Gilford Express 550 - Biosys

June 1999/2

URIC ACID FS* TBHBA

Order information Cat. No. Kit size 10 302 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 3021 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 302 023 R1 1 x 800

ml + R2 1 x 200 ml

10 300 030 6 x 3 ml standard

Method Enzymatic colorimetric test, “TBHBA“

Uric acid is oxidized to Allantoine by Uricase. The generated Hydrogen Peroxide reacts with 4-Aminoantipyrine and 2,4,6-Tribromo-3-hydroxybenzoic acid (TBHBA) to Chinonimine.

Reagent preparation and stability The reagents and the standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagents must be protected from light.

Specimen

Serum, heparinized or EDTA plasma, urine. For serum / plasma: Avoid hemolysis! Dilute urine 1 + 10 with distilled water.

Components and concentration in the test R1: Phosphate buffer pH 7.0 100 mmol/l

TBHBA (2,4,6-Tribromo-3-Hydroxy-benzoic acid)

1 mmol/l

R2: Phosphate buffer pH 7.0 100 mmol/l

4-Aminoantipyrine 0,3 mmol/l

Potassiumhexacyanoferrate (II) 10 µmol/l

POD > 2 KU/l

Uricase > 30 U/l

Standard: 6 mg/dl (357 µmol/l)

Notes

Ascorbic acid interferes.

Normal range (see reference 1,2)

Serum: Men: 3.4 - 7.0 mg/dl (200 - 420 µmol/l) Women: 2.4 - 5.7 mg/dl (140 - 340 µmol/l) Urine: 250 - 750 mg/24 h (1.5 - 4.5 mmol/24 h)

References

1. Thefeld, W., Hoffmeister, H., Busch, E.-W., Koller, P. U., Vollmar, J., Dtsch. Med. Wschr., 98, (1973), 380 – 384

2. Henry, R. J., Cannon, D. C., Winkelmann, J.: Clinical Chemistry, Principles and Technics, 2

nd edition, Harper & Row Publishers

Inc., Hagerstown Maryland 1974, 534 3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 - 27 4. Town, M.-H., Gehm, S., Hammer, B., Ziegenhorn, J.,

J. Clin. Chem. Clin. Biochem., 23, (1985), 591

* fluid stable

Gilford Express 550

Test Parameters Test Name Uric Acid Test UA Test Bar Code #020 Test Type Endpoint Curve Type Blanked linear Units mg/dl No. of decimal places 1 Primary Wavelength 510 nm Secondary Wavelength 600 nm Read Time/ Interval 20 Sample Blank yes Factor * Calibration Interval 24 Normalization Interval No. of Calibrators 3 (2) No. of Replicates 2 Low Blank A Limit -0.010 High Blank A Limit 0.350 Low A limit 0.000 High A Limit 2.00 Low Normal 2.4 High Normal 7.0 Linearity Limit 20 Curve S D Limit 0.5

Reagent Parameters Test Name Uric Acid Test UA Test Bar Code #020 Sample Volume 5µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent

Reagent 1: Volume 260 µl Diluent Volume µl

Bar Code UAIA Lag Time 300 sec

Reagent 2 : Volume 65 µl Diluent Volume µl

Bar Code Lag Time 300 sec

**Applications developed before December 2003 had been used

at a variety of customer laboratories and are validated by use.

Software upgrades at specific analysers may require further

adjustments as they are out of our control

February 1999/2

ALBUMIN FS

Order information Cat. No. Kit size 10 022 021 R 5 x 25 ml + 1 x 3 ml standard 1 0220 99 10 026 R 6 x 100 ml 10 022 023 R 1 x 1000

ml

10 020 030 6 x 3 ml standard

Method Colorimetric test, “Bromocresol green“

Serum albumin in the presence of Bromcresol green at a slightly acid pH produces a color change of the indicator from yellow-green to green-blue.

Reagent preparation and stability

The reagent is ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 25 °C and protected from light. Stability of standard: until expiry date, when stored at 2 – 8 °C

Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Stability in serum: 1 month at 2 – 8 °C 1 week at 15 – 25 °C

Components and concentration in the test Citrate buffer pH 4.2 30 mmol/l Bromcresol Green 0.26 mmol/l

Standard: 5 g/dl

Normal range (see reference 3)

Adults 3.5 - 5.0 g/dl

References

1. Doumas, B. T., Watson, W. A., Biggs, H. G., Clin. Chim. Acta., 31, (1971), 87 - 96

2. Webster, D., Clin. Chim. Acta, 53, (1974), 109 – 115 3. Tietz, N. W.: Textbook of Clinical Chemistry, 2

nd edition,

W. B. Saunders Company, Philadelphia 1994, 703 * fluid stable

Gilford Express 550

Test Parameters Test Name Albumin Test ALB Test Bar Code # Test Type Endpoint Curve Type Blanked linear Units g / dl No. of decimal places 2 Primary Wavelength 540 nm Secondary Wavelength 0 Read Time/ Interval 20 Sample Blank no Factor * Calibration Interval 24 Normalization Interval No. of Calibrators 3 No. of Replicates 2 Low Blank A Limit 0.010 High Blank A Limit 0.450 Low A limit -0.200 High A Limit 2.00 Low Normal 3.8 High Normal 5.1 Linearity Limit 8.0 Curve S D Limit 0.3

Reagent Parameters Test Name Albumin Test ALB Test Bar Code # Sample Volume 3 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 1 Predilution 1 Reagent Diluent

Reagent 1: Volume 300 µl l Diluent Volume µl

Bar Code ALBI Lag Time 90 sec

Reagent 2 : Volume µl Diluent Volume µl

Bar Code Lag Time sec

**Applications developed before December 2003 had

been used at a variety of customer laboratories and are

validated by use. Software upgrades at specific

analysers may require further adjustments as they are

out of our control

December 2000/2

-AMYLASE CC* FS** Substrate EPS-G7

Order information Cat. No. Kit size 10 050 021 R1 5 x 20 ml + R2 1 x 25 ml 10 050 022 R1 5 x 80 ml + R2 1 x 100 ml 10 050 023 R1 1 x 800 ml + R2 1 x 200 ml

Method Enzymatic color test with complete conversion of all PNP- Oligomaltosides produced by Amylase activity. The test results represent Total Amylase activity (all isoenzymes).

Substrate: 4,6-Ethyliden-(G7)-p-Nitrophenyl (G1)-- D-Maltoheptaoside (EPS-G7)

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 8 °C and protected from light.

Specimen Serum, heparinized or EDTA plasma, urine. For serum / plasma: Avoid hemolysis! Stability: serum / plasma: min. 1 week at 2 – 25 °C urine: 2 days at 15 – 25 °C 10 days at 2 - 8 °C

Components and concentration in the test R1: GOOD’s buffer pH 7.1 100 mmol/l

NaCl 50 mmol/l MgCl2 10 mmol/l Alpha-Glucosidase > 2 KU/l

R2: GOOD’s buffer pH 7.1 100 mmol/l

EPS-G7 1.6 mmol/l

Notes 1. For urine as sample material the sample volumes should be

divided in half. 2. Hemoglobin interferes.

3. Saliva and skin do contain -Amylase. Therefore never pipette by mouth and avoid skin contact with the reagents.

4. The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

5. Conversion factor refers to previous PNP- G7 methods which utilised factors in order to correlate and keep the same normal range.


without conversion factor 37 °C

Serum / plasma up to 100 U/l Random urine up to 450 U/l 24 h urine up to 410 U/24 h with conversion factor 37 °C

Serum / plasma up to 220 U/l Random urine up to 1000 U/l 24 h urine up to 900 U/24 h

References

1. Hohenwallner, W., et al., J. Clin. Chem. Clin. Biochem., 27, (1989), 97 – 101

2. Kruse-Jarres, J. D., et al., J. Clin. Chem. Clin. Biochem., 27, (1989), 103

* complete color ** fluid stable

Gilford Express 550

Test Parameters Test Name Amylase Test Amy Test Bar Code # Test Type Kinetic Curve Type Enzyme linear Units U/l No. of decimal places 0 Primary Wavelength 405

Secondary Wavelength 600

Read Time/ Interval 60 Sample Blank no Factor ** Calibration Interval 999 Normalization Interval No. of Calibrators 1 No. of Replicates 1 Low Blank A Limit 0.000 High Blank A Limit 2.00 Low A limit 0.000 High A Limit 2.00 Low Normal 0 High Normal 100 Linearity Limit 2000 Curve S D Limit 20 Reagent Parameters Test Name Amylase Test Amy Test Bar Code # Sample Volume 6µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent

Reagent 1: Volume 240 µl Diluent volume µl

Bar Code # Lag Time 60 s

Reagent 2 : Volume 60 µl Diluent volume µl

Bar Code Lag Time 120 s

#) Data entry by user **) factor must be checked by a calibration serum





December 2000/2

Gilford Express 550

Test Parameters Test Name APOA Test APOA Test Bar Code # Test Type Endpoint Curve Type Blank Linear Units mg/dl No. of decimal places 0 Primary Wavelength 570nm Secondary Wavelength NONE

Read Time/ Interval 20 Sample Blank yes Factor * Calibration Interval 48 Normalization Interval No. of Calibrators 4 No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 1.500 Low A limit 0.000 High A Limit 1.500 Low Normal 110 High Normal 190 Linearity Limit 250 Curve S D Limit 0.25 Reagent Parameters Test Name APOA Test APOA Test Bar Code # Sample Volume 3 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 2 Predilution 1 Reagent Diluent

Reagent 1: Volume 350 µl Diluent volume

Bar Code APO1A Lag Time 250sec

Reagent 2 : Volume 70 µl Diluent volume

Bar Code APO2A Lag Time 240sec

APOLIPOPROTEIN A1 FS

Order information Cat. No. Kit size 1 7102 99 10 015 R1 2 x 25 ml + R2 1 x 10 ml 10 710 021 R1 5 x 25 ml + R2 1 x 25 ml 1 7102 99 10 730 R1 4 x 20 ml + R2 2 x 8 ml 1 7100 99 10 041 3 x 1 ml TruCal Apo A1/B Calibrator set with 3 different levels

Notes

1. Please refer to the package insert for Apoliporotein A1 FS

for the detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics concerning; Measuring Range Specificity/Interferences Sensitivity/Limit of Detection

Precision (Reproducibility, Repeatability) Method Comparison Reference Ranges Literature 2. The stability of the reagent on board of the analyser is at

least one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.

**Applications developed before December 2003 had been

used at a variety of customer laboratories and are

validated by use. Software upgrades at specific analysers

may require further adjustments as they are out of our

control

September 2005/2

Gilford Express 550

Test Parameters Test Name APOB Test APOB Test Bar Code # Test Type Endpoint Curve Type Blank Linear Units mg/dl No. of decimal places 0 Primary Wavelength 340nm Secondary Wavelength NONE

Read Time/ Interval 20 Sample Blank yes Factor * Calibration Interval 48 Normalization Interval No. of Calibrators 4 No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 1.500 Low A limit 0.000 High A Limit 1.500 Low Normal 75 High Normal 155 Linearity Limit 250 Curve S D Limit 0.25 Reagent Parameters Test Name APOB Test APOB Test Bar Code # Sample Volume 3 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code APOB1A Lag Time 300sec


Bar Code APOB2A Lag Time 240sec

APOLIPOPROTEIN B FS

Order information Cat. No. Kit size 1 7112 99 10 015 R1 2 x 25 ml + R2 1 x 10 ml 10 711 021 R1 5 x 25 ml + R2 1 x 25 ml 1 7112 99 10 730 R1 4 x 20 ml + R2 2 x 8 ml 1 7100 99 10 041 3 x 1 ml TruCal Apo A1/B Calibrator set with 3 different levels

Notes

1. Please refer to the package insert for Apoliporotein B FS

for the detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics concerning; Measuring Range Specificity/Interferences Sensitivity/Limit of Detection

Precision (Reproducibility, Repeatability) Method Comparison Reference Ranges Literature 2. The stability of the reagent on board of the analyser is at

least one month provided that contamination and evaporation are avoided.

3. Manufactured by


**This application proposal is for guidelines only. To

avoid misinterpretation measured results have to be

validated and assessed with caution.

October 2004/2

Gilford Express 550

Test Parameters Test Name Bicarbonate Test CO2 Test Bar Code * Test Type Kinetic Curve Type Blanked linear Units mmol/l No. of decimal places 1 Primary Wavelength 405 nm Secondary Wavelength 510 nm Read Time/ Interval 120 Sample Blank no Factor * Calibration Interval * Normalization Interval Hours No. of Calibrators 2 No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 2.500 Low A limit 0.000 High A Limit 2.500 Low Normal 22 High Normal 29 Linearity Limit 50 Curve S D Limit 3.0

Reagent Parameters Test Name Bicarbonate Test CO2 Test Bar Code * Sample Volume 4 µl Sample Diluent Predilution Ratio 1 Rerun Dilution Ratio 1 Predilution Reagent Diluent

Reagent 1: Volume 350 µl Diluent Volume 0 µl

Bar Code * Lag Time 60 sec

Reagent 2 : Volume 0 µl Diluent Volume 0 µl


* User defined

BICARBONATE FS

Order information Cat. No. Kit size 1 0950 99 10 021 R 5 x 25 ml + 1 x 3 ml Std

1 0950 99 10 026 R 6 x 100 ml

1 0950 99 10 730 R 6 x 20 ml

1 0950 99 10 030 6 x 3 ml Standard

Notes

1. Please refer to the package insert for Bicarbonate FS for detailed

information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least one

month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid

misinterpretation measured results have to be validated and

assessed with caution.

July 1999/2

BILIRUBIN AUTO DIRECT FS*


Method Colorimetric test, “DCA (2,4-Dichloroaniline)“ Direct Bilirubin in presence of diazotized 2,4-Dichloroaniline forms a red colored azocompound in acidic solution.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent 2 must be protected from light.

Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Store protected from light. Test as soon as possible.

Components and concentration in the test R1: EDTA-Na2 0.07 mmol/l

NaCl 6.6 g/l Sulfamic Acid 70 mmol/l

R2: 2,4-Dichlorophenyl Diazoniumsalt 0.09 mmol/l HCl 130 mmol/l EDTA-Na2 0.02 mmol/l

Notes Hemoglobin interferes.


A normal range does not exist, false values up to 0.3 mg/dl (5 µmol/l) can occur.

References 1. Rand, R. N., di Pasqua, A., Clin. Chem., 8, (1962), 570 2. Henry, J., Cannon, D. C., Winkelmann, J. V.: Clinical

Chemistry, Principles and Technics, Harper & Row Publishers Inc., Hagerstown Maryland 1974, 1042

3. Thomas, L.: Labor und Diagnose, 4th edition, Die Medizinische Verlagsgesellschaft, Marburg 1992, 235

* fluid stable

Gilford Express 550

Test Parameters Test Name Direct Bili Test D-BIL Test Bar Code * Test Type Endpoint Curve Type Blanked linear Units mg/dl No. of decimal places 1 Primary Wavelength 540nm

Secondary Wavelength 600nm

Read Time/ Interval 20 Sample Blank yes Factor * Calibration Interval 48 Normalization Interval No. of Calibrators 2 No. of Replicates 2 Low Blank A Limit 0.00 High Blank A Limit 2.00 Low A limit 0.00 High A Limit 2.00 Low Normal 0 High Normal 0.25 Linearity Limit 10 Curve S D Limit 0.25 Reagent Parameters Test Name Direct bilirubin Test D-BIL Test Bar Code * Sample Volume 20 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code DB1A Lag Time 240sec


Bar Code DB2A Lag Time 240sec





June 1999/2

BILIRUBIN AUTO TOTAL FS*


Method Colorimetric test, “DCA (2,4-Dichloroaniline)“

Total Bilirubin in presence of diazotized 2,4-Dichloroaniline forms a red colored azocompound in acidic solution. A specific mixture of detergents enables a safe determination of the Total Bilirubin.


Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Store protected from light. Stability: 1 day at 15 – 25 °C 4 days at 2 – 8 °C up to 3 months at - 20 °C (not in case of repeated deep freezing)

Components and concentration in the test R1: TRIS pH 8.2 8 mmol/l

NaCl 7 g/l Detergents

R2: 2,4-Dichlorophenyl Diazoniumsalt 1 mmol/l

HCl 30 mmol/l Detergents

Notes Ascorbic acid and Hemoglobin interfere.


Newborn 0 - 24 h: up to 5 mg/dl ( 86 µmol/l) 24 - 48 h: up to 9 mg/dl ( 155 µmol/l) 3 – 5 days: up to 12 mg/dl ( 205 µmol/l) after 4 weeks: up to 1.5 mg/dl ( 26 µmol/l) Adults: up to 1.1 mg/dl (18.8 µmol/l)

References

1. Rand, R. N., di Pasqua, A., Clin Chem., 8, (1962), 570 2. Weigl, E., Bach, H., Krieg, D., Med. Klin., 70, (1975), 664 – 669 3. Keller, H.: Klinisch-chemische Labordiagnostik für die Praxis,

2nd

edition, Georg Thieme Verlag, Stuttgart 1991, 246 * fluid stable

Gilford Express 550

Test Parameters Test Name Total Bilirubin Test T-BIL Test Bar Code #007 Test Type Endpoint Curve Type Blank Linear Units mg/dl No. of decimal places 1 Primary Wavelength 540nm


Read Time/ Interval 20 Sample Blank yes Factor * Calibration Interval 48 Normalization Interval No. of Calibrators 2 No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 1.500 Low A limit 0.000 High A Limit 1.500 Low Normal 0.2 High Normal 1.1 Linearity Limit 30 Curve S D Limit 0.25 Reagent Parameters Test Name Bilirubin Test T-BIL Test Bar Code #007 Sample Volume 10 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code TB1A Lag Time 240sec







November 1999/2

CALCIUM AS FS*

Order information Cat. No. Kit size 1 1130 99 10 021 R 5 x 25 ml + 1 x 3 ml Standard 1 1130 99 10 026 R 6 x 100 ml 1 1130 99 10 023 R 1 x 1000 ml 1 1130 99 10 030 6 x 3 ml Standard

Method Photometric test using arsenazo III

Principle Calcium with Arsenazo III at neutral pH yields a blue colored complex, whose intensity is proportional to the calcium concentration. Interference by magnesium is eliminated by addition of 8-hydroyquinoline-5-sulfonic acid.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 8 °C and contamination is avoided. Do not freeze the reagents!.

Specimen Serum or heparin plasma. For urine add 10 ml concentrated HCl to the 24 h urine and heat the specimen to dissolve calcium oxalate.

Stability in serum/plasma:

7 days at 20 – 25°C 3 weeks at 2 – 8°C 8 months at -20°C Stability in urine:

2 days at 20 – 25°C 4 days at 2 – 8°C 3 weeks at -20°C

Components and Concentration in the Test

Reagent

Reagent pH 7.50 Phosphate buffer 50 mmol/l 8-Hydoxyquinoline-5-sulfonic acid 5 mmol/l Arsenazo III 120 µmol/l Detergents

Standard: 10 mg/dl ( 2.5 mmol/l)

Notes 1. As calcium is an urbiquitary ion, essential precaution must be

taken against accidental contaminations. Only use disposable materials.

2. Traces of chelating agent, such as EDTA, can prevent the formation of the colored complex.

3. For detailed product information see detailed package

insert.

Reference range

Serum/plasma 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l) Urine <250 mg/24h (6.24 mmol/24h)

<300 mg/24h (7.49 mmol/24h)

Performance Characteristics

Measuring Range The test has been developed to determine calcium concentrations within a measuring range from 0.04 – 25 mg/dl (0.01 – 6.25 mmol/l). When values exceed this range the samples should be diluted 1+1 with NaCl solution ( 9g/l) and the result multiplied by 2.

Sensitivity / Limit of detection The lower limit of detection is 0.04 mg/dl (0.01 mmol/l) * fluid stable

Gilford Express 550

Test Parameters Test Name Calcium Test CA Test Bar Code #009 Test Type Endpoint Curve Type Blanked linear Units mg/dl (mmol/l) No. of decimal places 1 (2) Primary Wavelength 600 nm

Secondary Wavelength 0 nm

Read Time/ Interval 20 Sample Blank no Factor * Calibration Interval 24 Normalization Interval No. of Calibrators 3 (2) No. of Replicates 2 Low Blank A Limit 0.0.05 High Blank A Limit 2.00 Low A limit 0.000 High A Limit 2.00 Low Normal 8.1 (2.02) High Normal 10.4 (2.60) Linearity Limit 15 (3.75) Curve S D Limit 0.4 (0.15)

Reagent Parameters Test Name Calcium Test CA Test Bar Code #009 Sample Volume 3 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 1 Predilution 1 Reagent Diluent


Bar Code CAIA Lag Time 120 sec

Reagent 2 : Volume µl Diluent volume µl






out of our control

July 2001/2

CK-MB FS*


Method Optimized UV test according to the recommendations of the DGKC (German Society of Clinical Chemistry) and IFCC (International Federation of Clinical Chemistry) for CK-NAC. The CK-MB consists of the subunits CK-M and CK-B. A specific antibody against CK-M inhibits the complete CK-MM activity (main part of the total CK activity) and the CK-M subunit of CK-MB. Only CK-B activity is measured, which is half of the CK-MB activity.


Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Loss of activity: at 2 – 8 °C after 24 h < 10 %

at 15 - 25 °C after 1 h < 10 %.

Components and concentration in the test R1 + R2 Imidazole pH 6.7 100 mmol/l Creatine Phosphate 30 mmol/l Glucose 20 mmol/l N-Acetyl Cysteine 20 mmol/l Magnesium Acetate 10 mmol/l EDTA 2 mmol/l ADP 2 mmol/l NADP 2 mmol/l AMP 5 mmol/l Diadenosine Pentaphosphate 10 µmol/l Glucose-6-phosphate Dehydrogenase > 1.5 KU/l Hexokinase > 2.5 KU/l CK-M (human) inhibiting polyclonal antibodies (sheep) inhibiting capacity > 2000 U/l

Notes 1. Hemoglobin interferes. 2. The reagents contain Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes.


The likelihood of a cardiac infarction is high under the following circumstances:

CK Women CK Men

37 °C > 167 U/l > 190 U/l

and

CK-MB 37 °C > 24 U/l

and

A CK-MB activity between 6 and 25 % of the Total CK activity

If a cardiac infarction is suspected but the above conditions are not fulfilled, a fresh infarction may have occured. The determination should then be repeated with a fresh sample after 4 hours.

References 1. Würzburg, U., et al., Klin. Wschr., 54, (1976), 357 – 360 2. Würzburg, U., et al.‚ J. Clin. Chem. Clin. Biochem., 15,

(1977), 131 3. Stein, W., Med. Welt., (1985), 572 - 577

* fluid stable

Gilford Express 550

Test Parameters Test Name CK MB Test CK MB Test Bar Code #012 Test Type Kinetic Curve Type Enzyme linear Units U/l No. of decimal places 0 Primary Wavelength 340 nm


Read Time/ Interval 60 Sample Blank no Factor *8250 Calibration Interval 999 Normalization Interval No. of Calibrators 1 No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 0.700 Low A limit 0.000 High A Limit 2.000 Low Normal 0 High Normal 24 Linearity Limit 1000 Curve S D Limit 20 Test Name CK MB Test CK MB Test Bar Code #012 Sample Volume 12 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent

Reagent 1: Volume 300 µl Diluent volume :µl

Bar Code CKIH Lag Time 500 secs



*Factor must be checked by a calibration serum





out of our control

July 2001/2

CK-MB FS*


Method Optimized UV test according to the recommendations of the DGKC (German Society of Clinical Chemistry) and IFCC (International Federation of Clinical Chemistry) for CK-NAC. The CK-MB consists of the subunits CK-M and CK-B. A specific antibody against CK-M inhibits the complete CK-MM activity (main part of the total CK activity) and the CK-M subunit of CK-MB. Only CK-B activity is measured, which is half of the CK-MB activity.


Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Loss of activity: at 2 – 8 °C after 24 h < 10 %

at 15 - 25 °C after 1 h < 10 %.

Components and concentration in the test R1 + R2 Imidazole pH 6.7 100 mmol/l Creatine Phosphate 30 mmol/l Glucose 20 mmol/l N-Acetyl Cysteine 20 mmol/l Magnesium Acetate 10 mmol/l EDTA 2 mmol/l ADP 2 mmol/l NADP 2 mmol/l AMP 5 mmol/l Diadenosine Pentaphosphate 10 µmol/l Glucose-6-phosphate Dehydrogenase > 1.5 KU/l Hexokinase > 2.5 KU/l CK-M (human) inhibiting polyclonal antibodies (sheep) inhibiting capacity > 2000 U/l

Notes 1. Hemoglobin interferes. 2. The reagents contain Sodium Azide (0.095 %) as preservative.



The likelihood of a cardiac infarction is high under the following circumstances:

CK Women CK Men

37 °C > 167 U/l > 190 U/l

and

CK-MB 37 °C > 24 U/l

and

A CK-MB activity between 6 and 25 % of the Total CK activity

If a cardiac infarction is suspected but the above conditions are not fulfilled, a fresh infarction may have occured. The determination should then be repeated with a fresh sample after 4 hours.

References 1. Würzburg, U., et al., Klin. Wschr., 54, (1976), 357 – 360 2. Würzburg, U., et al.‚ J. Clin. Chem. Clin. Biochem., 15,

(1977), 131 3. Stein, W., Med. Welt., (1985), 572 - 577

* fluid stable

Gilford Express 550

Test Parameters Test Name CK MB Test CK MB Test Bar Code #012 Test Type Kinetic Curve Type Enzyme linear Units U/l No. of decimal places 0 Primary Wavelength 340 nm


Read Time/ Interval 60 Sample Blank no Factor * Calibration Interval 999 Normalization Interval No. of Calibrators 1 No. of Replicates 1 Low Blank A Limit 0.000 High Blank A Limit 0.650 Low A limit 0.000 High A Limit 1.400 Low Normal High Normal Linearity Limit 1000 Curve S D Limit 20 Test Name CK MB Test CK MB Test Bar Code #012 Sample Volume 10 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent

Reagent 1: Volume 240 µl Diluent volume :µl

Bar Code CKIH Lag Time 240 secs


Bar Code CK2H Lag Time 120 sec

*Factor must be checked by a calibration serum





out of our control

June 1999/2

CK-NAC FS*


Method Optimized UV test according to the DGKC (German Society of Clinical Chemistry) and IFCC (International Federation of Clinical Chemistry).


Specimen

Serum, heparinized or EDTA plasma. Avoid hemolysis! Stability: 1 week at 2 – 8 °C 1 day at 15 – 25 °C

Components and concentration in the test R1 + R2 Imidazole pH 6.7 100 mmol/l Creatine Phosphate 30 mmol/l Glucose 20 mmol/l N-Acetyl Cysteine 20 mmol/l Magnesium Acetate 10 mmol/l EDTA 2 mmol/l ADP 2 mmol/l NADP 2 mmol/l AMP 5 mmol/l Diadenosine Pentaphosphate 10 µmol/l Glucose-6-phosphate Dehydrogenase > 1.5 KU/l Hexokinase > 2.5 KU/l

Notes 1. Hemoglobin up to 200 mg/dl does not interfere. 2. The reagents contain Sodium Azide (0.095 %) as preservative.



37 °C Women < 165 U/l Men < 190 U/l Babies (2 - 12 months) < 325 U/l Children (after 12 months) < 225 U/l

References 1. Recommendations of the German Society of Clinical Chemistry,

J. Clin. Chem. Clin. Biochem., 15, (1977), 255 - 260

2. The Committee on Enzymes of the Scandinavian Society for Clinical Chemistry and Clinical Physiology, Scand. J. Clin. Lab. Invest., 36, (1976), 711

3. Witt, I., Trendelenburg, Chr., J. Clin. Chem. Clin. Biochem., 20, (1982), 235 – 242

4. Chemnitz, G., Schmidt, E., Koller, P. U., Busch, E. W., Dtsch. Med. Wschr., 104, (1979), 257

* fluid stable

Gilford Express 550

Test Parameters Test Name CK NAC act. Test CK Test Bar Code # Test Type Kinetic Curve Type Enzyme linear Units U/l No. of decimal places 0 Primary Wavelength 340 nm Secondary Wavelength 380 nm Read Time/ Interval 60 Sample Blank no Factor **2220 Calibration Interval 999 Normalization Interval No. of Calibrators 1 No. of Replicates 1 Low Blank A Limit -0.100 High Blank A Limit 2.000 Low A limit -0.100 High A Limit 2.000 Low Normal 0 High Normal 190 Linearity Limit 1000 Curve S D Limit 20

Reagent Parameters Test Name CK NAC Test CK Test Bar Code # Sample Volume 10 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent

Reagent 1: Volume 240µl Diluent volume

Bar Code CKIH Lag Time 180 sec


Bar Code CK2H Lag Time 120 sec

** Must be checked by a calibration serum **Applications developed before December 2003 had




out of our control

June 1999/2

Gilford Express 550

Test Parameters Test Name Chloride Test Cl Test Bar Code # Test Type Endpoint Curve Type Blanked Linear Units mmol/l No. of decimal places 0 Primary Wavelength 405 nm


Read Time/ Interval 20 Sample Blank no Factor * Calibration Interval 999 Normalization Interval No. of Calibrators 1 No. of Replicates 1 Low Blank A Limit -0.100 High Blank A Limit 2.000 Low A limit -0.100 High A Limit 2.000 Low Normal 98 High Normal 110 Linearity Limit 130 Curve S D Limit 10 Reagent Parameters Test Name Chloride Test Cl Test Bar Code # Sample Volume 3 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent

Reagent 1: Volume 300 µl Diluent Volume :µl

Bar Code # Lag Time 300 secs


Bar Code Lag Time





out of our control

CHLORIDE FS

Order information

Cat. No. 1 1200 .. .. …

Notes

1. Please refer to the package insert for Chloride FS for detailed







3. Manufactured by


June 1999/2

CHOLESTEROL FS*

Order information Cat. No. Kit size 10 130 021 R 5 x 25 ml + 1 x 3 ml standard 1 1300 99 10 026 R 6 x 100 ml 10 130 023 R 1 x 1000 ml 10 130 030 6 x 3 ml standard

Method Enzymatic colorimetric test, “CHOD-PAP“

Determination of Cholesterol after enzymatic hydrolysis and oxidation. The colorimetric indicator is Chinonimine which is generated from 4-Aminoantipyrine and Phenol by Hydrogen Peroxide under the catalytic action of Peroxidase.

Reagent preparation and stability The reagent is ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 - 8 °C. The reagent must be protected from light. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen Serum, heparinized or EDTA plasma; Avoid hemolysis!

Components and concentration in the test GOOD's buffer pH 6.7 50 mmol/l Phenol 5 mmol/l 4-Aminoantipyrine 0.3 mmol/l Cholesterol Esterase > 200 U/l Cholesterol Oxidase > 50 U/l Peroxidase > 3 KU/l

Standard: 200 mg/dl (5.2 mmol/l)

Notes

The reagent contains Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

Clinical interpretation (see reference 4)

Suspect: over 220 mg/dl (5.7 mmol/l) Elevated: over 260 mg/dl (6.7 mmol/l) As per recommendation of the European Consensus Conference it is recommendable to lower the Cholesterol level in blood of about 180 mg/dl for adults up to 30 years of age and to about 200 mg/dl for adults of over 30 years of age.

References

1. Richmond, W., Clin. Chem., 19, (1973), 1350 - 1356 2. Roeschlau, P., Bernt, E., Gruber, W., Z. Klin. Chem. Klin.

Biochem, 12, (1974), 403 - 407 3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 4. Schettler, G., Nüssel, E., Arbeitsmed. Sozialmed.

Präventivmed., 10, (1975), 25 * fluid stable

Gilford Express 550

Test Parameters Test Name Cholesterol Test CHO Test Bar Code #011 Test Type Endpoint Curve Type Blanked linear Units mg/dl No. of decimal places 0 Primary Wavelength 510 nm Secondary Wavelength 600 nm Read Time/ Interval 20 Sample Blank no Factor * Calibration Interval 24/72 Normalization Interval No. of Calibrators 3 (2) No. of Replicates 2 Low Blank A Limit -0.010 High Blank A Limit 0.350 Low A limit 0.000 High A Limit 2.000 Low Normal 140 High Normal 220 Linearity Limit 800 Curve S D Limit 10.0

Reagent Parameters Test Name Cholesterol Test CHO Test Bar Code #011 Sample Volume 3 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 1 Predilution 1 Reagent Diluent


Bar Code CHIB Lag Time 600 sec







July 2006/3

Gilford Express 550

Test Parameters Test Name CHEopt. Test CHE Test Bar Code #002 Test Type Kinetic Curve Type Enzyme linear Units U/l No. of decimal places 0 Primary Wavelength 405 nm Secondary Wavelength 600 nm Read Time/ Interval 60 Sample Blank no Factor ** -XXXX Calibration Interval 999 Normalization Interval No. of Calibrators 1 No. of Replicates 1 Low Blank A Limit 0.000 High Blank A Limit 2.500 Low A limit 0.000 High A Limit 2.500 Low Normal 3930 High Normal 11500 Linearity Limit 20000 Curve S D Limit 20

Reagent Parameters Test Name CHE opt. Test CHE Test Bar Code #002 Sample Volume 5 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent

Reagent 1: Volume 240µl Diluent Volume µl

Bar Code CH1H Lag Time 60 sec

Reagent 2 : Volume 60 µl Diluent Volume

Bar Code Lag Time 60sec

**) Factor must be checked by a calibration serum

CHOLINESTERASE FS

Order information

Cat. No. 1 1401 .. .. …

Notes

1. Please refer to the package insert for Cholinesterase FS for

detailed information about the test on the following:






3. Manufactured by





February 2006/2

CREATININE FS*

Order information Cat. No. Kit size 10 171 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 1711 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 171 023 R1 1 x 800 ml + R2 1 x 200 ml 10 170 030 6 x 3 ml standard

Method Kinetic test without deproteinisation, “Jaffé“

Creatinine in an alkaline Picrate solution forms a colored orange-red complex. The delta absorbance at fixed times during conversion is proportional to the concentration of Creatinine in the sample.

Reagent preparation and stability The reagents and the standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 25 °C.

Specimen

Serum, heparinized plasma, urine. Dilute urine 1 + 49 with dist. water For serum / plasma: Avoid hemolysis! Stability in serum / plasma: 24 hours at 2 – 8 °C

Components and concentration in the test R1: Sodium Hydroxide 0.16 mol/l

R2: Pikric acid 4.0 mmol/l

Standard: 2 mg/dl (177 µmol/l)

Notes

1. Bilirubin interferes. 2. Reagent 1 contains Sodium Hydroxide. Keep out of the reach of

children. Wear suitable gloves and eye/face protection. In case of contact with eyes rinse immediately with plenty of water and seek medical advice. Remove contaminated clothing immediately.

3. Reagent 2 contains Picric Acid. Toxic by inhalation, in contact with skin and when swallowed. Wear suitable gloves and eye/face protection. After contact with skin, wash immediately with Polyethylenglycol 400 (DAB 8) or plenty of water. If sickness occurs seek medical advice.


Serum: Men 0.6 - 1.1 mg/dl (53 – 97 µmol/l) Women 0.5 - 0.9 mg/dl (44 – 80 µmol/l) Urine: 1000 - 1500 mg/24 h

Creatinine clearance (see reference 4)

Men: 98 – 156 ml/min Women: 95 – 160 ml/min

References

1. Hare, R. S., P. S. E. B. M., 74, (1950), 148 2. Kostir., J. V., Sonka, J., Biochim. Biophys. Acta, 8, (1952), 86 3. Schirmeister, J., Willmann, H., Kiefer, H., Dtsch. Med. Wschr.,

89, (1964), 1018 4. Schirmeister, J., Willmann, H., Kiefer, H., Hallauer, W.,

Dtsch. Med. Wschr., 89, (1964), 1640 5. Sarre, H.: Nierenkrankheiten, Georg Thieme Verlag,

Stuttgart 1959 * fluid stable

Gilford Express 550

Test Parameters Test Name Creatinine Test CREA Test Bar Code #013 Test Type Kinetic Curve Type Blanked linear Units mg/dl No. of decimal places 1 Primary Wavelength 510 nm Secondary Wavelength 600 nm Read Time/ Interval 60 Sample Blank no Factor * Calibration Interval 24 Normalization Interval No. of Calibrators 3 No. of Replicates 2 Low Blank A Limit -0.010 High Blank A Limit 2.000 Low A limit -0.100 High A Limit 2.000 Low Normal 0.5 High Normal 1.1 Linearity Limit 20 Curve S D Limit 0.5

Reagent Parameters Test Name Creatinine Test CREA Test Bar Code # Sample Volume 15 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code CRIA Lag Time 30 sec


Bar Code CR2A Lag Time 30 sec




April 2004/2

Gilford Express 550

Test Parameters Test Name Ferritin Test FER Test Bar Code # Test Type Two point Curve Type Blank Linear Units µg/l No. of decimal places 1 Primary Wavelength 570nm

Secondary Wavelength

Read Time/ Interval 20 Sample Blank yes Factor * Calibration Interval 48 Normalization Interval No. of Calibrators 2 No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 1.500 Low A limit 0.000 High A Limit 1.500 Low Normal 10 High Normal 300 Linearity Limit 1000 Curve S D Limit 0.25 Reagent Parameters Test Name FER Test FER Test Bar Code # Sample Volume 10 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 2 Predilution 1 Reagent Diluent





FERRITIN FS

Order information Cat. No. Kit size 1 7059 99 10 731 R1 3 x 20 ml + R2 3 x 10 ml 1 7059 99 10 735 R1 1 x 20 ml + R2 1 x 10 ml 1 7050 99 10 058 4 x 1 ml TruCal Ferritin: Calibrator set with 4 different levels

Notes

1. Please refer to the package insert for Ferritin FS for detailed

information about the test on the following

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature



3. Manufactured by





November 2006/3

Gilford Express 550

Test Parameters Test Name Iron Test FE Test Bar Code # Test Type Endpoint Curve Type Blanked linear Units µg/dl No. of decimal places 0 Primary Wavelength 600 nm

Secondary Wavelength -

Read Time/ Interval 20 Sample Blank yes Factor * Calibration Interval 120 (24) Normalization Interval No. of Calibrators 2 No. of Replicates 2 Low Blank A Limit 0.020 High Blank A Limit 0.200 Low A limit -0.005 High A Limit 2.000 Low Normal 23 High Normal 168 Linearity Limit 1000 Curve S D Limit 10 Reagent Parameters Test Name Iron Test FE Test Bar Code # Sample Volume 15 µl Sample Diluent Predilution Ratio Reran Dilution Ratio Predilution 2 Reagent Diluent 1


Bar Code FEIA Lag Time 240 sec


Bar Code FE2A Lag Time 240sec

IRON FS Ferene

Order information Cat. No. Kit size 1 1911 99 10 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3ml Std

1 1911 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

1 1911 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml

10 190 030 6 x 3 ml Standard

Notes

1. Please refer to the package insert for Iron FS Ferene for detailed







3. Manufactured by





April 1999/2

ALKALINE PHOSPHATASE IFCC FS*


Method Kinetic, colorimetric test according to IFCC (International Federation of Clinical Chemistry)

In alkaline buffer AP convertes p-Nitrophenylphosphate into p-Nitrophenol and Phosphate. The increase in absorbance from p-Nitrophenol is directly proportional to the activity of the AP.


Specimen Serum, heparinized plasma. Avoid hemolysis! Loss of activity after 2 – 3 days at 15 – 25 °C < 10 %.

Components and concentration in the test R1: 2-Amino-2-methyl-1-propanol pH 10.4 0.35 mol/l

Magnesium Sulphate 2.0 mmol/l

Zinc Sulphate 1.0 mmol/l

HEDTA 2.0 mmol/l

R2: p-Nitrophenylphosphate 16.0 mmol/l

Notes 1. The reagents contain Sodium Azide (0.095 %) as preservative.


2. During the reaction p-Nitrophenol is produced. This is poisonous when inhaled, swallowed or when absorbed throught the skin. If the reaction mixture comes into contact with skin or mucous membranes wash copiously with water!


37 °C Men (20 – 50 years) 53 – 128 U/l Men (> 60 years) 56 – 119 U/l Women (20 – 50 years) 42 – 98 U/l Women (> 60 years) 53 – 141 U/l

References

1. Tietz, N. W., Rinker, A. D., Shaw, L. M., J. Clin. Chem. Clin. Biochem., 21, (1983), 731 – 748

2. Tietz, N. W., Textbook of Clinical Chemistry, 2nd

edition, W. B. Saunders Company, Philadelphia 1994, 2202

* fluid stable

Gilford Express 550

Test Parameters Test Name AP opt. Test AP Test Bar Code #002 Test Type Kinetic Curve Type Enzyme linear Units U/l No. of decimal places 0 Primary Wavelength 405 nm


Read Time/ Interval 60 Sample Blank no Factor **4200 Calibration Interval 999 Normalization Interval No. of Calibrators 1 No. of Replicates 1 Low Blank A Limit 0.000 High Blank A Limit 1.000 Low A limit 0.000 High A Limit 1.800 Low Normal 42 High Normal 141 Linearity Limit 1800 Curve S D Limit 20 Reagent Parameters Test Name AP Test #002 Test Bar Code 5 µl Sample Volume Sample Diluent Predilution Ratio 2 Reran Dilution Ratio 1 Predilution Reagent Diluent


Bar Code Lag Time 60 secs


Bar Code

Lag Time 60 secs





FOSFATO UV FS* Cat. No. Kit size 1 5211 99 10 021 R1 4 x 20 ml + R2 1 x 20 ml + padrão 1 x 3 ml

Notas: 1. Para informações detalhadas do kit de Fosfato UV FS consulte a bula conforme a seguir: Relevância Clínica Método e Principio Composição e Estabilidade dos Reagentes Amostras Calibradores e Controles Performance Características com relação a: - Faixa de Medição - Especificidade/Interferentes - Sensibilidade/Limite de Detecção - Precisão (Reprodutibilidade, Repetibilidade) - Comparação de Método Valores de Referencia Literatura 2. A estabilidade do reagente no equipamento e ao menos de 4 semanas se a contaminação e evaporação for evitada.

Produzido por: Diasys Diagnostics Systems GmbH Importado e distribuído por: Biosys LTDA CGC: 02220795/0001-79 Resp. téc.: Vera Lúcia A. Janoni – CRF: 2848/RJ SVS: SAC (21) 3907-2534 - [email protected] * fluid stable

Gilford Express 550

Test Parameters Test Name Fosfato Test IP Test Bar Code #020 Test Type Endpoint Curve Type Blanked linear Units mg/dl No. of decimal places 1 Primary Wavelength 340 nm Secondary Wavelength 405 nm Read Time/ Interval 20 Sample Blank no Factor * Calibration Interval 24 Normalization Interval No. of Calibrators 3 (2) No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 1.600 Low A limit 0.000 High A Limit 2.000 Low Normal 2.6 High Normal 4.5 Linearity Limit 30 Curve S D Limit 0.25 Reagent Parameters Test Name Fosfato Test IP Test Bar Code #020 Sample Volume 4 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 1 Predilution 1 Reagent Diluent


Bar Code IPIA Lag Time 180 sec



27.04.06

February 1999/2

GAMMA-GT FS*


Method Kinetic colorimetric test according to Szasz / Persijn (1974)

Gamma-GT catalyzes the transfer of Glutamic acid to acceptors like Glycylglycine in this case. This process releases 5-Amino-2-Nitrobenzoate which absorbs light at 405 nm. The increase in absorbance at this wavelength is directly related to the activity of Gamma-GT.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Reagent 2 must be protected from light. For monoreagent mix 4 parts R1 + 1 part R2. This is stabile for 4 weeks at 2 - 8°C, 5 days at 15 - 25°C.

Specimen Serum, EDTA plasma. Avoid hemolysis. Stability: at least 1 week at between – 20 °C and + 20 °C.

Components and concentration in the test R1: TRIS buffer pH 8.25 100 mmol/l

Glycylglycine 100 mmol/l

R2: L-Gamma-glutamyl-3-carboxy- 4-nitroanilide

4 mmol/l

Notes The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.


37 °C Men: 11 - 50 U/l Women: 7 - 32 U/l

References 1. Szasz, G., Weimann, G., Stähler, F., Wahlefeld, A.-W.,

Persijn, J.-P., Z. Klin. Chem. Klin. Biochem., 12, (1974), 228 2. Persijn, J.-P., van der Slik, W., J. Clin. Chem. Clin. Biochem.,

14, (1976), 421 – 427 3. Szasz, G., Clin. Chem., 15, (1969), 124 – 136 4. Szasz, G., in Bergmeyer, H. U.: Methoden der enzymatischen

Analyse, 3rd

edition, Verlag Chemie, Weinheim / Bergstraße 1974, 759

* fluid stable

Gilford Express 550

Test Parameters Test Name Gamma GT Test GGT Test Bar Code #014 Test Type Kinetic Curve Type Enzyme linear Units U/l No. of decimal places 0 Primary Wavelength 405 nm Secondary Wavelength 600 nm Read Time/ Interval 60 no Sample Blank ** 1656 Factor 999 Calibration Interval Normalization Interval 1 No. of Calibrators 2 No. of Replicates 0.000 Low Blank A Limit 0.550 High Blank A Limit 0.000 Low A limit 1.700 High A Limit 4 Low Normal 28 High Normal 1000 Linearity Limit 20 Curve S D Limit

Reagent Parameters Test Name Gamma GT Test GGT Test Bar Code #014 Sample Volume 10 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code GTIA Lag Time 60 sec







Gilford Express 550

Test Parameters Test Name GLUCOSE Test GLU Test Bar Code # User inpüt‘ Test Type Endpoint Curve Type Blanked linear Units mg/dl No. of decimal places 0 Primary Wavelength 540 nm


Read Time/ Interval 20 Sample Blank no Factor * Calibration Interval 24 hours Normalization Interval 24 hoürs No. of Calibrators 1 No. of Replicates 1 Low Blank A Limit 0.000 High Blank A Limit 2.000 Low A limit 0.000 High A Limit 2.000 Low Normal 70 High Normal 110 Linearity Limit 500 Curve S D Limit 10 Reagent Parameters Test Name Glucose Test GLU Test Bar Code # Sample Volume 3 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 1 Predilution 1 Reagent Diluent

Reagent 1: Volume 300 µl Diluent Volume :µl

Bar Code Lag Time 600 secs


Bar Code Lag Time

GLUCOSE GOD FS

Order information Cat. No. Kit size 10 250 021 R 5 x 25 ml + 1 x 3 ml Std

1 2500 99 10 026 R 6 x 100 ml

10 250 023 R 1 x 1000 ml

10 250 030 6 x 3 ml Standard

Notes

1. Please refer to the package insert for Glucose FS for the detailed

information about the test on the following Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics concerning; Measuring Range Specificity/Interferences Sensitivity/Limit of Detection

Precision (Reproducibility, Repeatability) Method Comparison Reference Ranges Literature 2. The stability of the reagent on board the analyser is at least one

month provided that contamination and evaporation are avoided 3. Manufactured by DiaSys Diagnostic Systems GmbH Alte

Strasse 9, 65558 Holzheim, Germany





May 2000/2

January 2010/4

Gilford Express 550

Test Parameters Test Name HbA1c Test HBA Test Bar Code #007 Test Type Endpoint Curve Type 2-logit5 Units # No. of decimal places 1 Primary Wavelength 600 nm

Secondary Wavelength -

Read Time/ Interval 20 Sample Blank no Factor * Calibration Interval 48 Normalization Interval No. of Calibrators 5 No. of Replicates 2 Low Blank A Limit -0.100 High Blank A Limit 1.800 Low A limit 0.000 High A Limit 1.800 Low Normal # High Normal # Linearity Limit # Curve S D Limit 0.25 Reagent Parameters Test Name HbA1c Test HBA Test Bar Code #007 Sample Volume 5 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code HB1A Lag Time 240 sec


Bar Code HB2A Lag Time 180 sec

#) Data entry by user

oneHbA1c FS

Order information

Cat. No. 1 3329 .. .. …

Notes

1. Please refer to the package insert for oneHbA1c FS for detailed





2. The stability of the reagent on board the analyser is at least 30

days provided that contamination and evaporation are avoided.

3. Manufactured by





January 2005/2

Gilford Express 550

Test Parameters Test Name HDL Test HDL Test Bar Code # Test Type Endpoint Curve Type Blanked linear Units mg/dl No. of decimal places 1 Primary Wavelength 600 nm

Secondary Wavelength NONE nm

Read Time/ Interval 20 Sample Blank yes Factor * Calibration Interval 120 Normalization Interval No. of Calibrators 2 No. of Replicates 2 Low Blank A Limit -0.010 High Blank A Limit 2.000 Low A limit 0.000 High A Limit 2.000 Low Normal 35 High Normal 80 Linearity Limit 180 Curve S D Limit USER Reagent Parameters Test Name HDL Test HDL Test Bar Code # Sample Volume 3 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 1 Predilution 1 Reagent Diluent

Reagent 1: Volume 260 µl Diluent Volume l

Bar Code HD1A Lag Time 240 secs


Bar Code HD2A Lag Time 240 sec

HDL-C IMMUNO FS

Order information Cat. No. Kit size

1 3521 99 10 021 R1 5 x 20 ml + R2 1 x 25 ml

1 3521 99 10 022 R1 5 x 80 ml + R2 1 x 100 ml

1 3521 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml

1 3520 99 10 065 3 x 3 ml Calibrator

1 3521 99 10 717 R1 5 x 80 ml + R2 5 x 20 ml

Notes

1. Please refer to the package insert for HDL-C Immuno FS for the

detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics concerning; Measuring Range Specificity/Interferences Sensitivity/Limit of Detection

Precision (Reproducibility, Repeatability) Method Comparison Reference Ranges Literature 2. The stability of the reagent on board of the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by





January 2008/1

Gilford Express 550

Test Parameters Test Name Lactate Test LACT Test Bar Code #021 Test Type Endpoint Curve Type Blank Linear Units mg/dl No. of decimal places 1 Primary Wavelength 340 nm

Secondary Wavelength NONE

Read Time/ Interval 20 Sample Blank yes Factor * Calibration Interval 48 Normalization Interval No. of Calibrators 2 No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 2.000 Low A limit 0.000 High A Limit 2.000 Low Normal 4.5 High Normal 19.8 Linearity Limit 20.0 Curve S D Limit 0.25 Reagent Parameters Test Name Lactate Test LACT Test Bar Code #021 Sample Volume 4 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code LA1A Lag Time 240sec


Bar Code LA2A Lag Time 240sec

LACTATE FS

Order information

Cat. No. 1 4001 .. .. …

Notes

1. Please refer to the package insert for Lactate FS for detailed







3. Manufactured by





February 1999/2

LDH DGKC FS*


Method Optimized UV test according to DGKC (German Society of Clinical Chemistry)

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent 2 must be protected from light. For monoreagent mix 4 parts R1 + 1 part R2. This is stabile for 5 days at 2 - 8°C, 8 hours at 15 - 25°C.

Specimen

Serum or EDTA plasma. Avoid hemolysis! Loss of activity within 3 days at 2 - 8 °C < 8 % and at 15 – 25 °C < 2 %.

Components and concentration in the test

R1: Phosphate pH 7.5 50 mmol/l

Pyruvate 0,6 mmol/l

R2: NADH 0,18 mmol/l

Notes

1. Hemoglobin interferes. 2. The reagents contain Sodium Azide (0.095 %) as preservative.



37 °C Adults: 225 – 450 U/l

References 1. Empfehlungen der Deutschen Gesellschaft für Klinische

Chemie, Z. Klin. Chem. u. Klin. Biochem., 8, (1970), 658 2. Empfehlungen der Deutschen Gesellschaft für Klinische

Chemie, Z. Klin. Chem. u. Klin. Biochem., 10, (1972), 182 3. Elliot, B. A., Wilkinson, J. H., Clin. Sci., 24, (1963), 343 – 355 4. Weißhaar, D., Gossrau, E., Faderl, B., Med. Welt, 26,

(1975), 387 * fluid stable

Gilford Express 550

Test Parameters Test Name LDH opt. Test LDH Test Bar Code #017 Test Type Kinetic Curve Type Enzyme linear Units U/l No. of decimal places 0 Primary Wavelength 340 nm Secondary Wavelength 380 nm Read Time/ Interval 60 Sample Blank no Factor **-5550 Calibration Interval 999 Normalization Interval No. of Calibrators 1 No. of Replicates 2 Low Blank A Limit 1.000 High Blank A Limit 2.000 Low A limit 0.800 High A Limit 2.000 Low Normal 120 High Normal 240 Linearity Limit 1000 Curve S D Limit 20

Reagent Parameters Test Name LDH Test LDH Test Bar Code #017 Sample Volume 6 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code LDIA Lag Time 40 sec

Reagent 2 : Volume µl Diluent volume






November 2000/2

LDL-C SELECT FS*

Order information Cat. No. Kit size 1 4121 99 10 021 R1 4 x 20 ml + R2 1 x 20 ml 1 4121 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 1 4121 99 10 023 R1 1 x 800ml + R2 1 x 200 ml

Method Reagent 1 binds to LDL and protects it from enzyme reactions. Cholesterol esterase and oxidase react with non-LDL lipoproteins. The H2O2 produced by the reaction with non-LDL is decomposed by catalase in reagent 1.With the addition of reagent 2 the protecting agent is removed and the catalase inactivated. Cholesterol esterase and cholesterol oxidase react only with the LDL-C. The H2O2

produced gives a blue colored complex with a Trinder system.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Do not freeze the reagents! On board stability: 4 weeks at 2 - 8 °C

Specimen Serum, heparinized or EDTA plasma.

Stability: 5 days at 2 - 8 °C 3 months at below - 70 °C

Components and concentration in the test R1: Reagent pH 6.8

Goods buffer 20 mmol/l

Cholesterol esterase (CHE) 3 kU/l

Cholesterol oxidase (CHO) 3 kU/l HDAOS 0.48 mmol/l Catalase >500 kU/l Protecting reagent

R2: Reagent pH 7.0

Goods buffer 20 mmol/l

4-Aminoantipyrine 2.6 mmol/l Peroxidase (POD) >10 kU/l Sodium Azide Deprotecting reagent

Notes 1. The calibrator values were assigned by procedures traceable to

the National Reference System for Cholesterol (NRS/CHOL) and the calibrator level is around the medical decision level.

2. The reagent 2 contains Sodium Azide as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

Clinical interpretation

Normal / low risk < 130 mg/dl Borderline high risk 130 - 159 mg/dl High risk > 160 mg/dl

References 1. Assmann G. Lipid metabolism and atherosclerosis.

Stuttgart: Schattauer-Verlag, 1982. 2. Recommendation of the second Joint Task Force of

European and other Societies on Coronary Prevention. Prevention of coronary heart disease in clinical practice. Eur Heart J 1998;19: 1434-503.

3. Bachorik PS. Measurement of low-density lipoprotein cholesterol. In: Rifal N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC press,;1997.p.145-60.

4. Schaefer EJ, McNamara J. Overview of the diagnosis and treatment of lipid disorders. In: Rifal N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC press; 1997.p.25-48.

* fluid stable

Gilford Express 550

Test Parameters Test Name LDL Test LDL Test Bar Code # Test Type Endpoint Curve Type Blanked linear Units Mg/dl No. of decimal places 1 Primary Wavelength 600 nm

Secondary Wavelength NONE nm

Read Time/ Interval 20 Sample Blank yes Factor * Calibration Interval 120 Normalization Interval No. of Calibrators 2 No. of Replicates 2 Low Blank A Limit -0.010 High Blank A Limit 2.000 Low A limit 0.000 High A Limit 2.000 Low Normal # High Normal # Linearity Limit 400 Curve S D Limit USER Reagent Parameters Test Name LDL Test LDL Test Bar Code # Sample Volume 3 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 1 Predilution 1 Reagent Diluent

Reagent 1: Volume 260 µl Diluent Volume l

Bar Code LD1A Lag Time 240 secs


Bar Code LD2A Lag Time 240 sec





June 2003/2

Gilford Express 550

Test Parameters Test Name Lipase Test LIP Test Bar Code User Test Type Kinetic Curve Type Enzyme linear Units U/l No. of decimal places 0 Primary Wavelength 570 nm Secondary Wavelength None Read Time/ Interval 60 Sample Blank no Factor - Calibration Interval Each run Normalization Interval 1 No. of Calibrators 2 No. of Replicates User Low Blank A Limit 0.00 High Blank A Limit 2.30 Low A limit 0.00 High A Limit 2.30 Low Normal 0 High Normal 60 Linearity Limit 300 Curve S D Limit User

Reagent Parameters Test Name Lipase Test LIP Test Bar Code User Sample Volume 6 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code LPIA Lag Time 60 sec



LIPASE DC FS

Order information Cat. No. Kit size 1 4321 99 10 021 R1 5 x 20 ml + R2 1 x 25 ml 1 4321 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

1 4321 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml

Notes

1. Please refer to the package insert for Lipase DC FS for detailed







3. Manufactured by






May 2009/1

Gilford Express 550

Test Parameters Test Name Lpa Test Lpa Test Bar Code # Test Type Two point Curve Type Non-linear Units mg/dl No. of decimal places 1 Primary Wavelength 570 nm


Read Time/ Interval 240 Sample Blank yes Factor * Calibration Interval 48 Normalization Interval No. of Calibrators 6 No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 2.000 Low A limit 0.000 High A Limit 2.000 Low Normal 0 High Normal 30 Linearity Limit 130 Curve S D Limit * Reagent Parameters Test Name Lpa Test Lpa Test Bar Code # Sample Volume 5 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code TB1A Lag Time 240 sec



Lp(a) 21 FS

Order information

Cat. No. 1 7139 .. .. …

Notes

1. Please refer to the package insert for Lp(a) 21 FS for detailed





2. The stability of the reagent on board the analyser is 3 weeks

provided that contamination and evaporation are avoided.

3. Manufactured by





January 2007/2

MAGNESIUM XL FS*

Order information

Cat. No. Kit size 1 4610 99 10 021 R 5 x 25 ml + 1 x 3 ml standard 1 4610 99 10 026 R 6 x 100 ml 1 4610 99 10 023 R 1 x 1000 ml 1 4610 99 10 030 6 x 3 ml standard

Method Photometric test using xylidyl blue.

Principle Magnesium ions form a purple colored complex with xylidyl blue in alkaline solution. In presence of GEDTA, which complexes calcium ions, the reaction is specific. The intensity of the purple color is proportional to the magnesium concentration.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Do not freeze the reagents!

Specimen

Serum, plasma, cerebrospinal fluid (CSF) and urine. Do not use EDTA plasma. Acidify urine with some drops of conc. HCl to pH 3 – 4 and then dilute 1 + 4 with dist. water. Multiply the result by 5.

Stability in serum/plasma:

7 days at 20 – 25°C 7 days at 2 – 8°C 1 year at -20°C

Stability in urine:

3 days at 20 – 25°C 3 days at 2 – 8°C 1 year at -20°C

Components and Concentration in the Test

Reagent

Reagent pH 11.0 Ethanolamine 1 mol/l GEDTA 60 µmoll Xylidyl blue 110 µmol/l Detergents


Notes 1. Hemoglobin interferes.

2. For detailed product information see package insert

Reference range

Serum / plasma

Neonates 1.2 – 2.6 mg/dl (0.48 – 1.05 mmol/l) Children 1.5 – 2.3 mg/dl (0.60 – 0.95 mmol/l) Women 1.9 – 2.5 mg/dl (0.77 – 1.03 mmol/l) Men 1.8 – 2.6 mg/dl (0.73 – 1.06 mmol/l)

Urine 73 – 122 mg/24 h (3 – 5 mmol/24 h

CSF 2.1 – 3.3 mg/dl (0.85 – 1.35 mmol/l)

Performance Characteristics

Measuring Range The test has been developed to determine magnesium concentrations within a measuring range from 0.05 – 5 mg/dl (0.02 – 2.05 mmol/l). When values exceed this range samples should be diluted 1+4 with NaCl solution ( 9g/l) and the result multiplied by 5.

Sensitivity / Limit of detection The lower limit of detection is 0.05 mg/dl (0.02 mmol/l) fluid stable

Gilford Express 550

Test Parameters Test Name Magnesium Test MG Test Bar Code # User input Test Type Endpoint Curve Type Blank linear Units mmol/l No. of decimal places 1 Primary Wavelength 540nm


Read Time/ Interval 20 Sample Blank no Factor - Calibration Interval 24 hours Normalization Interval 24 hours No. of Calibrators 1 No. of Replicates 1 Low Blank A Limit 0.000 High Blank A Limit 2.00 Low A limit 0 High A Limit 2.00 Low Normal 0.8 High Normal 1.0 Linearity Limit 2.30 Curve S D Limit 10.0 Reagent Parameters Test Name Magnesium Test MG Test Bar Code # user input Sample Volume 3 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 1 Predilution 1 Reagent Diluent

Reagent 1: Volume 300µl Diluent Volume 0:µl

Bar Code # Lag Time 360 secs

Reagent 2: Volume µl : Diluent Volume

µl





October 2004/2

Gilford Express 550

Test Parameters Test Name CRP Test CRP Test Bar Code # Test Type Two point Curve Type Logit 5 Units mg/l No. of decimal places 1 Primary Wavelength 510nm


Read Time/ Interval 240 Sample Blank yes Factor * Calibration Interval 48 Normalization Interval No. of Calibrators 6 No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 2.000 Low A limit 0.000 High A Limit 2.000 Low Normal 0 High Normal 5 Linearity Limit 20 Curve S D Limit * Reagent Parameters Test Name CRP Test CRP Test Bar Code # Sample Volume 15 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 2 Predilution 1 Reagent Diluent





CRP U-hs High sensitive (hs) application

Order information

Cat. No. Kit size

1 7045 99 10 730 R1 3 x 20 ml + R2 3 x 20 ml Calibrator set for high sensitive (hs) range (5 levels) 1 7080 99 10 059 5 x 1 ml TruCal CRP hs

Notes 1. Please refer to the package insert for CRP U-hs for detailed





3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Straße 9, 65558 Holzheim, Germany




October 2004/2

Gilford Express 550

Test Parameters Test Name CRP Test CRP Test Bar Code # Test Type Two point Curve Type Logit 5 Units mg/l No. of decimal places 1 Primary Wavelength 510nm


Read Time/ Interval 240 Sample Blank yes Factor * Calibration Interval 48 Normalization Interval No. of Calibrators 6 No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 2.000 Low A limit 0.000 High A Limit 2.000 Low Normal 0 High Normal 5 Linearity Limit 300 Curve S D Limit * Reagent Parameters Test Name CRP Test CRP Test Bar Code # Sample Volume 3 µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 2 Predilution 1 Reagent Diluent





CRP U-hs Universal (U) application

Order information Cat. No. Kit size

1 7045 99 10 730 R1 3 x 20 ml + R2 3 x 20 ml Calibrator set for high sensitive (hs) range (5 levels) 1 7040 99 10 059 5 x 1 ml TruCal CRP U

Notes

1. Please refer to the package insert for CRP U-hs FS for detailed







3. Manufactured by





April 1999/2

TOTAL PROTEIN FS* Order information Cat. No. Kit size 10 231 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std 1 2311 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 231 023 R1 1 x 800 ml + R2 1 x 200 ml 10 230 030 6 x 3 ml standard

Method Colorimetric test, “Biuret“

Proteins together with Copper ions form a violet blue complex in alkaline solution. The absorbance of the color is directly proportional to the concentration.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 25 °C. Stability of standard: until expiry date, when stored at 2 – 8 °C

Specimen

Serum or plasma. Avoid hemolysis!


R1: Sodium Hydroxide 80 mmol/l

Potassium Sodium Tartrate 12.8 mmol/l

R2: Sodium Hydroxide 100 mmol/l

Potassium Sodium Tartrate 16 mmol/l Potassium Iodide 15 mmol/l Copper Sulphate 6 mmol/l

Standard: 5 g/dl

Notes

1. Serum or plasma from patients who have received large intravenous amounts of Polydextrans yields values which are too high with the Biuret method. In such cases the protein concentration should be determined by an alternative method (e. g. Kjeldahl).

2. The reagents contain Sodium Hydroxide. Do not swallow! If the reagents come in contact with skin of mucous membranes rinse immediately with water!


Adults: 6,2 – 8,4 g/dl Children 1 day – 4 weeks: 4,52 – 6,86 g/dl 2 – 12 months: 4,57 – 7,33 g/dl > 12 months: 5,85 – 8,01 g/dl

References

1. Henry, R. J., Sobel, C., Berkmann, S., Anal. Chem., 29, (1957), 1491

2. Peters, T., Clin. Chem., 14, (1968), 1147 3. Keller, H.: Klinisch-chemische Labordiagnostik für die Praxis,

2nd

edition, Georg Thieme Verlag, Stuttgart 1991, 263 * fluid stable

Gilford Express 550

Test Parameters Test Name T. Protein Test TP Test Bar Code # Test Type Endpoint Curve Type Blanked linear Units g/dl (g/l) No. of decimal places 1 (0) Primary Wavelength 540 nm Secondary Wavelength 600 nm Read Time/ Interval 20 Sample Blank no Factor * Calibration Interval 168 Normalization Interval No. of Calibrators 3 (2) No. of Replicates 2 Low Blank A Limit 0.010 High Blank A Limit 0.250 Low A limit -0.250 High A Limit 1.000 Low Normal 6.6 (66) High Normal 8.7 (87) Linearity Limit 15 (150) Curve S D Limit 0.25

Reagent Parameters Test Name T. Protein Test TP Test Bar Code # Sample Volume 6 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code TPIA Lag Time 240 sec







April 1999/2

Gilford Express 550

Test Parameters Test Name TPU Test TPU Test Bar Code # Test Type Endpoint Curve Type Blanked linear Units mg/l No. of decimal places 0 Primary Wavelength 600

Secondary Wavelength 0

Read Time/ Interval 20 Sample Blank no Factor Calibration Interval 168 Normalization Interval No. of Calibrators 2 No. of Replicates 2 Low Blank A Limit 0.000 High Blank A Limit 1.000 Low A limit -0.25 High A Limit 1.500 Low Normal High Normal Linearity Limit 1000 Curve S D Limit 20 Reagent Parameters Test Name TPU Test TPU Test Bar Code # Sample Volume 6µl Sample Diluent Predilution Ratio Rerun Dilution Ratio 2 Predilution 1 Reagent Diluent

Reagent 1: Volume 300µl Diluent Volume 0µl

Bar Code TP1A Lag Time 240 secs

Reagent 2 : Volume Diluent Volume

Bar Code Lag Time





TOTAL PROTEIN UC FS

Order information

Cat. No. 1 0210 .. .. …

Notes

1. Please refer to the package insert for Total Protein UC FS for

detailed information about the test on the following






3. Manufactured by


February 2003/2

GOT (ASAT) IFCC mod. FS* with / without Pyridoxal-5-phosphate


10 501 030 6 x 3 ml For determination with Pyridoxal-5-phosphate activation additionally required:

Method Optimized UV test according to the recommendations of IFCC (International Federation of Clinical Chemistry)

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent 2 must be protected from light. For monoreagent mix 4 parts R1 + 1 part R2. This is stabile for 4 weeks at 2 - 8°C, 5 days at 15 - 25°C.

Specimen Serum heparinized or EDTA plasma. Avoid hemolysis! Loss of activity within 3 days at 2 - 8 °C < 8 % and at 15 – 25 °C < 10 %.


L-Aspartate 240 mmol/l

MDH > 600 U/l

LDH > 600 U/l

R2: 2-Oxoglutarate 12 mmol/l

NADH 0.18 mmol/l

Pyridoxal-5-phosphate FS GOOD‘s Buffer pH 9.6 0.1 mol/l Pyridoxal-5-phosphate 13.8 mmol/l

Notes 1. For the determination with Pyridoxal-5-phosphate activation a

supplementary kit (Cat. No. 10501030) is necessary. Mix 1 part of P-5-P with 100 parts of Reagent 1.

Stability after mixing: 6 days at 2 – 8 °C 24 h at 15 – 25 °C

2. Hemoglobin interferes. 3. The reagents contain Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and miucous membranes!

Normal range without Pyridoxal-5-phosphate activation

(see reference 1)

37 °C Men up to 37 U/l Women up to 31 U/l

with Pyridoxal-5-phosphate activation (see reference 6)

37 °C Men 10 – 50 U/l Women 10 – 35 U/l

References 1. Wallhöfer, H., et al.: Synopsis der Leberkrankheiten,

Georg Thieme Verlag, Stuttgart 1974 2. Thefeld, W., et al., Dtsch. Med. Wschr., 99, (1974), 343 – 351 3. Bergmeyer, H. U., et al., J. Clin. Chem. Clin. Biochem., 24,

(1986), 497 – 510 4. Deutsche Gesellschaft für Klinische Chemie, Eur. J. Clin.

Chem. Clin. Biochem., 31, (1993), 901 - 909 5. Lorentz, K., Sonntag, O., DG Klinische Chemie Mitteil., 24,

(1993), 101 - 105 6. Lorentz, K., Lübeck, G., Röhle, G., Siekmann, L., DG Klinische

Chemie Mitteil., 26, (1993), 190

* fluid stable

Gilford Express 550

Test Parameters Test Name AST opt. Test AST Test Bar Code #005 Test Type Kinetic Curve Type Enzyme linear Units U/l No. of decimal places 0 Primary Wavelength 340 nm Secondary Wavelength 380 nm Read Time/ Interval 60 Sample Blank no Factor **-1102 Calibration Interval 999 Normalization Interval No. of Calibrators 1 No. of Replicates 2 Low Blank A Limit 0.800 High Blank A Limit 2.000 Low A limit 0.500 High A Limit 2.000 Low Normal 0 High Normal 37 Linearity Limit 400 Curve S D Limit 20

Reagent Parameters Test Name AST opt. Test AST Test Bar Code # Sample Volume 20 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent


Bar Code # Lag Time 120 sec


Bar Code # Lag Time sec





out of our control

February 1999/2

GPT (ALAT) IFCC mod. FS* with / without Pyridoxal-5-phosphate


For determination with Pyridoxal-5-phosphate activation additionally required: 10 501 030 6 x 3 ml

Method Optimized UV test according to the recommendations of IFCC (International Federation of Clinical Chemistry)

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent 2 must be protected from light. For monoreagent mix 4 parts R1 + 1 part R2. This is stabile for 4 weeks at 2 - 8°C, 5 days at 15 - 25°C.

Specimen Serum heparinized or EDTA plasma. Avoid hemolysis! Loss of activity within 3 days at 2 - 8 °C < 10 % and at 15 – 25 °C < 17 %.


L-Alanine 500 mmol/l

LDH > 1200 U/l

R2: 2-Oxoglutarate 15 mmol/l

NADH 0.18 mmol/l

Pyridoxal-5-phosphate FS GOOD‘s Buffer pH 9.6 0.1 mol/l Pyridoxal-5-phosphate 13.8 mmol/l

Notes 1. For the determination with Pyridoxal-5-phosphate activation a

supplementary kit (Cat-No. 10501030) is necessary. Mix 1 part of P-5-P with 100 parts of Reagent 1. Stability after mixing: 6 days at 2 – 8 °C 24 h at 15 – 25 °C

2. The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and miucous membranes!

Normal range without Pyridoxal-5-phosphate activation

(see reference 1)

37 °C Men up to 42 U/l Women up to 32 U/l

with Pyridoxal-5-phosphate activation (see reference 6)

37 °C Men 10 – 50 U/l Women 10 – 35 U/l

References 1. Wallhöfer, H., et al.: Synopsis der Leberkrankheiten,

Georg Thieme Verlag, Stuttgart 1974 2. Thefeld, W., et al., Dtsch. Med. Wschr., 99, (1974), 343 – 351 3. Bergmeyer, H. U., et al., J. Clin. Chem. Clin. Biochem., 24,

(1986), 481 - 493 4. Deutsche Gesellschaft für Klinische Chemie, Eur. J. Clin.

Chem. Clin. Biochem., 31, (1993), 901 - 909 5. Lorentz, K., Sonntag, O., DG Klinische Chemie Mitteil., 24,

(1993), 101 - 105 6. Lorentz, K., Lübeck, G., Röhle, G., Siekmann, L., DG Klinische

Chemie Mitteil., 26, (1993), 190

* fluid stable

Gilford Express 550

Test Parameters Test Name ALT opt. Test ALT Test Bar Code #003 Test Type Kinetic Curve Type Enzyme linear Units U/l No. of decimal places 0 Primary Wavelength 340 nm Secondary Wavelength 380 nm Read Time/ Interval 60 Sample Blank no Factor **-1213 Calibration Interval 999 Normalization Interval No. of Calibrators 1 No. of Replicates 2 Low Blank A Limit 0.800 High Blank A Limit 2.000 Low A limit 0.500 High A Limit 2.000 Low Normal 0 High Normal 22 Linearity Limit 600 Curve S D Limit 20

Reagent Parameters Test Name ALT opt. Test ALT Test Bar Code #003 Sample Volume 20 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution Reagent Diluent


Bar Code ALIH Lag Time 60 sec







out of our control

Febraury 1999/2

TRIGLYCERIDES FS*

Order information Cat. No. Kit size 10 571 021 R 5 x 25 ml + 1 x 3 ml standard 1 5710 99 10 026 R 6 x 100 ml 10 571 023 R 1 x 1000 ml 10 570 030 6 x 3 ml standard

Method Colorimetric enzymatic test, “GPO“

Determination of Triglycerides after enzymatic splitting with Lipoprotein Lipase. Indicator is Chinonimine, which is generated from 4-Aminoantipyrine and Phenol by Hydrogen Peroxide under the catalytic action of Peroxidase.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent must be protected from light.

Specimen

Serum, heparinized or EDTA plasma. Avoid hemolysis!


GOOD‘ s buffer pH 7.2 50 mmol/l 4-Chlorophenol 4 mmol/l

Mg2+ 15 mmol/l

ATP 2 mmol/l Glycerokinase > 0.4 KU/l Peroxidase > 2 KU/l Lipoprotein Lipase > 2 KU/l 4-Aminoantipyrine 0.5 mmol/l Glycerol-3- phosphate Oxidase > 0.5 KU/l


Notes

1. To correct for free Glycerol, subtract 10 mg/dl (0.11 mmol/l) from the Triglycerides result.

2. Ascorbic acid interferes. 3. The reagent contains Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes !

Clinical interpretation (see reference 1)

Suspect over: 150 mg/dl (1.71 mmol/l) Increased over: 200 mg/dl (2.28 mmol/l)

References

1. Schettler, G., Nüssel, E., Arbeitsmedizin Sozialmedizin Präventivmedizin, 10, (1975), 25

2. Jacobs, N. J., Vandemark, P. J., Arch. Biochem. Biophys., 88, (1960), 250 – 255

3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 4. Koditschek, L. K., Umbreit, W. W., Journ. of Bacteriol., 98,

(1969), 1063 - 1068

* fluid stable

Gilford Express 550

Test Parameters Test Name Triglyceride Test TRI Test Bar Code #019 Test Type Endpoint Curve Type Blanked linear Units mg/dl No. of decimal places 0 Primary Wavelength 510 nm Secondary Wavelength 600 nm Read Time/ Interval 20 Sample Blank no Factor * Calibration Interval 24 Normalization Interval No. of Calibrators 2 No. of Replicates 2 Low Blank A Limit -0.010 High Blank A Limit 0.450 Low A limit -0.010 High A Limit 1.600 Low Normal 50 High Normal 200 Linearity Limit 1000 Curve S D Limit 10

Reagent Parameters Test Name Triglyceride Test TRI Test Bar Code # Sample Volume 3 µl Sample Diluent Predilution Ratio Reran Dilution Ratio 1 Predilution 1 Reagent Diluent

Reagent 1: Volume 300µl

Diluent Volume µl

Bar Code TGIB Lag Time 480 sec







November 2005/2

UREA FS*

Order information Cat. No. Kit size 10 310 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 3101 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 310 023 R1 1 x 800 ml + R2 1 x 200 ml 10 310 030 6 x 3 ml standard

Method Enzymatic UV test, “Urease - GLDH“

Urease acts on Urea to produce Ammonium and Carbonate ions. Glutamic Dehydrogenase catalyzes the oxidation of Ammonium ions with 2-Oxoglutarate and NADH under formation of Glutamate. The decrease of NADH is proportional to the Urea concentration.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Stability of standard: until expiry date, when stored at 2 – 25 °C Specimen Serum, plasma (no Ammonium Heparin), fresh urine. For serum / plasma: Avoid hemolysis! Dilute urine 1 + 100 with dist. water Stability in serum / plasma: 1 week at 2 – 8 °C 2 days at 15 – 25 °C

Components and concentration in the test R1: Tris buffer pH 7.8 120 mmol/l

2-Oxoglutarate 7 mmol/l ADP 0.6 mmol/l Urease > 6 KU/l GLDH > 1 KU/l

R2: NADH 0.25 mmol/l


NOTES 1. The reagents contain Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes!

2. To convert Urea into BUN multiply by 0.47; to convert BUN into Urea multiply by 2.14.


Serum / plasma: 10 - 50 mg/dl (1.7 - 8.3 mmol/l) Urine: 20 - 35 g/24 h (333 - 583 mmol/24 h)

References 1. Talke, H., Schubert, G. E., Klin. Wschr., 43, (1965), 174 2. MacKay, E. M., MacKay, L. L., J. Clin. Invest., 4, (1927), 295 3. Sarre, H.: Nierenkrankheiten, Georg Thieme Verlag,

Stuttgart 1959 * fluid stable

Gilford Express 550

Test Parameters Test Name Urea Test UREA Test Bar Code #008 Test Type Kinetic Curve Type Blanked linear Units mg/dl No. of decimal places 1 Primary Wavelength 340 nm Secondary Wavelength 380 nm Read Time/ Interval 40 Sample Blank no Factor * Calibration Interval 24 Normalization Interval No. of Calibrators 3 (2) No. of Replicates 2 Low Blank A Limit 0.600 High Blank A Limit 2.000 Low A limit 0.600 High A Limit 2.000 Low Normal 10 (5) High Normal 50 (25) Linearity Limit 350 (200) Curve S D Limit 20

Reagent Parameters Test Name Urea Test UREA Test Bar Code #008 Sample Volume 3µl Sample Diluent Predilution Ratio Reran Dilution Ratio 2 Predilution 1 Reagent Diluent

Reagent 1: Volume 275 µl

Diluent Volume 0 µl

Bar Code BUIA Lag Time 30 sec






Documents

Gilford Express 550 - Biosys