BIOLABO - Applications Humastar 180

BIOLABO REAGENTS 03
www.biolabo.fr ACID PHOSPHATASE

MANUFACTURER: Kinetic Method (Total / Non Prostatic)
BIOLABO SA,
02160, MAIZY, FRANCE
R1 10 × 15 mL Citrate Buffer
|
REF 82560 R2 5 × 15 mL Citrate/Tartrate Buffer IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS R3 10 × 15 mL Substrate
Tel: (33) 03 23 25 15 50 R4 1 × 5 mL Stabiliser
Fax : (33) 03 23 256 256
Humastar 180 - Preliminary
Principle :
Kinetic photometric test. ASSAY PARAMETERS AT 37°C
Reaction direction: increase in absorbance. PROGRAMMING TESTS
Reagents preparation : Test ID ACP T / NP
Reagent 1 : is ACP T or ACP NP reagent in the method. Name ACP T/NP
Reagent (ACP T): Add promptly the contents of vial R3 (Substrate) into Test Type Kinetic
vial R1 (Citrate Buffer). Mix gently and wait for complete dissolution Units IU/L
before using reagent (approximately 2 minutes).
Digits 1
Reagent (ACP NP): Add promptly the contents of vial R3 (Substrate)
into vial R2 (Citrate/Tartrate Buffer). Mix gently and wait for complete Temperature (°C) 37
dissolution (approximately 2 minutes). Clinical normal values Lower / Upper
Vial R3: Use a non-sharp instrument to remove aluminium cap. Reag. Blank #|#
Vial R4 is ready for use.
man #
Stability and storage: woman #
Store at 2-8° C in the original vial and away from l ight. child #
Without contamination and used as described in the packaging insert, Descending reaction NO
reagents are stable until expiry date stated on the label. OD limit for used 2500
Once reconstituted, ACP T / ACP NP reagents are stable for 10 days at substrate
2-8°C.
Discard any ACP T / ACP NP reagents if cloudy or if absorbance Linearity limit 150 / 75
measured at 405 nm > 0.600. Filter (nm) 405
Don’t use any working reagent after expiry date stated on the label of Ref. Filter (nm)
the kit. Blank
Specimen collection and handling: Reagents 1
Unhemolysed serum. Separate from clot as soon as possible after Bottletype #
collection and promptly assayed. Acidify at pH 5.4-6.2 by adding a drop Controls #
(20 µL) of Reagent R4 (Stabiliser) for 1 mL of serum. Volume Sample (µl) 20
Acid phosphatase activity in serum is labile (activity decreases of 50% in
8 hours).
Reagent 1 (µl) 200
Acid phosphatase activity is stable in the acidified serum for 7 days at 2- Reagent 2 (µl)
8°C. Reagent 3 (µl)
Performance characteristics: Calibration Multicalibrator (**)
Volume water
ACP T: the assay is linear up to 150 IU/L (2.5 µKat/L).
ACP NP: the assay is linear up to 75 IU/L (1.25 µKat/L).
Calibration Fixfactor
Detection limit: approx. 1.0 IU/L. Correlation Factor
Correlation Offset
Calibration:
Method definition PR1
It is recommended to verify the calibration factor with BIOLABO PS
Multicalibrator REF 95015 or a Multicalibrator traceable to a reference
method or material.
InkR300
MDOD180
Quality Control:
BIOLABO EXATROL-N (Normal values) REF 95010 (10 x 5 mL) Mixing Parameter
BIOLABO EXATROL-P (pathological values) REF 95011 (10 x 5 mL) Volume (µl) 170
or any assayed control sera referring to the same method. Repetitions 2
Results: # Data entered by user
Determine on this channel: (**) Refer to §Calibration
- ACP T = Total Acid Phosphatase activity
- ACP NP = Non Prostatic Acid Phosphatase activity.
For calculation of prostatic acid phosphatase assign 2 methods, i.e.
ACP-T (total ACP) and ACP-NP (non-prostatic ACP). Use intermethod.
calculation to subtract the results of ACP-NP from ACP-T in order to
calculate the fraction of prostatic acid phosphatase
Expected values:
Prostatic Acid Phosphatase at 30 or 37°C
0 – 0.6 IU/L 0 – 0.01 µKat/L
For more details, see packing insert. MAJ 25/07/2008

Version AT 82560 25 10 2005
Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 04
www.biolabo.fr ALBUMIN
MANUFACTURER: BCG Method
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 80002 R1 2 x 200 mL R2 1x 5 mL
IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Principle: ASSAY PARAMETER at 37°C

PROGRAMMING TESTS
End point photometric test.
Reaction direction: increase in absorbance. Test ID ALB
Name ALB
Reagents preparation:
Test Type End point
Reagents are ready for use
Units g/dL
Stability and storage: Digits 1
Temperature (°C) 37
Store at 2-8° C in the original vial and away from l ight. Clinical normal values Lower | Upper
Standard (vial R2): Transfer the requested quantity, recap and
store at 2-8°C. #|#
Reag. Blank
Without contamination and used as described in the
packaging insert, reagents are stable until expiry date stated man #
on the label. woman #
Discard reagent if cloudy or if absorbance measured at child #
620 nm is > 0.300.
Descending reaction NO
Specimen collection and handling: OD limit for used
300
substrate
Serum or plasma (see § Interferences in the packing insert).
Serum albumin is stable in serum for: 72 hours at 2-8°C or Linearity limit 6.0
6 months at -20°C.
Filter (nm) 620
Performances characteristics: Ref. Filter (nm)
Linearity: up to 6.0 g/dL (903 µmol/L). Blank Normal blank
Detection limit: approximately 0.3 g/dL. Reagents 1
Bottletype #
Calibration: Controls #
Volume
Use Standard enclosed in the Kit (vial R2), Sample (µl) 2
BIOLABO Multicalibrator REF 95015 Reagent 1 (µl) 400
or any calibrator traceable to a reference method or material.
Reagent 2 (µl)
Quality Control: Reagent 3 (µl)
Calibration Multicalibrator(**)
BIOLABO EXATROL-N (normal values) REF 95010 Volume water
(10 x 5 mL) Calibration Fixfactor
BIOLABO EXATROL-P (pathological values) REF 95011 Correlation Factor
(10 x 5 mL) or any assayed control sera referring to the same Correlation Offset
method.
Expected values: PS
InkR300
Albumin g/dL µmol/L
MesOD
0 to 4 days 2.8-4.4 421-662
4 days to 14 years 3.8-5.4 572-813 Mixing Parameter
14 to 18 years 3.2-4.5 482-677 Volume (µl) 170
Repetitions 2
18 to 60 years 3.4-4.8 512-722
# Data entered by user
60 to 90 years 3.2-4.6 482-692 (**) refer to § calibration
> 90 years 2.9-4.5 436-677

Version AT 80002 21 02 2005
BIOLABO REAGENTS 05’
www.biolabo.fr ALCOHOL (Ethanol)
MANUFACTURER: Enzymatic method
BIOLABO SA,
REF 99029 R1 10 X 10 mL R2 1 x 5 mL IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS REF 99059 R1 2 x 100 mL R2 1 x 10 mL
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

With deproteinization (whole blood, haemolysed, icteric or cloudy sera or
plasmas)
Principle: ASSAY PARAMETERS AT 37°C

Enzymatic End Point method. PROGRAMMING TESTS
Reaction direction: Increase in absorbance.
REF 99029: Use a non-sharp instrument to remove aluminium cap. Test ID ALC2
Add promptly to the contents of the vial R1 the volume of demineralised Name ALC2
water stated on the label. Mix gently and wait for complete dissolution Test Type End point
before using reagent (approximately 10 minutes). Units mg/dL
Standard (vial R2) :
Transfer the requested quantity, recap and store at 2-8°C. Digits 0
Stability and storage Clinical normal values Lower | Upper
Reag. Blank #|#
Store at 2-8°C, in the original vial and away from l ight. man #
Without contamination and use as described in the packaging insert, woman #
reagents are stable until expiry date stated on the label. child #
Once reconstituted, working reagent (vial R1) is stable at least for
7 days when free from contamination.
Discard any reagent if cloudy or if absorbance at 340 nm is > 0.500. OD limit for used 500
Don’t use working reagent after expiry date stated on the label. substrate
Linearity limit 300
Performances characteristics: Filter (nm) 340
Linearity: the assay is linear up to 300 mg/dL (65 mmol/L) Ref. Filter (nm)
Detection limit: approximately 10 mg/dL. Blank Normal Blank
Reagents 1
Specimen collection and handling: Bottletype #
Whole blood, hemolysed, icteric or cloudy sera or plasma: Controls #
Stability in whole blood (without sodium fluoride as preservative): Volume
at 18-25° C up to 2 days, at 2-8° C up to 2 weeks, at –15° C up to (1) Sample (µl) 10
4 weeks. Reagent 1 (µl) 300
Stability in whole blood (with sodium fluoride as preservative) :
at 18-25° C up to 2 weeks at 2-8° C up to 3 months , at –15° C up to Reagent 2 (µl)
6 months. Reagent 3 (µl)
Specimens must be kept capped to avoid evaporative loss to the Calibration (**)
atmosphere. Volume water
Prepare supernatant as indicated in packing insert § Manual Procedure Calibration Fixfactor
(n ° 2 : with deproteinization). Correlation Factor
Correlation Offset
Calibration: Method definition PR1
Use Standard (vial R2) enclosed in the kit or any calibrator traceable to PS
a reference method or material. InkR600
Dilute as indicated in packing insert § Manual Procedure (Procedure
MesOD
n ° 2: With deproteinization).
Quality Control: Mixing Parameter

Volume (µl) 170
Assayed control referring to the same method. Repetitions 2
Dilute as indicated in packing insert § Manual Procedure (Procedure
n ° 2: With deproteinization). (1) Sample : supernatant
(**) Refer to §Calibration

Version AT 99029 20 02 2007
BIOLABO REAGENTS 05
www.biolabo.fr ALCOHOL (Ethanol)
MANUFACTURER: Enzymatic method
BIOLABO SA,
REF 99029 R1 10 X 10 mL R2 1 x 5 mL IVD : IN VITRO DIAGNOSTIC USE
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

(sera, plasmas, urines)
ASSAY PARAMETERS AT 37°C

Principle: PROGRAMMING TESTS
Enzymatic End Point method.
Reaction direction: Increase in absorbance.
Reagents preparation: Test ID ALC1

REF 99029: Use a non-sharp instrument to remove aluminium cap. Name ALC1
Add promptly to the contents of the vial R1 the volume of demineralised Test Type End point
water stated on the label. Mix gently and wait for complete dissolution Units mg/dL
before using reagent (approximately 10 minutes). Digits 0
Standard (vial R2) : Transfer the requested quantity, recap and store Temperature (°C) 37
at 2-8°C. Clinical normal values Lower | Upper
Reag. Blank #|#
Stability and storage man #
Store at 2-8°C, on the original vial and away from l ight. woman #
Without contamination and used as described in the packaging insert,
child #
reagents are stable until expiry date stated on the label. Descending reaction NO
Once reconstituted, working reagent (vial R1) is stable at least for OD limit for used 500
7 days when free from contamination. substrate
Discard any reagent if cloudy or if absorbance at 340 nm is > 0.500.
Linearity limit 300
Don’t use working reagent after expiry date stated on the label.
Filter (nm) 340
Performance characteristics: Ref. Filter (nm)
Blank Normal Blank
Linearity: the assay is linear up to 300 mg/dL (65 mmol/L)
Detection limit: approximately 10 mg/dL.
Reagents 1
Bottletype #
Specimen collection and handling: Controls #
Volume
Urines. Serum, plasma (alcohol swabs should not be used during blood Sample (µl) 3
specimen collection). Use heparin, Potassium oxalate, E.D.T.A.,
Sodium citrate or fluoride as anticoagulant. Reagent 1 (µl) 999
Stability in whole blood (without sodium fluoride as preservative): Reagent 2 (µl)
at 18-25° C up to 2 days, at 2-8° C up to 2 weeks, at –15° C up to 4 Reagent 3 (µl)
weeks **
Calibration **
Stability in whole blood (with sodium fluoride as preservative) :
at 18-25° C up to 2 weeks at 2-8° C up to 3 months , at –15° C up to 6 Volume water
months. Calibration Fixfactor
Specimens must be kept capped to avoid evaporative loss to the Correlation Factor
atmosphere. Correlation Offset
(1)Whole blood, haemolysed, icteric or cloudy sera or plasma: Method definition PR1
See special (With deproteinization) available on request. PS
InkR600
Calibration: MesOD
Use Standard (vial R2) enclosed in the kit or any calibrator traceable to
a reference method or material. Mixing Parameter
Volume (µl) 170
Quality Control: Repetitions 2
Assayed control referring to the same method.
** Refer to §Calibration

Version AT 99029 20 02 2007
BIOLABO REAGENTS 06
www.biolabo.fr ALKALINE PHOSPHATASE
MANUFACTURER: DEA Method
BIOLABO SA,
REF 92214 R1 8 × 30 mL R2 8 × 30 mL
REF 92314 R1 10 × 100 mL R2 10 x 100 mL IVD : IN VITRO DIAGNOSTIC USE
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Principle:
Kinetic photometric test ASSAY PARAMETERS AT 37°C
Reagents preparation: Test ID ALKP
Vial R2: Use a non-sharp instrument to remove aluminium cap.
Name ALKP
Add promptly the contents of vial R2 (Substrate) into vial R1
(Buffer).
Test Type Kinetic
Mix gently and wait for complete dissolution before using Units UI/L
reagent (approximately 2 minutes). Digits 1
Stability and storage: Clinical normal values Lower | Upper
Store at 2-8°C, well recap in the original vial and away from
Reag. Blank #|#
light.
Unopened, when used and stored as described in the insert, man #
reagents are stable until expiry date stated on the label. woman #
Once reconstituted, working reagent is stable at least for 30 child #
days when free from contamination. Descending reaction NO
Discard any reagent if cloudy or if absorbance of working OD limit for used 2500
reagent at 405 nm is > 0.800. substrate
Don’t use working reagent after expiry date stated on the label. Linearity limit 1200
Specimen collection and handling: Filter (nm) 405
Unhemolysed serum or heparinised plasma, immediately Ref. Filter (nm)
refrigerated. Blank
ALP activity is stable in the specimen for 2-3 days at 2-8°C, or Reagents 1
1 month at -25°C. Bottletype #
Performances characteristics: Controls #
Linearity: the assay is linear up to 1200 IU/L (20 µKat/L) in the Volume Sample (µl) 3
conditions describe opposite. Reagent 1 (µl) 300
Detection limit: approx. 30 IU/L. Reagent 2 (µl)
Reagent 3 (µl)
**
Calibration: Calibration Multicalibrator
It is recommended to verify the calibration factor (5450/1 cm Volume water
pathlength) with BIOLABO-Multicalibrator REF 95015 Calibration Fixfactor **
(10 x 5 mL) or any calibrator traceable to a reference method Correlation Factor
or material.
Correlation Offset
Quality Control:
BIOLABO EXATROL-N (normal values) REF 95010 PS
(10 x 5 mL) InkR60
BIOLABO EXATROL-P (pathological values) REF 95011 MDOD180
(10 x 5 mL) or any control sera referring to the same method.
Mixing Parameter
Expected values: Volume (µl) 170
Repetitions 2
ALP (IU/L à 37°C) # Data entered by user
Age Men Women
20-29 years 100-320 70-260
30-39 years 90-320 70-260
40-49 years 100-360 80-290
50-59 years 110-390 110-380
60-69 years 120-450 110-380
> 69 years 120-460 90-430

Version AT 92214 21 01 2005
BIOLABO REAGENTS 07
www.biolabo.fr ALT/TGP
MANUFACTURER: IFCC Method
BIOLABO SA,
REF 80027 R1 20 x 10 mL REF 80127 R1 8 x 30 mL IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS REF 80227 R1 10 x 125 mL REF 80127 R1 6 x 200 mL
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Kinetic photometric test. PROGRAMMING TESTS
Reaction direction: decrease in absorbance.
Test ID GPT
Reagents preparation: Name GPT
REF 80027: Use a non sharp-instrument to remove the cap. Test Type Kinetic
Add promptly to the contents of the vial the amount of Units U/L
demineralised water stated on the label. Mix gently and wait for Digits 1
complete dissolution before using reagent (approximately
2 minutes).
Clinical normal values Lower/Upper
Stability and storage: Reag. Blank #|#
Store at 2-8° C, well recap in the original vial and away from man #
light. woman #
Unopened, when used and stored as described in the insert, child #
reagents are stable until expiry date stated on the label. Descending reaction YES
Once reconstituted, working reagent is stable at least for 60 OD limit for used #
days when free from contamination. substrate
Discard any reagent if cloudy or if absorbance measured at Linearity limit 350
365 nm is < 1.000.
Filter (nm) 365
Ref. Filter (nm)
Specimen collection and handling: Blank
Unhemolysed serum or heparinised plasma. Reagents 1
ALT is stable in serum or plasma for: Bottletype #
24 hours at room temperature. Controls #
7 days at 2-8° C. Volume Sample (µl) 25
Reagent 1 (µl) 250
Performance characteristics: Reagent 2 (µl)
Linearity: The assay is linear up to 350 IU/L. Reagent 3 (µl)
Detection limit: approximately 7 IU/L. **
Calibration Multicalibrator
Volume water
Calibration: Calibration Fixfactor **
It is recommended to determine the calibration factor (K=1746 / Correlation Factor
1 cm pathlength) with BIOLABO-Multicalibrator REF 95015 or a Correlation Offset
multiparametric calibrator traceable to a reference method or
material.
PS
Quality Control: InkR60
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL) MDOD180
BIOLABO EXATROL-P (pathological values) REF 95011
(10 x 5 mL) or any assayed control sera referring to the same Mixing Parameter
method. Volume (µl) 170
Repetitions 2
Expected values: # Data entered by user
** refer to § Calibration
ALT
IU/L at 30°C IU/L at 37°C
Newborns, infants 9-32 13-45
Men 7-28 10-40
Women 5-25 7-35

Version AT 80027 08 04 2005
BIOLABO REAGENTS 08
www.biolabo.fr AMMONIA
MANUFACTURER: Enzymatic Method
BIOLABO SA,
R1 6 × 20 mL Coenzyme-Buffer
|
REF 99261 R2 1 x 1,5 mL Enzymes IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS R3 1 x 10 mL Standard 500 µg/dL
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Humastar 180 – Preliminary

Enzymatic method. PROGRAMMING TESTS
Reaction direction: decrease in absorbance.
Test ID Amm
Reagents preparation: Name Amm
Reagent 1 (Vial R1): Add promptly 20 mL of demineralised Test Type End Point
water. Mix gently and wait for complete dissolution before using Units µg/dL
reagents (approximately 2 minutes). Digits 0
Reagent 2 : Mix 1 volume of vial R2 with 9 volumes of vial R1.
Clinical normal values Lower | Upper
Stability and storage:
Store at 2-8° C, in the original vial and away from light. Reag. Blank #|#
When free from contamination, stored and used as indicated in man #
the insert, reagents are stable until expiry date stated on the woman #
label. child #
Working reagent (vial R1) is stable at least for 1 month. Descending reaction YES
Once diluted, vial R2 is stable for at least 8 h at 2-8° C. OD limit for used 600
Discard any reagent if cloudy or if working reagent absorbance substrate
measured at 340 nm is < 0.600. Linearity limit 2000
Don’t use any working reagent after expiry date stated on the
Filter (nm) 340
label of the kit.
Ref. Filter (nm)
Specimen collection and handling: Blank Process Blank
Plasma (EDTA or heparin other than ammonium heparinate). Reagents 2
Collect blood from a stasis-free vein into an evacuated tube Bottletype #
avoiding partial filling. Put on ice and centrifuge within Controls #
15 minutes in a stoppered tube. Volume Sample (µl) 20
Separate plasma and perform the analysis immediately to avoid Reagent 1 (µl) 300
overestimated ammonia results. Reagent 2 (µl) (*) 20
Reagent 3 (µl)
Performances characteristics: Calibration Multicalibrator (**)
Linearity: the assay is linear up to 2000 µg/dL (1175 µmol/L).
Volume water
Detection limit: approximately 45.3 µg/dL.
Correlation Factor
Calibration:
Use Standard (vial R3) enclosed in the kit or any calibrator Correlation Offset
traceable to a reference method or material. Method definition PR1
PS
InkR60
Quality Control: Process blank
Assayed control referring to the same method. PR2
InkR600
MesOD
Expected values: Mixing Parameter
AMMONIA (NH3) Volume (µl) 170
In Plasma µg/dL µmol/L Repetitions 2
0-10 days 170-341 [100-200] (**) Refer to §Calibration
10 days to 2 years 68-136 [40-80] (*) see § Reagents Preparation: Reagent 2
> 2 years 19-60 [11-35]
For more details, see packing insert.

Version AT 99261 01 02 2005
BIOLABO REAGENTS 09
www.biolabo.fr AMYLASE
MANUFACTURER: E-PNPG7 Method
BIOLABO SA,
REF 80023 R1 20 × 3 mL
REF 80123 R1 8 × 20 mL IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS REF 80223 R1 10 × 100 mL
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Reaction direction: increase in absorbance.
REF 80023: Use a non-sharp instrument to remove the cap. Test ID AMG7
Once opened, add promptly the amount of demineralised water Name AMG7
stated on the label. Mix gently and wait for complete dissolution Test Type Kinetic
before using reagent (approximately 2 minutes). Units UI/L
Store at 2-8° C, well recap in the original vial and away from Temperature (°C) 37
light. Clinical normal values Lower | Upper
Unopened, when used and stored as described in the insert, Reag. Blank #|#
reagents are stable until expiry date stated on the label. man #
Once reconstituted, working reagent is stable at least for 3 woman #
months when free from contamination.
child #
Discard any reagent if cloudy or if reagent blank at 405 nm
is > 0.600. Descending reaction NO
Don’t use working reagent after expiry date stated on the label. OD limit for used 2500
substrate
Specimen collection and handling: Linearity limit 2000
Unhemolysed serum or heparinized plasma. Filter (nm) 405
α-amylase activity is stable in serum/plasma for : Ref. Filter (nm)
at least 7 days at room temperature and 1 month at 2-8° C. Blank
Urines: Adjust pH to alkalin range before storage. Reagents 1
α-amylase activity is stable in urines for 7 days at 2-8° C. Bottle type #
In case of delay in transporting urines to the laboratory, use a
Controls #
preservative as merthiolate (thimerosal) 0.24mM or 0.1 g/L.
Volume Sample (µl) 6
Performance characteristics: Reagent 1 (µl) 250
Linearity: the assay is linear up to 2000 IU/L (33 µKat/L) Reagent 2 (µl)
Detection limit: approximately 10 IU/L (0.1 µKay/L). Reagent 3 (µl)
**
Calibration: Volume water
It is recommended to determine the calibration factor Calibration Fixfactor **
(5140 / 1 cm pathlength) with BIOLABO-Multicalibrator Correlation Factor
REF 95015 or a multiparametric calibrator traceable to a Correlation Offset
reference method or material. Method definition PR1
PS
Quality Control: InkR60
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL)
MDOD180
(10 x 5 mL)
Mixing Parameter
or any assayed control sera referring to the same method.
Volume (µl) 170
Expected values: Repetitions 2
α-AMYLASE at 37°C ** Refer to §Calibration
IU/L µKat/L
Serum 22-80 0.38-1.36
Urines (37°C) : 24-408 IU/24 hours (0.41-6.94 µKat/24 hours)

Version AT 80023 20 02 2007
BIOLABO REAGENTS 10
www.biolabo.fr AMYLASE
MANUFACTURER: CNPG3 Method
BIOLABO SA,
REF 99523 R1 1 × 105 mL R2 20 x 5 mL
TECHNICAL SUPPORT AND ORDERS REF 99223 R1 10 × 100 mL R2 10 x 100 mL
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Test ID AMG3
Name AMG3
REF 99523: Once opened add promptly 5 mL of reagent R1 (Buffer) to
the contents of vial R2 (Substrate). Test Type Kinetic
REF 99123 and 99223: Once opened add promptly the contents of vial Units UI/L
R2 (Substrate) into vial R1 (Buffer). Digits 1
To avoid contamination with salivary amylase, do not pipette by mouth. Temperature (°C) 37
Mix gently and wait for complete dissolution before using reagents
(approximately 2 minutes).
Reag. Blank #|#
Stability and storage: man #
woman #
Store at 2-8 °C, in the original vial and away from light.
child #
Without contamination and use as described in the packaging insert, Descending reaction NO
reagents are stable until expiry date stated on the label. OD limit for used 2500
Once reconstituted, working reagent is stable at least for 15 days at
18-25° C and for 90 days at 2-8° C.
substrate
Discard any reagent if cloudy or if reagent blank at 405 nm is > 0.600. Linearity limit 2000
Don’t use working reagent after expiry date stated on the label. Filter (nm) 405
Ref. Filter (nm)
Unhemolysed serum or heparinized plasma. Reagents 1
α-amylase activity is stable in serum/plasma for : Bottletype #
at least 7 days at room temperature and 1 month at 2-8° C. Controls #
Urines: Adjust pH to alkalin range before storage.
α-amylase activity is stable in urines for 7 days at 2-8° C. Volume Sample (µl) 6
In case of delay in transporting urines to the laboratory, use a Reagent 1 (µl) 250
preservative as merthiolate (thimerosal) 0.24mM or 0.1 g/L. Reagent 2 (µl)
Reagent 3 (µl)
Performance characteristics: Calibration
**
Multicalibrator
Linearity: the assay is linear up to 2000 IU/L (33 µKat/L) Volume water
Detection limit: approximately 6 IU/L (0.1 µKay/L). Calibration Fixfactor **
Correlation Factor
Calibration: Correlation Offset
It is recommended to verify the calibration factor with Method definition PR1
BIOLABO-Multicalibrator REF 95015 or a multiparametric calibrator PS
traceable to a reference method or material. InkR30
MDOD90
Quality Control:
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL) Mixing Parameter
BIOLABO EXATROL-P (pathological values) REF 95011 (10 x 5 mL) Volume (µl) 170
or any assayed control sera referring to the same method. Repetitions 2
Expected values: ** Refer to §Calibration
α-AMYLASE at 37°C
IU/L µKat/L
Serum 22-80 0.38-1.36
Urines (37°C) : 24-408 IU/24 hours (0.41-6.94 µKat/24 hours)

Version AT 99523 25 02 2005
BIOLABO REAGENTS 12
www.biolabo.fr BICARBONATES
MANUFACTURER: Enzymatic Method
BIOLABO SA,
REF 99832 R1 8 × 30 mL R2 1 x 30 mL
REF 99852 R1 6 × 100 mL R2 1 x 30 mL
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Principle:
Determination of total CO2 by end point photometric test. ASSAY PARAMETERS AT 37°C
Reaction direction: decrease in absorbance. PROGRAMMING TESTS
Reagents preparation :
To avoid CO2 contamination, use fresh demineralised water.
Do not pipette by mouth.
Add promptly to the contents of vial R1 the amount of Test ID CO2
demineralised water stated on the label. Name CO2
Mix gently and wait for complete dissolution before use (approx. Test Type End point
2 min.) Units mEq/L
Digits 0
Stability and storage
Store at 2-8°C, well recap in the original vial and away from
light. Clinical normal values Lower | Upper
Reag. Blank #|#
• Standard (vial R2) : Transfer the requested quantity, recap
man #
and store at 2-8°C.
woman #
• Reagents are stable until expiry date stated on the label of the
kit when stored and used as described in the insert. child #
• Once reconstituted, working reagent (vial R1) is stable for Descending reaction YES
4 months when free from contamination. Recap promptly OD limit for used 2500
after use. substrate
• Discard any reagent if cloudy or if blank (R1+R2) measured at Linearity limit 50
365 nm is < 1.000 or >1,900. Filter (nm) 365
• Don’t use working reagent after expiry date stated on the label Ref. Filter (nm)
of the Kit. Blank Normal blank
Reagents 1
Specimen collection and handling :
Bottle type #
Unhemolysed serum. Collect specimen anaerobically.
Heparin is the preferred anticoagulant.
Controls #
Do not store specimen more than 1 hour at 2-8° C. Volume
Sample (µl) 3
Performances characteristics: Reagent 1 (µl) 150
Linearity: the assay is linear up to 50 mEq (50 mmol/L). Reagent 2 (µl) * 150
Detection limit: approximately 3 mEq (mmol/L). Reagent 3 (µl)
**
Calibration: Volume water
Use Standard (vial R2) enclosed in the kit or any calibrator
traceable to a reference method or material.
Correlation Factor
Quality Control: Correlation Offset
Assayed control referring to the same method. Method definition PR1
PS
Expected values: InkR300
Total CO2 concentration is approximately 10% higher than MesOD
Bicarbonate concentration.
Mixing Parameter
The assay gives the concentration of TCO2 which is the sum Volume (µl) 170
of dissolved CO2 + Bicarbonate.
Repetitions 2
BICARBONATE * Demineralised water
mEq/L mmol/L ** Refer to §Calibration
Arterial 21-28 21-28
Venous 22-29 22-29

Version AT 99832 05 09 2005
BIOLABO REAGENTS 13
www.biolabo.fr TOTAL BILIRUBIN
MANUFACTURER: DCA Method
BIOLABO SA,
REF 97443 R1 2 × 200 mL R2 1 × 10 mL IVD : IN VITRO DIAGNOSTIC USE
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Principle : ASSAY PARAMETERS AT 37°C

End point photometric test PROGRAMMING TESTS
Reaction direction: increase in absorbance
Reagents are ready for use.
Test ID BILT
Name BILT
Stability and storage: Test Type End point
Store at 2-8° C, well recap in the original vial and away Units mg/dL
from light. Digits 2
Unopened, reagents are stable until expiry date stated on the Temperature (°C) 37
label. Clinical normal values Lower | Upper
Once opened, reagents R1 and R2 are stable at least 6 months Reag. Blank #|#
when freefrom contamination. man #
Discard any reagent if cloudy or if absorbance > 0.100 at
woman #
546 nm.
Don’t use working reagent after expiry date stated on the label. child #
Specimen collection and handling: OD limit for used 2500
Unhemolysed serum or plasma. substrate
Bilirubin is photolabile. Store the specimen away from light. Linearity limit 20
Stability in the specimen: 4 to 7 days at 2-8° C, or 2 days at Filter (nm) 546
room temperature. Ref. Filter (nm)
Blank Process blank
Icteric or pediatric specimens: do not dilute, see specific Reagents 2
procedure
Bottletype #
Controls #
Performances characteristics: Volume
Linearity: the reaction is linear up to 20 mg/dL (342 µmol/L) Sample (µl) 25
Detection limit: approximately 0.1 mg/dL Reagent 1 (µl) 250
Reagent 2 (µl) 5
Calibration: Reagent 3 (µl)
**
Use BIOLABO Multicalibrator REF 95015 or a calibrator Calibration Multicalibrator
traceable to a reference method or material. Volume water
Correlation Factor
Quality Control:
Correlation Offset
BIOLABO EXATROL-N (normal values) REF 95010 (10 x
5 mL)
BIOLABO EXATROL-P (pathological values) REF 95011 (10 x
PS
5 mL) InkR300
or other assayed control sera referring to the same method. Process blank
PR2
MesOD
Mixing Parameter
Adult and Direct Bilirubin Volume (µl) #
mg/dL [µmol/L] Repetitions #
Child > 5 days # Data entered by user
> 5 days-60 years <0.2 [< 3,4] ** Refer to §Calibration
60-90 years < 0.2 [< 3,4]
< 0.2 [< 3,4]
> 90 years

Version AT 97443 22 02 2005
BIOLABO REAGENTS 13'
BIOLABO SA,
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256 Specific procedure "icteric or pediatric specimen"
Test ID BILT
Name BILT
Once opened, reagents R1 and R2 are stable at least 6 months Reag. Blank #|#
when freefrom contamination. man #
woman #
546 nm.
Don’t use working reagent after expiry date stated on the label. child #
Specimen collection and handling: OD limit for used 2500
Unhemolysed serum or plasma. substrate
Stability in the specimen: 4 to 7 days at 2-8° C, or 2 days at Filter (nm) 546
room temperature. Ref. Filter (nm)
Blank Process blank
procedure
Bottletype #
Controls #
Performances characteristics: Volume
Linearity: the reaction is linear up to 20 mg/dL (342 µmol/L). Sample (µl) 5
Detection limit: approximately 0.1 mg/dL. Reagent 1 (µl) 250
Reagent 2 (µl) 5
Calibration: Reagent 3 (µl)
**
Use BIOLABO Multicalibrator REF 95015 or a calibrator Calibration Multicalibrator
traceable to a reference method or material. Volume water
Correlation Factor
Quality Control:
Correlation Offset
5 mL)
PS
5 mL) InkR300
or other assayed control sera referring to the same method. Process blank
PR2
MesOD
Total Bilirubin (mg/dL) [µmol/L] Mixing Parameter
new-born Premature Full term Premature Full term Volume (µl) #
in cord < 2.0 < 2.0 [< 34] [< 34] Repetitions #
0-1 day < 8.0 1.4-8.7 [< 137] [24-149] ** Refer to §Calibration
1-2 days < 12.0 3.4-11.5 [< 205] [58-197]
3-5 days < 16.0 1.5-12.0 [< 274] [26-205]

Version AT 97443 22 02 2005
BIOLABO REAGENTS 14
www.biolabo.fr DIRECT BILIRUBIN
BIOLABO SA,
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

Test ID BILD
Stability and storage: Name BILD
Store at 2-8° C, well recap in the original vial and away Test Type End point
from light. Units mg/dL
Unopened, reagents are stable until expiry date stated on the Digits 2
label. Temperature (°C) 37
Once opened, reagents R1 and R2 are stable at least 6 months Clinical normal values Lower | Upper
when free from contamination. Reag. Blank #|#
Discard any reagent if cloudy or if absorbance > 0.100 at man #
546 nm.
woman #
child #
Specimen collection and handling: Descending reaction NO
Unhemolysed serum or plasma. OD limit for used 2500
Bilirubin is photolabile. Store the specimen away from light. substrate
Stability in the specimen: 4 to 7 days at 2-8° C, or 2 days at Linearity limit 20
room temperature. Filter (nm) 546
Ref. Filter (nm)
Icteric or pediatric specimens: do not dilute, see specific Blank Process blank
procedure Reagents 2
Bottletype #
Linearity: the reaction is linear up to 20 mg/dL (342 µmol/L) Volume
Detection limit: approximately 0.1 mg/dL Sample (µl) 25
Reagent 1 (µl) 200
Calibration: Reagent 2 (µl) 50
Use BIOLABO Multicalibrator REF 95015 or a calibrator Reagent 3 (µl)
**
traceable to a reference method or material. Calibration Multicalibrator
Volume water
Quality Control: Correlation Factor
BIOLABO EXATROL-N (normal values) REF 95010 (10 x Correlation Offset
5 mL)
PS
5 mL)
or other assayed control sera referring to the same method. InkR300
Process blank
Expected values: PR2
InkR300
Direct Bilirubin MesOD
Adult and Mixing Parameter
Child > 5 days mg/dL [µmol/L]
Volume (µl) #
> 5 days-60 years <0.2 [< 3,4] Repetitions #
60-90 years < 0.2 [< 3,4] # Data entered by user
< 0.2 [< 3,4] ** Refer to §Calibration
> 90 years

Version AT 97553 19 03 2007
BIOLABO SA,
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256 Specific procedure "icteric or pediatric specimen"

Test ID BDP
Stability and storage: Name BDP
Once opened, reagents R1 and R2 are stable at least 6 months Clinical normal values Lower | Upper
when free from contamination. Reag. Blank #|#
man #
546 nm.
Don’t use working reagent after expiry date stated on the label. woman #
child #
Unhemolysed serum or plasma. OD limit for used 2500
Bilirubin is photolabile. Store the specimen away from light. substrate
Stability in the specimen: 4 to 7 days at 2-8° C, or 2 days at Linearity limit 20
room temperature. Filter (nm) 546
Ref. Filter (nm)
Icteric or pediatric specimens: do not dilute, see specific Blank Process blank
procedure
Reagents 2
Bottletype #
Linearity: the reaction is linear up to 20 mg/dL (342 µmol/L). Volume
Detection limit: approximately 0.1 mg/dL. Sample (µl) 5
Reagent 1 (µl) 200
**
traceable to a reference method or material. Calibration Multicalibrator
Volume water
Quality Control:
Correlation Factor
Correlation Offset
5 mL)
5 mL) PS
Process blank
Expected values: PR2
InkR300
Total Bilirubin (mg/dL) [µmol/L] MesOD
new-born Premature Full term Premature Full term Mixing Parameter
in cord < 2.0 < 2.0 [< 34] [< 34] Volume (µl) #
0-1 day < 8.0 1.4-8.7 [< 137] [24-149] Repetitions #
1-2 days < 12.0 3.4-11.5 [< 205] [58-197] ** Refer to §Calibration
3-5 days < 16.0 1.5-12.0 [< 274] [26-205]

Version AT 97553 19 03 2007
BIOLABO REAGENTS 15
MANUFACTURER: Sulfanilic Acid Method
BIOLABO SA,
REF 80403 R1 1 x 200 mL Total Bilirubin
R2 1 x 200 mL Direct Bilirubin
Tel : (33) 03 23 25 15 50 R3 1 x 20 mL Nitrite Solution
Fax : (33) 03 23 256 256 REF 80443 R1 2 x 200 mL Total Bilirubin
R3 1 x 20 mL Nitrite Solution

End point photometric test. PROGRAMMING TESTS
Reagents preparation: Test ID BILT
Reagents are ready for use. Name BILT
Once opened, reagents R1, R2 and R3 are stable at least 6 Reag. Blank #|#
months when free from contamination. man #
Reagent working is stable away from light for 2 days at 2-8° C. woman #
Discard any reagent if cloudy or if absorbance >0.100 at 546nm.
child #
Specimen collection and handling: OD limit for used substrate 2500
Unhemolysed serum or plasma. Linearity limit 20
Bilirubin is photolabile. Store the specimen away from light. Filter (nm) 546
Stability in the specimen : 4 days at 2-8° C, 2 day s at room Ref. Filter (nm)
temperature.
Blank Process blank
Icteric or pediatric specimens : do not dilute, see specific
procedure. Reagents 2
Bottletype #
Use BIOLABO Multicalibrator REF 95015 or a calibrator Reagent 2 (µl) 15
traceable to a reference method or material. Reagent 3 (µl)
**
Quality Control:
Volume water
5 mL)
Correlation Factor
5 mL) Correlation Offset
or other assayed control sera referring to the same method. Method definition PR1
Expected values: PS
InkR180
Total (mg/dL) [µmol/L]
Process blank
Bilirubin
PR2
new-born Premature Full term Premature Full term
InkR180
in cord < 2.0 < 2.0 [< 34] [< 34] MesOD
0-1 day < 8.0 1.4-8.7 [< 137] [24-149] Mixing Parameter
1-2 days < 12.0 3.4-11.5 [< 205] [58-197] Volume (µl) #
Repetitions #
3-5 days < 16.0 1.5-12.0 [< 274] [26-205]
Adult and Total Bilirubin ** Refer to §Calibration
> 5 days-60 years 0.3-1.2 [5-21]
60-90 years 0.2-1.1 [3-19]
> 90 years 0.2-0.9 [3-15]

Version AT 80403 28 02 2005
BIOLABO SA,
Fax : (33) 03 23 256 256 REF 80443 R1 2 x 200 mL Total Bilirubin
Specific procedure "icteric or pediatric specimen"

Principle :
End point photometric test. ASSAY PARAMETERS AT 37°C
Reaction direction: increase in absorbance PROGRAMMING TESTS
Reagents are ready for use. Test ID BTP
Stability and storage: Name BTP
Once opened, reagents R1, R2 and R3 are stable at least 6 Clinical normal values Lower | Upper
months when free from contamination. Reag. Blank #|#
Reagent working is stable away from light for 2 days at 2-8° C.
man #
Discard any reagent if cloudy or if absorbance >0.100 at 546nm.
Don’t use working reagent after expiry date stated on the label. woman #
child #
Unhemolysed serum or plasma. OD limit for used substrate 2500
Stability in the specimen : 4 days at 2-8° C, 2 day s at room
Filter (nm) 546
temperature.
Icteric or pediatric specimens : do not dilute, see specific Ref. Filter (nm)
procedure. Blank Process blank
Reagents 2
Performances characteristics: Bottletype #
Linearity: the reaction is linear up to 20 mg/dL (342 µmol/L) Controls #
Detection limit: approximately 0.2 mg/dL
Volume
Calibration: Sample (µl) 6
Use BIOLABO Multicalibrator REF 95015 or a calibrator Reagent 1 (µl) 300
traceable to a reference method or material. Reagent 2 (µl) 15
Reagent 3 (µl)
Quality Control: **
5 mL) Volume water
BIOLABO EXATROL-P (pathological values) REF 95011 (10 x Calibration Fixfactor
5 mL) Correlation Factor
or other assayed control sera referring to the same method. Correlation Offset
Expected values: PS
Total (mg/dL) [µmol/L] InkR180
Bilirubin Process blank
new-born Premature Full term Premature Full term PR2
in cord < 2.0 < 2.0 [< 34] [< 34] InkR180
MesOD
0-1 day < 8.0 1.4-8.7 [< 137] [24-149]
Mixing Parameter
1-2 days < 12.0 3.4-11.5 [< 205] [58-197] Volume (µl) #
3-5 days < 16.0 1.5-12.0 [< 274] [26-205] Repetitions #
Adult and Total Bilirubin # Data entered by user
> 5 days-60 years 0.3-1.2 [5-21]
60-90 years 0.2-1.1 [3-19]
> 90 years 0.2-0.9 [3-15]

Version AT 80403 28 02 2005
BIOLABO REAGENTS 16
BIOLABO SA,
Fax : (33) 03 23 256 256 REF 80553 R2 2 x 200 mL Direct Bilirubin

PROGRAMMING TESTS
Reagents preparation: Test ID BILD
Name BILD
Reagent 1 corresponds to vial R2.
Reagent 2 corresponds to vial R3. Test Type End point
Units mg/dL
Store at 2-8° C, well recap in the original vial and away Temperature (°C) 37
from light. Clinical normal values Lower | Upper
Unopened, reagents are stable until expiry date stated on the
Reag. Blank #|#
label.
Once opened, reagents R1, R2 and R3 are stable at least 6 man #
months when free from contamination. woman #
Reagent working is stable away from light for 2 days at 2-8° C. child #
Discard any reagent if cloudy or if absorbance >0.100 at 546nm Descending reaction NO
substrate
Specimen collection and handling:
Unhemolysed serum or plasma.
Linearity limit 20
Stability in the specimen: 4 days at 2-8° C, 2 days at room Ref. Filter (nm)
temperature. Blank Process blank
procedure. Bottletype #
Reagent 1 (µl) 300
traceable to a reference method or material. **
Volume water
Quality Control: Calibration Fixfactor
BIOLABO EXATROL-N (normal values) REF 95010 (10 x Correlation Factor
BIOLABO EXATROL-P (pathological values) REF 95011 (10 x Method definition PR1
5 mL) PS
Expected values: Process blank
PR2
Direct Bilirubin InkR180
Adult and MesOD
Mixing Parameter
> 5 days-60 years <0.2 [< 3,4] Volume (µl) #
60-90 years < 0.2 [< 3,4] Repetitions #
< 0.2 [< 3,4] # Data entered by user
> 90 years ** Refer to §Calibration

Version AT 80403 28 02 2005
BIOLABO SA,
Fax : (33) 03 23 256 256 REF 80553 R2 2 x 200 mL Direct Bilirubin
Specific procedure "icteric or pediatric specimen"

Principle :
PROGRAMMING TESTS
Test ID BDP
Reagent 1 corresponds to vial R2.
Reagent 2 corresponds to vial R3. Name BDP
Test Type End point
Stability and storage: Units mg/dL
Store at 2-8° C, well recap in the original vial and away Digits 1
from light. Temperature (°C) 37
Unopened, reagents are stable until expiry date stated on the
label.
Once opened, reagents R1, R2 and R3 are stable at least 6
Reag. Blank #|#
months when free from contamination. man #
Reagent working is stable away from light for 2 days at 2-8° C. woman #
Discard any reagent if cloudy or if absorbance >0.100 at 546nm child #
Don’t use working reagent after expiry date stated on the label. Descending reaction NO
OD limit for used 2500
Specimen collection and handling: substrate
Unhemolysed serum or plasma. Linearity limit 20
Stability in the specimen : 4 days at 2-8° C, 2 day s at room Ref. Filter (nm)
temperature. Blank Process blank
Icteric or pediatric specimens : do not dilute, see specific Reagents 2
procedure. Bottletype #
Reagent 1 (µl) 300
Calibration:
Reagent 2 (µl) 15
Use BIOLABO Multicalibrator REF 95015 or a calibrator
traceable to a reference method or material. Reagent 3 (µl)
**
Volume water
Quality Control: Calibration Fixfactor
BIOLABO EXATROL-N (normal values) REF 95010 (10 x Correlation Factor
BIOLABO EXATROL-P (pathological values) REF 95011 (10 x Method definition PR1
5 mL)
PS
or other assayed control sera referring to the same method.
InkR180
Expected values: Process blank
PR2
Total Bilirubin (mg/dL) [µmol/L] InkR180
MesOD
new-born Premature Full term Premature Full term
Mixing Parameter
in cord < 2.0 < 2.0 [< 34] [< 34] Volume (µl) #
0-1 day < 8.0 1.4-8.7 [< 137] [24-149] Repetitions #
1-2 days < 12.0 3.4-11.5 [< 205] [58-197] # Data entered by user
3-5 days < 16.0 1.5-12.0 [< 274] [26-205]

Version AT 80403 28 02 2005
BIOLABO REAGENTS 17
www.biolabo.fr CALCIUM
MANUFACTURER: CPC Method
BIOLABO SA,
REF 80004 R1 1 x 200 mL R2 1 x 200 mL
R3 1 x 10 mL R4 1 x 10 mL IVD : IN VITRO DIAGNOSTIC USE
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

Endpoint photometric test. PROGRAMMING TESTS
Reagent 1 : Contents of vial R1; Reagent 2 : Contents of vial R2 Test ID CA
Stability and storage: Name CA
Store at 18-25° C, in the original vial and away fro m light. Test Type End point
Without contamination and used as indicated, reagents are stable until Units mg/dL
expiry date stated on the label of the kit. Digits 2
Discard reagent if cloudy or reagent blank at 546 nm is > 0.800.
Specimen collection and handling: Clinical normal values Lower / Upper
Serum or heparinised plasma. Do not use citrate, oxalate or EDTA. Reag. Blank #|#
Blood obtained on fasting patient with minimal venous occlusion and man #
without exercise or after restoring circulation at least for 1 minute. woman #
24 h Urines : Acidify before assay with 20 to 30 mL HCl 6 N to dissolve child #
calcium salts. Descending reaction NO
Mix well then dilute (1 + 2) with demineralised water before performing
the test. OD limit for used 800
Calcium is stable in serum for : substrate
• at least 7 days at 2-8°C. Linearity limit 17.5
• 6 months at -20°C. Filter (nm) 546
Plastic and glass may adsorb calcium during storage, especially with Ref. Filter (nm)
diluted solution. Blank Normal blank
Long-term freezing may lead to associated evaporation, lyophilisation or Reagents 2
coprecipitation with fibrin (i.e. heparinised plasma) or lipids.
Bottletype #
Linearity between 7.5 and 17.5 mg/dL (1.88 to 4.37 mmol/L). Volume
Detection limit: approximately 0.16 mg/dL.
Sample (µl) 5
Use Standard enclosed in the Kit (vial R2), BIOLABO Multicalibrator Reagent 2 (µl) 100
REF 95015 or any calibrator traceable to a reference method or Reagent 3 (µl)
material. Calibration Multicalibrator (**)
Quality Control: Volume water
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL) Calibration Fixfactor
BIOLABO EXATROL-P (pathological values) REF 95011 (10 x 5 mL) or Correlation Factor
any assayed control sera referring to the same method. Correlation Offset
Expected values: PS
in serum : PR2
Population mg/dL mmol/L InKR300
Premature 6.2-11.0 [1.55-2.75] MesOD
0-10 days 7.6-10.4 [1.90-2.60] Mixing Parameter
10 days –24 months 9.0-11.0 [2.25-2.75] Volume (µl) 170
24 months –12 years 8.8-10.8 [2.20-2.70] Repetitions 2
12 years -18 years 8.4-10.2 [2.10-2.55] # Data entered by user
18-60 years 8.6-10.0 [2.15-2.50] (**) Refer to §Calibration
60-90 years 8.8-10.2 [2.20-2.55]
> 90 years 8.2-9.6 [2.05-2.40]
in 24 h Urines : 100-300 mg/24 h (2.5-7.5 mmol/24 h).

Version AT 80004 21 02 2005
BIOLABO REAGENTS 18
www.biolabo.fr CALCIUM
MANUFACTURER: Arsenazo III Method
BIOLABO SA,
REF 90004 R1 2 x125 mL R2 1 x 10 mL
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

Reaction direction : increase in absorbance. Test ID CAA
Name CAA
Test Type End point
Standard (Vial R2) : transfer the requested quantity, recap and Units mg/dL
store at 18-25°C. Digits 1
Stability and storage : Clinical normal values Lower | Upper
Store at 18-25° C, well recap in the original vial a nd away Reag. Blank #|#
from light. man #
Without contamination, used and stored as indicated in the woman #
insert, reagents are stable until expiry date stated on the label of child #
the kit. Descending reaction NO
Discard reagent if cloudy or reagent blank at 620 nm is > 0.400.
substrate
Specimen collection and handling :
Serum or heparinised plasma.
Linearity limit 15.0
Do not use citrate, oxalate or EDTA. Blood obtained on fasting Filter (nm) 620
patient with minimal veinous occlusion and without exercise or Ref. Filter (nm)
after restoring circulation Blank Normal blank
at least for 1 minute. Reagents 1
24 h Urines : Acidify after collection with 20 to 30 mL HCl 6 N in Bottle type #
order to dissolve calcium salts. Controls #
Dilute (1+ 2) with demineralised water before performing the test Volume
and multiply the obtained result by 3.
Sample (µl) 6
Total calcium is stable in serum for at least 7 days at 2-8° C or
6 months at -20° C. Reagent 1 (µl) 300
Long-term freezing may lead to associated evaporation, Reagent 2 (µl)
lyophilisation or coprecipitation with fibrin (i.e. heparinised Reagent 3 (µl)
**
plasma) or lipids. Calibration Multicalibrator
Volume water
Performances characteristics : Calibration Fixfactor
Linearity : The assay is linear up to 15.0 mg/dL (3.75 mmol/L) Correlation Factor
Detection limit : approximately 0.21 mg/dL. Correlation Offset
Calibration: PS
Use Standard enclosed in the kit (vial R2),
InkR60
BIOLABO-Multicalibrator REF 95015 or any calibrator traceable
to a reference method or material. MesOD
Quality Control: Mixing Parameter

BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL) Volume (µl) 170
BIOLABO EXATROL-P (pathological values) REF 95011 Repetitions 2
(10 x 5 mL) or any assayed control sera referring to the same # Data entered by user
method. ** Refer to §Calibration
Expected values : see packing insert REF AT 90004

Version AT 90004 21 02 2005
BIOLABO REAGENTS 19
www.biolabo.fr CHLORIDE
MANUFACTURER: Colorimetric Method
BIOLABO SA,
REF 80005 R1 2 x125 mL R2 1 x 5 mL
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

Reaction direction : increase in absorbance. Test ID CL
Reagents preparation : Name CL
Reagents are ready for use. Test Type End point
Standard (Vial R2) : transfer the requested quantity, recap and Units mEq/L
store at 18-25° C. Digits 0
Stability and storage :
Store at 18-25° C, well recap in the original vial a nd away
from light. Reag. Blank #|#
Without contamination, used and stored as indicated in the insert, man #
reagents are stable until expiry date stated on the label of the kit. woman #
Discard any reagent if cloudy or if absorbance at 505 nm > 0.100. child #
Specimen collection and handling : OD limit for used 2500
Unhemolysed serum or heparinised plasma.
substrate
Urines or CSF.
Chloride is stable in the specimen for :
Linearity limit 140
1 week at room temperature or 2-8° C. Filter (nm) 505
Ref. Filter (nm)
Performances characteristics : Blank Normal blank
Linearity : The assay is linear beetwen 70 and 140 mEq/L. Reagents 1
Detection limit : approximately 1.4 mEq/L. Bottle type #
Calibration: Controls #
Use Standard enclosed in the kit (vial R2), Volume
BIOLABO-Multicalibrator REF 95015 or any calibrator traceable Sample (µl) 3
to a reference method or material. Reagent 1 (µl) 300
Reagent 2 (µl)
Quality Control:
Reagent 3 (µl)
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL) **
(10 x 5 mL) or any assayed control sera referring to the same Volume water
method. Calibration Fixfactor
Correlation Factor
Expected values : Correlation Offset
Serum/Plasma mEq/L [mmol/L] Method definition PR1
In cord 96-104 [96-104]
PS
Premature 95-110 [95-110] InkR120
0 to 30 days 98-113 [98-113] MesOD
up to 90 years 98-107(108) [98-107(108)]
> 90 years 98-111 [98-111]
Mixing Parameter
CSF mEq/L [mmol/L] Volume (µl) 170
Child 110-130 [110-130] Repetitions 2
Adult 118-132 [118-132]
24h Urines mEq/L [mmol/L]
Newborn 2-10 [2-10]
Child < 6 years 15-40 [15-40]
6-10 years, M 36-110 [36-110]
6-10 years, F 18-74 [18-74]
10-14 years, M 64-176 [64-176]
10-14 years, F 36-173 [36-173]
Adult 110-250 [110-250]
> 60 years 95-195 [95-195]

Version AT 80005 22 02 2005
BIOLABO REAGENTS 20
www.biolabo.fr CHOLESTEROL
MANUFACTURER: CHOD-PAP Method
BIOLABO SA,
REF 80106 R1 2 x 100 mL R2 2 x 100 mL R3 1 x 5 mL
REF 87356 R1 10 x 100 mL R2 10 x 100 mL R3 1 x 5 mL IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS REF 87656 R1 6 x 500 mL R2 6 x 500 mL R3 1 x 10 mL
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

Test ID Chol
Reagents preparation: Name Chol
Vial R2: use a non-sharp instrument to remove aluminium cap.
Test Type End Point
Add promptly the content of vial R2 (Enzymes) into vial R1
(Buffer). Units mg/dL
Mix gently until complete dissolution (approximately 2 minutes). Digits 0
Store at 2-8°C, well recap in the original vial and away from Reag. Blank #|#
light. man #
• Standard (vial R3) : Transfer the requested quantity, recap woman #
and store at 2-8°C. child #
• Reagents are stable until expiry date stated on the label of the Descending reaction NO
kit when stored and used as described in the insert. OD limit for used 2500
• Once reconstituted, working reagent is stable at least for substrate
2 years when free from contamination.
Linearity limit 500
• Discard any reagent if cloudy or if reagent blank at 505 nm >
0.400. Filter (nm) 505
• Don’t use working reagent after expiry date stated on the label Ref. Filter (nm)
of the Kit. Blank Normal Blank
Reagents 1
Specimen collection and handling: Bottle type #
Serum or plasma (Heparin or EDTA). Controls #
Do not use oxalate, fluoride or citrate. Collect on fasting patient. Volume Sample (µl) 3
Separate serum from cells within 2 hours.
Reagent 1 (µl) 300
Cholesterol is stable in the specimen for : Reagent 2 (µl)
• 5-7 days at 2-8°C Reagent 3 (µl)
• 3 months at –20°C **
• Many years at –70°C.
Avoid repeated freezing and thawing.
Volume water
Performance characteristics: Correlation Factor
Linearity: the reaction is linear up to 500 mg/dL (12.9 mmol/L) Correlation Offset
Detection limit: approximately 1 mg/dL. Method definition PR1
PS
Calibration: InkR300
Use standard (Vial R3) enclosed in the kit, MesOD
Mixing Parameter
to reference method or material.
Volume (µl) 170
Quality Control: Repetitions 2
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL) # Data entered by user
BIOLABO EXATROL-P (pathological values) REF 95011 ** Refer to §Calibration
(10 x 5 mL) or any assayed control sera referring to the same
method.
Expected values:
TOTAL CHOLESTEROL
Serum or Plasma mg/dL mmol/L
Recommended value < 200 < 5.18
low risk 200 - 239 5.18 – 6.19
high risk ≥ 240 ≥ 6.22
Version AT 80106 14 05 2008 MAJ 08/08/2008
BIOLABO REAGENTS 22
www.biolabo.fr HDL CHOLESTEROL
MANUFACTURER : Direct Method
BIOLABO SA,
REF 90206 200-250 tests R1 1 × 60 mL R2 1 × 20 mL |
TECHNICAL SUPPORT AND ORDERS REF 90406 400-500 tests R1 2 × 60 mL R2 2 × 20 mL
Tel : (33) 03 23 25 15 50 REF 90426 2000-2500 tests R1 4 × 150 mL R2 4 × 50 mL IVD : IN VITRO DIAGNOSTIC USE
Fax : (33) 03 23 256 256

Principle: PROGRAMMING TESTS
Reagents preparations:
Reagents are ready for use. Test ID HDLD
Name HDLD
Store at 2-8° C, in the original vial and away from light. Units mg/dL
Unopened, reagents are stable until expiry date stated on the label. Digits 1
Once opened, when free from contamination, reagents are stable at least
for 3 months at 2-8° C, 24 h at room temperature an d 30 days on board of
refrigerated analyser. Clinical normal values Lower | Upper
Discard any reagent if cloudy or if reagent blank > 0.100 at 620 nm. Reag. Blank #|#
This Kit should be refrigerated during transport. man #
woman #
Specimen collection and handling: child #
Specimens should be collected after 12-14h fasting.
Plasma: collected on EDTA ot lithium/sodium heparinate.
Centrifuge and remove plasma from blood cells as soon as possible. OD limit for used 100
(within 3 hours). substrate
Serum: Centrifuge and remove serum from clot as soon as possible. Linearity limit 200
(within 3 hours).
HDL Cholesterol is stable in specimen for 1 to 3 days at 2-8° C, 1 month
Filter (nm) 620
at -20° C (Avoid repeated freezing and thawing). Ref. Filter (nm)
Blank Process Blank
Performances characteristics: Reagents 1|2
The reaction is linear from 2.5 to 200 mg/dL (0.065 to 5.17 mmol/L). Bottletype #|#
Detection limit: approximately 2.5 mg/dL (0.065 mmol/L). Controls #|#
Volume
Calibration:
Sample (µl) 3
Do not use aqueous calibrator.
Use BIOLABO HDL-Cholesterol Calibrator REF 95406 or a calibrator of Reagent 1 (µl) 300
human origin traceable to reference method or material. Reagent 2 (µl) 100
Reagent 3 (µl)
**
Quality Control: Calibration **
Assayed control sera of human origin referring to the same Volume water
method :( accelerator selective detergent). Calibration Fixfactor
Correlation Factor
Expected values: Correlation Offset
HDL-Cholesterol mg/dL [mmol/L] PS
Low level (Risk factor) < 40 < 1.0 InkR300
High level (Protective factor) > 60 > 1.5 Process blank
PR2
InkR300
MesOD
Mixing Parameter
Volume (µl)
Repetitions
for more details, , see packing insert. MAJ 25/07/2008

Version AT 90406 05 06 2006
Manufacturer Date de péremption IVD : Usage in vitro Température de conservation REF: Référence du produit Consulter la notice LOT : Numéro de lot
BIOLABO REAGENTS 24
www.biolabo.fr CK-MB Isoenzyme
MANUFACTURER: Immunoinhibition Method
BIOLABO SA,
REF 97217 R1 10 × 3 mL R2 1 x 30 mL
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Principle:
Kinetic UV photometric test. ASSAY PARAMETERS AT 37°C
PROGRAMMING TESTS
REF 97317: Add promptly the contents of vial R1 (Enzymes- Test ID CK-MB
Substrate) into vial R2 (Buffer). Name CK-MB
REF 97217: Add promptly 3 mL of vial R2 (Buffer) into vial R1 Test Type Kinetic
(Enzymes-Substrate). Units U/L
Mix gently and wait for complete dissolution before using Digits 1
reagents (approximately 2 minutes). Temperature (°C) 37
Stability and storage : Clinical normal values Lower/Upper
Store at 2-8° C, well recap in the original vial and away from Reag. Blank 0.0/0.7
light. man #
Unopened, when used and stored as described in the insert, woman #
Once reconstituted, working reagent is stable at least for 7 days Descending reaction NO
when free from contamination.
Discard any reagent if cloudy or if absorbance at 365 nm
is > 0.700. substrate
Don’t use working reagent after expiry date stated on the label. Linearity limit 1000
Filter (nm) 365
Specimen collection and handling: Ref. Filter (nm)
Unhemolysed serum. Use an airtight container to prevent loss
Blank
of CO2. Plasma is not recommended because anticoagulants
as heparine, EDTA, Citrate or fluoride interfere with the Reagents 1
determination. Bottle type #
If myocardial infraction is suspected, it is recommended to Controls #
collect patient after 6 hours, 12 hours and 24 hours. Minimum Volume Sample (µl) 10
requested number of collects is two: 12 hours and 24 hours Reagent 1 (µl) 200
after symptoms appearance. Reagent 2 (µl)
CK-MB activity in serum is stable for : 4 to 8 hours at room Reagent 3 (µl)
temperature, 1 to 2 days at 2-8° C or 1 month at -2 0° C. Calibration
**
Multicalibrator
Performance characteristics: Volume water
Linearity: the assay is linear up to 1000 IU/L (17µKat/L) Calibration Fixfactor **
Detection limit: approximately 5 IU/L. Correlation Factor
Calibration: Correlation Offset
It is recommended to determine the calibration factor Method definition PR1
(6667/1 cm pathlength) with REF 95516 HDL / LDL / CK-MB PS
Calibrator or any human calibrator traceable to a reference InkR300
method or material. MDOD300
Quality Control:
• REF 95516 HDL / LDL / CK-MB Control, level 1 (2 x 2 mL)
Mixing Parameter
Volume (µl) 170
• REF 95526 HDL / LDL / CK-MB Control, level 2 (2 x 2 mL).
Or any assayed human control sera referring to the same
Repetitions 2
method. # Data entered by user
Expected values:
CK-MB (IU/L)
Serum at 30° C at 37° C

< 16 < 25
CK-MB/CK %: a ratio between 6 and 25 % is consistent with
acute myocardial infarction. In case of suspicion of myocardial
infarction, CK-MB values rise and afterwards return to normal in
48 hours.

Version AT 97217 13 05 2008
BIOLABO REAGENTS 25
www.biolabo.fr CK-NAC
MANUFACTURER: IFCC Single Vial
BIOLABO SA,
REF 92207 R1 20 × 3 mL R2 1 x 60 mL
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Principle :
Kinetic UV photometric test. ASSAY PARAMETERS AT 37°C
Vial R1: Use a non-sharp instrument to remove aluminium cap. Test ID CK-NAC
REF 92307: Transfer promptly the contents of vial R1 Name CK-NAC
(Enzymes-Substrate) into vial R2 (Buffer).
Test Type Kinetic
REF 92207: Transfer promptly 3 mL of vial R2 (Buffer) into vial
R1 (Enzymes-Substrate). Units U/L
reagent (approximately 2 minutes) Temperature (°C) 37
Clinical normal values Lower/Upper
Stability and storage: Reag. Blank 0.0 / 0.4
light. woman #
Unopened, when used and stored as described in the insert, child #
reagents are stable until expiry date stated on the label. Descending reaction NO
Once reconstituted, working reagent is stable at least for 30
days when free from contamination. OD limit for used 2500
Discard any reagent if cloudy or if absorbance at 365 nm is substrate
> 0.800. Linearity limit 1000
Don’t use working reagent after expiry date stated on the label. Filter (nm) 365
Ref. Filter (nm)
Unhemolysed serum. Avoid anticoagulants such as heparin, Reagents 1
EDTA, Citrate or fluoride. Protect from light and store in an Bottle type #
airtight container to prevent loss of CO2. Adjunction of thiols is
not necessary.
Controls #
CK activity is stable in serum for 4 to 8 h at room temperature, Volume Sample (µl) 15
1 to 2 days at 2-8° C, 1 month at -20° C. Reagent 1 (µl) 300
Reagent 2 (µl)
Performance characteristics: Reagent 3 (µl)
**
Linearity: the assay is linear up to 1000 IU/L (17µKat/L) Calibration Multicalibrator
Detection limit: approximately 10 IU/L. Volume water
Calibration Fixfactor **
Calibration: Correlation Factor
It is recommended to determine the calibration factor Correlation Offset
(3333/ 1 cm pathlength) with BIOLABO-Multicalibrator
REF 95015 or any multiparametric calibrator traceable to a
reference method. PS
InkR120
Quality Control: MDOD180
BIOLABO EXATROL-N (normal values) REF 95010
(10 x 5 mL) Mixing Parameter
BIOLABO EXATROL-P (pathological values) REF 95011 Volume (µl) 170
(10 x 5 mL) or any assayed control sera referring to the same Repetitions 2
method. # Data entered by user
Expected values:
CK-NAC at 37° C
Serum UI/L µKat/L
Men 38 - 174 0.65 - 2.96
Women 26 - 140 0.46 - 2.38

Version AT 92207 02 12 2004
www.biolabo.fr CREATININE
MANUFACTURER: Kinetic Method - Bi-reagent
BIOLABO SA,
REF 80107 R1 1 × 125 mL R2 1 × 125 mL R3 1 × 10 mL
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

Fixed time Kinetic photometric test. PROGRAMMING TESTS
Test ID CREA
Name CREA
Store at 18-25°C, well recap in the original vial an d away
from light. Test Type Initial Rate
Unopened: Reagents are stable until expiry date stated on the Units mg/dL
label. Digits 1
Once opened, reagents are stable at least for 6 months when Temperature (°C) 37
free from contamination. Clinical normal values Lower | Upper
Working reagent is stable at least for 30 days at 2-8° C. Reag. Blank #|#
Standard stability (vial R3): several weeks once opened man #
(transfer the requested quantity, recap and store at 18-25° C). woman #
Discard any reagent if cloudy or if absorbance of working
child #
reagent is > 0.300 at 505 nm.
Specimen collection and handling: substrate
Serum or heparinised plasma. Linearity limit 15
Urines: Dilute 1+19 with demineralised water and multiply the Filter (nm) 505
obtained results by the dilution factor or use special procedure
Ref. Filter (nm)
(with sample pre-dilution).
Creatinine is stable in the specimen for 24 h at 2-8° C. Blank Normal blank
Freeze for longer storage. Reagents 2
Bottletype #
Linearity: The assay is linear up to 15 mg/dL (1327 µmol/L) Volume
Detection limit: approximately 0.2 mg/dL.
Sample (µl) 20
Use standard (vial R3) enclosed in the kit, BIOLABO- Reagent 2 (µl) 100
Multicalibrator REF 95015 or any calibrator traceable to a Reagent 3 (µl)
**
reference method or material. Calibration Multicalibrator
Quality Control: Volume water
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL) Calibration Fixfactor
BIOLABO EXATROL-P (pathological values) REF 95011 Correlation Factor
(10 x 5 mL) or any assayed control sera referring to the same Correlation Offset
method. Method definition
PR1
Expected values: PS
Serum, Plasma mg/dL µmol/L InkR300
Men 0.9 to 1.3 80 to 115 PR2
Women 0.6 to 1.1 53 to 97 InkR10
MelR120
Interferences
Haemolysis, bilirubin and lipemia may cause falsely negative Mixing Parameter
results. Volume (µl) 170
Bilirubin: see Bi-reagent procedure. Repetitions 2
Ascorbic acid, glucose and some antibiotics interfere also with # Data entered by user
the determination of creatinine according to Jaffe method. ** Refer to §Calibration
Reading interval is the main determinant for the specificity of the
Jaffe reaction; some interferents act quickly (acetoacetate) and
others slowly (proteins). The majority of kinetic methods
recommend a reading interval between 30 and 150 seconds.

Version AT 80107 05 07 2004
BIOLABO REAGENTS 26
www.biolabo.fr CREATININE
MANUFACTURER: Kinetic Method – Single reagent
BIOLABO SA,
REF 80107 R1 1 × 125 mL R2 1 × 125 mL R3 1 × 10 mL IVD : IN VITRO DIAGNOSTIC USE
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

Fixed time Kinetic photometric test. PROGRAMMING TESTS
Test ID CREA
Name CREA
Store at 18-25° C, in the original vial and away fro m light.
Without contamination and used as indicated in the insert, Test Type Initial Rate
reagents are stable until expiry date stated on the label of the Units mg/dL
kit. Digits 1
Standard (vial R3): transfer the requested quantity, recap and Temperature (°C) 37
store at 18-25° C. Clinical normal values Lower | Upper
Discard any working reagent (1 vol. R1 + 1 vol. R2) if cloudy or Reag. Blank #|#
if absorbance of working reagent is > 0.300 at 505 nm. man #
Specimen collection and handling: woman #
Serum or heparinised plasma. child #
Urines: Dilute 1+19 with demineralised water and multiply the Descending reaction NO
obtained results by the dilution. OD limit for used 2500
Creatinine is stable in the specimen for 24 h at 2-8° C. substrate
Freeze for longer storage. Linearity limit 15
Performances characteristics: Filter (nm) 505
Linearity: The assay is linear up to 15 mg/dL (1327 µmol/L) Ref. Filter (nm)
Detection limit: approximately 0.2 mg/dL. Blank Normal blank
Reagents 1
Calibration:
Bottletype #
Use standard (vial R3) enclosed in the kit,
BIOLABO-Multicalibrator REF 95015 or any calibrator traceable Controls #
to a reference method or material. Volume
Sample (µl) 20
Quality Control: Reagent 1 (µl) 100
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL) Reagent 2 (µl) 100
Reagent 3 (µl)
(10 x 5 mL) or any assayed control sera referring to the same **
method.
Volume water
Expected values: Calibration Fixfactor
Serum, Plasma mg/dL µmol/L Correlation Factor
Men 0.9 to 1.3 80 to 115
Correlation Offset
Women 0.6 to 1.1 53 to 97
PR2
Interferences PS
Haemolysis, bilirubin and lipemia may cause falsely negative InkR 30
results. MelR 120
Bilirubin: see Bi-reagent procedure.
Ascorbic acid, glucose and some antibiotics interfere also with Mixing Parameter
the determination of creatinine according to Jaffe method. Volume (µl) 170
Reading interval is the main determinant for the specificity of the Repetitions 2
Jaffe reaction; some interferents act quickly (acetoacetate) and
others slowly (proteins). The majority of kinetic methods
recommend a reading interval between 30 and 150 seconds.

Version AT 80107 05 07 2004
BIOLABO REAGENTS 27
www.biolabo.fr GAMMA GT
MANUFACTURER: Soluble GPNA Method
BIOLABO SA,
REF 80110 R1 8 x 30 mL R2 8 x 30 mL
REF 80210 R1 1 x 105 mL R2 10 x 10 mL IVD : IN VITRO DIAGNOSTIC USE
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Reaction direction : increase in absorbance.
Test ID GGT
Reagents preparation : Name GGT
Use a non-sharp instrument to remove aluminium cap.Add Test Type Kinetic
promptly the contents of vial R2 (Substrate) into vial R1 (Buffer). Units U/L
reagent (approximately 2 minutes).
Clinical normal values Lower / Upper
Stability and storage :
Store at 2-8° C, well recap in the original vial and away from Reag. Blank #/#
light. man #
Unopened, when used and stored as described in the insert, woman #
Once reconstituted, working reagent is stable at least for 30 Descending reaction NO
days when free from contamination. OD limit for used 2500
Discard any reagent if cloudy or if reagent blank at 405 nm substrate
is > 0.400. Linearity limit 320
Filter (nm) 405
Specimen collection and handling : Ref. Filter (nm)
Unhemolysed serum or EDTA plasma (up to 1 mg/mL of blood). Blank
Heparin produces turbidity in the reaction mixture; citrate, Reagents 1
oxalate and fluoride depress GGT activity by 10 to 15%. Bottle type #
GGT is stable in serum for : Controls #
1 month at 2-8° C or 1 year at -20° C. Volume Sample (µl) 15
Reagent 1 (µl) 300
Performance characteristics : Reagent 2 (µl)
Linearity: the assay is linear up to 320 IU/L (5.33 µKat/L)
Reagent 3 (µl)
Detection limit: approximately 4 IU/L. **
Calibration : Volume water
It is recommended to determine the calibration factor Calibration Fixfactor **
(2121 / 1 cm pathlength) with BIOLABO-Multicalibrator Correlation Factor
REF 95015 or a multiparametric calibrator traceable to a Correlation Offset
reference method or material. Method definition PR1
PS
Quality Control : InkR30
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL) MDOD180
(10 x 5 mL) or any assayed control sera referring to the same
Mixing Parameter
method.
Volume (µl) 170
Expected values : Repetitions 2
GGT at 37° C ** refer to § Calibration
IU/L
Men 2 - 30
Women 1 - 24

Version AT 80110 25 01 2005
BIOLABO REAGENTS 28
www.biolabo.fr GLUCOSE
MANUFACTURER: GOD-PAP Method
BIOLABO SA,
REF 80009 R1 1 × 500 mL R2 1 x 7,5 mL R3 1 x 5 mL
REF 87109 R1 6 × 250 mL R2 6 x 3,75 mL R3 1 x 5 mL IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS REF 16GL8 R1 6 × 1000 mL R2 6 x 15 mL R3 1 x 10 mL
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Principle:
Fixed Time photometric test. ASSAY PARAMETERS AT 37°C
Vial R1 and R2 : if appropriate, use a non-sharp instrument to
remove aluminium cap. Test ID GLU
Using a volumetric flask, measure the volume of demineralised
Name GLU
water stated on the label of the vial R1 (Enzymes-Buffer).
Transfer the contents of vial R1 into the flask and mix gently
Test Type Initial Rate
until complete dissolution (approximately 2 minutes). Then add Units mg/dL
the contents of vial R2 and mix gently. Digits 0
Store at 2-8°C, well recap in the original vial and away from Reag. Blank #|#
light. man #
• Standard (vial R3) : Transfer the requested quantity, recap woman #
and store at 2-8°C. child #
• Reagents are stable until expiry date stated on the label of the Descending reaction NO
kit when stored and used as described in the insert. OD limit for used 400
• Working reagent is stable at least for 2 years. substrate
• Discard any reagent if cloudy or if reagent blank at 505 nm > Linearity limit 500
0.400.
Filter (nm) 505
• Don’t use working reagent after expiry date stated on the label
of the Kit.
Ref. Filter (nm)
Blank Normal blank
Serum or plasma: Separate promptly from blood cells to prevent Bottle type #
glycolysis. Controls #
If fluorure is used as a preservative, a decrease of 9 mg/dL is Volume
seen within the first 2 hours, then concentration stabilises. Sample (µl) 3
Glucose is stable: Reagent 1 (µl) 300
- in serum or heparinised plasma for 8 hours at 25°C or 72 Reagent 2 (µl)
hours at 2-8° C,
- in plasma (fluoride or Iodoacetate) for 24 hours at room
Reagent 3 (µl)
**
temperature. Calibration Multicalibrator
CSF: process immediately to avoid falsely low results. Store at Volume water
-20° C. Calibration Fixfactor
Urines: collect in dark bottle and store at 2-8° C. Preser ve 24h Correlation Factor
urines with 5 mL glacial acetic acid or 5 g sodium benzoate or Correlation Offset
sodium fluoride. Method definition PR1
Performances characteristics: PS10
Linearity: the assay is linear up to 500 mg/dL (28 mmol/L)
InkR120
Detection limit: approximately 10 mg/dL.
MesOD
Calibration:
Standard enclosed in the kit (vial R3) Mixing Parameter
or BIOLABO Multicalibrator REF 95015 Volume (µl) 170
or any calibrator traceable to a reference method or material. Repetitions 2
Quality Control: ** Refer to §Calibration
(10 x 5 mL) or others assayed control sera referring to the same
method.
Expected values: refer to packing insert REF 80009

Version AT 80009 24 02 2005
BIOLABO REAGENTS 30
www.biolabo.fr IRON / T. I. B. C.
MANUFACTURER: Direct Method (Ferene)
BIOLABO SA,
REF 92108 R1 2 × 125 mL R2 1 × 5 mL R3 1 × 10 mL IVD : IN VITRO DIAGNOSTIC USE
Tel : (33) 03 23 25 15 50 REF 92308 R1 1 × 60 mL R2 1 × 30 capsules
Fax : (33) 03 23 256 256

Iron and T.I.B.C.: use BIOLABO REF 92108 to determine the
Test ID IRON
concentration in specimens.
Name IRON
R1: Contents of vial R1 is ready for use. Test Type End point
R2*: Mix 1 volume of the contents of vial R2 with 5 volumes of Units µg/dL
the contents of vial R1. Digits 0
Use carefully cleaned material with HCL 0.1 N and well rinsed Temperature (°C) 37
with distilled water. Give a special care to the quality of water,
reagents and/or specimens.
Reag. Blank #|#
Stability and storage: man #
Store at 2-8° C, well recap in the original vial and away from woman #
light. child #
Unopened: Reagents are stable until expiry date stated on the Descending reaction NO
label. OD limit for used 2500
Once opened: Reagents are stable for at least 6 months at substrate
2-8°C when free from contamination. Linearity limit 1500
Standard stability (Vial R3): Several weeks (transfer the Filter (nm) 620
requested quantity, recap and store at 2-8°C). Ref. Filter (nm)
Discard reagents if cloudy or if absorbance of working reagent
(R1: 50 vol. + R2 : 1 vol.) is > 0.120 at 620 nm.
Blank Normal blank
Don’t use working reagent after expiry date stated on the label. Reagents 2
Bottletype #
Specimen collection and handling: Controls #
Serum or heparinised plasma. Unhemolysed morning specimen. Volume
Draw blood before other specimens that require anticoagulants. Sample (µl) 30
Do not use EDTA, Oxalate or citrate. Reagent 1 (µl) 170
Serum Iron is stable in specimen for: 4 days at room Reagent 2 (µl) 20
temperature.1 week stored at 2-8°C.
Reagent 3 (µl)
TIBC (*): Use BIOLABO REF 92308 to prepare the supernatant. **
Use the supernatant as sample.
Volume water
Performance characteristics:
Correlation Factor
Linearity: the assay is linear up to at least 1500 µg/dL Correlation Offset
(26 µmol/L).
Detection limit: approximately 11 µg/dL (2 µmol/L)
PS
Calibration: InkR180
Process blank
Use standard (vial R3) enclosed in the kit,
PR2
InkR180
to a reference method or material.
TIBC: Sample = Supernatant MesOD
Multiply the obtained result by 3 to take into account the
dilution factor (due to the preparation of the supernatant).
Mixing Parameter
Quality Control: Volume (µl) 170
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL) Repetitions 2
BIOLABO EXATROL-P (pathological values) REF 95011 # Data entered by user
(10 x 5 mL) ** Refer to §Calibration
or any assayed control sera referring to the same method.
Expected values: See packaging insert REF 92308

Version AT 92108 21 02 2005 / AT 92308 22 10 2004
BIOLABO REAGENTS 41
www.biolabo.fr UREA U.V.
MANUFACTURER: Kinetic Method
BIOLABO SA,
REF 92032 R1 7 x 30 mL R2 7 x 30 mL R3 1 x 5 mL IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS REF 92132 R1 10 x 100 mL R2 10 x 100 mL R3 1 x 5 mL
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
2 points rate photometric test. PROGRAMMING TESTS
Reaction direction : decrease in absorbance.
Test ID URUV
Reagents preparation : Name UREA UV
Add promptly the contents of vial R2 (Enzymes-coenzyme) into
Test Type Fixed Time
vial R1 (Buffer).
Mix gently and wait for complete dissolution before using reagent Units mg/dL
(2 minutes). Digits 0
Vial R2: use a non-sharp instrument to remove aluminium cap. Temperature (°C) 37
Clinical normal values lower
Stability and storage: Reag. Blank
light.
woman #
Unopened: Reagents are stable until expiry date stated on the
label. child #
Once opened: Working reagent is stable for at least 1 month Descending reaction YES
when free from contamination. OD limit for used 1100
Standard stability (vial R3) : several weeks (transfer the substrate
requested quantity recap, and store at 2-8° C). Linearity limit 250
Discard working reagent if cloudy or if absorbance is < 1.100 at Filter (nm) 365
365 nm. Ref. Filter (nm)
Don’t use working reagent after expiry date stated on the label. Blank
Unhemolysed serum or heparinised plasma. Avoid fluoride or Bottletype #
ammonium heparinate as anticoagulants which interfere with the Controls #
assay. Volume Sample (µl) 3
Urea is stable in serum or plasma for 24 h at room temperature, Reagent 1 (µl) 600
several days Reagent 2 (µl)
at 2-8° C, at least 2-3 months at -20° C. Reagent 3 (µl)
24 h Urines: diluted 1 + 19 with demineralised water before **
assay and multiply the obtained result by 20.
Urea is stable in Urines for 4 days at 2-8° C. Volume water
Add antibacterial agent as Thymol to improve the stability. Calibration Fixfactor **
Correlation Factor
Performances characteristics: Correlation Offset
Linearity: the assay is linear up to 250 mg/dL (41.7 mmol/L) Method definition PR1
Detection limit: approximately 7 mg/dL (1.17 mmol/L) PS
Calibration: InkR30
Use standard (vial R3) enclosed in the kit, BIOLABO- Mel60
Multicalibrator Mixing Parameter
REF 95015 or any calibrator traceable to a reference method or Volume (µl) #
material. Repetitions #
Quality Control: ** refer to § Calibration
5 mL)
or any assayed control sera referring to the same method. Serum
or plasma mg/dL mmol/L
Expected values: refer to opposite =>
In Cord 45-86 7.5-14.3
Urines: 26-43 g/24h 0.43-0.71 mol/24h Premature 6-54 1.1-8.9
To calculate Blood Urea Nitrogen (BUN), multiply the value < 1 year 9-41 1.4-6.8
of Urea (mg/dL) by 0.467.
Children 11-39 1.8-6.4
18-60 years 13-43 2.1-7.1
60-90 years 17-49 2.9-8.2
For more details, see packing insert. > 90 years 21-66 3.6-11.1
Version AT 92032 25 02 2005
BIOLABO REAGENTS 42
www.biolabo.fr URIC ACID
MANUFACTURER: Uricase Method
BIOLABO SA,
Tel : (33) 03 23 25 15 50 REF 87601 R1 6 x 200 mL R2 6 x 200 mL R3 1 x 10 mL
Fax : (33) 03 23 256 256
Principle:
End point photometric test ASSAY PARAMETERS AT 37°C
Reaction direction: increase in absorbance PROGRAMMING TESTS
Add promptly the contents of vial R1 (Enzymes) into vial R2
(Buffer). Test ID URA
Mix gently until complete dissolution before using reagent Name URA
(approximately 2 minutes). Test Type End point
Units mg/dL
Store at 2-8° C, well recap in the original vial and away from Temperature (°C) 37
light.
Unopened reagents are stable until expiry date stated on the
label when stored and used as described in the insert.
Reag. Blank #|#
Once reconstituted, working reagent is stable at least for man #
1 month when free from contamination. woman #
Discard any reagent if cloudy or if absorbance measured at child #
505 nm is > 0.100. Descending reaction NO
substrate
Specimen collection and handling:
Unhemolysed serum or plasma (heparin or EDTA)
Linearity limit 25
Urines: Dilute 1+9 in demineralised water before assay and Filter (nm) 505
multiply the obtained result by 10 or pre-dilute the sample with Ref. Filter (nm)
the instrument. Blank Normal blank
Uric acid is stable in the specimen for: Reagents 1
3 days at room temperature, 1 week at 2-8° C, 6 mon ths frozen Bottle type #
at -20° C. Controls #
Add Na OH to keep urine alkaline and prevent uric acid Volume
precipitation.
Sample (µl) 6
Performance characteristics: Reagent 1 (µl) 250
Linearity: The reaction is linear up to 25 mg/dL (1487.5 µmol/L). Reagent 2 (µl)
Detection limit: approximately 0.3 mg/dL. Reagent 3 (µl)
**
Calibration:
Volume water
Use Standard (vial R3) enclosed in the kit,
BIOLABO Multicalibrator REF 95015 or any calibrator traceable
to a reference method or material. Correlation Factor
Correlation Offset
Quality Control: Method definition PR1
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL) PS
BIOLABO EXATROL-P (pathological values) REF 95011 InkR300
(10 x 5 mL) or any assayed control sera referring to the same MesOD
method.
Expected values: Mixing Parameter

URIC ACID Volume (µl) 170
Repetitions 2
Serum or Plasma mg/dl µmol/L # Data entered by user
Child (*) 2.0-5.5 119-327 ** Refer to §Calibration
Men 3.5-7.2 208-428
Women(**) 2.6-6.0 155-357
(*) Higher value in newborn.
(**) Lower during pregnancy.
Urines: 250-750 mg/24h (1.48-4.43 mmol/24h)

Version AT 80001 24 02 2005

BIOLABO - Applications Humastar 180

Uploaded by

Copyright:

Available Formats

BIOLABO - Applications Humastar 180

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

BIOLABO - Applications Humastar 180

Uploaded by

Copyright:

Available Formats

BIOLABO REAGENTS 03

www.biolabo.fr ACID PHOSPHATASE

For more details, see packing insert. MAJ 25/07/2008

Principle: ASSAY PARAMETER at 37°C

For more details, see packing insert. MAJ 25/07/2008

Humastar 180 - Preliminary

Principle: ASSAY PARAMETERS AT 37°C

Quality Control: Mixing Parameter

For more details, see packing insert. MAJ 25/07/2008

Humastar 180 - Preliminary

ASSAY PARAMETERS AT 37°C

Reagents preparation: Test ID ALC1

For more details, see packing insert. MAJ 25/07/2008

For more details, see packing insert. MAJ 08/08/2008

For more details, see packing insert. MAJ 08/08/2008

Principle: ASSAY PARAMETERS AT 37°C

For more details, see packing insert.

Urines (37°C) : 24-408 IU/24 hours (0.41-6.94 µKat/24 hours)

For more details, see packing insert. MAJ 08/08/2008

Urines (37°C) : 24-408 IU/24 hours (0.41-6.94 µKat/24 hours)

For more details, see packing insert. MAJ 25/07/2008

For more details, see packing insert. MAJ 08/08/2008

Principle : ASSAY PARAMETERS AT 37°C

For more details, see packing insert.

For more details, see packing insert.

Principle: ASSAY PARAMETERS AT 37°C

For more details, see packing insert.

Principle: ASSAY PARAMETERS AT 37°C

For more details, see packing insert.

Humastar 180 - Preliminary

For more details, see packing insert.

Specific procedure "icteric or pediatric specimen"

For more details, see packing insert.

Humastar 180 - Preliminary

Principle : ASSAY PARAMETERS AT 37°C

For more details, see packing insert.

Specific procedure "icteric or pediatric specimen"

For more details, see packing insert.

Principle: ASSAY PARAMETERS AT 37°C

in 24 h Urines : 100-300 mg/24 h (2.5-7.5 mmol/24 h).

For more details, see packing insert. MAJ 25/07/2008

Principle : ASSAY PARAMETERS AT 37°C

Quality Control: Mixing Parameter

Expected values : see packing insert REF AT 90004

For more details, see packing insert. MAJ 08/08/2008

Principle : ASSAY PARAMETERS AT 37°C

For more details, see packing insert. MAJ 08/08/2008

Principle: ASSAY PARAMETERS AT 37°C

Humastar 180 - Preliminary

ASSAY PARAMETERS AT 37°C

for more details, , see packing insert. MAJ 25/07/2008

Serum at 30° C at 37° C

For more details, see packing insert. MAJ 08/08/2008

For more details, see packing insert. MAJ 08/08/2008

Principle: ASSAY PARAMETERS AT 37°C

For more details, see packing insert.

Principle: ASSAY PARAMETERS AT 37°C

For more details, see packing insert. MAJ 08/08/2008

For more details, see packing insert. MAJ 08/08/2008