ELITECH ELITECH ELITECH

EXPRESS PLUS
AA-EXPRESSPLUS-CAT-6

A Version I Version

ACID PHOSPHATASE .......................... PACI-2 ................. PRO Update IRON FERROZINE..............................FEFR-4................. CE

ALBUMIN ............................................... ALBU-3 ................... CE
ALP (DEA) ............................................. PALC-2 ................ PRO
ALP (DEA) SL monoprocedure.............. PASLmono-3........... CE
Update ALT / GPT.............................................. ALAT-3 ................. PRO L
ALT / GPT SL4+1 monoprocedure ........ ALSL4+1mono-2 ..... CE
AMYLASE SL......................................... AMSL-3 ................... CE LACTATE............................................LACT-3.............. PRO
Update AST / GOT............................................. ASAT-3 ................ PRO LDH - P SL4+1 monoprocedure .........LDSL4+1mono-2 .. CE
AST / GOT SL4+1 monoprocedure........ ASSL4+1mono-2..... CE Update LDH - P................................................LDHP-4 ................ CE

B M
BILIRUBIN DIRECT ............................... BILID-3 ................. PRO MAGNESIUM CALMAGITE ................MAGN-3 ............... CE
BILIRUBIN TOTAL................................. BILIT-3 ................. PRO

P
C
PHOSPHORUS ..................................PHOS-3................ CE
CALCIUM ARSENAZO .......................... CALA-3 ................... CE
CALCIUM OCPC ................................... CALO-2 ................ PRO
CHLORIDE ............................................ CHLO-3 ................... CE
Update CHOLESTEROL SL .............................. CHSL-4 ................... CE T
CHOLESTEROL .................................... CHOL-4 ................... CE
CHOLESTEROL HDL ............................ HDLC-3 ................ PRO TOTAL PROTEIN ...............................PRTB-3 ................ CE
CHOLESTEROL HDL DIRECT SL ........ HDLD-4 ................ PRO Update TRIGLYCERIDES ...............................TRIG-4 ................. CE
CHOLESTEROL LDL DIRECT SL......... LDLD-2................. PRO Update TRIGLYCERIDES MONO SL NEW ....TGMLN-4 .......... PRO
Update CHOLINESTERASE.............................. CHES-3 ................ PRO
CK - MB SL monoprocedure.................. CMSLmono-4 .......... CE
CK - MB ................................................. CKMB-3 .................. CE
CK NAC SL monoprocedure.................. CKSLmono-3 .......... CE
U
Update CK NAC ................................................. CKNA-4 ................... CE
COPPER................................................ CUIV-2 ................. PRO
Update UREA UV SL monoprocedure.............URSLmono-4 ....... CE
CREATININE JAFFE monoprocedure ... CRCOmono-3 ......... CE
UREA UV............................................URUV-3................ CE
CREATININE JAFFE biprocedure ......... CRCObi-3................ CE
Update URIC ACID MONO SL ........................AUML-4 ................ CE
Update CREATININE PAP SL biprocedure ....... CRSL-3 ................ PRO
URIC ACID SL monoprocedure ..........AUSLmono-3........ CE
URIC ACID SL biprocedure ................AUSLbi-3.............. CE
URIC ACID .........................................ACUR-3................ CE
G
GAMMA GT SL monoprocedure............ GASLmono-3 .......... CE
GAMMA GT ........................................... GAGT-3 .................. CE
GLUCOSE HK SL monoprocedure........ GHSLmono-4.......... CE
Update GLUCOSE PAP SL ............................... GPSL-4 ................... CE
GLUCOSE PAP ..................................... GLUP-3................... CE

CE = These applications have been set up according to a specific protocol (PO-12-

105) based on:
1. Directive 98/79/CE
2. Vassault, A., et al., Protocole de validation de techniques (Document B,
stade 3). Ann. Biol. Clin., (1986), 44,686.
3. Vassault, A., et al., Analyses de biologie médicale: spécifications et normes
d'acceptabilité à l'usage de la validation des techniques,.Ann. Biol. Clin.
(1999), 57,685.

PRO = PROPOSAL: These applications have been established theoretically. It is

advised to check it.

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ACID
PHOSPHATASE Ref. : PACI-0030 18 x 3 mL

TOTAL AND PROSTATIC

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Acid Phosphatase Test : PACI
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 405 nm Secondary Wavelength : None
Read Time/Interval : 60 Sample blank : No
Factor : 853
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 2
Low Blank A Limit : 0.0000 High Blank A Limit : 0.400
Low A Limit : 0.0000 High A Limit : 1.800
Low Normal : xx High Normal : xx
Linearity Limit : 40 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : Acid Phosphatase Test : PACI
Test Bar Code : xx
Sample Volume : 25 µL
Rerun Dilution Ratio : 2 Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 250 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

(09/2005)
AA-EXPRESSPLUS-PACI-2

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

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ALBUMIN Réf. : ALBU-0600

ALBU-0700
2 x 125 mL
4 x 250 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : ALBUMIN Test : ALBU
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : g/L No of Decimal Places : 1
Primary Wavelength : 600 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.000 High Blank A Limit : 2.000
Low A Limit : 0.000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 60.0 Curve S.D. Limit : 5.0000*
REAGENT PARAMETERS
Test name : ALBUMIN Test : ALBU
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 15 to 60 g/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 47.6 g/L CV = 2.4 %
Pathological sera : n = 20 m = 36.5 g/L CV = 1.1 %

-Between-run reproducibility
Normal sera : n = 20 m = 43.5 g/L CV = 3.5 %
Pathological sera : n = 20 m = 32.6 g/L CV = 2.0 %

• Correlation
A comparative study has been performed between Elitech method on EXPREES PLUS and a method validated on another analyser on 38
human sera. The sample concentration ranged from 12.5 to 59.5 g/L. The parameters ef linear regressions are as follows:
Correlation coefficient (r): 0.9963
Linear regression: y= 0.963 x + 0.8822

(09/2005)
AA-EXPRESSPLUS-ALBU-3

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Ref.: PALC-0030 20 x 3 mL
ALP (DEA) PALC-0200 12 x 20 mL

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Alkaline Phosphatase Test : PALC
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 405 nm Secondary Wavelength : None
Read Time/Interval : 20 Sample blank : No
Factor : 2750
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 2
Low Blank A Limit : -0.300 High Blank A Limit : 0.800
Low A Limit : -0.500 High A Limit : 1.500
Low Normal : xx High Normal : xx
Linearity Limit : 700 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : Alkaline Phosphatase Test : PALC
Test Bar Code : xx
Sample Volume : 5 µL
Rerun Dilution Ratio : 2 Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 250 µL xx µL 60 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

(09/2005)
AA-EXPRESSPLUS-PALC-2

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

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ALP (DEA) SL Réf. : PASL-0400 2 x 62.5 mL

PASL-0420 4 x 62.5 mL
PASL-0500 5 x 125 mL
ONE REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : PAL SL Test : PASL
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 405 nm Secondary Wavelength : None
Read Time/Interval : 120 Sample blank : No
Factor : 2750.00
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : 0.0000 High Blank A Limit : 1.200
Low A Limit : 0.1000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 1000 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : PAL SL Test : PASL
Test Bar Code : xx
Sample Volume : 6 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 60 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 65 to 1000 U/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 188.6 U/L CV = 1.6 %
Pathological sera : n = 20 m = 369.9 U/L CV = 1.5 %

(09/2005)
AA-EXPRESSPLUS-PASLmono-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

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Ref.: ALAT-0200 12 x 20 mL
ALT / GPT ALAT-0400 9 x 50 mL

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : ALAT Test : ALAT
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 340 nm Secondary Wavelength : 380
Read Time/Interval : 20 Sample blank : No
Factor : -1746
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 2
Low Blank A Limit : 1.000 High Blank A Limit : 2.000
Low A Limit : 0.500 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 250 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : ALAT Test : ALAT
Test Bar Code : xx
Sample Volume : 25 µL
Rerun Dilution Ratio : 2 Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 250 µL xx µL 120 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

Modification from the previous version

(02/2009)
AA-EXPRESSPLUS-ALAT-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

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ALT / GPT 4 + 1 SL Ref. : ALSL-0410

ALSL-0430
2 x 62.5 mL
4 x 62.5 mL
ALSL-0510 5 x 125 mL
ONE REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : GPT Test : ALSL
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 340 nm Secondary Wavelength : None
Read Time/Interval : 60 Sample blank : No
Factor : -1746.0
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : 0.9000 High Blank A Limit : 2.000
Low A Limit : 0.8500 High A Limit : 2.000
Low Normal : xx High Normal : xx
Linearity Limit : 250 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : GPT Test : ALSL
Test Bar Code : xx
Sample Volume : 25 µL
Rerun Dilution Ratio : 5 Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 250 µL xx µL 30 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator.

PERFORMANCES

• Analytical range
The reagent is linear from 15 to 250 U/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 30 U/L CV = 3.9 %
Pathological sera : n = 20 m = 120 U/L CV = 1.1 %

(09/2005)
AA-EXPRESSPLUS-ALSL4+1mono-2

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

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Réf. : AMSL-0390 1 x 50 mL
AMYLASE SL AMSL-0400 6 x 50 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : AMYLASE SL Test : AMSL
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 405 nm Secondary Wavelength : None
Read Time/Interval : 60 Sample blank : No
Factor : 5211.00
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : 0.0000 High Blank A Limit : 0.800
Low A Limit : 0.0000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 2000 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : AMYLASE SL Test : AMSL
Test Bar Code : xx
Sample Volume : 4 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 60 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 50 to 2000 U/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 51.3 U/L CV = 3.1 %
Pathological sera : n = 20 m = 147.6 U/L CV = 1.2 %

-Between-run reproducibility
Normal sera : n = 20 m = 53.9 U/L CV = 5.0 %
Pathological sera : n = 20 m = 140.3 U/L CV = 3.5 %

(09/2005)
AA-EXPRESSPLUS-AMSL-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

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AST (GOT) Ref.: ASAT-0200

ASAT-0400
12 x 20 mL
9 x 50 mL

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : ASAT Test : ASAT
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 340 nm Secondary Wavelength : 380
Read Time/Interval : 20 Sample blank : No
Factor : -1746
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 2
Low Blank A Limit : 1.000 High Blank A Limit : 2.000
Low A Limit : 0.450 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 250 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : ASAT Test : ASAT
Test Bar Code : xx
Sample Volume : 25 µL
Rerun Dilution Ratio : 2 Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 250 µL xx µL 120 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

Modification from the previous version

(02/2009)
AA-EXPRESSPLUS-ASAT-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

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AST / GOT 4+1 SL Ref.: ASSL-0410 2 x 62,5 mL

ASSL-0430 4 x 62,5 mL
ASSL-0510 5 x 125 mL
ONE REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : GOT Test : ASSL
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 340 nm Secondary Wavelength : None
Read Time/Interval : 60 Sample blank : No
Factor : -1746.00
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : 0.9000 High Blank A Limit : 2.000
Low A Limit : 0.8500 High A Limit : 2.000
Low Normal : xx High Normal : xx
Linearity Limit : 250 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : GOT Test : ASSL
Test Bar Code : xx
Sample Volume : 25 µL
Rerun Dilution Ratio : 5 Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 250 µL xx µL 30 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator.

PERFORMANCES

• Analytical range
The reagent is linear from 15 to 250 U/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 34 U/L CV = 3.7 %
Pathological sera : n = 20 m = 115 U/L CV = 1.2 %

-Between-run reproducibility
Normal sera : n = 20 m = 35 U/L CV = 3.7 %
Pathological sera : n = 20 m = 115 U/L CV = 3.4 %

(09/2005)
AA-EXPRESSPLUS-ASSL4+1mono-2

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

BILIRUBIN Réf. : BILI-0620 2 x 125 mL

BILI-0600 1 x 125 mL Total
DIRECT 1 x 125 mL Direct

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Bili dir Test : BILID
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/L No of Decimal Places : 1
Primary Wavelength : 540 nm Secondary Wavelength : None
Read Time/Interval : 20 Sample blank : Yes
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.100 High Blank A Limit : 0.100
Low A Limit : -0.100 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 180 Curve S.D. Limit : 5.0*
REAGENT PARAMETERS
Test name : Bili dir Test : BILID
Test Bar Code : xx
Sample Volume : 20 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 290 µL xx µL 50 seconds xx
Reagent 2 : 60 µL xx µL 300 seconds xx
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear up to 180 mg/L.

Preparation of working reagents:

Reagent 1: Ready to use..
Reagent 2: Mix 5 volumes of reagent 1 with 1 volume of reagent 2.

(09/2005)
AA-EXPRESSPLUS-BILID-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

BILIRUBIN Réf. :BILI-0640 2 x 125 mL

BILI-0600 1 x 125 mL Total
TOTAL 1 x 125 mL Direct

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Bili tot Test : BILIT
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/L No of Decimal Places : 1
Primary Wavelength : 540 nm Secondary Wavelength : None
Read Time/Interval : 20 Sample blank : Yes
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.100 High Blank A Limit : 0.100
Low A Limit : -0.100 High A Limit : 2.500
Low Normal : 0.0* High Normal : 10.0*
Linearity Limit : 200 Curve S.D. Limit : 5.0*
REAGENT PARAMETERS
Test name : Bili tot Test : BILIT
Test Bar Code : xx
Sample Volume : 20 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 290 µL xx µL 50 seconds xx
Reagent 2 : 60 µL xx µL 300 seconds xx
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear up to 200 mg/L.

Preparation of working reagents:

Reagent 1: Ready to use.
Reagent 2: Mix 5 volumes of reagent 1 with 1 volume of reagent 2.

(09/2005)
AA-EXPRESSPLUS-BILIT-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CALCIUM Réf. : CALA-0600 2 x 125 mL

ARSENAZO
APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : CALCIUM Test : CALA
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/L No of Decimal Places : 1
Primary Wavelength : 600 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.200 High Blank A Limit : 2.000
Low A Limit : 0.200 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 150.0 Curve S.D. Limit : 5.00*
REAGENT PARAMETERS
Test name : CALCIUM Test : CALA
Test Bar Code : xx
Sample Volume : 7 µL
Rerun Dilution Ratio : 2 Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 195 µL xx 195 µL (#) 60 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.
(#) : Distilled water.

PERFORMANCES

• Analytical range
The reagent is linear from 50 to 150 mg/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 94 mg/L CV = 1.7 %
Pathological sera : n = 20 m = 139.5 mg/L CV = 0.9%

-Between-run reproducibility
Normal sera : n = 20 m = 92.1 mg/L CV = 2.3 %
Pathological sera : n = 20 m = 134.7 mg/L CV = 2.3 %

(09/2005)
AA-EXPRESSPLUS-CALA-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CALCIUM OCPC
Ref.: CALO-0600 2 x 125 mL
ONE REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : CALCIUM OCPC Test : CALO
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/L No of Decimal Places : 0
Primary Wavelength : 570 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : xx High Blank A Limit : xx
Low A Limit : xx High A Limit : xx
Low Normal : xx High Normal : xx
Linearity Limit : 135 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : CALCIUM OCPC Test : CALO
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 5* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

(09/2005)
AA-EXPRESSPLUS-CALO-2

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CHLORIDE Réf. : CHLO-0600 2 x 125 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : CHLORIDE Test : CHLO
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mEq/L No of Decimal Places : 1
Primary Wavelength : 510 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.0000 High Blank A Limit : 1.000
Low A Limit : 0.0500 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 130 Curve S.D. Limit : 2.5000*
REAGENT PARAMETERS
Test name : CHLORIDE Test : CHLO
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 250 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 50 to 130 mEq/L.

• Precision
-Within-run reproducibility :
Medium level : n = 20 m = 111.8 mEq/L CV = 1.1 %
High level : n = 20 m = 126.5 mEq/L CV = 0.6%

-Between-run reproducibility
Normal sera : n = 20 m = 100.5 mEq/L CV = 2.3 %
Pathological sera : n = 20 m = 91.5 mEq/L CV = 2.8 %

(09/2005)
AA-EXPRESSPLUS-CHLO-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

Réf. : CHSL-0490 1 x 100 mL

CHSL-0500 6 x 100 mL
CHOLESTEROL SL CHSL-0700
CHSL-0507
4 x 250 mL
6 x 100 mL + STD
CHSL-0707 4 x 250 mL + STD

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : CHOLESTEROL Test : CHSL
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : g/L No of Decimal Places : 2
Primary Wavelength : 510 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.000 High Blank A Limit : 0.150
Low A Limit : 0.000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 6.00 Curve S.D. Limit : 0.4000*
REAGENT PARAMETERS
Test name : CHOLESTEROL Test : CHSL
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 0.1 to 6 g/L.

• Precision
-Within-run reproducibility :
Low level : n = 20 m = 1.29 g/L CV = 3.1 %
Medium level : n = 20 m = 1.85 g/L CV = 3.9 %
High level : n = 20 m = 2.52 g/L CV = 3.2%

-Between-run reproducibility
Low level : n = 20 m = 0.84 g/L CV = 2.6 %
Medium level : n = 20 m = 1.81 g/L CV = 4.0 %
High level : n = 20 m = 2.20 g/L CV = 3.6 %

• Correlation
A comparative study has been performed between Elitech method on EXPREES PLUS and a method validated on another analyser on 32
human sera.The sample concentration ranged from 0.42 to 6.11 g/L. The parameters ef linear regressions are as follows:
Correlation coefficient (r): 0.9988
Linear regression: y= 0.9787 x - 0.0501

Modification from the previous version (02/2009)

AA-EXPRESSPLUS-CHSL-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

Réf. : CHOL-0220 12 x 20 mL
CHOL-0420 9 x 50 mL
CHOLESTEROL CHOL-0520
CHOL-0720
6 x 500 mL
4 x 250 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : CHOLESTEROL Test : CHOL
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : g/L No of Decimal Places : 2
Primary Wavelength : 510 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.000 High Blank A Limit : 0.100
Low A Limit : 0.000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 5.00 Curve S.D. Limit : 0.4000*
REAGENT PARAMETERS
Test name : CHOLESTEROL Test : CHOL
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 0.1 to 5 g/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 1.90 g/L CV = 2.8 %
Pathological sera : n = 20 m = 0.88 g/L CV = 3.5 %

-Between-run reproducibility
Low level : n = 20 m = 0.85 g/L CV = 4.5 %
Medium level : n = 20 m = 1.85 g/L CV = 4.6 %
High level : n = 20 m = 2.24 g/L CV = 4.1 %

• Correlation
A comparative study has been performed between Elitech method on EXPREES PLUS and a method validated on another analyser on 32
human sera.The sample concentration ranged from 0.43 to 5.12 g/L. The parameters ef linear regressions are as follows:
Correlation coefficient (r): 0.9988
Linear regression: y= 0.9105 x - 0.0458
(06/2006)
AA-EXPRESSPLUS-CHOL-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

Réf. : HDLC-0060 3 x 10 mL
CHOLESTEROL HDL HDLC-0520 3 x 100 mL

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : HDL chol Test : HDLC
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/dL No of Decimal Places : 1
Primary Wavelength : 510 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.000 High Blank A Limit : 0.500
Low A Limit : 0.000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 200.0 Curve S.D. Limit : 2.0*
REAGENT PARAMETERS
Test name : HDL chol Test : HDLC
Test Bar Code : xx
Sample Volume : 15 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

It is advised to dilute (d1/2) the samples in NaCl to eliminate the interferences with triglycerides.

PERFORMANCES

• Analytical range
The reagent is linear from 20 to 200 mg/dL.

(09/2005)
AA-EXPRESSPLUS-HDLC-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CHOLESTEROL Réf. : HDLD-0360 1 x 60 mL

HDLD-0370 3 x 60 mL
HDL DIRECT SL
APPLICATION FOR EXPRESS PLUS
PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : HDL direct Test : HDLD
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/dL No of Decimal Places : 0
Primary Wavelength : 600 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : Yes
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.000 High Blank A Limit : 0.500
Low A Limit : 0.000 High A Limit : 2.000
Low Normal : xx High Normal : xx
Linearity Limit : 180.0 Curve S.D. Limit : 5.0000*
REAGENT PARAMETERS
Test name : HDL direct Test : HDLD
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 240 µL xx µL 240 seconds xx
Reagent 2 : 60 µL xx µL 300 seconds xx
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

(09/2005)
AA-EXPRESSPLUS-HDLD-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CHOLESTEROL .

Réf. : LDLD-0360 1 x 60 mL

LDL DIRECT SL
APPLICATION FOR EXPRESS PLUS
PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : LDL direct Test : LDLD
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/dL No of Decimal Places : 0
Primary Wavelength : 600 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : Yes
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.000 High Blank A Limit : 0.500
Low A Limit : 0.000 High A Limit : 2.000
Low Normal : xx High Normal : xx
Linearity Limit : 320.0 Curve S.D. Limit : xx
REAGENT PARAMETERS
Test name : LDL direct Test : LDLD
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 240 µL xx µL 240 seconds xx
Reagent 2 : 60 µL xx µL 300 seconds xx
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

(09/2005)
AA-EXPRESSPLUS-LDLD-2

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CHOLINESTERASE Ref.: CHES-0053 16 x 3 mL

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : CHOLINESTERASE Test : CHES
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 1
Primary Wavelength : 405 nm Secondary Wavelength : 600
Read Time/Interval : 20 Sample blank : No
Factor : 19770
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 2
Low Blank A Limit : xx High Blank A Limit : xx
Low A Limit : xx High A Limit : xx
Low Normal : xx High Normal : xx
Linearity Limit : 8000 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : CHOLINESTERASE Test : CHES
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 2 Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 30 seconds xx
Reagent 2 : 10 µL µL 90 seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

Modification from the previous version

(02/2009)
AA-EXPRESSPLUS-CHES-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CK - MB SL Réf. : CMSL-0410 2 x 62.5 mL

CMSL-0430 4 x 62.5 mL
ONE REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : CKMB Test : CMSL
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 340 nm Secondary Wavelength : None
Read Time/Interval : 120 Sample blank : No
Factor : 8254.00
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : -0.500 High Blank A Limit : 0.800
Low A Limit : -0.500 High A Limit : 1.700
Low Normal : xx High Normal : xx
Linearity Limit : 600 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : CKMB Test : CMSL
Test Bar Code : xx
Sample Volume : 12 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 15 to 600 U/L.

• Precision
-Within-run reproducibility :
Medium level : n = 20 m = 88.9 U/L CV = 2.8 %
High level : n = 20 m = 120.3 U/L CV = 2.8 %

-Between-run reproducibility :
Medium level : n = 20 m = 113.5 U/L CV = 2.9 %
High level : n = 20 m = 244.8 U/L CV = 3.2 %

(06/2006)
AA-EXPRESSPLUS-CMSLmono-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CK - MB Réf. : CKMB-0030 20 x 3 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : CK-MB Test : CKMB
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 1
Primary Wavelength : 340 nm Secondary Wavelength : None
Read Time/Interval : 180 Sample blank : No
Factor : 6752.00
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : 0.0050 High Blank A Limit : 1.000
Low A Limit : 0.0050 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 600 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : CK-MB Test : CKMB
Test Bar Code : xx
Sample Volume : 15 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 15 to 600 U/L.

• Precision
-Within-run reproducibility :
Medium level : n = 20 m = 79.9 U/L CV = 1.9 %
High level : n = 20 m = 101.8 U/L CV = 1.7 %

-Between-run reproducibility :
Medium level : n = 20 m = 97.6 U/L CV = 3.5 %
High level : n = 20 m = 215.11 U/L CV = 2.5 %

(09/2005)
AA-EXPRESSPLUS-CKMB-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CK NAC SL Réf. : CKSL-0410 2 x 62.5 mL

CKSL-0430 4 x 62.5 mL
ONE REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : CK-NAC Test : CKSL
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 340 nm Secondary Wavelength : None
Read Time/Interval : 100 Sample blank : No
Factor : 4127.00
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : 0.0000 High Blank A Limit : 1.500
Low A Limit : 0.0000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 1700 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : CK-NAC Test : CKSL
Test Bar Code : xx
Sample Volume : 12 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 150 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 70 to 1700 U/L.

• Precision
-Within-run reproducibility :
Low level : n = 20 m = 69.2 U/L CV = 3.4 %
Medium level : n = 20 m = 137.6 U/L CV = 2.7 %
High level : n = 20 m = 435.1 U/L CV = 2.3 %

-Between-run reproducibility :
Low level : n = 20 m =61.6 U/L CV = 2.5 %
Medium level : n = 20 m = 154.7 U/L CV = 2.1 %
High level : n = 20 m = 435.2 U/L CV = 1.4 %

(09/2005)
AA-EXPRESSPLUS-CKSLmono-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CK NAC Réf. : CKNA-0030 20 x 3 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : CK-NAC Test : CKNA
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 1
Primary Wavelength : 340 nm Secondary Wavelength : None
Read Time/Interval : 100 Sample blank : No
Factor : 4920.00
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : 0.0000 High Blank A Limit : 1.000
Low A Limit : 0.0000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 1800 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : CK-NAC Test : CKNA
Test Bar Code : xx
Sample Volume : 10 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 120 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 30 to 1800 U/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 180.4 U/L CV = 2.4 %
Pathological sera : n = 20 m = 438.0 U/L CV = 1.1 %

-Between-run reproducibility :
Low level : n = 20 m =59.5 U/L CV = 3.5 %
Medium level : n = 20 m = 149.4 U/L CV = 2.3 %
High level : n = 20 m = 431.3 U/L CV = 2.2 %

Modification from the previous version

(02/2009)
AA-EXPRESSPLUS-CKNA-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

COPPER Ref.: CUIV-0050 5 x 10 mL

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : COPPER Test : CUIV
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/L No of Decimal Places : 1
Primary Wavelength : 580 nm Secondary Wavelength : None
Read Time/Interval : 12 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 3 No of replicates : 2
Low Blank A Limit : xx High Blank A Limit : xx
Low A Limit : xx High A Limit : xx
Low Normal : xx High Normal : xx
Linearity Limit : 5 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : COPPER Test : CUIV
Test Bar Code : xx
Sample Volume : 15 µL
Rerun Dilution Ratio : 1 Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

(09/2005)
AA-EXPRESSPLUS-CUIV-2

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CREATININE
JAFFE Réf. : CRCO-0600
CRCO-0700
2 x 125 mL
4 x 250 mL

ONE REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Creatinine Test : CRCO
Test Bar Code : xx
Test Type : TWO POINT Curve Type : Blanked Linear
Units : mg/dL No of Decimal Places : 3
Primary Wavelength : 510 nm Secondary Wavelength : None
Read Time/Interval : 120 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.000 High Blank A Limit : 0.300
Low A Limit : 0.000 High A Limit : 2.000
Low Normal : xx High Normal : xx
Linearity Limit : 15.0 Curve S.D. Limit : 0.3000*
REAGENT PARAMETERS
Test name : Creatinine Test : CRCO
Test Bar Code : xx
Sample Volume : 30 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 10 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 1 to 15 mg/dL.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 1.16 mg/dL CV = 1.6 %
Pathological sera : n = 20 m = 3.26 mg/dL CV = 0.9 %

-Between-run reproducibility :
Normal level : n = 20 m =1.07 mg/dL CV = 3.3 %
Pathological sera: n = 20 m = 3.5 mg/dL CV = 2.0 %

• Correlation
A comparative study has been performed between Elitech method on EXPREES PLUS and a method validated on another analyser on 23
human sera.The sample concentration ranged from 3.67 to 139.8 mg/L. The parameters ef linear regressions are as follows:
Correlation coefficient (r): 0.9998
Linear regression: y= 0.958 x - 0.0198
(09/2005)
AA-EXPRESSPLUS-CRCOmono-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CREATININE
JAFFE Réf. : CRCO-0600
CRCO-0700
2 x 125 mL
4 x 250 mL

TWO REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Creatinine Test : CRCO
Test Bar Code : xx
Test Type : TWO POINT Curve Type : Blanked Linear
Units : mg/dL No of Decimal Places : 3
Primary Wavelength : 510 nm Secondary Wavelength : None
Read Time/Interval : 120 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.0100 High Blank A Limit : 0.300
Low A Limit : -0.0100 High A Limit : 2.000
Low Normal : xx High Normal : xx
Linearity Limit : 15.0 Curve S.D. Limit : 0.3000*
REAGENT PARAMETERS
Test name : Creatinine Test : CRCO
Test Bar Code : xx
Sample Volume : 30 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 150 µL xx µL 0 seconds xx
Reagent 2 : 150 µL xx µL 10 seconds xx
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 1 to 15 mg/dL.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 1.19 mg/dL CV = 2.5 %
Pathological sera : n = 20 m = 3.44 mg/dL CV = 1.0 %

-Between-run reproducibility :
Normal level : n = 20 m =1.05 mg/dL CV = 3.4 %
Pathological sera: n = 20 m = 3.55 mg/dL CV = 2.0 %

• Correlation
A comparative study has been performed between Elitech method on EXPREES PLUS and a method validated on another analyser on 23
human sera.The sample concentration ranged from 3.67 to 139.8 mg/L. The parameters ef linear regressions are as follows:
Correlation coefficient (r): 0.9998
Linear regression: y= 0.9917 x + 0.2604
(09/2005)
AA-EXPRESSPLUS-CRCObi-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

CREATININE PAP Ref.: CRSL-0630 2 x 133 mL

CRSL-0637 2 x 133 mL + STD
SL
TWO REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : CRSL Test : CRSL
Test Bar Code : xx
Test Type : KINETIC Curve Type : Blanked Linear
Units : mg/L No of Decimal Places : 0
Primary Wavelength : 540 nm Secondary Wavelength : None
Read Time/Interval : 20 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : xx High Blank A Limit : xx
Low A Limit : xx High A Limit : xx
Low Normal : xx High Normal : xx
Linearity Limit : 300 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : CRSL Test : CRSL
Test Bar Code : xx
Sample Volume : 5 µL
Rerun Dilution Ratio : 5* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 210 µL xx µL 180 seconds xx
Reagent 2 : 70 µL µL 120 seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

Modification from the previous version

(02/2009)
AA-EXPRESSPLUS-CRSL-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

GAMMA GT SL Réf. : GASL-0400

GASL-0420
2 x 62.5 mL
4 x 62.5 mL
GASL-0500 5 x 125 mL
ONE REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : GAMMA-GT SL Test : GASL
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 405 nm Secondary Wavelength : None
Read Time/Interval : 60 Sample blank : No
Factor : 1158.00
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : 0.0000 High Blank A Limit : 1.500
Low A Limit : 0.0000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 350 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : GAMMA-GT SL Test : GASL
Test Bar Code : xx
Sample Volume : 25 µL
Rerun Dilution Ratio : 2 Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 250 µL xx µL 60 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 20 to 350 U/L.

• Precision
-Within-run reproducibility :
Low level : n = 20 m = 35.6 U/L CV = 1.5 %
Medium level : n = 20 m = 108.1 U/L CV = 1.3 %
High level: n = 20 m = 168.2 U/L CV = 1.1 %

-Between-run reproducibility :
Low level : n = 20 m = 34.2 U/L CV = 2.6 %
Medium level : n = 20 m = 157.5 U/L CV = 1.7 %
High level: n = 20 m = 238.5 U/L CV = 1.3 %

(09/2005)
AA-EXPRESSPLUS-GASLmono-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

Réf. : GAGT-0030 20 x 3 mL
GAMMA GT GAGT-0200 12 x 20 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : GAMMA-GT Test : GAGT
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 405 nm Secondary Wavelength : None
Read Time/Interval : 180 Sample blank : No
Factor : 1111.00
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : 0.1500 High Blank A Limit : 1.000
Low A Limit : 0.1500 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 250 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : GAMMA-GT Test : GAGT
Test Bar Code : xx
Sample Volume : 25 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 250 µL xx µL 60 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 20 to 250 U/L.

• Precision
-Within-run reproducibility :
Low level : n = 20 m = 30.6 U/L CV = 1.4 %
Medium level : n = 20 m = 69.8 U/L CV = 0.9 %
High level: n = 20 m = 137.1 U/L CV = 1.4 %

(09/2005)
AA-EXPRESSPLUS-GAGT-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

GLUCOSE HK SL Réf. : GHSL-0600 5 x 125 mL

ONE REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Glucose Test : GHSL
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : g/L No of Decimal Places : 2
Primary Wavelength : 340 nm Secondary Wavelength : none
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.100 High Blank A Limit : 1.000
Low A Limit : -0.100 High A Limit : 3.000
Low Normal : xx High Normal : xx
Linearity Limit : 6.00 Curve S.D. Limit : 0.2000*
REAGENT PARAMETERS
Test name : Glucose Test : GHSL
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 0.5 to 6 g/L.

• Precision
-Within-run reproducibility :
Low level : n = 20 m = 0.85 g/L CV = 1.3 %
Medium level : n = 20 m = 1.05 g/L CV = 1.7 %
High level: n = 20 m = 2.5 g/L CV = 1.4 %

(06/2006)
AA-EXPRESSPLUS-GHSLmono-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

Réf. : GPSL-0490 1 x 100 mL

GLUCOSE PAP SL GPSL-0500
GPSL-0507
6 x 100 mL
6 x 100 mL + STD
GPSL-0707 4 x 250 mL + STD

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Glucose Test : GPSL
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : g/L No of Decimal Places : 2
Primary Wavelength : 510 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.100 High Blank A Limit : 0.300
Low A Limit : -0.100 High A Limit : 3.000
Low Normal : xx High Normal : xx
Linearity Limit : 4 Curve S.D. Limit : 0.2000*
REAGENT PARAMETERS
Test name : Glucose Test : GPSL
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 0.5 to 4 g/L.

• Precision
-Within-run reproducibility :
Low level : n = 20 m = 0.98 g/L CV = 3.0 %
Medium level : n = 20 m = 1.25 g/L CV = 3.9 %
High level: n = 20 m = 2.5 g/L CV = 2.1 %

-Between-run reproducibility :
Low level : n = 20 m = 0.89 g/L CV = 4.2 %
Medium level : n = 20 m = 1.04 g/L CV = 3.9 %
High level: n = 20 m = 2.44 g/L CV = 3.5 %

• Correlation
A comparative study has been performed between Elitech method on EXPREES PLUS and a method validated on another analyser on 23
human sera.The sample concentration ranged from 0.23 to 4.36 g/L. The parameters ef linear regressions are as follows:
Correlation coefficient (r): 0.9993
Linear regression: y= 0.9941 x + 0.0042

Modification from the previous version (02/2009)

AA-EXPRESSPLUS-GPSL-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

Réf. : GLUP-0700 4 x 250 mL

GLUCOSE PAP GLUP-0800 5 x 500 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Glucose Test : GLUP
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : g/L No of Decimal Places : 2
Primary Wavelength : 510 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.100 High Blank A Limit : 2.000
Low A Limit : -0.100 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 4 Curve S.D. Limit : 0.5000*
REAGENT PARAMETERS
Test name : Glucose Test : GLUP
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 0.5 to 4 g/L.

• Precision
-Within-run reproducibility :
Low level : n = 20 m = 0.98 g/L CV = 3.0 %
Medium level : n = 20 m = 1.25 g/L CV = 3.9 %
High level: n = 20 m = 2.5 g/L CV = 2.1 %

-Between-run reproducibility :
Low level : n = 20 m = 0.89 g/L CV = 4.2 %
Medium level : n = 20 m = 1.04 g/L CV = 3.9 %
High level: n = 20 m = 2.44 g/L CV = 3.5 %

• Correlation
A comparative study has been performed between Elitech method on EXPREES PLUS and a method validated on another analyser on 23
human sera.The sample concentration ranged from 0.23 to 4.36 g/L. The parameters ef linear regressions are as follows:
Correlation coefficient (r): 0.9993
Linear regression: y= 0.9941 x + 0.0042
(09/2005)
AA-EXPRESSPLUS-GLUP-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

IRON Réf. : FEFR-0600 2 x 125 mL

FERROZINE®
APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Iron Test : FEFR
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : µg/dL No of Decimal Places : 1
Primary Wavelength : 570 nm Secondary Wavelength : None
Read Time/Interval : 20 Sample blank : Yes
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.000 High Blank A Limit : 0.100
Low A Limit : 0.000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 900 Curve S.D. Limit : 10.0*
REAGENT PARAMETERS
Test name : Iron Test : FEFR
Test Bar Code : xx
Sample Volume : 30 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 260 µL xx µL 30 seconds xx
Reagent 2 : 50 µL xx µL 270 seconds xx
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 30 to 900 µg/dL.

• Precision
-Within-run reproducibility :
Low level : n = 20 m = 69.8 µg/dL CV = 2.3 %
Medium level : n = 20 m = 101.8 µg/dL CV = 1.5 %
High level: n = 20 m = 168 µg/dL CV = 1.3 %

Preparation of working reagents:

Working reagent 1 (WR1): Dissolve 1 level measuring spoonful of reagent RA in 50 mL of reagent 1.
Working reagent 2 (WR2): Add 1mL of Ferrozine (Reagent 2) in 4 mL of working reagent 1. WR2 should be prepared before use.

Modification from the previous version

(02/2009)
AA-EXPRESSPLUS-FEFR-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

LACTATE Réf. : LACT-0100 10 x 10 mL

APPLICATION FOR EXPRESS PLUS

PROPOSAL.

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : LACTATE Test : LACT
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : g/L No of Decimal Places : 3
Primary Wavelength : 540 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.000 High Blank A Limit : 0.300
Low A Limit : 0.000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 1.20 Curve S.D. Limit : 0.4000*
REAGENT PARAMETERS
Test name : LACTATE Test : LACT
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 0.1 to 1.2 g/L.

(09/2005)
AA-EXPRESSPLUS-LACT-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

LDH-P 4 + 1 SL Ref. : LDSL-0410 2 x 62.5 mL

LDSL-0430 4 x 62.5 mL
ONE REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : LDH-P Test : LDSL
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 340 nm Secondary Wavelength : None
Read Time/Interval : 180 Sample blank : No
Factor : -8095.00
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : 0.9000 High Blank A Limit : 1.800
Low A Limit : 0.7000 High A Limit : 1.800
Low Normal : xx High Normal : xx
Linearity Limit : 1500 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : LDH-P Test : LDSL
Test Bar Code : xx
Sample Volume : 6 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 60 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 50 to 1500 U/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 296 U/L CV = 2.0 %
Pathological sera : n = 20 m = 490 U/L CV = 1.8 %

(09/2005)
AA-EXPRESSPLUS-LDSL4+1mono-2

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

LDH - P Réf. : LDHP-0030 20 x 3 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : LDH-P Test : LDHP
Test Bar Code : xx
Test Type : KINETIC Curve Type : Enz. Linear
Units : U/L No of Decimal Places : 0
Primary Wavelength : 340 nm Secondary Wavelength : None
Read Time/Interval : 180 Sample blank : No
Factor : -8095.00
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 1 No of replicates : 3
Low Blank A Limit : 0.9000 High Blank A Limit : 2.000
Low A Limit : 0.7000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 1500 Curve S.D. Limit :
REAGENT PARAMETERS
Test name : LDH-P Test : LDHP
Test Bar Code : xx
Sample Volume : 6 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 60 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 50 to 1500 U/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 336.3 U/L CV = 1.3 %
Pathological sera : n = 20 m = 527.9 U/L CV = 1.4 %

Modification from the previous version

(02/2009)
AA-EXPRESSPLUS-LDHP-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

MAGNESIUM Réf. : MAGN-0600 2 x 125 mL

CALMAGITE
APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Magnesium Test : MAGN
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/L No of Decimal Places : 1
Primary Wavelength : 510 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.300 High Blank A Limit : 1.000
Low A Limit : 0.300 High A Limit : 1.500
Low Normal : xx High Normal : xx
Linearity Limit : 50.0 Curve S.D. Limit : 5.00*
REAGENT PARAMETERS
Test name : Magnesium Test : MAGN
Test Bar Code : xx
Sample Volume : 6 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 10 to 50 mg/L.

• Precision
-Within-run reproducibility :
Medium level : n = 20 m = 26.3 mg/L CV = 2.3 %
High level : n = 20 m = 53.4 mg/L CV = 2.0 %

-Between-run reproducibility :
Medium level : n = 20 m = 27.5 mg/L CV = 2.3 %
High level : n = 20 m = 52.8 mg/L CV = 2.1 %

(09/2005)
AA-EXPRESSPLUS-MAGN-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

PHOSPHORUS Réf. : PHOS-0600 2 x 125 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Phosphorus Test : PHOS
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/dL No of Decimal Places : 2
Primary Wavelength : 340 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.1500 High Blank A Limit : 0.300
Low A Limit : 0.1500 High A Limit : 1.500
Low Normal : xx High Normal : xx
Linearity Limit : 20 Curve S.D. Limit : 0.5000*
REAGENT PARAMETERS
Test name : Phosphorus Test : PHOS
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear up to 20 mg/dL.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 3.9 mg/dL CV = 2.3 %
Pathological sera : n = 20 m = 5.7 mg/dL CV = 1.6 %

-Between-run reproducibility :
Normal sera : n = 20 m = 4.2 mg/dL CV = 4.1 %
Pathological sera : n = 20 m = 6.4 mg/dL CV = 3..3 %

(09/2005)
AA-EXPRESSPLUS-PHOS-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

TOTAL PROTEIN Réf. : PRTB-0600

PRTB-0900
2 x 125 mL
1 x 1000 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : PROTEIN Test : PRTB
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : g/dL No of Decimal Places : 2
Primary Wavelength : 540 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.000 High Blank A Limit : 0.600
Low A Limit : 0.000 High A Limit : 2.000
Low Normal : xx High Normal : xx
Linearity Limit : 10.00 Curve S.D. Limit : 0.5000*
REAGENT PARAMETERS
Test name : PROTEIN Test : PRTB
Test Bar Code : xx
Sample Volume : 6 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 360 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 1 to 10 g/dL.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 6.8 g/dL CV = 1.6 %
Pathological sera : n = 20 m = 5.1 g/dL CV = 1.4 %

• Correlation
A comparative study has been performed between Elitech method on EXPREES PLUS and a method validated on another analyser on 60
human sera.The sample concentration ranged from 0.21 to 10.04 g/dL. The parameters ef linear regressions are as follows:
Correlation coefficient (r): 0.9988
Linear regression: y= 0.943 x - 0.198

(09/2005)
AA-EXPRESSPLUS-PRTB-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

TRIGLYCERIDES Réf. : TRIG-0200

TRIG-0400
12 x 20 mL
9 x 50 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Trigly Test : TRIG
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : g/L No of Decimal Places : 2
Primary Wavelength : 540 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.0100 High Blank A Limit : 0.1000
Low A Limit : -0.0100 High A Limit : 2.5000
Low Normal : xx High Normal : xx
Linearity Limit : 10.00 Curve S.D. Limit : 1.0000*
REAGENT PARAMETERS
Test name : Trigly Test : TRIG
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 0.2 to 10 g/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 0.8 g/L CV = 2.8 %
Pathological sera : n = 20 m = 4.1 g/L CV = 2.1 %

-Between-run reproducibility :
Normal sera : n = 20 m = 0.6 g/L CV = 3.8 %
Pathological sera : n = 20 m = 1.9 g/L CV = 3.5 %

Modification from the previous version

(02/2009)
AA-EXPRESSPLUS-TRIG-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

Réf. : TGML-0425 6 x 50 mL
TRIGLYCERIDES TGML-0515
TGML-0700
6 x 100 mL
4 x 250 mL

MONO SL NEW TGML-0427

TGML-0517
TGML-0707
6 x 50 mL + STD
6 x 100 mL + STD
4 x 250 mL + STD

APPLICATION FOR EXPRESS PLUS

PROPOSAL

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Trigly Test : TGMLN
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/dL No of Decimal Places : 1
Primary Wavelength : 510 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.2500 High Blank A Limit : 1.5000
Low A Limit : -0.1000 High A Limit : 2.0000
Low Normal : xx High Normal : xx
Linearity Limit : 1000 Curve S.D. Limit : 10. 000*
REAGENT PARAMETERS
Test name : Trigly Test : TGMLN
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 590 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

Modification from the previous version

(02/2009)
AA-EXPRESSPLUS-TGMLN-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

Réf. : URSL-0400 2 x 62.5 mL

UREA UV SL URSL-0420
URSL-0500
4 x 62.5 mL
5 x 125 mL
URSL-0407 2 x 62.5 mL + STD
ONE REAGENT PROCEDURE URSL-0427 4 x 62.5 mL + STD
URSL-0507 5 x 125 mL + STD

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Urea Test : URSL
Test Bar Code : xx
Test Type : TWO POINT Curve Type : Blanked Linear
Units : mg/dL No of Decimal Places : 1
Primary Wavelength : 340 nm Secondary Wavelength : None
Read Time/Interval : 60 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.200 High Blank A Limit : 1.900
Low A Limit : -0.200 High A Limit : 2.000
Low Normal : xx High Normal : xx
Linearity Limit : 30.0 Curve S.D. Limit : 2.0000*
REAGENT PARAMETERS
Test name : Urea Test : URSL
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 30 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear up to 30 mg/dL.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 4.7 mg/dL CV = 2.0 %
Pathological sera : n = 20 m = 15.6 mg/dL CV = 1.0 %

-Between-run reproducibility :
Normal sera : n = 20 m = 4.8 mg/dL CV = 3.2 %
Pathological sera : n = 20 m = 15.8 mg/dL CV = 3.8 %

Modification from the previous version

(02/2009)
AA-EXPRESSPLUS-URSLmono-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

Réf. : URUV-0400 9 x 50 mL
UREA UV URUV-0500 6 x 100 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : Urea Test : URUV
Test Bar Code : xx
Test Type : TWO POINTS Curve Type : Blanked Linear
Units : g/L No of Decimal Places : 2
Primary Wavelength : 340 nm Secondary Wavelength : None
Read Time/Interval : 30 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.200 High Blank A Limit : 2.000
Low A Limit : -0.200 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 3.0 Curve S.D. Limit : 0.5000*
REAGENT PARAMETERS
Test name : Urea Test : URUV
Test Bar Code : xx
Sample Volume : 3 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 300 µL xx µL 30 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 0.1 to 3 g/L.

• Precision
-Within-run reproducibility :
Low level : n = 20 m = 0.37 g/L CV = 1.2 %
Medium level : n = 20 m = 0.65 g/L CV = 1.0 %
High level : n = 20 m = 1.53 g/L CV = 1.4 %

• Detection limit
Determined according to SFBC protocol, the detection limit is equal to 0.06 g/L.

(09/2005)
AA-EXPRESSPLUS-URUV-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

Réf. : AUML-0420 6 x 50 mL
URIC ACID AUML-0500
AUML-0427
6 x 100 mL
6 x 50 mL + STD

MONO SL AUML-0507
AUML-0707
6 x 100 mL + STD
4 x 250 mL + STD

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : URIC ACID Test : AUML
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/L No of Decimal Places : 1
Primary Wavelength : 540 nm Secondary Wavelength : 600
Read Time/Interval : 20 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : 0.000 High Blank A Limit : 0.500
Low A Limit : 0.000 High A Limit : 2.000
Low Normal : xx High Normal : xx
Linearity Limit : 250.0 Curve S.D. Limit : 5.00*
REAGENT PARAMETERS
Test name : URIC ACID Test : AUML
Test Bar Code : xx
Sample Volume : 6 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 250 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 35 to 250 mg/L.

• Precision
-Within-run reproducibility :
Low level : n = 20 m = 32.6 mg/L CV = 3.7 %
Medium level : n = 20 m = 43.7 mg/L CV = 2.5 %
High level : n = 20 m = 102.2 mg/L CV = 2.4 %

-Between-run reproducibility :
Low level : n = 20 m = 44 mg/L CV = 3.0 %
Medium level : n = 20 m = 69.4 mg/L CV = 3.8 %
High level : n = 20 m = 110.8 mg/L CV = 2.7 %

Modification from the previous version

(02/2009)
AA-EXPRESSPLUS-AUML-4

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

URIC ACID SL Réf. : AUSL-0400

AUSL-0420
2 x 62.5 mL
4 x 62.5 mL
AUSL-0600 5 x 125 mL
ONE REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : URIC ACID Test : AUSLmono
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/dL No of Decimal Places : 2
Primary Wavelength : 540 nm Secondary Wavelength : 600
Read Time/Interval : 20 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.1500 High Blank A Limit : 0.5000
Low A Limit : -0.1500 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 25.00 Curve S.D. Limit : 0.5000*
REAGENT PARAMETERS
Test name : URIC ACID Test : AUSLmono
Test Bar Code : xx
Sample Volume : 6 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 250 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 3.2 to 25 mg/dL.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 5.1 mg/dL CV = 1.6 %
Pathological sera : n = 20 m = 10.9 mg/dL CV = 1.8 %

-Between-run reproducibility :
Normal sera : n = 20 m = 4.4 mg/dL CV = 2.8 %
Pathological sera : n = 20 m = 10.7 mg/dL CV = 2.1 %

(09/2005)
AA-EXPRESSPLUS-AUSLmono-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

URIC ACID SL Réf. : AUSL-0400 2 x 62.5 mL

AUSL-0420 4 x 62.5 mL
AUSL-0600 5 x 125 mL
TWO REAGENT PROCEDURE

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : URIC ACID Test : AUSLbi
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/dL No of Decimal Places : 2
Primary Wavelength : 540 nm Secondary Wavelength : 600
Read Time/Interval : 20 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.1500 High Blank A Limit : 0.5000
Low A Limit : -0.1500 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 25.00 Curve S.D. Limit : 0.5000*
REAGENT PARAMETERS
Test name : URIC ACID Test : AUSLbi
Test Bar Code : xx
Sample Volume : 5 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 200 µL xx µL 60 seconds xx
Reagent 2 : 50 µL µL 300 seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 2.6 to 25 mg/dL.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 5.2 mg/dL CV = 1.4 %
Pathological sera : n = 20 m = 10.9 mg/dL CV = 1.6 %

-Between-run reproducibility :
Normal sera : n = 20 m = 4.5 mg/dL CV = 2.3 %
Pathological sera : n = 20 m = 10.7 mg/dL CV = 2.1 %

(09/2005)
AA-EXPRESSPLUS-AUSLbi-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE

 ELITECH ELITECH ELITECH

Réf. : ACUR-0200 12 x 20 mL
URIC ACID ACUR-0400
ACUR-0600
9 x 50 mL
6 x 100 mL

APPLICATION FOR EXPRESS PLUS

Instruction for use :

Working temperature : 37°C

TEST PARAMETERS
Test name : URIC ACID Test : ACUR
Test Bar Code : xx
Test Type : END POINT Curve Type : Blanked Linear
Units : mg/L No of Decimal Places : 0
Primary Wavelength : 510 nm Secondary Wavelength : None
Read Time/Interval : 10 Sample blank : No
Factor :
Calibration Interval : xx Hours
Normalization Interval : xx Hours
No of Calibrators : 2 No of replicates : 3
Low Blank A Limit : -0.1000 High Blank A Limit : 0.500
Low A Limit : -0.1000 High A Limit : 2.500
Low Normal : xx High Normal : xx
Linearity Limit : 250.0 Curve S.D. Limit : 5.00*
REAGENT PARAMETERS
Test name : URIC ACID Test : ACUR
Test Bar Code : xx
Sample Volume : 8 µL
Rerun Dilution Ratio : 1* Predilution Ratio : 1
Sample diluent Bar code :
Sample diluent Bottle type : xx
Reagent diluent Bar code :
Reagent diluent Bottle type : xx
Reagent Volume Bar Code Diluent Volume Lag Time Bottle Type
Reagent 1 : 320 µL xx µL 300 seconds xx
Reagent 2 : µL µL seconds
Reagent 3 : µL µL seconds
Reagent 4 : µL µL seconds
Controls : xx
xx : Data entered by the operator. * : For information only.

PERFORMANCES

• Analytical range
The reagent is linear from 25 to 250 mg/L.

• Precision
-Within-run reproducibility :
Normal sera : n = 20 m = 44 mg/L CV = 1.9 %
Pathological sera : n = 20 m = 110.9 mg/L CV = 1.4 %

-Between-run reproducibility :
Normal sera : n = 20 m = 46.9 mg/L CV = 1.8 %
Pathological sera : n = 20 m = 109.2 mg/L CV = 1.7 %

(09/2005)
AA-EXPRESSPLUS-ACUR-3

SEPPIM S.A.S- ZONE INDUSTRIELLE - 61500 SEES - FRANCE