Selectra Pro XS, Flexor EL80 Manual Configuración de Reactivos

7/24/2019 Selectra Pro XS, Flexor EL80 Manual Configuracin de Reactivos

1/123

SEPPIM S.A.S

Zone industrielle

61500 SEES FRANCE

: +33 (0)2 33 81 21 00 : +33 (0)2 33 28 77 81 Version: CAT-1 May 2009

APPLICATIONS


2/123

AA-PROXS/EL80-CAT-1

BIOCHEMISTRY

L

ACID PHOSPHATASE PACI-1 PRO LACTATE LACT-1 PRO

ALBUMIN ALBU-1 CE LDH-L SL Two-reagent procedure LLSLbi-1 PRO

ALP(DEA)SL One-reagent procedure PASLmono-1 CE LDH-P 4+1 SL One reagent procedure LDSL4+1mono-1 CE

ALP(DEA)SL Two-reagent procedure PASLbi-1 CE LDH-P 4+1 SL Two reagent procedure LDSL4+1bi-1 CE

ALP(DEA) PALC-1 PRO LDH-P LDHP-1 PRO

ALT / GPT 4+1 SL One-reagent procedure ALSL4+1mono-1 CE

ALT / GPT 4+1 SL Two-reagent procedure ALSL4+1bi-1 CE

ALT / GPT ALAT-1 PRO MAMYLASE SL AMSL-1 CE MAGNESIUM CALMAGITE One-reagent procedure MAGNmono-1 CE

AST / GOT 4+1 SL One-reagent procedure ASSL4+1mono-1 CE MAGNESIUM CALMAGITE Two-reagent procedure MAGNbi-1 CE

AST / GOT 4+1 SL Two-reagent procedure ASSL4+1bi-1 CE MICROPROTEIN PRTP-1 CE

AST / GOT ASAT-1 PRO

B P

BILIRUBIN TOTAL 4+1 BITO-1 CE PHOSPHORUS PHOS-1 CE

BILIRUBIN DIRECT 4+1 BIDI-1 CE

C T

CALCIUM ARSENAZO CALA-1 CE TOTAL PROTEIN PRTB-1 CE

CALCIUM OCPC One-reagent procedure CALOmono-1 PRO TRIGLYCERIDES MONO SL NE TGMLN-1 CE

CHLORIDE CHLO-1 CE TRIGLYCERIDES TRIG-1 PRO

CHOLESTEROL SL CHSL-1 CE

CHOLESTEROL CHOL-1 PRO

CHOLESTEROL HDL SL 2G HDLL-1 CE U

CHOLESTEROL LDL SL 2G LDLL-1 CE UREA UV One-reagent procedure URSLmono-1 CE

HDL CHOLESTEROL HDLC-1 PRO UREA UV Two-reagent procedure URSLbi-1 CE

CHOLINESTERASE CHES-1 PRO UREA UV URUV-1 PROCK-MB SL One-reagent procedure CMSLmono-1 CE URIC ACID MONO SL AUML-1 CE

CK-MB CKMB-1 PRO URIC ACID SL One-reagent procedure AUSLmono-1 CE

CK NAC SL One-reagent procedure CKSLmono-1 CE URIC ACID SL Two-reagent procedure AUSLbi-1 CE

CK NAC CKNA-1 PRO URIC ACID ACUR-1 PRO

COPPER One-reagent procedure CUIVmono-1 PRO

CREATININE JAFFE One-reagent procedure CRCOmono-1 CE

CREATININE JAFFE Two-reagent procedure CRCObi-1 CE

CREATININE PAP SL Two-reagent procedure CRSLbi-1 CE

G SPECIFIC PROTEINSGAMMA GT SL One-reagent procedure GASLmono-1 CE

GAMMA GT SL Two-reagent procedure GASLbi-1 CE APOA1 IP IAPA-1 CE

GAMMA GT GAGT-1 PRO APOB IP IAPB-1 CE

GLUCOSE HK SL One-reagent procedure GHSLmono-1 CE CRP IP ICRP-1 CE

GLUCOSE HK SL Two-reagent procedure GHSLbi-1 CE HAPTOGLOBIN IP IHAP-1 CE

GLUCOSE PAP SL GPSL-1 CE HbA1c HBAC-1 CE

GLUCOSE PAP GLUP-1 PRO IgA IP IIGA-1 CE

IgG IP IIGG-1 CE

IgM IP IIGM-1 CE

I ALBUMIN IP IMAL-1 CE

IRON FERROZINE FEFR-1 CE OROSOMUCOID IP IORO-1 CE

PREALBUMIN IP IPAL-1 CE

TRANSFERRIN IP ITRF-1 CE

CE = In agreement with 98/78/EC directive, these applications have been validated according to our internal specific procedure (PO-12-105) based on Vassault protocols

1. Vassault, A., et al., Protocole de validation de techniques (Document B, stade 3). Ann. Biol. Clin ., (1986), 44, 686.

2. Vassault, A., et al., Analyses de biologie mdicale: spcifications et normes d'acceptabilit l'usage de la validation des techniques,. Ann. Biol. Clin . (1999), 57, 685.

3 Evaluation of Precision Performance of Quantitat ive Measurement Methods; Approved GuidelineSecond Edition. CLSI (NCCLS) document EP5-A2, vol 24, No. 25, August 2004.

4. Evaluation of the Linearity of the Measurement of Quantitative Procedures: a Statistical Approach; Approved Guideline. CLSI (NCCLS) document EP6-A, vol 23, No. 16, April 2003

5. Method Comparison and Bias estimation Using Patient Samples; Approved GuidelineSecond Edition. CLSI (NCCLS) document EP9-A2, vol 22, No. 19, September 2002

6. Interference Testing in Clinical Chemistry; Approved GuidelineSecond Edition. CLSI (NCCLS) document EP7-A2, vol 25, No. 27, November 2005

PR0 = PROPOSAL: These applications have been established theoretically. It is advised to check it.

2/123


3/123

Ref : PACI-0030 18 x 3 mL

Instruction for use :

General Sample types

Name Normal

Abbreviated name PACI Allowed Yes

Code Predilution No 0

Mode Reference values

Wavelength 405 nm 0 Male XXX - XXX U/L

Units U/L Female XXX - XXX U/L

Decimals 0 Pediatric XXX - XXX U/L

Test repeats 1 Panic XXX - XXX U/L

Controls

Control 1

Concentration limits 0 - 40 U/L Control 2

Calibrator name Control 3

Correlation

Prozone check Correlation factor 1.000

Correlation offset 0.000 U/L

General Measurement

Name Slope Blank No 0 0

Predilution No 0 Delay, min. time 307 0 106 sec

Sample

Sample blank No Alinearity 10 %normal volume rerun volume* Factor 823.00

20.0 L 15.0 l Absorbance limits

Reagents Absorbance 0.000 - 3.000 Abs

Reagent blank Yes Repeats 3 R. Absorbance 0.000 - 3.000 Abs

normal volume rerun volume*

Reagent addition at - 2.25 minutes (R1) R. Abs. deviation 3.000 Abs

200 L 205 l

Reagent addition at 2.90 minutes (R2) 0

0 L 0 l 0 9.000 0 9.000 0

Reagent addition at 4.70 minutes (R3) 0 9.000 0 9.000 0

0 L 0 l 0 9.000 0

* : For information only

ACID PHOSPHATASETOTAL AND PROSTATIC

Testpa

rameters1

Testparameters2

No

ACID PHOSPHATASE

APPLICATION Selectra ProXS / Flexor EL80 PROPOSAL

XXX: Enter data by the user

ACID PHOSPHATASE

Kinetic

XXX

XXX

XXX

Modification from the previous version

(05/2009)

AA-PROXS/EL80-PACI-1

3/123


4/123

Ref : ALBU-0250 12 x 20 mL

ALBU-0600 2 x 125 mL

ALBU-0700 4 x 250 mL



Name Normal

Abbreviated name ALB Allowed Yes

Code 100 Predilution No 0


Wavelength 620 nm 0 Male XXX - XXX g/dL

Units g/dL Female XXX - XXX g/dL

Decimals 2 Pediatric XXX - XXX g/dL

Test repeats 1 Panic XXX - XXX g/dL

Controls

Control 1

Concentration limits 1.5 - 6 g/dL Control 2


Correlation


Correlation offset 0.000 g/dL

General Measurement


Predilution No 0 Incubation time 4.5 min 0

Sample

Sample blank No 0 0

normal volume rerun volume* Factor 1.00



Reagent blank Yes 3 R. Absorbance 0.100 - 0.300 Abs


Reagent addition at - 2.25 minutes (R1) 0 9.000 0

360 L 398 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0

Calibrator Predilution

Name Auto predilution No

Number of standards 1 0

Calibration accepted - 0 0

Repeats 3 Cut-off

Interval 28 days Cut-off No

Curvefit 0

0 0 0

0 0 0 9.000 9.000

Auto accept calibration Yes 0 9.000 9.000

N Used Concentration

#1 Standard #1 XXX 0

0 0

0 0

0 0 * : For information only0 0

0 0

0 0

0 0

Testp

arameters1

Testparameters2

FAUX

FAUX

0

Calibration

0

FAUX

FAUX

XXX

No

ALBUMIN

ALBUMIN

ALBUMIN

End point monochromatic

FAUX

XXX

XXX


FAUX

FAUX

APPLICATION Selectra ProXS / Flexor EL80

XXX

XXX

FAUX


(05/2009)

AA-PROXS/EL80-ALBU-1

4/123


5/123

Ref : ALBU-0250 12 x 20 mL

ALBU-0600 2 x 125 mL

ALBU-0700 4 x 250 mL


ALBUMIN


0 0

PERFORMANCE DATA

Analytical rangeThe reagent is linear from 1.5 to 6 g/dL.

Detection limi tDetermined according to SFBC protocol, the detection limit is equal to 0.03 g/dL.

Precision

Within run reproducibility Between run reproducibility

N CV%

Level 1 20 Level 1 1.9%



CorrelationA comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples.

The sample concentrations were between 1.42 and 5.96 g/dL.

The parameters of linear regression are as follows :

Correlation coefficient (r) :0.9987

Linear regression : y= 1.0334 x - 0.12 g/dL

InterferencesAccording to SFBC recommendations some studies have been performed to determine the level of interference

from different compounds:

Unconjugated bilirubin :No significant interference up to 35 mg/dL.

Conjugated bilirubin :No significant interference up to 25 mg/dL.

Haemoglobin: Positive bias from 350 mg/dL on normal human serum and from 50 mg/dL on pathological human serum.

Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent.

Other compounds may interfere (see product insert).

On board stability (refrigerated position)The reagent is stable 4 weeks on analyser without recalibrating.

3.26

4.68

FAUX

4.69 20

20

Mean (g/dL) NCV%

0.8%

0.7%

0.6%

Mean (g/dL)

2.11

3.30

2.13 20


(05/2009)

AA-PROXS/EL80-ALBU-1

5/123


6/123

Ref : PASL-0400 2 x 62.5 mL

PASL-0420 4 x 62.5 mL

PASL-0500 5 x 125 mL



Name Normal

Abbreviated name PASL Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample

Sample blank No Alinearity 10 %







250 L 252 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0



Number of standards 1 0Calibration accepted - 0 0

Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000



#1 Standard #1 xxx 0

0 0

0 0


0 00 0

0 0

Tes

tparameters1

Testparameters2

FAUX

FAUX

0

Calibration

0

FAUX

XXX


FAUX

ALP (DEA) SL

ALP (DEA) SLONE-REAGENT PROCEDURE

XXX

XXX

XXX


Kinetic

FAUX

XXX

No

ALP (DEA) SL

FAUX

FAUX

FAUX


(05/2009)

AA-PROXS/EL80-PASLmono-1

6/123


7/123

Ref : PASL-0400 2 x 62.5 mL

PASL-0420 4 x 62.5 mL

PASL-0500 5 x 125 mL



ALP (DEA) SLONE-REAGENT PROCEDURE

0 0

PERFORMANCE DATA

Analytical rangeThe reagent is linear from 20 to 900 U/L.

Detection limitDetermined according to SFBC protocol, the detection limit is equal to 5 U/L.

Precision


N CV%





The sample concentrations were between 20 and 1041 U/L.



Linear regression : y= 1.0284 x + 1.5 U/L



Unconjugated bilirubin :No significant inteference up to 36 mg/dL.


Hemoglobin: No significant interference up to 500 mg/dL



On board stability (refrigerated position)

The working reagent is stable 3 weeks on analyser with a new calibration every week.

33

711

FAUX

720 20

20134

Mean (U/L)

37

N

20

137

Mean (U/L)

0.6%

0.6%

1.7%

CV%


(05/2009)

AA-PROXS/EL80-PASLmono-1

7/123


8/123

Ref : PASL-0230 4 x 25 mL

PASL-0400 2 x 62.5 mL

PASL-0420 4 x 62.5 mL

Instruction for use : PASL-0500 5 x 125 mL


Name Normal

Abbreviated name PASL Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample





Reagent blank Yes 3 R. Absorbance -0.050 - 0.050 Abs


Reagent addition at - 2.25 minutes (R1) Substrate depletion 0.100 Abs

200 L 202 l


0 L 0 l 0 9.000 0 9.000 0


50 L 50 l 0 9.000 0




Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 00 0

0 0

ALP (DEA) SLTWO-REAGENT PROCEDURE

XXX

FAUX


XXX

XXX

FAUX

XXX


FAUX

FAUX

FAUX

FAUX

Calibration

0

FAUX

0

FAUX

Tes

tparameters1

Testparameters2

XXX

No

ALP (DEA) SL

ALP (DEA) SL

Kinetic


(05/2009)

AA-PROXS/EL80-PASLbi-1

8/123


9/123

Ref : PASL-0230 4 x 25 mL

PASL-0400 2 x 62.5 mL

PASL-0420 4 x 62.5 mL

Instruction for use : PASL-0500 5 x 125 mL

ALP (DEA) SLTWO-REAGENT PROCEDURE


0 0

PERFORMANCE DATA



Precision


N CV%








Linear regression : y= 1.038 x - 0.08 U/L



Unconjugated bilirubin :No significant inteference up to 36 mg/dL.


Hemoglobin: No significant interfeence up to 500 mg/dL




The reagents are stable 3 weeks on analyser with a new calibration every week.

N

20 34

706

Mean (U/L)

14920

CV%Mean (U/L)

40

712

147

0.4%

0.6%

1.1%

20

FAUX


(05/2009)

AA-PROXS/EL80-PASLbi-1

9/123


10/123

Ref : PALC-0030 20 x 3 mL

PALC-0200 12 x 20 mL



Name Normal

Abbreviated name PALC Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample








250 L 252 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0





Repeats 3 Cut-off

Interval xxx days Cut-off No

Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0

Testp

arameters1

Testparameters2

FAUX

FAUX

0

Calibration

FAUX

FAUX

ALP(DEA)

XXX

0


XXX

ALP(DEA)

Kinetic

FAUX

XXX

XXX

FAUX


FAUX

FAUX

XXX

No

ALP(DEA)


(05/2009)

AA-PROXS/EL80-PALC-1

10/123


11/123

Ref : ALSL-0410 2 x 62.5 mL

ALSL-0430 4 x 62.5 mL

ALSL-0510 5 x 125 mL



Name Normal

Abbreviated name ALSL Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample








300 L 300 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0




Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 00 0

0 0

ALT / GPT 4+1 SLONE-REAGENT PROCEDURE

XXX

FAUX


XXX

XXX

FAUX

XXX


FAUX

FAUX

FAUX

FAUX

Calibration

0

FAUX

0

FAUX

Tes

tparameters1

Testparameters2

XXX

No

ALT / GPT 4+1 SL

ALT / GPT 4+1 SL

Kinetic


(05/2009)

AA-PROXS/EL80-ALSL4+1mono-1

11/123


12/123

Ref : ALSL-0410 2 x 62.5 mL

ALSL-0430 4 x 62.5 mL

ALSL-0510 5 x 125 mL


ALT / GPT 4+1 SLONE-REAGENT PROCEDURE


0 0

PERFORMANCE DATA


Detection limitDetermined according to SFBC protocol, the detection limit is equal to 1.5 U/L.

Precision


N CV%




CorrelationA comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 30 human sera samples.




Linear regression : y= 0.9747 x + 1.6 U/L



Unconjugated bilirubin :Negative bias from 15 mg/dL.

Conjugated bilirubin :Negative bias from 16 mg/dL.



Note:

Hemolysed sera should not be used since significant haemolysis may increase ALT concentrations

because of high levels of ALT in erythrocytes.

On board stability (refrigerated position)The working reagent is stable 2 weeks on analyser without recalibrating.

N

20 17

202

Mean (U/L)

5020

CV%Mean (U/L)

19

207

47

0.2%

0.6%

1.4%

20

FAUX


(05/2009)

AA-PROXS/EL80-ALSL4+1mono-1

12/123


13/123

Ref : ALSL-0250 8 x 25 mL

ALSL-0410 2 x 62.5 mL

ALSL-0430 4 x 62.5 mL

Instruction for use : ALSL-0455 4 x 55 mL

ALSL-0510 5 x 125 mL


Name Normal

Abbreviated name ALSL Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample







Reagent addition at - 2.25 minutes (R1) Substrate depletion -0.500 Abs

240 L 240 l


0 L 0 l 0 9.000 0 9.000 0


60 L 60 l 0 9.000 0




Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 00 0

0 0

FAUX

Tes

tparameters1

Testparameters2

FAUX

FAUX

0

Calibration

0

ALT / GPT 4+1 SL

XXX

FAUX

ALT / GPT 4+1 SLTWO-REAGENT PROCEDURE

XXX


Kinetic

XXX

No

ALT / GPT 4+1 SL

FAUX

FAUX


FAUX

XXX

XXX

FAUX


(05/2009)

AA-PROXS/EL80-ALSL4+1bi-1

13/123


14/123

Ref : ALSL-0250 8 x 25 mL

ALSL-0410 2 x 62.5 mL

ALSL-0430 4 x 62.5 mL

Instruction for use : ALSL-0455 4 x 55 mL

ALSL-0510 5 x 125 mL

ALT / GPT 4+1 SLTWO-REAGENT PROCEDURE


0 0

PERFORMANCE DATA



Precision


N CV%















Note:

Hemolysed sera should not be used since significant haemolysis may increase ALT concentrations

because of high levels of ALT in erythrocytes.

On board stability (refrigerated position)The reagents are stable 4 weeks on analyser without recalibrating.

FAUX

211 20

2046

Mean (U/L)

19

Mean (U/L)

20

217

N

20

0.4%

1.2%

2.8%

CV%

53


(05/2009)

AA-PROXS/EL80-ALSL4+1bi-1

14/123


15/123

Ref : ALAT-0200 12 x 20 mL

ALAT-0400 9 x 50 mL



Name Normal

Abbreviated name ALAT Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample








250 L 262 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0





Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0 FAUX

XXX

XXX

FAUX

FAUX

XXX

No

ALT/GPT

FAUX

FAUX

ALT/GPT

XXX

0


ALT/GPT

Kinetic


XXX

FAUX

Testp

arameters1

Testparameters2

FAUX

FAUX

0

Calibration


(05/2009)

AA-PROXS/EL80-ALAT-1

15/123


16/123

Ref : AMSL-0230 6 x 20 mL

AMSL-0390 1 x 50 mL

AMSL-0400 6 x 50 mL



Name Normal

Abbreviated name AMSL Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample








300 L 301 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0





Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0

AMYLASE SL

XXX

FAUX


XXX

XXX

FAUX

XXX


FAUX

FAUX

FAUX

FAUX

Calibration

0

FAUX

0

FAUX

Testp

arameters1

Testparameters2

XXX

No

AMYLASE SL

AMYLASE SL

Kinetic


(05/2009)

AA-PROXS/EL80-AMSL-1

16/123


17/123

Ref : AMSL-0230 6 x 20 mL

AMSL-0390 1 x 50 mL

AMSL-0400 6 x 50 mL


AMYLASE SL


0 0

PERFORMANCE DATA


Detection limi tDetermined according to SFBC protocol, the detection limit is equal to 2 U/L.

Precision


N CV%











Unconjugated bilirubin :Negative bias from17 mg/dL on pathological human.

No significant interference up to 35 mg/dL on normal human sera.

Conjugated bilirubin :Negative bias from 21mg/dL on pathological human.

No significant interference up to 25 mg/dL on normal human sera.

Haemoglobin: No significant interference up to 400 mg/dL.




N

20 52

404

Mean (U/L)

15620

CV%Mean (U/L)

52

403

154

0.6%

0.7%

1.2%

20

FAUX


(05/2009)

AA-PROXS/EL80-AMSL-1

17/123


18/123

Ref : ASSL-0410 2 x 62.5 mL

ASSL-0430 4 x 62.5 mL

ASSL-0510 5 x 125 mL



Name Normal

Abbreviated name ASSL Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample








300 L 300 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0




Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 00 0

0 0

FAUX

Tes

tparameters1

Testparameters2

FAUX

FAUX

0

Calibration

0

AST / GOT 4+1 SL

XXX

FAUX

AST / GOT 4+1 SLONE-REAGENT PROCEDURE

XXX


Kinetic

XXX

No

AST / GOT 4+1 SL

FAUX

FAUX


FAUX

XXX

XXX

FAUX


(05/2009)

AA-PROXS/EL80-ASSL4+1mono-1

18/123


19/123

Ref : ASSL-0410 2 x 62.5 mL

ASSL-0430 4 x 62.5 mL

ASSL-0510 5 x 125 mL


AST / GOT 4+1 SLONE-REAGENT PROCEDURE


0 0

PERFORMANCE DATA



Precision


N CV%














Note:

Hemolysed sera should not be used since significant haemolysis may increase AST concentrations

because of high levels of AST in erythrocytes.


The working reagent is stable 2 weeks on analyser without recalibrating.

FAUX

182 20

2054

Mean (U/L)

19

Mean (U/L)

20

193

N

20

0.3%

2.3%

2.1%

CV%

44


(05/2009)

AA-PROXS/EL80-ASSL4+1mono-1

19/123


20/123

Ref : ASSL-0250 8 x 25 mL

ASSL-0410 2 x 62.5 mL

ASSL-0430 4 x 62.5 mL

Instruction for use : ASSL-0455 4 x 55 mL

ASSL-0510 5 x 125 mL


Name Normal

Abbreviated name ASSL Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample







Reagent addition at - 2.25 minutes (R1) Substrate depletion -0.500 Abs

240 L 240 l


0 L 0 l 0 9.000 0 9.000 0


60 L 60 l 0 9.000 0




Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 00 0

0 0

AST / GOT 4+1 SLTWO-REAGENT PROCEDURE

XXX

FAUX


XXX

XXX

FAUX

XXX


FAUX

FAUX

FAUX

FAUX

Calibration

0

FAUX

0

FAUX

Tes

tparameters1

Testparameters2

XXX

No

AST / GOT 4+1 SL

AST / GOT 4+1 SL

Kinetic


(05/2009)

AA-PROXS/EL80-ASSL4+1bi-1

20/123


21/123

Ref : ASSL-0250 8 x 25 mL

ASSL-0410 2 x 62.5 mL

ASSL-0430 4 x 62.5 mL

Instruction for use : ASSL-0455 4 x 55 mL

ASSL-0510 5 x 125 mL

AST / GOT 4+1 SLTWO-REAGENT PROCEDURE


0 0

PERFORMANCE DATA



Precision


N CV%















Note:

Hemolysed sera should not be used since significant haemolysis may increase AST concentrations

because of high levels of AST in erythrocytes.


N

20 20

206

Mean (U/L)

4620

CV%Mean (U/L)

21

208

46

0.8%

0.9%

1.7%

20

FAUX


(05/2009)

AA-PROXS/EL80-ASSL4+1bi-1

21/123


22/123

Ref : ASAT-0200 12 x 20 mL

ASAT-0400 9 x 50 mL



Name Normal

Abbreviated name ASAT Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample








250 L 262 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0





Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0

Testp

arameters1

Testparameters2

FAUX

FAUX

0

Calibration

FAUX

FAUX

AST/GOT

XXX

0


XXX

AST/GOT

Kinetic

FAUX

XXX

XXX

FAUX


FAUX

FAUX

XXX

No

AST/GOT


(05/2009)

AA-PROXS/EL80-ASAT-1

22/123


23/123

Ref : BITO-0600 2 x 125 mL

BITD-0600 2 x 125 mL

BITO-0250 8 x 25 mL



Name Normal

Abbreviated name BITO Allowed Yes



Wavelength 546 nm 0 Male XXX - XXX mg/dL

Units mg/dL Female XXX - XXX mg/dL

Decimals 2 Pediatric XXX - XXX mg/dL

Test repeats 1 Panic XXX - XXX mg/dL

Controls

Control 1

Concentration limits 0.3 - 20 mg/dL Control 2


Correlation


Correlation offset 0.000 mg/dL

General Measurement



Sample

Sample blank No 0 0



Reagents Absorbance -0.010 - 2.500 Abs




240 L 240 l


0 L 0 l 0 9.000 0 9.000 0


60 L 60 l 0 9.000 0




Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 00 0

0 0

BILIRUBIN TOTAL 4+1

XXX

FAUX


XXX

XXX

FAUX

XXX


FAUX

FAUX

FAUX

FAUX

Calibration

0

FAUX

0

FAUX

Tes

tparameters1

Testparameters2

XXX

No

BILIRUBIN TOTAL 4+1

BILIRUBIN TOTAL 4+1



(05/2009)

AA-PROXS/EL80-BITO-1

23/123


24/123

Ref : BITO-0600 2 x 125 mL

BITD-0600 2 x 125 mL

BITO-0250 8 x 25 mL


BILIRUBIN TOTAL 4+1


0 0

PREPARATION OF REAGENTS:Position R1: Reagent 1 (Ready to use)

Position R3: Reagent 2 (Ready to use)

PERFORMANCE DATA

Analytical rangeThe reagent is linear from 0.3 to 20 mg/dL.

Detection limit

Determined according to SFBC protocol, the detection limit is equal to 0.04 mg/dL.

Precision


N CV%





The sample concentrations were between 0.17 and 28.82 mg/dL.



Linear regression : y= 1.0084 x + 0.034 mg/dL

Interferences

According to SFBC recommendations some studies have been performed to determine the level of interference



Hemoglobin: No significant interference up to 500 mg/dL.

Ascorbic acid: No significant interference up to 20 mg/dL.


On board stability (refrigerated position)The reagents are stable 4 weeks on analyser with a new calibration every 2 weeks.

N

20 0.77

9.46

Mean (mg/dL)

2.7820

CV%Mean (mg/dL)

0.82

9.39

2.91

0.5%

0.4%

2.1%

20

FAUX


(05/2009)

AA-PROXS/EL80-BITO-1

24/123


25/123

Ref : BITD-0600 2 x 125 mL

BIDI-0600 2 x 125 mL

BIDI-0250 8 x 25 mL



Name Normal

Abbreviated name BIDI Allowed Yes







Controls

Control 1

Concentration limits 0.15 - 18 mg/dL Control 2


Correlation



General Measurement



Sample

Sample blank No 0 0







240 L 240 l


0 L 0 l 0 9.000 0 9.000 0


60 L 60 l 0 9.000 0




Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 00 0

0 0

Tes

tparameters1

Testparameters2

FAUX

FAUX

0

Calibration

0

FAUX

BILIRUBIN DIRECT 4+1


XXX

XXX


FAUX

XXX


FAUX

FAUX


FAUX


XXX

No

FAUX

XXX


(05/2009)

AA-PROXS/EL80-BIDI-1

25/123


26/123

Ref : BITD-0600 2 x 125 mL

BIDI-0600 2 x 125 mL

BIDI-0250 8 x 25 mL




0 0

PREPARATION OF REAGENTS:Position R1: Reagent 1 (Ready to use)

Position R3: Reagent 2 (Ready to use)

PERFORMANCE DATA

Analytical rangeThe reagent is linear from 0.15 to 18 mg/dL.

Detection limit


Precision


N CV%








Linear regression : y= 1.0127 x - 0.014 mg/dL

Interferences

According to SFBC recommendations some studies have been performed to determine the level of interference



Hemoglobin: Negative bias from 100 mg/dL.

Ascorbic acid: Positive bias from 2 mg/dL.


On board stability (refrigerated position)The reagents are stable 4 weeks on analyser with a new calibration every 2 weeks.

9.35

FAUX

Mean (mg/dL)Mean (mg/dL) N

9.76 20

20

0.7320

2.63

0.85

0.8%

0.6%

0.7%

CV%

2.77


(05/2009)

AA-PROXS/EL80-BIDI-1

26/123


27/123

Ref : CALA-0250 12 x 20 mL

CALA-0600 2 x 125 mL



Name Normal

Abbreviated name CALA Allowed Yes







Controls

Control 1

Concentration limits 5 - 15 mg/dL Control 2


Correlation



General Measurement



Sample

Sample blank No 0 0







300 L 300 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0





Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0

CALCIUM ARSENAZO

XXX

FAUX


XXX

XXX

FAUX

XXX


FAUX

FAUX

FAUX

FAUX

Calibration

0

FAUX

0

FAUX

Testp

arameters1

Testparameters2

XXX

No

CALCIUM ARSENAZO

CALCIUM ARSENAZO



(05/2009)

AA-PROXS/EL80-CALA-1

27/123


28/123

Ref : CALA-0250 12 x 20 mL

CALA-0600 2 x 125 mL


CALCIUM ARSENAZO


0 0

PERFORMANCE DATA

Analytical rangeThe reagent is linear from 5 to 15 mg/dL.

Detection limi tDetermined according to SFBC protocol, the detection limit is equal to 0.03 mg/dL.

Precision


N CV%











Unconjugated bilirubin :Positive bias from 3 mg/dL.


Haemoglobin: Positive bias from 450 mg/dL.

Turbidity :Positive bias from 400 mg/dL Triglycerides equivalent.



N

20 7.1

12.3

Mean (mg/dL)

9.420

CV%Mean (mg/dL)

7.0

12.5

9.4

0.4%

0.8%

1.0%

20

FAUX


(05/2009)

AA-PROXS/EL80-CALA-1

28/123


29/123

Ref : CALO-0600 2 x 125 mL



Name Normal

Abbreviated name CALO Allowed Yes



Wavelength 578 nm 620 nm Male XXX - XXX mg/dL




Controls

Control 1

Concentration limits 5 - 13.5 mg/dL Control 2


Correlation



General Measurement



Sample

Sample blank No 0 0







300 L 301 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0





Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0

Testp

arameters1

Testparameters2

FAUX

FAUX

0

Calibration

0

FAUX

FAUX

CALCIUM OCPCONE-REAGENT PROCEDURE

XXX

XXX

XXX

No

CALCIUM OCPC

CALCIUM OCPC

End point bichromatic

FAUX

FAUX

XXX


XXX

FAUX


FAUX


(05/2009)

AA-PROXS/EL80-CALOmono-1

29/123


30/123

Ref : CHLO-0250 12 x 20 mL

CHLO-0600 2 x 125 mL



Name Normal

Abbreviated name CHLO Allowed Yes



Wavelength 505 nm 0 Male XXX - XXX mEq/L

Units mEq/L Female XXX - XXX mEq/L

Decimals 1 Pediatric XXX - XXX mEq/L

Test repeats 1 Panic XXX - XXX mEq/L

Controls

Control 1

Concentration limits 50 - 130 mEq/L Control 2


Correlation


Correlation offset 0.000 mEq/L

General Measurement



Sample

Sample blank No 0 0







300 L 301 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0





Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000



#1 Standard #1 XXX 0

0 0

0 0


0 0

0 0

0 0


XXX

XXX

FAUX


FAUX

FAUX

CHLORIDE

CHLORIDE


FAUX

XXX

XXX

XXX

No

CHLORIDE

Testp

arameters1

Testparameters2

FAUX

FAUX

0

Calibration

0

FAUX

FAUX


(05/2009)

AA-PROXS/EL80-CHLO-1

30/123


31/123

Ref : CHLO-0250 12 x 20 mL

CHLO-0600 2 x 125 mL



CHLORIDE

0 0

PERFORMANCE DATA

Analytical rangeThe reagent is linear from 50 to 130 mEq/L.

Detection limi tDetermined according to SFBC protocol, the detection limit is equal to 1 mEq/L.

Precision


N CV%





The sample concentrations were between 48 and 128.7 mEq/L.



Linear regression : y= 0.9994 x + 0.07 mEq/L



Unconjugated bilirubin :No significant interference up to 35 mg/dL on normal human sera.

Positive bias from 23 mg/dL on pathological human sera.


Haemoglobin: Positive bias from 250 mg/dL

Turbidity :Positive bias from 300 mg/dL Triglycerides equivalent.


On board stability (refrigerated position)The reagent is stable 4 weeks on analyser with a new calibration every week.

80.6 20

0.3%

0.4%

0.5%

Mean (mEq/L)

82.5

107.1

Mean (mEq/L) NCV%

112.3

117.4

FAUX

113.8 19

20


(05/2009)

AA-PROXS/EL80-CHLO-1

31/123


32/123

Ref : 12 x 20 mL

6 x 45 mL

1 x 100 mL

6 x 100 mL

Instruction for use : 4 x 250 mL

6 x 100 mL +STD

4 x 250 mL +STD


Name Normal

Abbreviated name CHSL Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample

Sample blank No 0 0normal volume rerun volume* Factor 1.00






300 L 300 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0

Calibrator PredilutionName Auto predilution No

Number of standard 1 0


Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0

XXX

CHSL-0250

CHSL-0455

CHSL-0490

CHSL-0707

CHSL-0507

CHSL-0700

CHSL-0500


CHOLESTEROL SL

XXX

FAUX

XXX


FAUX

FAUX

CHOLESTEROL SL

FAUX

0

FAUX

FAUX

FAUX

Calibration

0

FAUX

CHOLESTEROL SL


XXX

Testpa

rameters1

Testparameters2

XXX

No


(05/2009)

AA-PROXS/EL80-CHSL-1

32/123


33/123

Ref : 12 x 20 mL

6 x 45 mL

1 x 100 mL

6 x 100 mL

Instruction for use : 4 x 250 mL

6 x 100 mL +STD

4 x 250 mL +STD

CHSL-0250

CHSL-0455

CHSL-0490

CHSL-0707

CHSL-0507

CHSL-0700

CHSL-0500


CHOLESTEROL SL

0 0

PERFORMANCE DATA

Analytical rangeThe reagent is linear from 20 to 600 mg/dL.

Detection limitDetermined according to SFBC protocol, the detection limit is equal to 2 mg/dL.

Precision


N CV%





The sample concentrations were between 9 and 626 mg/dL.

The parameters of linear regression are as follows :Correlation coefficient (r) :0.9993

Linear regression : y= 1.0351 x - 4 mg/dL





Haemoglobin: No significant interference up to 500 mg/dL.




N

20

1.3%

1.6%

114

292

Mean (mg/dL)

2.4%

CV%

187

20

20188

Mean (mg/dL)

115

296

FAUX


(05/2009)

AA-PROXS/EL80-CHSL-1

33/123


34/123

Ref : CHOL-0220 12 x 20 mL

CHOL-0420 9 x 50 mL

CHOL-0520 6 x 100 mL

Instruction for use : CHOL-0720 4 x 250 mL


Name Normal

Abbreviated name CHOL Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample

Sample blank No 0 0







300 L 301 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0





Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0

FAUX

FAUX

CHOLESTEROL

FAUX

FAUX

0

FAUX

FAUX

CHOLESTEROL

XXX


XXX

XXX

No



CHOLESTEROL

Testp

arameters1

Testparameters2

XXX

XXX

Calibration

0

FAUX

FAUX


(05/2009)

AA-PROXS/EL80-CHOL-1

34/123


35/123

Ref : HDLL-0230 4 x 28 mL

HDLL-0380 1 x 80 mL

Instruction for use : HDLL-0390 3 x 80 mL


Name Normal

Abbreviated name HDLL Allowed Yes







Controls

Control 1

Concentration limits 5.0 - 200.0 mg/dL Control 2


Correlation



General Measurement


Predilution No 0 Point one, two -3 0 236 sec

Sample

Sample blank No 0 0







240 L 240 l


0 L 0 l 0 9.000 0 9.000 0


80 L 80 l 0 9.000 0





Repeats 3 Cut-off

Interval XXX days Cut-off No

Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0

Testp

arameters1

Testparameters2

FAUX

FAUX

0

Calibration

0

FAUX

CHOLESTEROL HDL SL 2G



Two point


FAUX

XXX

XXXXXX

No


XXX

FAUX

FAUX

XXX

FAUX

FAUX


(05/2009)

AA-PROXS/EL80-HDLL-1

35/123


36/123

Ref : HDLL-0230 4 x 28 mL

HDLL-0380 1 x 80 mL

Instruction for use : HDLL-0390 3 x 80 mL



0 0

PERFORMANCE DATA

Analytical rangeDetermined according to EP6-A protocol of CLSI

The reagent is linear from 5 to 200 mg/dL.

Detection limi t


Precision

Determined according to EP5-A2 protocol of CLSI

N

Level 1 80

Level 2 80

Level 3 80

Correlation

Determined according to EP9-A2 protocol of CLSI.A comparative study has been performed against a concurrent system on 83 human samples.

The sample concentrations were between 9.3 and 151 mg/dL.


Correlation coefficient (r): 0.996


InterferencesAccording to SFBC recommendations and EP7-A2 protocol of CLSI, studies have been performed to determine the level of interference


Unconjugated bilirubin: No significant interference up to 616 mol/L.

Conjugated bilirubin: No significant interference up to 427 mol/L.

Turbidity: No significant interference up to 500 mg/dL Triglycerides equivalent.

Hemoglobine: No significant interference up to 500 mg/dL.Other compounds may interfere. (see product insert)

On board stability (refrigerated position)The reagents are stable 3 weeks on analyser. A new calibration is required when the quality control result are outside

expected specification. To increase the calibration stability, it is recommended to close the vials when they are not used.

87.3

2.8%55.6

Within-run

30.8

Total

CV% CV%

FAUX

3.0%

0.7%

Mean (mg/dL)

1.4% 3.3%

1.4%


(05/2009)

AA-PROXS/EL80-HDLL-1

36/123


37/123

Ref : LDLL-0230 4 x 28 mL

LDLL-0380 1 x 80 mL



Name Normal

Abbreviated name LDLL Allowed Yes







Controls

Control 1

Concentration limits 15 - 700.0 mg/dL Control 2


Correlation



General Measurement


Predilution No 0 Point one, two -3 0 236 sec

Sample

Sample blank No 0 0







240 L 240 l


0 L 0 l 0 9.000 0 9.000 0


80 L 80 l 0 9.000 0





Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0

XXX

FAUX

FAUX

CHOLESTEROL LDL SL 2G

Two point

FAUX


XXX


FAUX

0

FAUX

0

FAUX

FAUX

Calibration


Testp

arameters1

Testparameters2

XXX

FAUX

XXX

No


XXX


(05/2009)

AA-PROXS/EL80-LDLL-1

37/123


38/123

Ref : LDLL-0230 4 x 28 mL

LDLL-0380 1 x 80 mL




0 0

PERFORMANCE DATA

Analytical rangeDetermined according to EP6-A protocol of CLSI

The reagent is linear from 15 to 700 mg/dL.

Detection limi t


Precision

Determined according to EP5-A2 protocol of CLSI

N

Level 1 80

Level 2 80

Level 3 80

Correlation

Determined according to EP9-A2 protocol of CLSI.A comparative study has been performed against a concurrent system on 60 human samples.



Correlation coefficient (r) : 0.985

Linear regression : y= 0.937 x + 9.4 mg/dL

InterferencesAccording to SFBC recommendations and EP7-A2 protocol of CLSI, studies have been performed to determine the level of interference


Unconjugated bilirubin: No significant interference up to 513 mol/L.

Conjugated bilirubin: No significant interference up to 359 mol/L.

Turbidity: No significant interference up to 600 mg/dL Triglycerides equivalent.

Hemoglobine: No significant interference up to 500 mg/dL.Other compounds may interfere (see product insert)


2.3%

161.7 1.9% 3.3%

121.4 1.3%

101.9

Mean (mg/dL)

Within-run

1.8% 3.4%

Total

CV% CV%

FAUX


(05/2009)

AA-PROXS/EL80-LDLL-1

38/123


39/123

Ref : HDLC-0060 3 x 10 mL

HDLC-0520 3 x 100 mL



Name Normal

Abbreviated name HDLC Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample

Sample blank No 0 0







300 L 305 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0





Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0

Testp

arameters1

Testparameters2

FAUX

FAUX

0

Calibration

0


FAUX

XXX

XXX


FAUX

XXX

No

HDL CHOLESTEROL

FAUX

XXX

FAUX

XXX

HDL CHOLESTEROL

FAUX

FAUX


HDL CHOLESTEROL


(05/2009)

AA-PROXS/EL80-HDLC-1

39/123


40/123

Ref : CHES-0053 16 x 3 mL



Name Normal

Abbreviated name CHES Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample








360 L 360 l


0 L 0 l 0 9.000 0 9.000 0


12 L 12 l 0 9.000 0





Repeats 3 Cut-off


Curvefit 0

0 0 0

0 0 0 9.000 9.000




0 0

0 0


0 0

0 0

0 0 FAUX

XXX

XXX

FAUX

FAUX

XXX

No

CHOLINESTERASE

FAUX

FAUX

CHOLINESTERASE

XXX

0


CHOLINESTERASE

Kinetic


XXX

FAUX

Testp

arameters1

Testparameters2

FAUX

FAUX

0

Calibration


(05/2009)

AA-PROXS/EL80-CHES-1

40/123


41/123

Ref : CMSL-0230 4 x 25 mL

CMSL-0410 2 x 62.5 mL

CMSL-0430 4 x 62.5 mL



Name Normal

Abbreviated name CMSL Allowed Yes







Controls

Control 1



Correlation



General Measurement



Sample





Reagent blank Yes Repeats 3 R. Absorbance 0.000 - 1.000 Abs



250 L 255 l


0 L 0 l 0 9.000 0 9.000 0


0 L 0 l 0 9.000 0

* : For information only

Testp

arameters1

Testparameters2

CK-MB SL

Kinetic

No

CK-MB SL

XXX


CK-MB SLONE-REAGENT PROCEDURE


XXX

XXX


(05/2009)

AA-PROXS/EL80-CMSLmono-1

41/123


42/123

Ref : CMSL-0230 4 x 25 mL

CMSL-0410 2 x 62.5 mL

CMSL-0430 4 x 62.5 mL



CK-MB SLONE-REAGENT PROCEDURE

PERFORMANCE DATA


Detection limi tDetermined according to SFBC protocol, the detection limit is equal to 3 U/L.

Precision


N CV%




CorrelationA comparative study has been performed

Documents

Selectra Pro XS, Flexor EL80 Manual Configuración de Reactivos