details.d Taken from literature, refer to Chemistry Information Sheet for source.



Chemistry C3 C4 CAR

Methodology Immuno-Turbidimetry Immuno-Turbidimetry Immuno-Turbidimetry




Sample Volume

Serum/Plasma 40 µL (20 fold dil.)b 40 µL (20 fold dil.)b 3 µL

Urine NAc NA NA

CSF NA NA NA

ORDAC NA NA NA


Cartridge Volume

A 200 µL 200 µL 230 µL

B 30 µL 34 µL 30 µL

C NA NA 32 µL







Default Unit mg/dL mg/dL µg/mL



Analytical Range

Serum/Plasma 10–350 mg/dL (100–3500 mg/L) 5–120 mg/dL (50–1200 mg/L) 2.0–20.0 µg/mL (8.5–84.6 µmol/L)

Urine NA NA NA

CSF NA NA NA


Reference Interval

Serum/Plasma 83–177 mg/dL (830–1770 mg/L)d 28.7–67.5 mg/dL (287–675 mg/L)d See Chemistry Information Sheet

Urine NA NA NA

CSF NA NA NA


greater number)

Serum/Plasma 3.5 mg/dL (35 mg/L) or 4.5% 2.0 mg/dL (20 mg/L) or 4.5% 0.6 µg/mL (2.5 µmol/L) or 5.0%

Urine NA NA NA

CSF NA NA NA

ORDAC NA NA NA

Comment DIL1 required for Sample dilution. DIL1 required for Sample dilution. NA

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b Reaction volume, actual required sample volume differs due to on-board dilution. Refer to Chemistry Information Sheet for details.c NA = Not applicable.d Taken from literature, refer to Chemistry Information Sheet for source.



Chemistry CHOL CK CK-

Methodology Enzymatic Rosalki NAC activated

Reaction Typea EP-2 RATE-1 RATE-1



Sample Volume


Urine NAb NA NA

CSF NA NA NA



Cartridge Volume

A 290 µL 238 µL 242 µL

B NA 22 µL 22 µL

C 10 µL NA NA



Tests per Cartridge 300 200 or 400 200




Default Unit mg/dL IU/L IU/L



Analytical Range

Serum/Plasma 5–750 mg/dL (0.13–19.43 mmol/L) 5–1200 IU/L (0.1–20.0 µkat/L) 5–1200 IU/L (0.1–20.0 µkat/L)

Urine NA NA NA

CSF NA NA NA

ORDAC Range 600–1000 mg/dL (15.54–25.90

mmol/L)

860–4100 IU/L (14.3–68.3 µkat/L) 860–4100 IU/L (14.3–68.3 µkat/L)

Reference Interval

M 49–397 IU/L (0.83–6.75 µkat/L) M 171 IU/L (2.85 µkat/LcSerum/Plasma See Chemistry Information Sheet

F 38–234 IU/L (0.65–3.98 µkat/L) F 145 IU/L (2.41 µkat/L)c

Urine NA NA NA

CSF NA NA NA


greater number)

Serum/Plasma 5.0 mg/dL (0.13 mmol/L) or 3.0% 5.0 IU/L (0.08 µkat/L) or 3.5% 5.0 IU/L (0.08 µkat/L) or 3.5%

Urine NA NA NA

CSF NA NA NA

ORDAC 10% 10% 10%

Comment NA Mix C into A. (for 200 tests) Mix C into A. Calibration required.

Mix CK (A-reagent) into A (for 400

tests)


Table 12.0 Cartridgea 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b NA = Not applicable.c Serum values.



Chemistry COCM CO2E CRP

Methodology EIA PEPC activated Immuno-Turbidimetry

Reaction Typea RATE-1 RATE-1 EP-2


Sample Type Urine Serum/Plasma Serum/Plasma

Sample Volume

Serum/Plasma NAb 6 µL 10 µL

Urine 20 µL NA NA

CSF NA NA NA

ORDAC NA NA 4 µL


Cartridge Volume

A 200 µL 244 µL 250 µL

B 50 µL NA NA

C NA 6 µL 10 µL







Default Unit mAbs/min mmo/L mg/dL

Calibration Frequency 14 days 24 hrs. 30 days


Analytical Range

Serum/Plasma NA 5–45 mg/dL 0.5–20.0 mg/dL (5.0–200.0 mg/L)

Urine NA NA NA

CSF NA NA NA

ORDAC Range NA NA 15.0–48.8 mg/dL (150.0–488.0 mg/L)

Reference Interval

Serum/Plasma NA 23–29 mmol/L <1.0 mg/dL (<10.0 mg/L)c

Urine NA NA NA

CSF NA NA NA


greater number)

Serum/Plasma NA 3% or 1 mmol/L 0.2 mg/dL (2.0 mg/L) or 5.0%

Urine 2.0% NA NA

CSF NA NA NA

ORDAC NA NA 10%

Comment Qualitative, POS/NEG NA NA




Chemistry CRP CRPH (Cardiac) CR-E

Methodology Latex Turbidimetry Immuno-Turbidimetry Enzymatic



Sample Type Serum/Plasma Serum/Plasma Serum/Plasma/Urine

Sample Volume


Urine NAb NA 10 µL (10 fold dil.)c

CSF NA NA NA

ORDAC 3 µL 12 µL NA


Cartridge Volume

A 250 µL 185 µL 180 µL

B 50 µL 70 µL 60 µL

C NA NA NA







Default Unit mg/dL mg/dL mg/dL



Analytical Range

Serum/Plasma 0.1–25.0 mg/dL (1.0–250 mg/L) 0.020–8.000 mg/dL (0.20–80.00 mg/L) 0.1 mg/dL–25 mg/dL (9–2210 µmol/L)

Urine NA NA 10 mg/dL–400 mg/dL (884–35360

µmol/L)

CSF NA NA NA

ORDAC Range 15.0–50.0 mg/dL (150.0–500.0 mg/L) 6.000–38.000 mg/dL (60.00–380.00

mg/L)

NA

Reference Interval

M 0.9–1.3 mg/dL (80–115 µmol/L)Serum/Plasma <0.75 mg/dL <0.748 mg/dL (<7.48 mg/L)

F 0.6–1.1 mg/dL (53–97 µmol/L)

M 800–2000 mg/24 hrs. (7.1–17.7

mmol/24 hrs.)

Urine NA NA

F 600–1800 mg/24 hrs. (5.3–15.9

mmol/24 hrs.)

CSF NA NA NA


greater number)

Serum/Plasma 0.05 mg/dL (0.5 mg/L) or 5.0% 0.005 mg/dL (0.050 mg/L) or 5.0% 0.1 mg/dL (8.8 µmol/L) or 3.0%

Urine NA NA 1.0 mg/dL (88 µmol/L) or 3.0%

CSF NA NA NA


Table 14.0 CartridgeChemistry CRP CRPH (Cardiac) CR-E

ORDAC 10% 7.5% NA

Comment NA NA NA

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b NA = Not applicable.c Reaction volume, actual required sample volume differs due to on-board dilution. Refer to Chemistry Information Sheet for details.



Chemistry CR-S DBIL DIGN

Methodology Rate-Jaffe Diazo Immuno-Turbidimetry

Reaction Typea RATE-1 EP-2 RATE-1


Sample Type Serum/Plasma/Urine Serum/Plasma Serum/Plasma

Sample Volume


Urine 3 µL NA NA

CSF NAb NA NA

ORDAC NA NA NA


Cartridge Volume

A 175 µL 310 µL 185 µL

B 44 µL 10 µL 15 µL

C NA NA 25 µL

Storage Room Temperature Room Temperature +2°C to +8°C


Tests per Cartridge 300 200 or 300 100




Default Unit mg/dL mg/dL ng/mL



Analytical Range

Serum/Plasma 0.3 mg/dL–25 mg/dL (27–2210 µmol/L) 0.1–10 mg/dL (1.7–171.0 µmol/L) 0.2–4.5 ng/mL (0.256–5.76 nmol/L)

Urine 10 mg/dL–400 mg/dL (884–35360

µmol/L)

NA NA

CSF NA NA NA


Reference Interval

M 0.9–1.3 mg/dL (80–115 µmol/L)Serum/Plasma

F 0.6–1.1 mg/dL (53–97 µmol/L)

0.1–0.5 mg/dL (1.7–8.6 µmol/L) See Chemistry Information Sheet

M 800–2000 mg/24 hrs. (7.1–17.7

mmol/24 hrs.)

Urine

F 600–1800 mg/24 hrs. (5.3–15.9

mmol/24 hrs.)

NA NA

CSF NA NA NA


greater number)

Serum/Plasma 0.2 mg/dL (18 µmol/L) or 2.0% 0.15 mg/dL (2.6 µmol/L) or 5.0% 0.1 ng/mL (0.128 nmol/L) or 5.0%

Urine 2.0 mg/dL (177 µmol/L) or 2.0% NA NA

CSF NA NA NA


Table 15.0 CartridgeChemistry CR-S DBIL DIGN

ORDAC NA NA NA

Comment Add 1 drop of antifoam to compartment

A.

Reaction starts with Reagent B

triggering.

NA




Chemistry ETOH FE GEN

Methodology Enzymatic FerroZine Immuno-Turbidimetry



Sample Type Serum/Plasma/Urine/Whole blood Serum/Plasma Serum/Plasma

Sample Volume

Serum/Plasma 10 µLb 25 µL 3 µL

Whole Blood 10 µL NAc NA

Urine 10 µL NA NA

CSF NA NA NA

ORDAC NA NA NA


Cartridge Volume

A 200 µL 200 µL 245 µL

B 75 µL NA 40 µL

C NA 10 µL 30 µL







Default Unit mg/dL µg/dL µg/mL



Analytical Range

Serum/Plasma 5–600 mg/dL (1.1–130 mmol/L) 5–500 µg/dL (0.9–89.5 µmol/L) 0.5–12.0 µg/mL (1.0–25.1 µmol/L)

Urine 10–700 mg/dL (2.2–152 mmol/L) NA NA

CSF 5–600 mg/dL (1.1–130 mmol/L) NA NA


Reference Interval

M 45–182 µg/dL (8.1–32.6 µmol/L)Serum/Plasma See Chemistry Information Sheet

F 28–170 µg/dL (5.0–30.4 µmol/L)

See Chemistry Information Sheet

Urine NA NA NA

CSF NA NA NA


greater number)

Serum/Plasma 2.4 mg/dL (0.52 mmol/L) or 3.0% 3.5 µg/dL (0.6 µmol/L) or 2.5% 0.2 µg/mL (0.4 µmol/L) or 5.0%

Treated Whole Blood 3.2 mg/dL (0.70 mmol/L) or 4.0% NA NA

Urine 2.4 mg/dL (0.52 mmol/L) or 3.0% NA NA

CSF NA NA NA

ORDAC NA NA NA

Comment NA NA NA

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.


Table 16.0 Cartridgeb Sample size for treated whole blood.c NA = Not applicable.



Chemistry GGT GGT (IFCC)

Methodology Szasz Szasz

Reaction Typea RATE-1 RATE-1

Analytical Wavelength 410 nm 410 nm

Sample Type Serum/Plasma Serum/Plasma

Sample Volume

Serum/Plasma 13 µL 13 µL

Urine NAb NA

CSF NA NA

ORDAC 3 µL 3 µL

Reagent Volume 260 µL 260 µL

Cartridge Volume

A 237 µL 237 µL

B 23 µL 23 µL

C NA NA

Storage +2°C to +8°C +2°C to +8°C

On-Instrument Stability 7 days 30 days

Tests per Cartridge 200 or 400 200 or 400


Start 64 sec. 64 sec.

Stop 184 sec. 184 sec.

Default Unit IU/L IU.L

Calibration Frequency NA 7 days

Within-lot Cal. Freq. NA 30 days

Analytical Range

Serum/Plasma 5–750 IU/L (0.1–12.5 µkat/L) 5–750 IU/L (0.1–12.5 µkat/L)

Urine NA NA

CSF NA NA

URDAC Range NA NA

ORDAC Range 550–3000 IU/L (9.2–50.0 µkat/L) 550–3000 IU/L (9.2–50.0 µkat/L)

Reference Interval

M 55 IU/L (0.92 µkat/L)cSerum/Plasma 7–50 IU/L (0.1–0.9 µkat/L)

F 38 IU/L (0.63 µkat/L)c

Urine NA NA

CSF NA NA


Serum/Plasma 3.0 IU/L (0.05 µkat/L) or 3.5% 3.0 IU/L (0.05 µkat/L) or 3.5%

Urine NA NA

CSF NA NA

ORDAC 10% 10%

Comment NA Calibration required.




Chemistry GLU GLUH

Methodology UV-Hexokinase UV-Hexokinase

Reaction Typea EP-2 EP-3


Sample Type Serum/Plasma/CSF Serum/Plasma/Urine/CSF

Sample Volume


Urine NAb 3 µL

CSF 3 µL 3 µL

ORDAC NA NA


Cartridge Volume

A 273 µL 273 µL

B 27 µL 27 µL

C NA NA



Tests per Cartridge 300 300




Default Unit mg/dL mg/dL

Calibration Frequency 14 days 14 days

Within-lot Cal. Freq. 90 days 90 days

Analytical Range

Serum/Plasma 5–700 mg/dL (0.3–38.8 mmol/L) 5–700 mg/dL (0.3–38.8 mmol/L)

Urine NA 5–700 mg/dL (0.3–38.8 mmol/L)

CSF 5–700 mg/dL (0.3–38.8 mmol/L) 5–700 mg/dL (0.3–38.8 mmol/L)

URDAC Range NA NA

ORDAC Range NA NA

Reference Interval

Serum/Plasma 79–115 mg/dL (4.4–6.4 mmol/L) 74–106 mg/dL (4.1–5.9 mmol/L)

Urine NA 1–15 mg/dL (0.06– 0.83 mmol/L)

Urine (timed) NA < 0.5 g/24 hrs (<2.8 mmol/24 hrs)

CSF 40–70 mg/dL (2.2–3.9 mmol/L)c 40–70 mg/dL (2.2–3.9 mmol/L)c


Serum/Plasma 2.0 mg/dL (0.11 mmol/L) or 2.0% 2.0 mg/dL (0.11 mmol/L) or 2.0%

Urine NA 2.0 mg/dL (0.11 mmol/L) or 2.0%

Urine (timed) NA 2.0 mg/dL (0.11 mmol/L) or 2.0%

CSF 2.0 mg/dL (0.11 mmol/L) or 2.0% 2.0 mg/dL (0.11 mmol/L) or 2.0%

ORDAC NA NA

Comment NA NA



Table 18.0 Cartridgec Taken from literature, refer to Chemistry Information Sheet for source.



Chemistry HbA1c3 HbA1c-

HB3 A1C3 HB- A1C-

Methodology Colorimetric Immuno-Turbidimetry Colorimetric Immuno-Turbidimetry

Reaction Typea EP-2 EP-2 EP-3 EP-3

Analytical Wavelength 410 nm 340 nm 410 nm 340 nm

Sample Type Whole Blood Whole Blood Whole Blood Whole Blood

Sample Volume

Serum/Plasma 25 µLc 10 µLc 25 µLc 10 µLc

Urine NAd NA NA NA

CSF NA NA NA NA

URDAC NA NA NA NA

ORDAC NA NA NA NA

Reagent Volume 215 µL 280 µL 215 µL 280 µL

Cartridge Volume

A 215 µL 220 µL 215 µL 220 µL

B NA 60 µL NA 60 µL

C NA NA NA NA

Storage +2°C to +8°C +2°C to +8°C +2°C to +8°C +2°C to +8°C

On-Instrument Stability 30 days 30 days 30 days 30 days

Tests per Cartridge 125 125 400 200


Start 56 sec. 600 sec. 56 sec. 600 sec.

Stop 120 sec. 664 sec. 120 sec. 664 sec.

Default Unit g/dL g/dL g/dL g/dL

Calibration Frequency 15 days 15 days 7 days 7 days

Within-lot Cal. Freq. 30 days 30 days 30 days 30 days

Analytical Range

Serum/Plasma 6–24 g/dL 0.3 g/dLb – Cal 5e 6–24 g/dL 0.3 g/dLb – Cal 5e

Urine NA NA NA NA

CSF NA NA NA NA

URDAC Range NA NA NA NA

ORDAC Range NA NA NA NA

Reference Interval

Serum/Plasma 4–6%b,f 4–6%b, 4–6%b,f 4–6%b,

Urine NA NA NA NA

CSF NA NA NA NA

Precision Specication (Use

the greater number)


Table 19.0 CartridgeChemistry HbA1c3 HbA1c-

HB3 A1C3 HB- A1C-

< 5 %HbA1c NGSP < 5 %HbA1c NGSP < 5 %HbA1c NGSP < 5 %HbA1c NGSP

< 0.4 g/dL A1c < 0.4 g/dL A1c < 0.4 g/dL A1c < 0.4 g/dL A1c

Within-run HbA1c %CV: 5.0 % Within-run HbA1c %CV: 5.0 % Within-run HbA1c %CV: 5.0 % Within-run HbA1c %CV: 5.0 %

Total HbA1c %CV: 7.5% Total HbA1c %CV: 7.5% Total HbA1c %CV: 7.5% Total HbA1c %CV: 7.5%

≥ 5 %HbA1c NGSP ≥ 5 %HbA1c NGSP ≥ 5 %HbA1c NGSP ≥ 5 %HbA1c NGSP

≥ 0.4 g/dL A1c ≥ 0.4 g/dL A1c ≥ 0.4 g/dL A1c ≥ 0.4 g/dL A1c

Within-run HbA1c %CV: 4.0% Within-run HbA1c %CV: 4.0% Within-run HbA1c %CV: 4.0% Within-run HbA1c %CV: 4.0%

Serum/Plasma

Total HbA1c %CV: 4.0% Total HbA1c %CV: 4.0% Total HbA1c %CV: 4.0% Total HbA1c %CV: 4.0%

Urine NA NA NA NA

CSF NA NA NA NA

ORDAC NA NA NA NA

Comment HbDIL required for sample

dilution

HbDIL required for sample

dilution

Requires Sample preparation. Requires Sample preparation.

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.c Hemolysate values.d NA = Not applicable.e Cal 5 Value is printed on the HbA1c calibrator value assignment sheet included in the kit.f Taken from literature, refer to Chemistry Information Sheet for source.



Chemistry HDL HDLD HPT

Methodology Homogeneous Homogeneous Immuno-Turbidimetry

Reaction Typea EP-2 EP-2 EP-2



Sample Volume

Serum/Plasma 3 µL 3 µL 12 µL (20 fold dil.)c

Urine NAb NA NA

CSF NA NA NA

URDAC NA NA 3 µL neat

ORDAC NA NA 12 µL ( 1:100 fold dil.)c


Cartridge Volume

A 210 µL 210 µL 200 µL

B 70 µL 70 µL NA

C NA NA 20 µL










Analytical Range

Serum/Plasma 5–135 mg/dL (0.13–3.50 mmol/L) 5–135 mg/dL (0.13–3.50 mmol/L) 15–300 mg/dL (150–3000 mg/L)

Urine NA NA NA

CSF NA NA NA

URDAC Range NA NA 1–25 mg/dL (10–250 mg/L)

ORDAC Range NA NA 240–1200 mg/dL (2400–12000 mg/L)

Reference Interval

Serum/Plasma See Chemistry Information Sheet See Chemistry Information Sheet 40–240 mg/dLd (400–2400 mg/L)d

Urine NA NA NA

CSF NA NA NA


Serum/Plasma 1.3mg/dL (0.03mmol/L) or 3.0% 3.0 mg/dL (0.07 mmol/L) or 3.0% 2.5 mg/dL (25 mg/L) or 4.5%

Urine NA NA NA

CSF NA NA NA

ORDAC NA NA 6.75%

Comment NA NA DIL1 required for Sample dilution.

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.c Refer to Chemistry Information Sheet for details.b NA = Not applicable.


Table 20.0 Cartridged Taken from literature, refer to Chemistry Information Sheet for source.



Chemistry IBCT Ig-A Ig-G

Methodology FerroZine Immuno-Turbidimetry Immuno-Turbidimetry




Sample Volume

Serum/Plasma 25 µL 15 µLc 15 µLc

Urine NAb NA NA

CSF NA NA NA

URDAC NA 5 µL (neat) NA

ORDAC NA 4 µL (100 fold dil.) 4 µL (100 fold dil.)c


Cartridge Volume

A 200 µL 200 µL 200 µL

B NA 30 µL 30 µL

C 10 µL NA NA







Default Unit µg/dL mg/dL mg/dL


Within-lot Cal. Freq. NA 90 days 90 days

Analytical Range

Serum/Plasma 10.0–1000 µg/dL (1.8–179.1 µmol/L) 40–700 mg/dL (0.4–7.0 g/L) 200–3200 mg/dL (2–32 g/L)

Urine NA NA NA

CSF NA NA NA

URDAC Range NA 6–50 mg/dL (0.06–0.5 g/L) NA

ORDAC Range NA 560–8000 mg/dL (5.6–80.0 g/L) 2560–12,000 mg/dL (25.6–120.0 g/L)

Reference Interval

Serum/Plasma 261–478 µg/dL (46.7–85.6 µmol/L) 66–436 mg/dL (0.7–4.4 g/L) 791–1643 mg/dL (7.9–16.4 g/L)

Urine NA NA NA

CSF NA NA NA


greater number)

Serum/Plasma 10.0 µg/dL (1.8 µmol/L) or 4.0% 5.0 mg/dL (0.05 g/L) or 5.0% 20.0 mg/dL (0.20 g/L) or 5.0%

Urine NA NA NA

CSF NA NA NA

ORDAC NA 10% 10%

Comment Requires Sample preparation. DIL1 required for Sample dilution. DIL1 required for Sample dilution.

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.c Refer to Chemistry Information Sheet for details.


Table 21.0 Cartridgeb NA = Not applicable.



Chemistry Ig-M LACT LD

Methodology Immuno-Turbidimetry Enzymatic Lactate to Pyruvate

Reaction Typea EP-2 EP-3 RATE-1


Sample Type Serum/Plasma Plasma/CSF Serum/Plasma

Sample Volume


Urine NAb NA

CSF 3 µL NA

ORDAC


NA 3 µL

Reagent Volume See Chemistry Information Sheet 300 µL 260 µL

Cartridge Volume

A NA 251 µL

B 250 µL NA

C


50 µL 9 µL



Tests per Cartridge 150 50 200 or 300




Default Unit mg/dL mmol/L IU/L



Analytical Range

Serum/Plasma 25–2400 mg/dL (0.3–24.0 g/L) 0.3–11.0 mmol/L (2.7–98.2 mg/dL)c 5–750 IU/L (0.1–12.5 µkat/L)

Urine NA NA NA

CSF NA 0.3–11.0 mmol/L (2.7–98.2 mg/dL) NA

ORDAC Range 1920–12,000 mg/dL (19.2–120.0 g/L) NA 600–2700 IU/L (10.0–45.0 µkat/L)

Reference Interval

Serum/Plasma 43–279 mg/dL (0.4–2.8 g/L) 0.5–2.2 mmol/L (4.5–19.8 mg/dL)c,d 98–192 IU/L (1.6–3.2 µkat/L)

Urine NA NA NA

CSF NA <2.8 mmol/L (<25.2 mg/dL)d NA


greater number)

Serum/Plasma 5.0 mg/dL (0.05 g/L) or 5.0% 0.13 mmol/L (1.2 mg/dL) or 3.0% 5.0 IU/L (0.08 µkat/L) or 3.5%

Urine NA NA NA

CSF NA 0.13 mmol/L (1.2 mg/dL) or 3.0% NA

ORDAC 10% NA 10%

Comment DIL1 required for Sample dilution. Sodium Fluoride and Potassium

Oxalate plasma only.

NA

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b NA = Not applicable.c Plasma values.d Taken from literature, refer to Chemistry Information Sheet for source.



Chemistry LD (IFCC) LDLD LD-P

Methodology Lactate to Pyruvate Colorimetric Pyruvate to Lactate




Sample Volume


Urine NAb NA NA

CSF NA NA NA

ORDAC 3 µL NA 3 µL


Cartridge Volume

A 251 µL 210 µL 242 µL

B NA 70 µL 8 µL

C 9 µL NA NA



Tests per Cartridge 200 or 300 100 200




Default Unit IU/L mg/dL IU/L



Analytical Range

Serum/Plasma 5–750 IU/L (0.1–12.5 µkat/L) 10–550 mg/dL (0.26–14.2 mmol/L) 20–2500 IU/L (0.3–41.7 µkat/L)

Urine NA NA NA

CSF NA NA NA

ORDAC Range 600–2700 IU/L (10.0–45.0 µkat/L) NA 1800–3800 IU/L (30.0–63.3 µkat/L)

Reference Interval

Serum/Plasma 248 IU/L (4.13 µkat/L)c See Chemistry Information Sheet 266–500 IU/L (4.4–8.3 µkat/L)

Urine NA NA NA

CSF NA NA NA


greater number)

Serum/Plasma 5.0 IU/L (0.08 µkat/L) or 3.5% 2 mg/dL (0.05 mmol/L) or 2.0% 15.0 IU/L (0.25 µkat/L) or 3.5%

Urine NA NA NA

CSF NA NA NA

ORDAC 10% NA 10%

Comment Calibration required. NA NA




Chemistry LIP MA

Methodology Enzymatic Immuno-Turbidimetry

Reaction Typea RATE-2 EP-2


Sample Type Serum/Plasma Urine

Sample Volume

Serum/Plasma 4 µL NA

Urine NAb 10 µL

CSF NA NA

ORDAC 2 µL 3 µL


Cartridge Volume

A 660 µL (wash) 215 µL

B 167 µL 25 µL

C 50 µL NA







Default Unit U/L mg/dL



Analytical Range

Serum/Plasma 10–200 U/L (0.17–3.40 µkat/L) NA

Urine NA 0.2–30 mg/dL (2–300 mg/L)

CSF NA NA

ORDAC Range 180–400 U/L (3.06–6.80 µkat/L) 24–97 mg/dL (240–970 mg/L)

Reference Interval

Serum/Plasma 22–51 U/L (0.36–0.85 µkat/L) NA

Urine NA See Chemistry Information Sheet

CSF NA NA


Serum/Plasma 7.0 U/L (0.12 µkat/L) or 7% NA

Urine NA 0.125 mg/dL (1.25 mg/L) or 5.4%

CSF NA NA

ORDAC 10% 5.4%

Comment NA NA




Chemistry METD METQ MG

Methodology EIA EIA Calmagite



Sample Type Urine Urine Serum/Plasma/Urine

Sample Volume

Serum/Plasma NAb NA 3 µL

Urine 10 µL 10 µL 3 µL (10 fold dil.)c

CSF NA NA NA

ORDAC NA NA NA


Cartridge Volume

A 200 µL 200 µL 280 µL

B 50 µL 50 µL 28 µL

C NA NA NA

Storage +2°C to +8°C +2°C to +8°C Room Temperature






Default Unit mAbs/min mAbs/min mg/dL



Analytical Range

Serum/Plasma NA NA 0.1–7.0 mg/dL (0.04–2.88 mmol/L)

Urine NA NA 1.0–70.0 mg/dL (0.4–28.8 mmol/L)

CSF NA NA NA


Reference Interval

Serum/Plasma NA NA 1.8–2.5 mg/dL (0.74–1.03 mmol/L)

Urine NA NA 72.9–121.5 mg/24 hrs. (3.00–5.00

mmol/24 hrs.)d

CSF NA NA NA


greater number)

Serum/Plasma NA NA 0.11 mg/dL (0.04 mmol/L) or 2.5%

Urine 2.0% 2.0% 0.8 mg/dL (0.3 mmol/L) or 3.0%

CSF NA NA NA

ORDAC NA NA NA

Comment Qualitative Pos/Neg Qualitative Pos/Neg Urine Samples require DIL1.

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b NA = Not applicable.c Reaction volume, actual sample volume required differs due to on-board dilution. Refer to Chemistry Information Sheet for details.d Taken from literature, refer to Chemistry Information Sheet for source.



Chemistry M-TP OP OP2

Methodology Pyrogallol Red EIA EIA



Sample Type CSF/Urine Urine Urine

Sample Volume

Serum/Plasma NAb NA NA


CSF 5 µL NA NA

ORDAC NA NA NA


Cartridge Volume

A NA 200 µL 200 µL

B 300 µL 50 µL 50 µL

C NA NA NA







Default Unit mg/dL mAbs/min mAbs/min



Analytical Range

Serum/Plasma NA NA NA

Urine 6–150 mg/dL (0.06–1.50 g/L) NA NA

CSF 6–300 mg/dL (0.06–3.00 g/L) NA NA


Reference Interval


Urine 1–14 mg/dL (0.01–0.14 g/L)c NA NA

CSF 15–45 mg/dL (0.15–0.45 g/L)c NA NA


greater number)


Urine 2 mg/dL (0.02 g/L) or 4.0% 2.0% 2.0%

CSF 2 mg/dL (0.02 g/L) or 4.0% NA NA

ORDAC NA NA NA

Comment NA Qualitative, POS/NEG Qualitative, POS/NEG




Chemistry PAB PAM PCP

Methodology Immuno-Turbidimetry Immuno-Inhibition EPS-Substrate EIA



Sample Type Serum/Plasma Serum/Plasma/Urine Urine

Sample Volume

Serum/Plasma 3 µL 10 µL NA

Urine NAb 10 µL 20 µL

CSF NA NA NA

ORDAC NA 3 µL NA


Cartridge Volume

A 200 µL NA 200 µL

B NA 200 µL 50 µL

C 10 µL 40 µL NA







Default Unit mg/dL U/L mAbs/min



Analytical Range

Serum/Plasma 2–60 mg/dL (20–600 mg/L) 7–600 U/L (0.12–10 µkat/L) NA

Urine NA 7–600 U/L (0.12–10 µkat/L) NA

CSF NA NA NA

ORDAC Range NA 480–1800 U/L (8–30 µkat/L) NA

Reference Interval

Serum/Plasma See Chemistry Information Sheet 0–46 U/L (0–0.8 µkat/L) NA

Urine NA < 320 U/L (< 5.3 µkat/L) NA

CSF NA NA NA


greater number)

Serum/Plasma 0.92 mg/dL (9.2 mg/L) or 5.25% 5.0 U/L (0.08 µkat/L) or 3.5% NA

Urine NA 5.0 U/L (0.08 µkat/L) or 3.5% NA

CSF NA NA NA

ORDAC NA 10% 2.0%

Comment NA NA Qualitative Pos/Neg




Chemistry PHE PHS PHY

Methodology Immuno-Turbidimetry Phospho-Molybdate Immuno-Turbidimetry



Sample Type Serum/Plasma Serum/Plasma/Urine Serum/Plasma

Sample Volume


Urine NAb 4 µL (10 fold)c NA

CSF NA NA NA

ORDAC NA NA NA


Cartridge Volume

A 210 µL 243 µL 230 µL

B 55 µL 24 µL 40 µL

C 30 µL NA 32 µL

Storage +2°C to +8°C Room Temperature +2°C to +8°C






Default Unit µg/mL mg/dL µg/mL



Analytical Range

Serum/Plasma 5.0–80.0 µg/mL (21.5–345.0 µmol/L) 1–12 mg/dL 2.5–40.0 µg/mL (9.9–158.4 µmol/L)

Urine NA 10–120 mg/dL NA

CSF NA NA NA


Reference Interval

Serum/Plasma See Chemistry Information Sheet 2.5–4.6 mg/dL (0.81–1.49 mmol/L) See Chemistry Information Sheet

Urine NA 0.4–1.3 g/24 hrs. (12.9–42 mmol/24

hrs.)

NA

CSF NA NA NA


greater number)

Serum/Plasma 1.0 µg/mL (4.3 µmol/L) or 4.0% 0.2 mg/dL or 2.0% 0.5 µg/mL (2.0 µmol/L) or 4.0%

Urine NA 2.0 mg/dL or 2.0% NA

CSF NA NA NA

ORDAC NA NA NA

Comment NA Urine Samples require DIL1. NA

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b NA = Not applicable.c Reaction volume, actual sample volume required differs due to on-board dilution. Refer to Chemistry Information Sheet for details.



Chemistry PROX SALY

Methodology EIA Enzymatic (Salicylate Hydroxylase)



Sample Type Urine Serum/Plasma

Sample Volume

Serum/Plasma NAb 4 µL

Urine 10 µL NA

CSF NA NA

ORDAC NA NA


Cartridge Volume

A 200 µL NA

B 50 µL 150 µL

C NA 75 µL







Default Unit mAbs/min mg/dL



Analytical Range

Serum/Plasma NA 4.0–100 mg/dL (0.3–7.2 mmol/L)

Urine NA NA

CSF NA NA

ORDAC Range NA NA

Reference Interval

Serum/Plasma NA See Chemistry Information Sheet

Urine NA NA

CSF NA NA


Serum/Plasma NA 1.5 mg/dL (0.09 mmol/L) or 5.0%

Urine 2.0%% NA

CSF NA NA

ORDAC NA NA

Comment Qualitative, POS/NEG Calibrator is included in Reagent kit.




Chemistry TBIL TG TG-B

Methodology Jendrassik-Grof Enzymatic (GPO-Trinder) Enzymatic (GPO-Trinder)

Glycerol Blanked




Sample Volume


Urine NAb NA NA

CSF NA NA NA

ORDAC NA NA NA


Cartridge Volume

A 255 µL 285 µL 275 µL

B 25 µL 15 µL 15 µL

C NA NA 10 µL

Storage Room Temperature +2°C to +8°C +2°C to +8°C


Tests per Cartridge 300 or 400 300 300







Analytical Range

Serum/Plasma 0.1–30 mg/dL (1.7–513.0 µmol/L) 10–1000 mg/dL (0.1–11.3 mmol/L) 10–1000 mg/dL (0.1–11.3 mmol/L)

Urine NA NA NA

CSF NA NA NA


Reference Interval

Serum/Plasma 0.3–1.2 mg/dL (5.1–20.5 µmol/L) See Chemistry Information Sheet See Chemistry Information Sheet

Urine NA NA NA

CSF NA NA NA


greater number)

Serum/Plasma 0.15 mg/dL (2.6 µmol/L) or 3.0% 5.0 mg/dL (0.1 mmol/L) or 3.0% 5.0 mg/dL (0.1 mmol/L) or 3.0%

Urine NA NA NA

CSF NA NA NA

ORDAC NA NA NA

Comment Mix 0.1 mL of C into B (for 300 tests) Mix C into A. NA

Mix 0.2 mL of C into B (for 400 tests)




Chemistry THC THC2 THC5

Methodology EIA EIA EIA



Sample Type Urine Urine Urine

Sample Volume

Serum/Plasma NAb NA NA


CSF NA NA NA

ORDAC NA NA NA


Cartridge Volume

A 200 µL 200 µL 200 µL

B 50 µL 50 µL 50 µL

C NA NA NA







Default Unit ,Abs/min mAbs/min mAbs/min



Analytical Range


Urine NA NA NA

CSF NA NA NA


Reference Interval


Urine NA NA NA

CSF NA NA NA


greater number)


Urine 2.0% 2.0% 2.0%

CSF NA NA NA

ORDAC NA NA NA

Comment Qualitative, POS/NEG Qualitative, POS/NEG Qualitative, POS/NEG




Chemistry THE TOB TP

Methodology Immuno-Turbidimetry Immuno-Turbidimetry Biuret




Sample Volume


Urine NAb NA NA

CSF NA NA NA

ORDAC NA NA NA


Cartridge Volume

A 230 µL 200 µL 300 µL

B 30 µL 40 µL NA

C 32 µL 30 µL NA

Storage +2°C to +8°C +2°C to +8°C Room Temperature






Default Unit µg/mL µg/mL g/dL



Analytical Range

Serum/Plasma 2.0–40.0 µg/mL (11.1–222.0 µmol/L) 0.5–12.0 µg/mL (1.1–25.7 µmol/L) 3 g/dL–12 g/dL (30–120 g/L)

Urine NA NA NA

CSF NA NA NA


Reference Interval

Serum/Plasma See Chemistry Information Sheet See Chemistry Information Sheet Adult ambulatory 6.4–8.3 g/dL (64–83

g/L)

Urine NA NA NA

CSF NA NA NA


greater number)

Serum/Plasma 0.5 µg/mL (2.8 µmol/L) or 4.0% 0.2 µg/mL (0.4 µmol/L) or 4.0% 0.3 g/dL (3.0 g/L) or 3.0%

Urine NA NA NA

CSF NA NA NA

ORDAC NA NA NA

Comment NA NA Run at 37°C only.




Chemistry TRFN

Methodology Immuno-Turbidimetry

Reaction Typea EP-2

Analytical Wavelength 340 nm

Sample Type Serum/Plasma

Sample Volume

Serum/Plasma 15 µLb

Urine NAc

CSF NA

ORDAC NA

Reagent Volume 225 µL

Cartridge Volume

A 200 µL

B 25 µL

C NA

Storage +2°C to +8°C

On-Instrument Stability 60 days

Tests per Cartridge 150


Start 432 sec.

Stop 480 sec.

Default Unit mg/dL

Calibration Frequency 14 days

Within-lot Cal. Freq. 90 days

Analytical Range

Serum/Plasma 70–850 mg/dL (0.7–8.5 g/L)

Urine NA

CSF NA

ORDAC Range NA

Reference Interval

M 180–329 mg/dL (1.8–3.3 g/L)Serum/Plasma

F 192–282 mg/dL (1.9–2.8 g/L)

Urine NA

CSF NA


Serum/Plasma 5.0 mg/dL (0.05 g/L) or 5.0%

Urine NA

CSF NA

ORDAC NA

Comment DIL1 required for Sample dilution.

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b Refer to Chemistry Information Sheet for details.c NA = Not applicable.



Chemistry UREA URIC

Methodology Enzymatic Enzymatic Trinder



Sample Type Serum/Plasma/Urine Serum/Plasma/Urine

Sample Volume


Urine 3 µL (10 fold dil.)b 12 µL (10 fold dil.)c

CSF NAd NA

ORDAC NA 6 µL


Cartridge Volume

A 285 µL 270 µL

B 15 µL 30 µL

C NA NA





Start 32 sec. 192 sec. (DxC system)

Stop 64 sec. 280 sec. (DxC system)

Default Unit mmol/L mg/dL

Calibration Frequency 24 hours 14 days


Analytical Range

Serum/Plasma 1.8–35.7 mmol/L (10.7–213.8 mg/dL) 0.5–12.0 mg/dL (30–714 µmol/L)

Urine 17.9–357.0 mmol/L (107.2–2138.4 mg/dL) 5.0–120.0 mg/dL (300–7140 µmol/L)

CSF NA NA

ORDAC Range NA 9–21 mg/dL (536–1250 µmol/L)

Reference Interval

M 4.8–8.7 mg/dL (286–518 µmol/L)Serum/Plasma 2.9–9.3 mmol/L (17.4–55.8 mg/dL)

F 2.6–8.0 mg/dL (155–476 µmol/L)

Urine 0.43–0.71 mol/24 hrs. (26–43 g/24 hrs.)c 250–750 mg/24 hrs. (1.48–4.43 mmol/24 hrs.)c

CSF NA NA


Serum/Plasma 0.7 mmol/L (4.3 mg/dL) or 3.0% 0.15 mg/dL (9.0 µmol/L) or 2.0%

Urine 1.1 mmol/L (6.6 mg/dL) or 3.0% 1.0 mg/dL (60.0 µmol/L) or 3.0%

CSF NA NA

ORDAC NA 10%

Comment Urine Samples require DIL1. Urine Samples require DIL1.

a 1 = Reagent blank not subtracted during calculation of result. 2 = Reagent blank subtracted during calculation of result.b Reaction volume, actual sample volume required differs due to on-board dilution. Refer to Chemistry Information Sheet for details.c Taken from literature, refer to Chemistry Information Sheet for source.d NA = Not applicable.



Chemistry VANC VPA

Methodology Immuno-Turbidimetry Immuno-Turbidimetry

Reaction Typea RATE-1 RATE-1


Sample Type Serum/Plasma Serum/Plasma

Sample Volume


Urine NAb NA

CSF NA NA

ORDAC 2 µL NA


Cartridge Volume

A 230 µL 287 µL

B 50 µL NA

C 32 µL 25 µL







Default Unit µg/mL µg/mL



Analytical Range

Serum/Plasma 3.5–40 µg/mL (2.4–27.6 µmol/L) 10.0–150.0 µg/mL (69–1040 µmol/L)

Urine NA NA

CSF NA NA

ORDAC Range 30–60 µg/mL (20.7–41.4 µmol/L) NA

Reference Interval

Serum/Plasma See Chemistry Information Sheet See Chemistry Information Sheet

Urine NA NA

CSF NA NA


Serum/Plasma 1.3 µg/mL (0.9 µmol/L) or 4.0% 3.6 µg/mL (25.0 µmol/L) or 6.0%

Urine NA NA

CSF NA NA

ORDAC NA NA

Comment Mix cartridge well before placing on instrument. Mix cartridge well before placing on instrument.



Chemistry SuppliesTable 1.0 Cartridge Reagents

Reagent Part Number Number of Tests Use Storage Temp.On-InsturmentStability Prep?

ACTM 472169 1 × 100 Acetaminophen +2 to +8°C 42 days No

ALB 442765 2 × 300 Albumin +2 to +8°C 30 days No

442670 2 × 200ALP

476821 2 × 400

Alkaline

Phosphatase

+2 to +8°C 10 days No

442670 2 × 200ALP (IFCC/DGKCh)

476821 2 × 400

Alkaline

Phosphatase


442620 2 × 200ALT

476826 2 × 400

Alanine

Aminotransferase

+2 to +8°C 30 days Yes

467840 2 × 300ALT-

467848 2 × 100

Alanine

Aminotransferase


AMM 439770 2 × 25 Ammonia +2 to +8°C 30 days No

AMPH 475000 1 × 250 Amphetamines +2 to +8°C 90 days No

AMY7 A71607 2 × 200 G7 Amylase +2 to +8°C 21 days No

ApoA 467900 2 × 100 Apolipoprotein A-1 +2 to +8°C 30 days No

ApoB 467905 2 × 100 Apolipoprotein B +2 to +8°C 30 days No

ASO- 469165 2 × 100 Antistreptolysin-O +2 to +8°C 60 days No

442665 2 × 200AST

476831 2 × 400

Aspartate

Aminotransferase


467845 2 × 300AST-

467849 2 × 100

Aspartate

Aminotransferase


BARB 475012 1 × 250 Barbiturates +2 to +8°C 90 days No

BNZG A18298‘ 1 × 250 Benzodiazepine +2 to +8°C 60 days No

BUN 442750 2 × 300 Urea Nitrogen +2 to +8°C 30 days No

C3 988462 2 × 100 Complement C3 +2 to +8°C 60 days No

C4 988471 2 × 100 Complement C4 +2 to +8°C 60 days No

CAR 469112 2 × 100 Carbamazepine +2 to +8°C 42 days No

CCWA 657133 2 × 300 Wash CC Sample

probe, reagent

probes, mixers and

cuvettes

Room Temperature 4 months No

CHOL 467825 2 × 300 Cholesterol +2 to +8°C 30 days No

442635 2 × 200CK

476836 2 × 400

Creatine Kinase +2 to +8°C 30 days Yes

CK- 467830 2 × 200 Creatine Kinase +2 to +8°C 21 days Yes

CO2E A60290 2 × 300 Enzymatic Carbon

Dioxide


COCM 475003 1 × 250 Cocaine Metabolite +2 to +8°C 90 days No

CRP 465131 2 × 200 C-Reactive Protein +2 to +8°C 60 days No

C-RP 969620 2 × 200 C-Reactive Protein +2 to +8°C 60 days No

A45586 AP Chemistry SuppliesDECEMBER 2016 Page 1 of 4

Table 1.0 Cartridge Reagents


CRPH (Cardiac) 378020 2 × 200 High Sensitivity

C-Reative Protein


CR-E A60298 2 × 200 Enzymatic

Creatinine


CR-S A40920 2 × 300 Creatinine

Standardized

Room Temperature 15 days Yes

439715 2 × 200DBIL

476856 2 × 300

Direct Bilirubin Room Temperature 30 days No

DIGN 650182 2 × 100 Digoxin +2 to +8°C 30 days No

ETOH 474947 2 × 150 Ethyl Alcohol +2 to +8°C 60 days No

FE 467910 2 × 200 Iron +2 to +8°C 60 days No

GEN 469137 2 × 100 Gentamicin +2 to +8°C 42 days No

442650 2 × 200GGT

476846 2 × 400

γ-Glutamyl

Transferase


442650 2 × 200GGT (IFCC)

476846 2 × 400

γ-Glutamyl

Transferase


GLUH B24985 2 × 300 Glucose +2 to +8°C 30 days No

Hb-: 1 × 400 Hb-: 30 daysHbA1c- A87905

A1c-: 2 × 200

Hemoglobin A1c +2 to +8°C

A1c: 30 days

No

Hb3:2 x 125 Hb3: 30 daysHbA1c3 B36415

A1c3:2 x 125

Hemoglobin A1c +2 to +8°C

A1c3: 30 days

No

HDLD 650207 2 × 200 HDL Cholesterol +2 to +8°C 60 days No

HDL A15625 2 × 200 HDL Cholesterol +2 to +8°C 60 days No

HPT 988413 2 × 100 Haptoglobin +2 to +8°C 60 days No

IBCT 465970 2 × 100 Total Iron-Binding

Capacity


Ig-A 467920 2 × 150 Immunoglobulin A +2 to +8°C 60 days No

Ig-G 467925 2 × 150 Immunoglobulin G +2 to +8°C 60 days No

Ig-M 467930 2 × 150 Immunoglobulin M +2 to +8°C 60 days No

LACT A95550 2 × 50 Lactate +2 to +8°C 30 days No

442655 2 × 200LD

476841 2 × 300

Lactate

Dehydrogenase


442655 2 × 200LD (IFCC)

476841 2 × 300

Lactate

Dehydrogenas


LDLD 969706 2 × 200 Direct LDL

Cholesterol


LD-P 442660 2 × 200 Lactate

Dehydrogenase


North America:

A19611

LI (Manufactured by

Thermo Electron,

Noble Park, Victoria,

Australia)Int’l: A20238

2 × 65 Lithium +2 to +8°C 14 days Yes

LIP 476851 2 × 60 Lipase +2 to +8°C 21 days No

Chemistry Supplies A45586 APPage 2 of 4 DECEMBER 2016

Table 1.0 Cartridge Reagents


MA 475100 2 × 100 Microalbumin +2 to +8°C 60 days No

METD 475018 1 × 250 Methadone +2 to +8°C 90 days No

METQ 475021 1 × 250 Methaqualone +2 to +8°C 90 days No

MG 445360 2 × 100 Magnesium Room Temperature 7 days No

M-TP 445860 2 × 50 Microprotein +2 to +8°C 30 days No

OP 475024 1 × 250 Opiate +2 to +8°C 90 days No

OP2 475006 1 × 250 Opiates (2000 ng) +2 to +8°C 90 days No

PAB 475106 2 × 100 Prealbumin +2 to +8°C 60 days No

PAM 969650 2 × 60 Pancreatic Amylase +2 to +8°C 30 days No

PCP 475009 1 × 250 Phencyclidine +2 to +8°C 90 days No

PHE 469785 2 × 100 Phenobarbitol +2 to +8°C 42 days No

PHS A09426 2 × 300 Phosphorus Room Temperature 30 days No

PHY 469188 2 × 100 Phenytoin +2 to +8°C 42 days No

PROX 475027 1 × 250 Propoxyphene +2 to +8°C 90 days No

SALY 378194 2 × 45 Salicylate +2 to +8°C 60 days No

442745 2 × 300TBIL

476861 2 × 400

Total Bilirubin Room Temperature 30 days Yes

TG 445850 2 × 300 Triglycerides +2 to +8°C 30 days Yes

TG-B 445850 2 × 300 Triglycerides

Blanked


THC 445990 1 × 150 Cannabinoid (100

ng)


THC2 445824 1 × 150 Cannabinoid (20 ng) +2 to +8°C 60 days No

THC5 475030 1 × 250 Cannabinoid (50 ng) +2 to +8°C 90 days No

THE 469126 2 × 100 Theophylline +2 to +8°C 42 days No

TOB 467983 2 × 100 Tobramycin +2 to +8°C 42 days No

TP 442740 2 × 300 Total Protein Room Temperature 20 days Yes

TRFN 467942 2 × 150 Transferrrin +2 to +8°C 60 days No

UREA 442820 2 × 300 Urea +2 to +8°C 30 days No

URIC 442785 2 × 300 Uric Acid +2 to +8°C 30 days No

VANC 474824 2 × 100 Vancomycin +2 to +8°C 42 days No

VPA 467995 2 × 100 Valproic Acid +2 to +8°C 42 days No

A45586 AP Chemistry SuppliesDECEMBER 2016 Page 3 of 4


Reagent Part Number Volume Use Storage Temp.On-InstrumentStability Prep?

ALBm 467858 2 × 2L Albumin Room Temperature 60 days No

BUNm/UREAm 472842 2 × 2L Urea Nitrogen +2 to +8°C 15 days Yes

CREm 472525 2 × 2L Creatinine Room Temperature 30 days Yes

GLUCm 472500 2 × 2L Glucose +2 to +8°C 30 days No

PHOSm 467868 2 × 2L Phosphorus Room Temperature 30 days Yes

TPm 465986 2 × 2L Total Protein Room Temperature 60 days No

ISE Electrolyte

Buffer

A28945 2 × 2L Electrolytes (NA, K,

CL, CO2, CALC)

Room Temperature 30 days No

ISE Electrolyte

Reference

A28937 2 × 2L Electrolytes (NA, K,

CL, CO2, CALC)


CO2 Acid 472481 2 × 2L CO2 Room Temperature 30 days No

CO2 Alkaline Buffer 472515 500 mL CO2 Room Temperature 30 days No

Chemistry Supplies A45586 APPage 4 of 4 DECEMBER 2016

CALIBRATION INFORMATIONTable 1.0 Calibrators

Calibrator Part Number UseOpen Bottle StorageTemp. Open Bottle Stability Prep?

Synchron AQUA CAL

Level 1 471288 NA, K, CL, CO2, CO2E,

CALC, CR-E, CR-S,

BUNm, UREAm, CREm,

GLUCm, GLUH, PHOSm

Level 2 471291 NA, K, CL, CO2,

CALC, CR-E, CR-S,

BUNm, UREAm, CREm,

GLUCm, PHOSm

Level 3 471294 NA, K, CL, CO2, CO2E,

CALC, BUNm, UREAm,

CREm, GLUCm, GLUH,

PHOSm


SynchronMulti Calibrator 442600 Multianalyte +2 to +8°C 20 days No

Synchron Drug Cal 1 469600 CAR, PHE, PHY, THE,

VPA

+2 to +8°C Expiration date No

Synchron Systems Drug

Cal 2

469630 ACTM, DIGN +2 to +8°C Expiration date No

Synchron Drug Cal 3

Plus

471080 TOB, GEN +2 to +8°C Expiration date No

Synchron Cal 1 468405 C3, C4, HPT, Ig-A, Ig-G,

Ig-M, TRFN


Synchron APO Cal 469170 ApoA, ApoB +2 to +8°C 90 days No

Synchron CAL 5 Plus 469965 ASO-, CRP, C-RP, CRPH +2 to +8°C Expiration date No

Synchron Systems

Ammonia Calibrator

439770 (Reagent Kit) AMM +2 to +8°C 60 days No

Synchron Systems

Bilirubin Calibrator

465915 DBIL, TBIL +2 to +8°C 24 hours No

Synchron Systems DAT

Negative Urine Calibrator

445803 AMPH, BARB, BNZG,

COCM, METD, METQ,

OP, OP2, PCP, PROX,

THC, THC2, THC5


Synchron Systems

ETOH Calibrator

474994 ETOH +2 to +8°C Expiration date No

Synchron Systems PAB

Calibrator

475081 PAB +2 to +8°C Expiration date No

Synchron SystemsDAT Multi-Drug UrineCalibrator

Low 474970 AMPH, COCM, OP2,

PCP, BARB, BNZG,

METD, METQ, PROX

High 474973 AMPH, COCM, OP2,

PCP, BARB, BNZG,

METD, METQ, PROX


A45586 AP CALIBRATION INFORMATIONDECEMBER 2016 Page 1 of 2

Table 1.0 Calibrators

Calibrator Part Number UseOpen Bottle StorageTemp. Open Bottle Stability Prep?

Synchron Systems

FE/IBCT Calibrator

442772 FE, IBCT Room Temperature Expiration date No

+15 to +25°C 8 hours


Synchron Systems

HbA1c- Calibrator

A87905 (Reagent Kit) HB-, A1C-

-15 to -20°C 60 days

Yes



Synchron Systems

HbA1c3 Calibrator

B36415 (Reagent Kit) HB3, A1C3

-15 to -20°C 60 days

Yes

Synchron Systems HDL

Calibrator

B23634 HDL +2 to +8°C 14 days

≤ -20°C 30 days

Refer to Chemistry

Information Sheet

+2 to +8°C 14 daysSynchron Systems LDLD

Calibrators

969706 (Reagent Kit) LDLD

-80°C 30 days

Refer to Chemistry

Information Sheet

Synchron Systems Lipid

Calibrators Level 1 and 2

650218 HDLD +2 to +8°C 60 days No

Synchron Systems

Microprotein Calibrator

445930 M-TP +2 to +8°C 60 days No

Synchron Systems OP300 Urine Calibrator

Low 474982 OP

High 474985 OP


Synchron Systems

Protein Calibrator

450202 ALBm, TPm +2 to +8°C 60 days No

Synchron Systems

Salicylate Calibrator

378194 (Reagent Kit) SALY +2 to +8°C 30 days No

Synchron SystemsTHC Urine Calibrator

20 ng/mL 464390 THC2

50 ng/mL 445809 THC2, THC5

100 ng/mL 445811 THC, THC5

200 ng/mL 445814 THC


Synchron Systems

Vancomycin Calibrator

Set

378045 VANC +2 to +8°C Expiration date No

Synchron Enzyme

Validator Set

441350 ALP, ALT-, AMY, AST-,

CK-, GGT, LD, LIP

-15 to -20°C 60 days No

Synchron systems MA

Calibrator

475089 MA +2 to +8°C Expiration date No

CALIBRATION INFORMATION A45586 APPage 2 of 2 DECEMBER 2016

CONTROL INFORMATIONTable 1.0 CONTROL INFORMATION

Controls Part Number UseOpen Bottle StorageTemp. Open Bottle Stability Prep?

Synchron Systems

Ammonia/Alcohol

Control

Level 1 465990 AMM, ETOH





Drug Free Urine Control

469945 AMPH, COCM, OP, OP2,

PCP, BARB, BNZG,

METD, METQ, PROX,

THC, THC2, THC5



Multi-Drug Urine Control

Low 474976 AMPH, COCM, OP2,

PCP, BARB, BNZG,

METD, METQ, PROX

High 474979 AMPH, COCM, OP2,

PCP, BARB, BNZG,

METD, METQ, PROX


Synchron Systems OP

300 Urine Control

Low 474988 OP

High 474991 OP


Synchron Systems THC

Urine Control

10 ng/mL 472107 THC2

20 ng/mL 465914 THC5

40 ng/mL 472110 THC2

75 ng/mL 465912 THC, THC5

125 ng/mL 465939 THC


Synchron Control Level

1,2,3

657365 Multianalyte +2 to +8°C 20 days No

Ultimate-D Control

Level 1 667710 DBIL, TBIL





Urine Protein Control

Level 1 465290 MA

Level 2 465300 MA


Vigil Serology Control

A45586 AP CONTROL INFORMATIONDECEMBER 2016 Page 1 of 2

Table 1.0 CONTROL INFORMATION

Controls Part Number UseOpen Bottle StorageTemp. Open Bottle Stability Prep?

Level 1 450162 ASO-, CRP, C-RP, CRPH


No


Level C 465440 CRPH

+2 to +8°C 60 days

No

Vigil Protein Control

Level 1 450120 ALBm, C3, C4, HPT, IgA,

IgG, IgM, PAB, TPm,

TRFN


IgG, IgM, PAB, TPm,

TRFN


IgG, IgM, PAB, TPm,

TRFN


Vigil HbA1c Controls

Hb-, A1c-, Hb3, A1c3 +2 to +8°Ca 1 week


Level 1, 2 650038

Note: Sample type

"OTHER" should be

used when running with

Hb3 and A1c3.

-15 to -25°C 3 months

Yes

Vigil Lipid Control

Level 1 469905 ApoA, ApoB, CHOL,

HDL, HDLD, TG, TG-B


HDL, HDLD, TG, TG-B

Level 3 465981 ApoA, ApoB, CHOL, TG,

TG-B


HDL, HDLD, TG, TG-B


Vigil TDM Control

Level 1 472461 ACTM, CAR, DIGN,

GEN, PHE, PHY, SALY,

THE, TOB, VPA



THE, TOB, VPA



THE, TOB, VPA


a Sample type "OTHER" should be used when running with Hb3 and A1c3.

CONTROL INFORMATION A45586 APPage 2 of 2 DECEMBER 2016

SOLUTION INFORMATIONTable 1.0 Solutions

Solutions Part Number Use Storage Temp.Open ConainerStability Prep?

Antifoam C (25 mL) 445967 Add to Creatinine

reagent (CR-S) to

impede foaming

+8 to +30°C N/A No

CCWA 657133 Wash cc sample probe,

reagent probes, mixers

and cuvettes

Room Temperature 4 months No

Clenz (6 x 2.5 mL) 664090 ISE ow cell cleaning +2 to 8°C (may be stored

at +20 to +25°C after

opening)

45 days No

CTS AUTO-GLOSS 657197 Lubricate cap pierce

cutting blades

+2 to +30°C N/A No

DIL1 467826 Serum Index,

On-board dilution

(immunoproteins, urines)


HbDIL A88469 Diluent for HbA1c3

on-line sample

preparation


469110NO FOAM

B64130

Waste Treatment Room Temperature Expiration date No

PVT2 442831 Performance Verication

Testing

Room Temperature N/A No


Testing



Testing


Sodium Chloride (500

mL) 0.90% w/v

A93901 ISE ow cell cleaning

and for sample dilution

Room Temperature Until expiration date if

stored properly

No

Sodium Hypochlorite

(500 mL)

A32319 ISE ow cell cleaning Room Temperature Until expiration date if

stored properly

No

Synchron and AU

Systems Hemolyzing

Reagent

472137 Diluent for HbA1c

sample preparation


Wash Concentrate II 445865 Wash cuvettes, rinse

probes and mixers

Room Temperature Expiration date No

A45586 AP SOLUTION INFORMATIONDECEMBER 2016 Page 1 of 1

Serum IndexPRINCIPLE

INTENDED USE

The serum index function, in conjunction with Synchron SystemsDIL1, is intended for the semi-quantitative determinationof sample condition in terms of icterus (bilirubin), hemolysis (hemoglobin), and lipemia in serum or plasma on SynchronSystems. Serum index is not intended to be used to diagnose a patient, but to indicate the condition of a test sample.

CLINICAL SIGNIFICANCE

Bilirubin, hemoglobin, and/or lipemia may act as an interferent depending upon an analyte being measured. Refer toindividual chemistry information sheets in this manual for more information on interferences affecting specic analytes.

METHODOLOGY

DIL1 buffer is used to measure the serum indices by a spectrophotometric method.

A precise volume of sample (14 microliters) is injected in a cuvette containing 200 microliters of buffer. The ratio used isone part sample to 14.3 parts reagent. The system monitors the absorbance at 340, 410, 470, 600, and 670 nanometersand solves a set of equations to determine the response for each index. The response is directly proportional to thesample condition in terms of icterus (bilirubin), hemolysis (hemoglobin), and lipemia.

SPECIMEN• Biological uid samples should be collected in the same manner routinely used for any laboratory test. Freshly drawn

serum or plasma are the preferred specimens.

• Tubes of blood should be kept closed at all times in a vertical, stopper-up position. Serum or plasma should bephysically separated from contact with cells as soon as possible. A maximum limit of two hours from the time ofcollection is recommended.

• Separated serum or plasma should not remain at +15°C to +30°C longer than 8 hours. If assays are not completedwithin 8 hours, serum or plasma should be stored at +2°C to +8°C. If assays are not completed within 48 hours, orthe separated sample is to be stored beyond 48 hours, samples should be frozen at -15°C to -20°C. Frozen samplesshould be thawed only once. Analyte deterioration may occur in samples that are repeatedly frozen and thawed.

• Sample discoloration can interfere with photometric tests. The users of these test systems should evaluate the samplequality and identify potentially interfering substances in these samples. This evaluation is normally done by visualassessment.

• Refer to individual chemistry information sheets for information on specimen requirements affecting specic analytes.

• Treated samples (e.g., after reagent treatment and centrifugation or column preparation) do not represent the originalspecimen condition for serum index.

REAGENTS

REAGENT REQUIREDSynchron Systems DIL1Kit Reorder #467826

CONTENTSEach kit contains two cartridges of DIL1.

Note: The number of tests available varies depending on the number of urine samples, serum index and immunoproteinassays in proportion to the total samples processed.

VOLUMES PER TESTSample Volume: 14 µL

A45586 AP Serum IndexDECEMBER 2016 Page 1 of 7

Reagent Volume: 200 µL

REAGENT PREPARATIONNo preparation is required.

STORAGE AND STABILITY

DIL1 stored unopened at room temperature is stable until the expiration date indicated on each cartridge. Once opened,DIL1 is stable for 60 days on instrument or until the expiration date, if sooner.

SYSTEM INFORMATION

CALIBRATION

Calibration is not required.

TESTING PROCEDURE1. If necessary, load the reagent onto the system.

2. With the serum index function enabled, program samples for analysis.

3. After loading samples onto the system, follow the protocols for system operation.

LIMITATIONS1. Sulfasalazine interferes with this methodology. Samples containing sulfasalazine should not be used.

2. The integrity of all indices should be veried if any of the indices are suppressed OIR HI.

3. Results for samples containing rare Ig-M immunocomplexes may be suppressed with RX RATE HI and INIT RATEHI messages.

4. Fluorescein interferes with this methodology. Samples containing uorescein should not be used.

INTERFERENCES

Table 1.0 Bilirubin Index Interferences

Level Tested SOURCE Level Tested Observed Effect

Hemoglobin RBC Hemolysate 500 mg/dL NSIa

Lipemia Intralipid 400 mg/dL NSI

a NSI = No Signicant Interference (within ± 1 unit).

Table 2.0 Hemoglobin Index Interferences

Substances SOURCE Level Tested Observed Effect

Bilirubin Bovine 30 mg/dL ≤ –2 units

Lipemia Intralipid 400 mg/dL NSIa


Table 3.0 Lipemia Index Interferences

Substances SOURCE Level Tested Observed Effect

Bilirubin Human 30 mg/dL NSIa

Hemoglobin RBC Hemolysate 500 mg/dL NSI


Samples at a Lipemia Index Level of 9 and above should be ultracentrifuged and the analysis performed on the infranate.The high percentage of inert lipid particles may cause inaccurate volumetric aspiration and delivery.

Serum Index A45586 APPage 2 of 7 DECEMBER 2016

ADDITIONAL INFORMATION

For more detailed information on Synchron Systems, refer to the appropriate Synchron System manual.

FURTHER READING• Tietz, N. W., "Specimen Collection and Processing; Sources of Biological Variation," Textbook of Clinical Chemistry,

2nd Edition, W. B. Saunders, Philadelphia, PA (1994).

• National Committee for Clinical Laboratory Standards, Procedures for the Handling and Processing of BloodSpecimens, Approved Guideline, NCCLS publication H18-A, Villanova, PA (1990).

• Tietz, N. W., "Clinical Guide to Laboratory Tests," 3rd Edition, W. B. Saunders, Philadelphia, PA (1995).

• Henry, J. B., "Clinical Diagnosis andManagement by LaboratoryMethods," 21st Edition, W. B. Saunders, Philadelphia,PA (2007).

• Friedman, R. B. and Young, D. S., Effects of Disease on Clinical Laboratory Tests, 4th Edition, AACC Press,Washington, D.C. (2001).

• Young, D. S., Effects of Preanalytical Variables on Clinical Laboratory Tests, 2nd Edition, AACC Press, Washington,D.C. (1997).

• Lee, Mary, "Basic Skills in Interpreting Laboratory Data" 5th Edition, American Society of Health-System Pharmacists,Inc., Bethesda, MD (2013).


Serum Index Tables

Introduction

Beckman Coulter has established the following serum index tables. Once the system has determined the level of aspecic interferent, it is applied to the table to derive the appropriate index value.

Table 4.0 Serum/Plasma Samples Chemistry Tolerance

CHEMISTRY REF Hemoglobin Bilirubin Lipemia

ACTM 472169 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 4+ (Visual)

ALB 442765 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 4+ (Visual)

ALBm 467858 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

ALP (IFCC-DGKCh) 442670, 476821 Yes NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

ALP 442670, 476821 Yes NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

ALT 442620, 476826 Yes NSI ≤ 30 mg/dL NSI ≤ 300 mg/dL

ALT (P5P) 467840, 467848 Yes NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

AMM 439770 Yes NSI ≤ 24 mg/dL Yes

AMY7 A71607 Yes Yes NSI ≤ 500 mg/dL

ApoA 467900 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 400 mg/dL

ApoB 467905 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated Yes

ASO- 469165 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 4+ (Visual)

AST 442665, 476831 Yes NSI ≤ 30 mg/dL unconjugated Yes

AST (P5P) 467845, 467849 Yes NSI ≤ 30 mg/dL unconjugated Yes

BUN 442750 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

BUNm / UREAm 472482 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

C3 988462 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 3+ (Visual)

C4 988471 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 3+ (Visual)

CALC A28937, A28945 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

CAR 469112 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 3+ (Visual)

CHOL 467825 NSI ≤ 500 mg/dL Yes NSI ≤ 400 mg/dL

CK 442635, 476836 Yes NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

CK- 467830 Yes NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

CL A28937, A28945 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

CO2 A28937, A28945 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

CO2E A60290 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

CR-E A60298 NSI ≤ 500 mg/dL Yes NSI ≤ 500 mg/dL

CREm 472525 NSI ≤ 500 mg/dL Yes NSI ≤ 500 mg/dL

CRP 465131 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 1+ (Visual)

C-RP 969620 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 3+ (Visual)

CRPH 378020 Yes Yes Yes

CR-S A40920 NSI ≤ 500 mg/dL NSI ≤ 15 mg/dL NSI ≤ 4+ (Visual)

DBIL 439715, 476856 Yes NSI ≤ 30 mg/dL unconjugated Yes

DIGN 650182 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 4+ (Visual)

ETOH 474947 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 4+ (Visual)

FE 467910 Yes Yes

GEN 469137 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 4+ (Visual)


Table 4.0 Serum/Plasma Samples Chemistry ToleranceCHEMISTRY REF Hemoglobin Bilirubin Lipemia

GGT (IFCC) 442650, 476846 Yes NSI ≤ 30 mg/dL NSI ≤ 500 mg/dL

GGT 442650, 476846 Yes NSI ≤ 30 mg/dL unconjugated

GLUH B24985 Yes Yes Yes

GLUCm 472500 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

HbA1c- A87905 N/A NSI ≤ 30 mg/dL unconjugated NSI ≤ 1000 mg/dL

HbA1c3 B36415 N/A NSI ≤ 30 mg/dL unconjugated NSI ≤ 1000 mg/dL

HDL A15625 NSI ≤ 500 mg/dL NSI ≤ 40 mg/dL unconjugated NSI ≤ 1500 mg/dL

HDLD 650207 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL Yes

HPT 988413 Yes NSI ≤ 30 mg/dL NSI ≤ 3+ (visual)

IBCT 465970, 465971 Yes Yes NSI ≤ 4+ (visual)

IgA 467920 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 400 mg/dL

IgG 467925 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 400 mg/dL

IgM 467930 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated Yes

K A28937, A28945 Yes NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

LACT A95550 NSI ≤ 500 mg/dL Yes NSI ≤ 500 mg/dL

LD (IFCC) 442655, 476841 Yes NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

LD 442655, 476841 Yes NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

LDLD 969706 NSI ≤ 400 mg/dL NSI ≤ 24 mg/dL NSI ≤ 800 mg/dL

LD-P 442660 Yes Yes Yes

LIP 476851 NSI ≤ 200 mg/dL NSI ≤ 30 mg/dL NSI ≤ 3+ (Visual)

MG 445360 Yes NSI ≤ 30 mg/dL unconjugated Yes

NA A28937, A28945 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

PAB 475106 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 2+ (Visual)

PAM 969650 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 500 mg/dL

PHE 469785 NSI ≤ 500 mg/dL NSI ≤ 500 mg/dL

PHOSm 467868 Yes NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

PHS A09426 Yes Yes NSI ≤ 4+ (Visual)

PHY 469188 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 4+ (Visual)

SALY 378194 Yes NSI ≤ 12 mg/dL NSI ≤ 2+ (Visual)

TBIL 442745, 476861 Yes N/A Yes

TG 445850 Yes Yes Yes

TG-B 445850 Yes Yes Yes

THE 469126 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 3+ (Visual)

TOB 467983 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 3+ (Visual)

TP 442740 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 4+ (Visual)

TPm 465986 NSI ≤ 500 mg/dL Yes

TRFN 467942 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 400 mg/dL

UREA 442820 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL unconjugated NSI ≤ 500 mg/dL

URIC 442785 Yes Yes Yes

VANC 474824 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 4+ (Visual)

VPA 467995 NSI ≤ 500 mg/dL NSI ≤ 30 mg/dL NSI ≤ 2+ (Visual)

NSI = No Signicant Interference, which is dened as either <10% or two times within-run precision


Table 4.0 Serum/Plasma Samples Chemistry ToleranceCHEMISTRY REF Hemoglobin Bilirubin Lipemia

Yes = There is at least some level of interference that could be signicant. For details please check the reagent Chemsitry Information Sheets.

Visual = Visual Turbidity Level

Table 5.0 Hemoglobin Index

Hemolysis Index Level Approximate Hemoglobin Range (mg/dL) Approximate Hemoglobin Range (g/L)

0 None detected None detected

1 – 2 0 to 75 0.0 to 0.75

3 – 4 75 to 150 0.75 to 150

5 – 6 150 to 225 1.50 to 2.25

7 – 8 225 to 275 2.25 to 2.75

9 – 10 275 to 350 2.75 to 3.50

Table 6.0 Bilirubin Index

Icteric Index Level Approximate Bilirubin Range (mg/dL) Approximate Bilirubin Range (µmol/L)


1 0.0 to 1.5 0.0 to 25.7

2 1.5 to 3.5 25.7 to 51.3

3 3.0 to 4.5 51.3 to 77.0

4 4.5 to 6.0 77.0 to 102.3

5 6.0 to 7.5 102.6 to 128.3

6 7.5 to 9.0 128.3 to 153.9

7 9.0 to 10.5 153.9 to 179.6

8 10.5 to 12.0 179.6 to 205.2

9 12.0 to 13.5 205.2 to 230.9

10 13.5 to 15.0 230.9 to 256.5

11 15.0 to 16.5 256.5 to 282.2

12 16.5 to 18.0 282.2 to 307.8

13 18.0 to 19.5 307.8 to 333.5

14 19.5 to 21.0 333.5 to 359.1

15 21.0 to 22.5 359.1 to 384.8

16 22.5 to 24.0 384.8 to 410.4

17 24.0 to 25.5 410.4 to 436.1

18 25.5 to 27.0 436.1 to 461.7

19 27.0 to 28.5 461.7 to 487.34

20 28.5 to 30.0 487.4 to 513.0


Table 7.0 Lipemia Index

Lipemia Index Level Visual Turbidity Level (Beckman Coulter scale) Approximate Range (Intralipidamg/dL)


1 0 0 to 40

2 1+ 40 to 80

3 2+ 80 to 120

4 2+ 120 to 160

5 2+ 160 to 200

6 3+ 200 to 240

7 3+ 240 to 280

8 3+ 280 to 320

9 4+ 320 to 360

10 4+ 360 to 400

a Intralipid is a registered trademark of KabiVitrum, Inc.


Operator TipsTable 1.0 STORE UN-OPENED CALIBRATORS & CONTROLS AS FOLLOWS:

ROOM TEMPERATURECALIBRATORS /CONTROLS REFRIGERATOR 2ºC to 8ºC FREEZER -15ºC to -20ºC

CALIBRATOR CALIBRATOR CALIBRATOR

FE/IBCT Calibrator Ammonia Calibrator APO Calibrator

CAL 5 Plus Bilirubin Calibrator

VANC Calibrator Enzyme Validator

DAT Calibrators Lipid Calibrator

DRUG Cal 1 M-TP Calibrator

DRUG Cal 2 Multi Calibrator

DRUG Cal 3 Plus Protein Calibrator

ETOH Calibrator

HbA1c- Calibrator

HbA1c3 Calibrator

HDL Calibrator

LDLD Calibrator

Lithium Calibrator

SYNCHRON Cal 1

SYNCHRON Aqua Cal 1, 2, 3

SYNCHRON MA Calibrator

SYNCHRON PAB Calibrator

Salicylate Calibrator

CONTROLS CONTROLS

ALC/AMM Controls All Vigil Controls (except Vigil HbA1c Controls)

Vigil HbA1c Controls SYNCHRON Controls

DAT Controls Ultimate Bilirubin Controls

MA Urine Protein Control

A45586 AP Operator TipsDECEMBER 2016 Page 1 of 35

Table 2.0 SYNCHRON REAGENT STORAGE FOR ALL UN-OPENED REAGENT/STORE AS FOLLOWS:

ROOM TEMPERATURE REFRIGERATOR 2ºC to 8ºC

ALBm/ALB ACTM

CO2 Acid Reagent ALP

CO2 Alkaline buffer ALT, ALT-

CREm/CREA/CR-S AMM

DBIL ApoA, ApoB

IBCT Columns ASO-

ISE Electrolyte Buffer AST, AST-

ISE Eelectrolyte Reference BUN/UREA

MG BUM/UREAm

PHOSm CAR

PHS CHE

TBIL CHOL

TPm/TP CK. CK-

Wash Concentrate ll CKMB

CCWA CO2E

NO FOAM C-RP, CRPH, CRP

AUTO-GLOSS C3

DIL 1 C4

DIGN

ETOH

FE

GEN

GGT

GLUH

GLUCm

HbA1c-

HbA1c3

HbDIL

HDL

HDLD

HPT

IBCT

Ig-A, Ig-G, Ig-M

LAC

LD, LD-P

LDLD

LI

LIP

MA

M-TP

PAB

PAM

Operator Tips A45586 APPage 2 of 35 DECEMBER 2016

Table 2.0 SYNCHRON REAGENT STORAGE FOR ALL UN-OPENED REAGENT/STORE AS FOLLOWS:ROOM TEMPERATURE REFRIGERATOR 2ºC to 8ºC

PHE

PHY

SALY

TG-TG-B

THE

TOB

TRFN

URIC

VPA

VANC

AMPH

COCM

BARB

BENZ

BNZG

METD

METQ

OP/OP2

PCP

PROX

THC2, THC5, THC


The following table lists materials for making sample dilutions as required. Unless otherwise stated, the material issuitable for all sample types. This table is meant as a GUIDE ONLY. As always, consult your Chemistry InformationSheets for more details.

Table 3.0 RECOMMENDED CHEMISTRY DILUTION MATERIAL

ACRONYM CHEMISTRY RECOMMENDED DILUTION MATERIAL

ACTM ACETAMINOPHEN Saline

ALB ALBUMIN (CC) Saline

ALBm ALBUMIN (MC) Saline

ALP ALKALINE PHOSPHATASE Saline

ALP (IFCC/DGKCh) ALKALINE PHOSPHATASE (IFCC/DGKCh) Saline

ALT ALANINE AMINOTRANSFERASE Saline

ALT- ALANINE AMINOTRANSFERASE (IFCC/DGKCh) Saline

AMM AMMONIA Ammonia Free Deionized Water

AMPH AMPHETAMINES DO NOT DILUTE

AMY7 AMYLASE Saline

ApoA APOLIPOPROTEIN A-1 Saline

ApoB APOLIPOPROTEIN B Saline

ASO- ANTISTREPTOLYSIN -O Saline

AST ASPARTATE AMINOTRANSFERASE Saline

AST- ASPARTATE AMINOTRANSFERASE (IFCC) Saline

BARB BARBITURATES DO NOT DILUTE

BNZG BENZODIAZEPINE DO NOT DILUTE

BUN BUN (CC) Saline

BUNm BUN (MC) Saline

C3 COMPLEMENT C3 Saline

C4 COMPLEMENT C4 Saline

CALC CALCIUM (ISE) Deionized Water

CAR CARBAMAZEPINE Saline

CHOL CHOLESTEROL Saline

CK CREATINE KINASE Saline

CK- CREATINE KINASE (IFCC/DGKCh) Saline

CL CHLORIDE Deionized Water

CO2, CO2E CARBON DIOXIDE Deionized Water

COCM COCAINE METABOLITE DO NOT DILUTE

CRE, CR-S, CR-E CREATININE (CC) Saline

CREm CREATININE (MC) Saline

CRP/C-RP/CRPH C-REACTIVE PROTEIN Saline

DBIL DIRECT BILIRUBIN Azide Free Human Serum Albumin

DIGN DIGOXIN Saline

ETOH ETHANOL ETOH level 1 calibrator

FE IRON Saline

GEN GENTAMICIN Saline

GGT GAMA GLUTAMYL TRANSFERASE Saline


Table 3.0 RECOMMENDED CHEMISTRY DILUTION MATERIALACRONYM CHEMISTRY RECOMMENDED DILUTION MATERIAL

GGT (IFCC/DGKCh) GAMA GLUTAMYL TRANSFERASE Saline

GLUH GLUCOSE H (CC) Saline

GLUCm GLUCOSE (MC) Saline

HbA1c- HEMOGLOBIN A1c DO NOT DILUTE

HbA1c3 HEMOGLOBIN A1c DO NOT DILUTE

HDL HDL CHOLESTEROL Saline

HDLD DIRECT HDL CHOLESTEROL Saline

HPT HAPTOGLOBIN Saline

IBCT TOTAL IRON BINDING CAPACITY Dilute efuent with saline

IgA, IgG, IgM IMMUNOGLOBULINS A. M, G Saline

K POTASSIUM Deionized Water

LACT LACTIC ACID Saline

LD LACTATE DEHYDROGENASE Saline

LD (IFCC/DGKCh) LACTATE DEHYDROGENASE Saline

LD-P LACTATE DEHYDROGENASE Saline

LDLD LDL CHOLESTEROL Saline

LI LITHIUM Deionized water

LIP LIPASE Patient sample with low lipase value

MA MICROALBUMIN Saline

METD METHADONE DO NOT DILUTE

METQ METHAQUALONE DO NOT DILUTE

MG MAGNESIUM Saline

M-TP MOCRO TOAL PROTEIN CSF - Saline

Urine - Saline

NA SODIUM Deionized Water

OP OPIATE DO NOT DILUTE

OP-2 OPIATE 2000 DO NOT DILUTE

PAB PREALBUMIN Saline

PAM PACREATIC AMYLASE Saline

PCP PHENCYCLIDINE DO NOT DILUTE

PHE PHENOBARBITAL Saline

PHY PHENYTOIN Saline

PHOSm PHOSPHOROUS MC Saline

PHS PHOSPHOROUS CC Saline

PROX PROPOXYPHENE DO NOT DILUTE

SALY SALICYLATE Saline

TBIL TOTAL BILIRUBIN Azide Free Human Serum with known bilirubin value

TG TRIGLYCERIDE Saline

TG-B TRIGLYCERIDE (BLANKED) Saline

THC CANNABINOID 100 ng DO NOT DILUTE

THC5 CANNABINOID 50 ng DO NOT DILUTE

THC2 CANNABINOID 20 ng DO NOT DILUTE


Table 3.0 RECOMMENDED CHEMISTRY DILUTION MATERIALACRONYM CHEMISTRY RECOMMENDED DILUTION MATERIAL

THE THEOPHYLLINE Saline

TOB TOBRAMYCIN Saline

TP TOTAL PROTEIN (CC) Saline

TPm TOTAL PROTEIN (MC) Saline

TRFN TRANSFERRIN Saline

UREA UREA (CC) Saline

UREAm UREA (MC) Saline

URIC URIC ACID Saline

VANC VANCOMYCIN Saline

VPA VALPROIC ACID Saline or zero level calibrator

NOTE:

CC (CARTRIDGE CHEMISTRY)

MC (MODULAR CHEMISTRY)


Table 4.0 TROUBLESHOOTING CHEMISTRY ERROR CODES ON THE CARTRIDGE CHEMISTRY SIDE

ACRONYM CHEMISTRY REACTION TYPE ERROR CODE TRANSLATION MEANINGHOW TO

TROUBLESHOOT

ALT* Alanine

Aminotransferase

RATE 1 RX RATE HI Reaction Rate High Reaction rate

exceeds the

allowable limit

ALT-* Alanine

Aminotransferase

(P5P)

INIT RATE HI Initial Rate High The reaction

following sample

addition exceeds

limits.

Dilute sample with

normal saline.

Digoxin – Dilute with

"Zero" calibrator.

ALP Alkaline

Phosphatase

OIR HI Out of Instrument

Range High

Result is greater

than top of analytical

limit

AMY 7 Amylase ORDAC HI Out of ORDAC

Range High

Result is greater

than top of ORDAC

limit

Dilute ASO- with

Saline.

ASO- Antistreptolysin-O SUB DEPL Substrate Depletion Very high result

concentration or an

interfering substance

is present in sample.

For enzymes dilute

with saline if error

message is INIT

RATE HI.

AST* Aspartate

Aminotransferase

RX RATE LO Reaction Rate Low The reaction rate

is less than the

allowable limits.

AST-* Aspartate

Aminotransferase

(P5P)

OIR LO Out of Instrument

Range Low

Result is lower than

bottom of analytical

range.

Dilute sample with

calibrator or known

control material to

ensure concentration

of the result is within

analytical range.

BUN* Blood Urea Nitrogen ORDAC LO Out of ORDAC

Range Low

Result is less

than lower limit of

ORDAC range, but

greater than nominal

analytical range.

Verify reagent was

prepared properly

(if reagent prep is

required).

C3 Compliment 3 ORR LO Out of Reportable

Range Low

Calculated result

is less than the

lower Reportable

Range. Result is not

reported.

CHE Cholinesterase BL RATE HI Blank Rate High Rate during blank

timing period

exceeds upper limits.

Check reagent

preparation

and handling

instructions.

CK Creatine Kinase Check reagent

probe for dripping or

hanging drop at tip.




TROUBLESHOOT

CK- Creatine Kinase

NAC

Check reagent

probe wash collar

functions.

CO2E Carbon Dioxide

(Enzymatic)

BL RATE LO Blank Rate Low Rate during blank

timing period

exceeds lower limit.

Check cuvette wash

station function

C-RP C Reactive Protein Check sample

/ reagent mixer

paddles.

CRPH High Sensitivity C

Reactive 2Protein

Peak Rate RX ABS LO Reaction

Absorbance Low

Mean reaction

absorbance exceeds

the lower limit.

Check reagent

preparation

and handling

instructions.

GGT Gamma-Glutamyl

Transferase

Check sample

handling system

/ sample syringe

for bubbles.

LD-P Lactate

Dehydrogenase

RX ABS HI Reaction

Absorbance High

Mean reaction

absorbance exceeds

the upper limit

Check sample

/ reagent mixer

functions.

Pyruvate → Lactate Check for bubbles

in sample.

LD Lactate

Dehydrogenase

Check integrity of

sample - lipemic /

icteric / hemolysis

/ how sample

collected.

Lactate → Pyruvate Order Serum Index

if desired.

PAM Pancreatic Amylase Peak Rate RX MEAN Reaction Mean

Deviation

Check of constant

rate change during

reaction timing

period.

Check sample /

reagent mixers

functions.

UREA Urea Check integrity of

sample - lipemic /

icteric / hemolysis

/ how sample

collected.

Order Serum Index

if desired.

RX MAX DEV Reaction Maximum

Deviation

One absorbance

reading exceeds the

max delta limit.

Check cuvette wash

station functions.

BL MEAN DEV Blank Mean

Deviation

blank rate not

constant,

Check sample

/ reagent mixer

functions




TROUBLESHOOT

Check for micro

bubbles in the

cuvette.

Check reagent

preparation

and handling

instructions.

BL MAX DEV Blank Maximum

Deviation

One blank

absorbance reading

exceeds the max

limit.

Check integrity of

sample - lipemic /

icteric / hemolysis

/ how sample

collected.

Order Serum Index

if desired.

CREA, CR-S Creatinine RATE 2 Sample

Blanked

BL ABS HI Blank Absorbance

High

The mean

absorbance from

the blank window

exceeds expected

limits.

Check integrity of

sample-lipemic /

icteric / hemolysis

/ how sample

collected

LIP Lipase Order Serum Index

if desired.

RX ABS HI Reaction

Absorbance High

Mean reaction

absorbance exceeds

the upper limit.

RX ABS HI Reaction

Absorbance High

Mean reaction

absorbance exceeds

the upper limit

CHOL Cholesterol Endpoint 2 Reagent

Blanked


Range High

Result is greater

than upper limit of

the analytical range.

ORDAC HI Out of ORDAC

Range High

Result is greater

than upper limit of

ORDAC range.

Dilute sample with

normal saline and

re-run

Suspect interfering

substance (See

the SYNCHRON®

Clinical Systems

Chemistry

Information Sheets)

INIT RATE HI Initial Rate High Reaction rate

following addition

of sample exceeds

allowable limits.

For Lipase, dilute

patient sample with

low lipase value

SUB DEPL Substrate Depletion Very high result

concentration or an

interfering substance

is present in sample




TROUBLESHOOT

LACT Lactate RX RATE LO Reaction Rate Low Reaction rate is less

than allowable limits.

Check integrity of

sample-lipemic /

icteric / hemolysis

/ how sample

collected Order

Serum Index if

desired.

MG Magnesium OIR LO Out of Instrument

Range Low

Result is lower than

bottom of analytical

range.

Check reagent

handling

instructions.

M-TP Micro Total Protein Check

sample/reagent

mixer functions.

SALY Salicylate RX ABS LO Reaction

Absorbance Low

The mean reaction

absorbance falls

below lower limit.

Check sampe

syringe for bubbles.

Look for bubbles in

the sample.

Dilute sample with

calibrator material to

ensure concentration

is below analytical

range.

TBIL Total Bilurubin Endpoint 2 Sample

Blanked


High

The mean

absorbance during

reagent blank

exceeds expected

upper limits.

Check reagent

preparation

and handling

instructions.

TG Triglycerides Check reagent

probes for drips.

Check reagent probe

alignment to collar

wash.

Check for reagent

contamination; use

fresh cartridge.

BL ABS LOW Blank Absorbance

Low

The mean

absorbance during

reagent blank

exceeds expected

lower limits.

Check cuvette wash

station alignment.

Check integrity of

sample-lipemic /

icteric / hemolysis

/ how sample

collected.




TROUBLESHOOT

Order Serum

Index if desired.

(for Endpoint 2

Chemistries ONLY)

URIC Uric Acid BL RATE HI Blank Rate High Rate during blank

period exceeds

upper limits.

Check reagent

preparation

and handling

instructions.

Check reagent



Check sample

/ reagent mixer

functions.

AMM Ammonia Endpoint 2 Sample

Blanked

BL RATE LO Blank Rate Low Rate during blank

period exceeds lower

limit.

Check reagent

probe collar wash

functions.

DBIL Direct Bilirubin Check cuvette wash

station functions.

Check reagent

stability and/or

integretity.

FE Iron RX RATE HI Reaction Rate High Reaction rate greater

than allowable limits.

Check reagent

preparation

and handling

instructions.

Check sample


HDLD Direct HDL

Cholesterol

Check sample

/ reagent mixer

paddles functions.

Check for bubbles

in sample.

Gently re-mix

reagent cartridge.

IBCT Total Iron Binding

Capacity

RX MEAN DEV Reaction Mean

Deviation

Check of constant

rate change during

reaction timing

period.

Associated with

"Noise" error – check

sample / reagent

mixers functions.

LDLD Direct LDL

Cholesterol


Deviation

One absorbance

reading exceeds the

max limit.

Check integrity of

sample-lipemic /

icteric / hemolysis

/ how sample

collected Order

Serum Index if

desired.

PHS Phosphorous




TROUBLESHOOT

TG-B Triglycerides Sample

Blaked

HPT Haptoglobin Ednpoint 3 BL MEAN DEV Blank Mean

Deviation

Blank Rate not

constant.

Check reagent

mixers paddles

functions.

LI Lithium Check for micro

bubbles in cuvette

GLUH Glucose H BL MAX DEV Blank Maximum

Deviation

One blank

absorbance reading

exceeds the max

limit.

Check reagent

preparation and

handling instructions

Hb Hemoglobin Gently re-mix

reagents.

A1c Glycated

Hemoglobin

NOTE: 1. Flagged sample results should not be reported until further investigation / troubleshooting resolves the indicated error

2. For more detailed information on individual reagents, consult your Chemistry Information Sheet.

3. This Troubleshooting Information is meant to act as a guide to some of the more common causes and resolutions. This is not all inclusive.

For more detailed information, consult your Diagnostic and Troubleshooting Manual.

4. Remember the Customer Technical Support Center (Hot Line) is there to help 24 Hrs / Day 1-800-854-3633

* NOTE: *Indicates decreasing (negative) reaction absorbance.


Table 5.0 TROUBLESHOOTING CHEMISTRY ERROR CODES ON THE MODULAR CHEMISTRY SIDE

ACRONYM CHEMISTRY ERROR CODE TRANSLATION MEANING HOW TO TROUBLESHOOT

ALL ISEs DAC Digital to Analog

Conversion

DAC checks

expected ranges

of electrode outputs.

Verify electrode

connections

Check reagent levels

Check electrodes for

damage

Perform

maintenance on

ow cell.

Na Sodium OIR HI Out of Instrument

Range High

Analyte value grater

than upper limit

Check integrity of

sample-lipemic /

icteric / hemolysis

/ how sample

collected. Order

Serum Index if

desired.

Check electrodes

for damage

K Potassium Dilute sample with

de-ionized water

Perform electrode

maintenance

Ensure correct

sample type was

programmed:Urine,

CSF, Serum, Plasma

Check reagents

expiration date

Perform ow cell

maintenance.

CL Chloride OIR LO Out of Instrument

Range Low

Analyte value less

than lower limit.

Check integrity of

sample - lipemic /

icteric / hemolysis

/ how sample

collected. Order

Serum Index if

desired.

Check for bubbles

in sample cups.

CALC Calcium ISE Ensure correct

sample type was

programmed:Urine,

CSF, Serum, Plasma

Check reagents

expiration date


Check sample probe

for blockage.

CO2 Carbon Dioxide CAL REF DRIFT Calibration reference

drift

Excessive reference

drift - sample to

calibration.

Check NA reference

electrode for bubbles

/ damage.

CO2 Ambient

temperature.


damage.

Check if previous

sample result was

"High".

Check uid levels of

dampers, check for

leakage.

Perform ow cell

maintenance.

SAMP REF DRIFT Sample Reference

Drift

Excessive reference

drift sample to

sample

Check NA reference

electrode for bubbles

/ damage.


Table 5.0 TROUBLESHOOTING CHEMISTRY ERROR CODES ON THE MODULAR CHEMISTRY SIDEACRONYM CHEMISTRY ERROR CODE TRANSLATION MEANING HOW TO TROUBLESHOOT

Check electrodes

for damage and/or

electrode age.

Check uid levels of

dampers, check for

leakage.

RX NOISE Reaction Noise. The difference

between the

reaction and line of

regression is greater

than allowed.

Verify electrode

connections.

Check reagent

levels.

Check electrode for

damage.

Check reagent

expiration dates.

Perform electrode

maintenance.

Perform

maintenance on

ow cell.

ALL CUPs OIR HI Out of Instrument

Range High

Analyte value greater

than upper limit

Check integrity of

sample - lipemic /

icteric / hemolysis

/ how sample

collected. Order

Serum Index if

desired.

Check for electrode

damage (GLUCm &

BUNm only).

ALBm Albumin Dilute sample with

de-ionized water.

Perform electrode

maintenance.

BUNm Urea Nitrogen Ensure correct

sample type was

programmed (Urine,

Serum, Plasma

CSF)

Perform cup

maintenance.

Check reagent

expiration date.

CREAm Creatinie OIR LO Out of instrument

Range Low

Analyte value less

than lower limit.

Check integrity of

sample - lipemic /

icteric / hemolysis

/ how sample

collected. Order

Serum Index if

desired.

Check reagent

expiration date.

GLUCm Glucose Ensure correct

sample type was

programmed (Urine,

Serum, Plasma

CSF)

Check reagent

levels.

Check sample probe

for blockage.

Check stirrer.



PHOSm Phosphorus RXN NOISE Reaction Noise Noise level in

absorbance or

conductance

measurement is

higher than the limit.

Check for bubbles

in the reagent line /

cup.

Ensure the

cleanliness of the

cups.

TPm Total Protein Check sample

integrity – lipemic

/ icteric / hemolysis

Ensure no bubbles

in sample probe line.

Check for myeloma

sample in case

PHOSm gets RXN

noise.

Check stirring.

Check electrode is

installed properly.

LOW REAGENT Reagent too Low. Reagent level inside

the cup is too low.

Check for bubbles


cup.

Verify electrode is

installed properly.

Perform MC probe

alignment.

Verify stirrer is in

the cup.

Check for cup

drain/ll function.

HI REAGENT Reagent too High. Reagent level inside

the cup is too high.

Check for bubbles


cup.

Check for cup

drain/ll function.

Perform MC probe

alignment.

SPECIFIC CUPS INIT ABS HI Initial absorbance

high.

Reagent blank

absorbance too

low (only for ALBm,

TPm, CREm and

PHOSm).

Check for

contaminated or

out of date reagent.

Perform lamp

calibration.

Check for the

cleanliness of cup.

INIT ABS LOW Initial absorbance

low.

Reagent blank

absorbance too

high (only for ALBm,

TPm, CREm, and

PHOSm).

Check for bubbles in

the reagent line/cup.

Perform lamp

calibration.

Make sure reagent is

prepared properly.

INIT RATE LOW Initial Reaction Rate

Low

Sample blank

absorbance or

conductivity too

low. (ALBm, BUNm,

GLUm, TPm)

Check stirrer and

stirrer motor

Check sample probe



Perform cup

maintenance.

Check sample type.

INIT COND HI Initial conductance

high.

Reagent

conductance is

higher than the upper

limit (only for BUNm,

and GLUCm).

Perform GLUCm

sensor calibration.

Verify GLUm

electrode is <6

months old.

Perform electrode

maintenance for

BUNm.

Perform cup

maintenance

INIT COND LOW Initail conductance

low.

Reagent

conductance is less

than the low limit

(only for BUNm and

GLUCm).

Ensure the BUNm

reagent is prepared

properly

Check for

contaminated or

out of date reagent.


reagetn line/cup.

Span Cal 1 - Cal

2 Calculation

Sensitivity Check

Reactivity between

calibrators is low

resulsting in poor

sensitivity.

ISEs CUP CHEMISTRIES

Or Cal 2 - Cal

3 Calculation

Sensitivity Check

Bleach ow cell Check reagent levels

/ expiration date

Check reagent

expiration dates

Ensure cups ll / stir

/ drain properly

Check electrodes

for damage and

electrode age

Check electrode

connection

Perform electrode

maintenance

Perform specic

cup /electrode

maintenance.

Check electrode

cables are plugged

in properly

Check heater

temperature of

reaction cups

Calibrators switched Calibrators switched

CO2 Ambient

Temperature

Do lamp calibration

Change CO2

membrane

Perform Glucose

electrode calibration



Change electrode

Back to Back Precision check The difference

between two

consecutive replicate

calibrator values

exceeds limits.


Bleach clean ow

cell


/ drain properly

Check electrodes

for damage and

electrode age

Ensure electrodes

seated properly in

the cup port.

Perform electrode

maintenance

Perform specic

cup/electrode

maintenance.

Check reagent

volume and

expiration date

Ensure BUNm

electrode does

not have too much

molykote.

Check sample probe

for clots

Check reagent

volume / expiration

date

Ambient temp (CO2) Ensure BUNm or

GLUCm reagent at

room temperature,

Check sample probe

alignment to EIC

Check sample probe

alignment to cups

Check creatinine

reagent for

precipitate,


reagent line/cup.

Range Accuracy check Calibrator set point

values fell outside

the acceptable range

of values for the

chemistry.


Check electrodes

for damage and

electrode age


/ drain properly


cables plugged in

properly

Check electrodes

are plugged in the

proper port.

Perform electrode

maintenance

Ensure electrodes

seated properly in

the cup port.


/ expiration dates.

Check heater

temperature of

reaction cups.



Perform ow cell

maintanence.

Ensure BUNm

electrode does

not have too much

molykote.

Verify calibrators in

correct order

Perform cup

/ electrode

maintenance.

Change CO2

membrane


/ expiration date

Check sample probe

and verify no air

bubbles in probe line

Check reagent

temperature.

Check sample probe

alignment

Check creatinine

reagent for

precipitate.

Ensure the calibrator

and calibrator disk

have the same lot

number for TPm

and ALBm.

Perform

lamp/electrode

calibration

Perform GLUm

electrode calibration

Check sample probe

alignment

Check sample probe

and verify no air

bubbles in probe line

NOTE: Flagged sample results should not be reported until further investigation / troubleshooting resolves the indicated error.

For more detailed information on individual reagents, consult your Chemistry Information Sheet.

This Troubleshooting Information is meant to act as a guide to some of the more common causes and resolutions. This is not all inclusive. For

more detailed information, consult your Diagnostic and Troubleshooting Manual.

Remember the Customer Technical Support Center (Hot Line) is there to help 24 Hrs / Day 1-800-854-3633


Table 6.0 TROUBLESHOOTING NON-LINEAR SINGLE or MULTI POINT CALIBRATED CHEMISTRIES ERROR CODES


TROUBLESHOOT

Endpoint 2 Sample

Blanked

RX ABS HI Reaction

Absorbance High

Reaction

absorbance is

greater than

allowable limit.

Dilute with

appropriate diluent

(consult Chemistry

Information Sheet).

ApoA Apolipoprotein A Suspect interfering

substance

(consult Chemistry

Information Sheet).

ApoB Apolipoprotein B INIT RATE HI Initial Rate High Reaction rate

following addition

of sample or trigger

reagent exceeds

allowable limit.

Conrm by alternate

method.


Range High

Result is greater than

analytical range.

C4 Complement ORDAC LO Out of Instrument

ORDAC Range Low

Result is less

than instrument

reportable ORDAC

range.

Dilute

immunoprotein

samples with

Diluent 1.

CRP C-Reactive Protein ORDAC HI Out of Instrument

ORDAC Range High

Result is greater

than instrument

reportable ORDAC

range.

HPT Haptoglobin RX ABS LO Reaction

Absorbance Low

Reaction

absorbance is less

than allowable limit.

Check reagent

handling

instructions, gently

re-mix reagent

cartridge.

TRFN Transferrin Check sample

integrity (interfering

substance/sample

collection).

Ig-A Immunoglobulin A OIR LO Out of Instrument

Range Low

Result is less than

analytical range.

Dilute sample with

control or material

of known analyte

concentration.

Ig-M Immunoglobulin M Conrm by alternate

method.

PAB Prealbumin Check

reagent/sample

probe and mixer

functions.

MA Microalbumin BL ABS HI Blank Absorbance

High

Absorbance during

blank period exceeds

high limits.

Check reagent

handling


re-mix reagent

cartridge.




TROUBLESHOOT

Check reagent



Ig-G Immunoglobulin G Endpoint 2 Reagent

Blanked

BL ABS LO Blank Absorbance

Low

Absorbance during

blank period is less

than low limits.

Check reagent

probe collar wash

functions.

Check cuvette wash

station functions.


Deviation

Check of constant

rate change during

reaction timing

period.

Check

reagent/sample

mixer functions.

Check sample


substance/sample

collection).


Deviation

Check of constant

rate change during

blank timing period.

Check

reagent/sample

mixer functions

Check for micro

bubbles in cuvette.


Deviation

One blank

absorbance reading

is highly erratic.

Check reagent

handling


re-mix reagent

cartridge.

BL RATE HI Blank Rate High Rate values during


high limit.

Check reagent

handling


re-mix reagent

cartridge.

Check reagent



BL RATE LO Blank Rate Low Rate values during



Check for bubbles

in sample

syringe/sample

material.

Check

reagent/sample

mixer and wash

station functions.

RX RATE HI Reaction Rate High Rate values during

reaction perid

exceeds high limit.

Check reagent

handling


re-mix reagent

cartridge.




TROUBLESHOOT

Check reagent mixer

functions.

RX RATE LO Reaction Rate Low Rate values during

reaction period is

less than allowable

limit.

Check reagent


Perform

reagent/sample

probe and mixer

weekly maintenance.

Applies to Ig-A and

Haptoglobin

OIR U LO Under ORDAC range

low

Result is grater

than the instrument

reportable Under

ORDAC range.

Check sample


substance/sample

collection).

Dilute sample with

control or material

of known analyte

concentration.

Conrm by alternate

method.

Applies to Endpoint

2 Sample Blanked

Chemistries ONLY

(In addition to

information listed

above)


Low

Absorbance during

blank period (after

sample addition) is

less than low limits.

Check sample


substance/sample

collection).

Conrm by alternate

method.


High

Absorbance value

taken during blank

reading (after sample

addition) exceeds

high limit.

Check sample


substance/sample

collection).

Dilute sample with

appropriate diluent

(consult Chemistry

Information Sheet).

Conrm by alternate

method.


Table 7.0 TROUBLESHOOTING NON-LINEAR MULTI POINT CALIBRATED CHEMISTRIES ERROR CODES


TROUBLESHOOT

CAR* Carbamazepine Endpoint 2 Sample

Blanked

RX ABS HI Reaction

Abosrbance High

Reaction

absorbance greaer


Suspect interfering

substance

(consult Chemistry

Information Sheet).

Dilute sample with

control or material

of known analyte

concentration.

THE* Theophyline INIT RATE HI Initial Rate High Reaction rate

following addition

of trigger reagent

exceeds allowable

limit.

Conrm by alternate

method.

GEN* Gentamicin OIR LO Out of Instrument

Range Low

result is less than

analytical range.

TOB* Tobramycin RX ABS LO Reaction

Absorbance Low

Reaction

absorbance is less


Check reagent

handling


re-mix reagent

cartridge.

Dilute sample

with drug free

serum/plasma

material.


Range High


analyticla range.

Suspect interfering

substance

(consult Chemistry

Information Sheet).

Conrm by alternate

method.


High

Absorbance during


high limits.

Check reagent

handling


re-mix reagent

cartridge.

Check reagent



Check reagent

probe collar wash

functions.


Low

Absorbance during

blank period less

than low limits.

Check cuvette wash

station functions.

Perform wash all

cuvettes.




TROUBLESHOOT

Check sample


substance/sample

collection).


Deviation

Check of constant

rate change during

reaction timing

period.

Check

reagent/sample

mixer functions

Check sample


substance/sample

collection).


Deviation

One reaction

absorbanc rading

is highly erratic.

RX ERROR Reaction Error Error occurred

during reaction read

window.

Rerun.

Conrm by alternate

method.


Deviation

Check of constant

rate change during


Check reagent mixer

functions.

Check for micro

bubbles in cuvette.


Deviation

One blank

absorbance reading

is highly erratic.

Check reagent

handling


re-mix reagent

cartridges.

BL RATE HI Blank Rate High Rate values during

blank period exveeds

high limit.

Check reagent

handling


re-mix reagent

cartridge.

Check sample for

bubbles.




Check sample


Check

reagent/sample

mixer functions.

Check cuvette wash

station functions.




TROUBLESHOOT

RX RATE HI Reaction Rate High Rate values during

reaction period

exceeds high limit.

Check reagent

handling


re-mix reagent

cartridge.

Check reagent mixer

functions.

RX RATE LO Reaction Rate Low Rate values during

reaction period is

less than allowable

limit.

Check reagent


Perform

reagent/sample

probe and mixer

weekly maintenance.

ACTM Acetaminophen RATE 1 RX RATE HI Reaction Rate High Rate values during

reaction period

exceeds high limit.

Check sample


substance/sample

collection).

Dilute sample with

control or material

of known analyte

concentration.

DIGN Digoxin INIT RATE HI Initial Rate High Reaction rate

following addition

of trigger reagent

exceeds allowable

limit.

ETOH Ethanol OIR LO Out of Instrument

Range Low

Result is less than

analytical range.

Conm by alternate

method

PHE Phenobarbital ORR LO Out of Reportable

Range Low

Result is less than

the low reportable

range limit. Result is

not reported.

PHY Phenytoin RX RATE LO Reaction Rate Low Rate values during

reaction period is

less than allowable

limit.

Check sample


substance/sample

collection).

Dilute sample

with drug free

serum/plasma

material.

VPA Valproic Acid OIR HI Out of Instrument

Range High


analytical range.

Conrm by alternate

method

VANC Vancomycin BL RATE HI Blank Rate High Rate values during


limit.

Check reagent

handling


re-mix reagent

cartridge.




TROUBLESHOOT

Check reagent





negative limit.

Check reagent

probe wash collar

functions.

Check cuvette wash

station functions


Deviation

Check of constant

rate change during

reaction timing

period.

Check

reagent/sample

mixer functions.

Check sample


substance/sample

collection).


Deviation

One reaction

absorbance reading

is highly erratic.

Check cuvette wash

station functions.


Deviation

Check of constant

rate change during


Check

reagent/sample

mixer functions.

Check sample


substance/sample

collection).


Deviation

One blank

absorbance reading

is highly ERRATIC.

Check reagent

handling


re-mix reagent

cartridge.

Check for micro

bubbles in civette

RX ERROR Reaction Error Error occurred

during reaction read

window.

Rerun.

Conrm by alternate

method.

RX ABS HI Reaction

Absorbance High

Reaction

absorbance is

greater than the

allowable limit.

Check reagent

handling


re-mix reagent

cartridge.

Check for bubbles

in sample

syringe/sample

material.




TROUBLESHOOT

RX ABS LO Reaction

Absorbance Low

Reaction

absorbance is less

than the allowable

limit.

Check sample


substance/sample

collection).

Dilute sample

with drug free

serum/plasma

material (RX ABS HI)

or dilute sample with

control or material

of known analyte

concentration (RX

ABS LO).

WHEN CALIBRATING ANY OF THE MULTI POINT CHEMISTRIES, THE FOLLOWING ERROR CODES MAY OCCUR:

RECOVERY Recovery Error Comparison of

calibrator set points

to the recovery

concentrations

doesn’t meet

specications.

Check order of

calibrator tested.

Check calibrator

handling.

Try new calibrator

set.

SENSITIVITY Sensitivity Error Check of each

calibrators level how

far value from actual

set point.

Check reagent

handling

Try new reagent

cartridge.

Check

reagent/sample

probe and mixer

functions.

SEV SENSITIVITY Severe Sensitivity

Error

Extreme sensitivity

error. Not

overrideable.

Check

reagent/sample

probes for scratches.

SEV RECOVERY Sever Revobery Erro Extreme recovery

error Not

Overrideable

Perform

reagent/sample

probe and mixer

weekly maintenance

Check

reagent/sample





TROUBLESHOOT

SPAN Multi Point Span Reactivity between

calibrator levels is

less than the allowed

limit.

MATH ERR Math Error Multi Point

calibration curve

cannot be t into the

math model.

* NOTE: *Indicates decreasing (negative) reaction absorbance.


Table 8.0 TROUBLESHOOTING DRUGS OF ABUSE CHEMISTRY ERROR CODES


TROUBLESHOOT

AMPH Amphetamines RATE 1 RX RATE HI Reaction Rate High Reaction rate

exceeds the

allowable limit

DO NOT DILUTE

Check sample

/ reagent mixer

paddles functioning

properly.

Conrm by alternate

method.

Check reagent

syringe for bubbles

BARB Barbiturates INIT RATE HI Initaial Rate High The reaction

following sample

addition exceeds

limits.

DO NOT DILUTE

Posible high

positive specimen

or interfering

substances.

BENZ, BNZG Benzodiazepines RX RATE LO Reaction Rate Low The reaction rate

less than the

allowable limits.

e.g. No reaction rate

detected.

Check integrity of

sample for turbidity

and how sample

was collected

Conrm by alternate

method.

COCM Cocaine Metabolite BL RATE HI Blank Rate High Rate during blank

timing period

exceeds limits.

DO NOT DILUTE

Check reagent

preparation

and handling

instructions.

Check reagent



METD Methadone BL RATE LO Blank Rate Low Rate during

blankRate during

blank timing period

exceeds negative

limit.

Check reagent probe

is centered over

wash cup.

Perform cuvette

wash station

maintenance.

METQ Methaqualone RX MEAN DEV Reaction Mean

Deviation

Check of constant

rate change during

reaction timing

period.

DO NOT DILUTE




TROUBLESHOOT

Associated with

Noise error check

sample / reagent

mixers are working

properly.

OP Opiate RX MAX DEV Reaction Maximum

Deviation

One absorbance

reading exceeds the

max limit.

Check integrity of

sample turbidity and

how sample was

collected.

OP2 Opiate – 2000 ng

Conrm by alternate

method

DO NOT DILUTE

PCP Phencyclidine BL MEAN DEV Blank Mean

Deviation

Blank rate not

constant

Check sample /

reagent mixers.

Check for micro

bubbles in cuvette

PROX Propoxyphene Check integrity of

sample turbidity and

how sample was

collected.

Check reagent

preparation

and handling

instructions.

THC2 Cannabinoid – 20 ng RX ABS LO Reaction

Absorbance Low

Mean reaction

absorbance falls

below the low limit.

DO NOT DILUTE

Check reagent

preparation

and handling

instructions.

Check sample

handling

system/sample


Check sample

/ reagent mixer

paddles functioning

properly.

THC5 Cannabinoid – 50 ng RX ABS HI Reaction

Absorbance High

Mean reaction

absorbance above

the upper limit

Bubbles in sample.

Check integrity

of sample for

hematuria, turbidity

and how sample

was collected.




TROUBLESHOOT

Conrm by alternate

method.

THC Cannabinoid – 100

ng

Check reagent /

sample syringes

for bubbles

NOTE: 1. Flagged sample results should not be reported until further investigation/troubleshooting resolves the indicated error

2. For more detailed information on individual reagents, consult your Chemistry Information Sheet.

3. This Troubleshooting Information is meant to act as a guide to some of the more common causes and resolutions. This is not all inclusive.

For more detailed information, consult your Diagnostic and Troubleshooting Manual.

4. Remember the Customer Technical Support Center (Hot Line) is there to help 24 Hrs/Day 1-800-854-3633


Table 9.0 Reagent Preparation Quick Reference

CHEMISTRY (LARGE TEST SIZE) PREPARATION REQUIRED VISUAL AID

ALT 476826

AST 476831

CK 476836

Dispense contents of Bottle A into

Compartment A (Largest). Invert

cartridge gently several times.

ALT- 467840

AST- 467845

Pipette "C" into "A". Invert cartridge

gently several times.

TBIL 476861 Mix 200 µL (0.2 mL) of "C" into "B".

Invert cartridge gently several times.

CHEMISTRY PREPARATION REQUIRED VISUAL AID

ALT 442620

ALT- 467848

AST 442665

AST- 467849

CK 442635

CK- 467830

TG 445850

Pipette "C" into "A". Invert cartridge

gently several times.

CR-S A40920 Add 1 drop Antifoam to Compartment

A. Invert cartridge gently several times.

TBIL 442745 Mix 100 µL (0.1 mL) of "C" into "B".

Invert cartridge gently several times.


Table 9.0 Reagent Preparation Quick ReferenceApoA 467900

ApoB 467905

C-RP 969620

CRPH 378020

DIGN 650182

VANC 474824

VPA 467995

Gently invert cartridge. Refer to

Chemistry Information Sheet.

TP 442740 1. Remove all screw caps from

cartridge. 2. Before the cartridge

is loaded onto the instrument, place

one environmental cap (P/N A65595)

on cartridge compartment "A" only.

Caps are not required for B and C

Compartments.

MODULAR CHEMISTRIES (MC) PREPARATION REQUIRED VISUAL AID

BUNm or UREAm 472482 Add Wetting Agent to Diluent, mix

gently. Add Urease, mix at least 10

times by gentle inversion. Loosen

cap slightly for out gassing. Allow the

reagent to warm to room temperature

for 2-3 hours if the Diluent was stored

at room temperature or for 8-12 hours

if the Diluent was stored refrigerated.

GLUCm 472500 Allow Reagent to equilibrate to room

temperature ~ 8 hours prior to use.

Invert Reagent 5 times.

CREm 472525 Gently mix Picric Acid with Buffer. Mix

at least 10 times by gentle inversion.

PHOSm 467868 Gently mix Molybdate with Diluent. Mix

at least 10 times by gentle inversion


Table 10.0 Reagent Preparation Quick Reference

CHEMISTRY PREPARATION REQUIRED

ApoA 467900 Allow calibrator to come to room temperature prior

to use

mix thoroughly by inversion prior to use

ApoB 467905 Allow calibrator to come to room temperature prior

to use

mix thoroughly by inversion prior to use

A87905 Carefully open calibrator bottles, avoiding loss of

lyophilizate.

Add exactly 2,000 µL of deionized water to each

bottle of calibrator and replace the stopper and cap,

matching each to the calibrator bottle.

Dissolve the contents for 30 minutes by occasional

gentle inversion or by placing on a rocker.

Vortex each bottle for 5 seconds at medium speed.

Avoid the formation of foam.

Record calibrator reconstitution date and time on

bottles.

NOTICE: Calibrators are lot-specic and should not

be interchanged.

HbA1c-

(Reagent Kit)

NOTICE: Calibrators DO NOT require pretreatment

with the Hemolyzing Reagent prior to assay.

B36415 Carefully open calibrator bottles, avoiding loss of

lyophilizate.

Add exactly 2,000 µL of deionized water to each

bottle of calibrator and replace the stopper and cap,

matching each to the calibrator bottle.

Dissolve the contents for 30 minutes by occasional

gentle inversion or by placing on a rocker.

Vortex each bottle for 5 seconds at medium speed.

Avoid the formation of foam.

Record calibrator reconstitution date and time on

bottles.

NOTICE: Calibrators are lot-specic and should not

be interchanged.

HbA1c3

(Reagent Kit)

NOTICE: Calibrators DO NOT require pretreatment

with the Hemolyzing Reagent prior to assay.

Use deionized water as the Level 1Calibrator.

Remove the metal cap around the HDL calibrator

bottle and gently tap the bottle on the table to remove

powder at the top of the stopper. Open the HDL

calibrator bottle carefully, avoiding loss of lyophilizate.

Add exactly 1.00 mL of deionized water to the bottle

of calibrator.

Replace the stopper and let stand for 5 minutes at

room temperature.

HDL A15625

Gently invert until the contents are dissolved avoiding

the formation of foam. DO NOT SHAKE.


Table 10.0 Reagent Preparation Quick ReferenceCHEMISTRY PREPARATION REQUIRED

969706LDLD

(Reagnet Kit)

Remove the metal cap around the calibrator bottle

and gently tap it on the table to remove powder at

the top of the cap. Slowly remove the cap to prevent

loss of lyophilized powder and add 1.0 mL distilled or

deionized water. Replace the cap and let stand for

5 minutes at room temperature. Gently invert until

the contents are dissolved. Avoid foaming and DO

NOT SHAKE.



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