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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

MINDRAY BS-300

Principle :
Kinetic photometric test. Performance characteristics:
Reaction direction: increase in absorbance. T ACP: the assay is linear up to 150 IU/L (2.5 µKat/L).
NP ACP: the assay is linear up to 75 IU/L (1.25 µKat/L).
Reagents preparation : Detection limit: approx. 1.0 IU/L.
Vial R4 is ready for use.
ACP Reagent: Add promptly the contents of vial R3 (Substrate) Calibration:
into vial R1 (Citrate Buffer). Mix gently and wait for complete It is recommented to verify the calibration factor (K=1460) with
dissolution before using reagent (approximately 2 minutes). BIOLABO Multicalibrator REF 95015 or a multicalibrator
NP ACP Reagent: Add promptly the contents of vial R3 traceable to a reference method or material.
(Substrate) into vial R2 (Citrate/Tartrate Buffer). Mix gently and
wait for complete dissolution (approximately 2 minutes). Quality Control:
Vial R3: Use a non-sharp instrument to remove aluminium cap. BIOLABO EXATROL-N (Normal values) REF 95010
(10 x 5 mL)
Stability and storage: BIOLABO EXATROL-P (pathological values) REF 95011
Store at 2-8° C away from light. (10 x 5 mL)
Unopened, reagents are stable until expiry date stated on the or any assayed control sera referring to the same method.
label.
Once opened, reagents (Vials R1, R2, R4) are stable at least for Results:
6 months, when free from contamination. Determine on this channel:
Once reconstitued, ACP and NP ACP reagents are stable for - T ACP = Total Acid Phosphatase activity
10 days at 2-8°C. - NP ACP = Non Prostatic Acid Phosphatase activity.
Discard any ACP or NP ACP reagents if cloudy or if absorbance
measured at 405 nm > 0.600. Calculate the results as follows:

Prostatic Acid Phosphatase Activity = (T ACP) - (NP ACP)


Specimen collection and handling:
Unhemolysed serum. Separate from clot as soon as possible Expected values:
after collection and promptly assayed. Acidify at pH 5.4-6.2 by
adding a drop (20 µL) of Reagent R4 (Stabiliser) for 1 mL of Prostatic Acid Phosphatase at 30 or 37°C
serum. 0 – 0.6 IU/L 0 – 0.01 µKat/L
Acid phosphatase activity in serum is labile (activity decreases
of 50% in 8 hours).
Acid phosphatase activity is stable in the acidified serum for
7 days at 2-8°C.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: ACP/NPACP Method: Kinetic Direction Ascend


Unit: IU/L Decimals: 1 Prim. Wave: 405 Sec. Wave: 0
Sample vol.: 30 R1 vol.: 300 R2 vol.: 0 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 25 15 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity Full Name: Total / Non Prostatic


Lower: 0 Lower 0 Lower: 1 Acid Phosphatase
Upper: 0 Upper 0 Upper: 150/75 Print No.: entered by user.

for more details, , see packing insert.


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

MINDRAY BS-300 - Validated

Principle: Calibration:

Endpoint photometric test. Use Standard enclosed in the Kit (vial R2),
Reaction direction: increase in absorbance. BIOLABO Multicalibrator REF 95015
or any calibrator traceable to a reference method or material.
Reagents preparation:
Quality Control:
Reagents are ready for use
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL)
Stability and storage: BIOLABO EXATROL-P (pathological values) REF 95011
(10 x 5 mL) or any assayed control sera referring to the same
Store at 2-8° C away from light. method.
Unopened reagents are stable until expiry date stated on the
label. Expected values:
Once opened: Reagent R1 is stable for at least 3 months when
free from contamination.
Albumin g/dL µmol/L
Standard stability (vial R2): several weeks (transfer the
requested quantity, recap and store at 2-8°C). 0 to 4 days 2.8-4.4 421-662
Discard reagent if cloudy or if absorbance at 630 nm > 0.300. 4 days to 14 years 3.8-5.4 572-813
14 to 18 years 3.2-4.5 482-677
Specimen collection and handling:
18 to 60 years 3.4-4.8 512-722
Serum or plasma (see § interferences in the packing insert). 60 to 90 years 3.2-4.6 482-692
Serum albumin is stable in serum for: 72 hours at 2-8°C or > 90 years 2.9-4.5 436-677
6 months at -20°C.

Performances characteristics:

Linearity: up to 4.0 g/dL (1505 µmol/L). Above, dilute the sample


in saline.
Detection limit: approximately 0.3 g/dL.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: ALBUMIN Method: End Point Direction Ascend


Unit: g/dL Decimals: 2 Prim. Wave: 630 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 450 R2 vol.: 0 Lin. limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 15 Substrate: 0 Upper: 5 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0.3 Full Name: ALBUMIN
Upper: 0.3 Upper 0 Upper: 4 Print No.: entered by user.

For more details, see packing insert.


Version: 20-02-2010
Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 05’
www.biolabo.fr ALCOHOL (Ethanol)
MANUFACTURER: Enzymatic method
BIOLABO SA,
02160, MAIZY, FRANCE |
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

MINDRAY BS-300 with deproteinisation


(whole blood, haemolysed, icteric or cloudy sera or plasmas)

Principle: Specimen collection and handling:


Enzymatic End Point method.
Reaction direction: Increase in absorbance. Whole blood, hemolysed, icteric or cloudy sera or plasma:
Prepare supernatant (deproteinisation) as indicated in packing
Reagents preparation: insert § Manual Procedure (Procedure n ° 2).
Add promptly to the contents of the vial R1 the volume of
demineralised water stated on the label. Mix gently and wait for Stability in whole blood (without sodium fluoride as
complete dissolution before using reagent (approximately preservative):
10 minutes). at 18-25° C up to 2 days, at 2-8° C up to 2 weeks, at –15° C
REF 99029: Use a non-sharp instrument to remove aluminium up to 4 weeks.
cap. 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
Stability and storage up to 6 months.
Store at 2-8°C away from light. Specimens must be kept capped to avoid evaporative loss to
Unopened: Reagents are stable until expiry date stated on the the atmosphere.
label.

Once reconstituted: Working reagent (vial R1) is stable at least Calibration:


for 7 days when free from contamination. Use Standard (vial R2) enclosed in the kit or any calibrator
Standard stability (vial R2) : several weeks (transfer requested traceable to a reference method or material.
quantity, recap and store at 2-8°C). Dilute as indicated in packing insert § Manual Procedure
Discard any reagent if cloudy or if absorbance at 340 nm (Procedure n ° 2).
is > 0.500.
Quality Control:
Performances characteristics: Assayed control referring to the same method.
Linearity: the assay is linear up to 300 mg/dL (65 mmol/L) Dilute as indicated in packing insert § Manual Procedure
Detection limit: approximately 10 mg/dL. (Procedure n ° 2).

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: ALCOHOL Method: Endpoint Direction Ascend


Unit: mg/dl Decimals: 0 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 10 R1 vol.: 180 R2 vol.: 0 Lin. limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 50 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 10 Full Name: ALCOHOL
Upper: 0 Upper 0 Upper: 300 Print No. : entered by user.

For more details, see packing insert.


Version AT 99029 20 02 2007

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 05
www.biolabo.fr ALCOHOL (Ethanol)
MANUFACTURER: Enzymatic method
BIOLABO SA,
02160, MAIZY, FRANCE |
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

MINDRAY BS-300 without deproteinisation


(sera, plasmas, urines)

Principle: Specimen collection and handling:


Enzymatic End Point method. Urines. Serum, plasma (alcohol swabs should not be used
Reaction direction: Increase in absorbance. during blood specimen collection). Use heparin, Potassium
oxalate, E.D.T.A., Sodium citrate or fluoride as anticoagulant.
Reagents preparation:
Add promptly to the contents of the vial R1 the volume of Stability in whole blood (without sodium fluoride as
demineralised water stated on the label. Mix gently and wait for preservative):
complete dissolution before using reagent (approximately at 18-25° C up to 2 days, at 2-8° C up to 2 weeks, at –15° C
10 minutes). up to 4 weeks
REF 99029: Use a non-sharp instrument to remove aluminium Stability in whole blood (with sodium fluoride as preservative) :
cap. at 18-25° C up to 2 weeks at 2-8° C up to 3 months, at –15° C
up to 6 months.
Stability and storage Specimens must be kept capped to avoid evaporative loss to
Store at 2-8°C away from light. the atmosphere.
Unopened: Reagents are stable until expiry date stated on the
label. (1)Whole blood, haemolysed, icteric or cloudy sera or plasma:
See special Procedure.
Once reconstituted: Working reagent (vial R1) is stable at least
for 7 days when free from contamination. Calibration:
Standard stability (vial R2) : several weeks (transfer requested Use Standard (vial R2) enclosed in the kit or any calibrator
quantity, recap and store at 2-8°C). traceable to a reference method or material.
Discard any reagent if cloudy or if absorbance at 340 nm
is > 0.500.
Quality Control:
Performance characteristics: Assayed control referring to the same method.
Linearity: the assay is linear up to 300 mg/dL (65 mmol/L)
Detection limit: approximately 10 mg/dL.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: ALCOHOL Method: Endpoint Direction Ascend


Unit: mg/dl Decimals: 0 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 0 Lin. limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 40
Reaction: 0 50 Substrate: 0 Upper: 0 Ratio: 3

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 10 Full Name: ALCOHOL
Upper: 0 Upper 0 Upper: 300 Print No. : entered by user.

For more details, see packing insert.


Version AT 99029 20 02 2007

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 06
www.biolabo.fr ALKALINE PHOSPHATASE
MANUFACTURER: DEA Method
BIOLABO SA,
02160, MAIZY, FRANCE |
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
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

Mindray BS-300 - Preliminary

Principle: Performances characteristics:


Kinetic photometric test Linearity: the assay is linear up to 1200 IU/L (20 µKat/L) in the
Reaction direction: increase in absorbance. conditions describe opposite.
Detection limit: approx. 30 IU/L.
Reagents preparation:
Add promptly the contents of vial R2 (Substrate) into vial R1 Calibration:
(Buffer).
It is recommended to verify the theorical factor (K=10900) with
Mix gently and wait for complete dissolution before using
BIOLABO-Multicalibrator REF 95015 (10 x 5 mL)
reagent (approximately 2 minutes).
or any calibrator traceable to a reference method or material.
Vial R2: Use a non-sharp instrument to remove aluminium cap.
Stability and storage: Quality Control:
Store at 2-8°C well recapped, in the original vial and away BIOLABO EXATROL-N (normal values) REF 95010 (10 x
from light. 5 mL)
Unopened, reagents are stable until expiry date stated on the BIOLABO EXATROL-P (pathological values) REF 95011 (10 x
label. 5 mL)
Once reconstituted, working reagent is stable at least for 30 or any assayed control sera referring to the same method.
days when free from contamination.
Discard any reagent if cloudy or if absorbance of working Expected values:
reagent at 405 nm is > 0.800. ALP (IU/L à 37°C)
Specimen collection and handling: Age Men Women
Unhemolysed serum or heparinised plasma, immediately 20-29 years 100-320 70-260
refrigerated. 30-39 years 90-320 70-260
ALP activity is stable in the specimen for 2-3 days at 2-8°C, or 40-49 years 100-360 80-290
1 month at -25°C.
50-59 years 110-390 110-380
60-69 years 120-450 110-380
> 69 years 120-460 90-430

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: ALP Method: Kinetic Direction Ascend


Unit: UI/L Decimals: 0 Prim. Wave: 405 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 0 Lin. limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 5 15 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 30 Full Name: ALP
Upper: 0 Upper 0 Upper: 1200 Print No.: entered by user.

For more details, see packing insert.


Version AT 92214 21 01 2005

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 07
www.biolabo.fr ALT/TGP
MANUFACTURER: IFCC Method
BIOLABO SA,
02160, MAIZY, FRANCE |
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 20 x 10 mL REF 80127 R1 8 x 30 mL
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

MINDRAY BS-300 - Validated

Principle: Performance characteristics:

Kinetic photometric test. Linearity: The assay is linear up to 350 IU/L.


Reaction direction: decrease in absorbance. Detection limit: approximately 7 IU/L.

Reagents preparation: Calibration:

Add promptly to the contents of the vial the amount of It is recommended to verify the theoretical calibration factor
demineralised water stated on the label. Mix gently and wait for (K =3492) with BIOLABO-Multicalibrator REF 95015 or a
complete dissolution before using reagent (approximately 2 multiparametric calibrator traceable to a reference method or
minutes). material.
REF 80027: Use a non sharp-instrument to remove aluminium
cap. Quality Control:
Stability and storage: BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL)
BIOLABO EXATROL-P (pathological values) REF 95011
Store at 2-8° C away from light. (10 x 5 mL) or any assayed control sera referring to the same
Unopened: Reagent is stable until expiry date stated on the method.
label.
Once opened: working reagent is stable at least for 60 days
when free from contamination. Expected values:
Discard any reagent if cloudy or if absorbance measured at ALT
340 nm is < 1.000. IU/L at 30°C IU/L at 37°C
Newborns, infants 9-32 13-45
Specimen collection and handling:
Men 7-28 10-40
Unhemolysed serum or heparinised plasma. Women 5-25 7-35
ALT is stable in serum or plasma for:
24 hours at room temperature.
7 days at 2-8° C.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: GPT Method: Kinetic Direction Descend


Unit: U/I Decimals: 1 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 20 R1 vol.: 200 R2 vol.: 0 Lin. limit: 25

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 15 Substrate: 0.85 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower : 1 Lower 0 Lower: 7 Full Name: GPT
Upper : 2.5 Upper 0 Upper: 350 Print No. : entered by user.

For more details, see packing insert. Version : 19-02-2010

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 08
www.biolabo.fr AMMONIA
MANUFACTURER: Enzymatic Method
BIOLABO SA,
02160, MAIZY, FRANCE
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

MINDRAY BS-300

Principle:
Enzymatic method.
Reaction direction: decrease in absorbance. Performances characteristics:
Linearity: the assay is linear up to 2000 µg/dL (1175 µmol/L).
Reagents preparation: Detection limit: approximately 45.3 µg/dL.
Reagent 1 (Vial R1): Add promptly 20 mL of demineralised
water. Mix gently and wait for complete dissolution before using Calibration:
reagents (approximately 2 minutes). Use Standard (vial R3) enclosed in the kit or any calibrator
Reagent 2 : Mix 1 volume of vial R2 with 9 volumes of vial R1. traceable to a reference method or material.

Stability and storage:


Store at 2-8° C away from light. Quality Control:
When free from contamination, stored and used as indicated in Assayed control referring to the same method.
the insert, reagents are stable until expiry date stated on the
label.
Working reagent (vial R1) is stable at least for 1 month. Expected values:
Once diluted, vial R2 is stable for at least 8 h at 2-8° C.
AMMONIA (NH3)
Discard any reagent if cloudy or if working reagent absorbance
measured at 340 nm is < 0.600. In Plasma µg/dL µmol/L
Don’t use any working reagent after expiry date stated on the 0-10 days 170-341 [100-200]
label of the kit.
10 days to 2 years 68-136 [40-80]
Specimen collection and handling: > 2 years 19-60 [11-35]
Plasma (EDTA or heparin other than ammonium heparinate).
Collect blood from a stasis-free vein into an evacuated tube
avoiding partial filling. Put on ice and centrifuge within
15 minutes in a stoppered tube.
Separate plasma and perform the analysis immediately to avoid
overestimated ammonia results.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: AMMONIAC Method: EndPoint Direction Descend


Unit: µg/dL Decimals: 0 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 20 R1 vol.: 300 R2 vol.: 20 Lin. limit: 20

Response
Incubation: 5 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 50 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 45.3 Full Name: AMMONIAC
Upper: 0 Upper 0 Upper: 2000 Print No. : entered by user.

For more details, see packing insert.


Version AT 99261 01 02 2005
Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 09
www.biolabo.fr AMYLASE
MANUFACTURER: E-PNPG7 Method
BIOLABO SA,
02160, MAIZY, FRANCE |
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

MINDRAY BS-300 - Validated

Principle: Calibration:
Kinetic photometric test. It is recommended to verify the calibration factor (K=10280) with
Reaction direction: increase in absorbance. BIOLABO-Multicalibrator REF 95015 or a multiparametric
calibrator traceable to a reference method or material.
Reagents preparation:
Once opened, add promptly the amount of demineralised water
stated on the label. Mix gently and wait for complete dissolution Quality Control:
before using reagent (approximately 2 minutes). BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL)
REF 80023: Use a non-sharp instrument to remove aluminium BIOLABO EXATROL-P (pathological values) REF 95011
cap. (10 x 5 mL) or any assayed control sera referring to the same
method.
Stability and storage:
Store at 2-8 °C away from light. Expected values:
Unopened: Reagent is stable until expiry date stated on the
label.
α-AMYLASE at 37°C
Once opened: working reagent is stable for at least 3 months at IU/L µKat/L
2-8° C Serum 22-80 0.38-1.36
Discard any reagent if cloudy or if reagent blank at 405 nm
is > 0.600.
Urines (37°C) : 24-408 IU/24 hours (0.41-6.94 µKat/24 hours)
Specimen collection and handling:
Unhemolysed serum or heparinized plasma.
a-amylase activity is stable in serum/plasma for :
at least 7 days at room temperature and 1 month at 2-8° C.
Urines: Adjust pH to alkalin range before storage
a-amylase activity is stable in urines for 7 days at 2-8° C.
In case of delay in transporting urines to the laboratory, use a
preservative as merthiolate (thimerosal) 0.24mM or 0.1 g/L.

Performances characteristics:
Linearity: the assay is linear up to 2000 IU/L (33 µKat/L)
Detection limit: approximately 10 IU/L.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: AMYL-PG7 Method: Kinetic Direction Ascend


Unit: UI/L Decimals: 1 Prim. Wave: 405 Sec. Wave: 0
Sample vol.: 5 R1 vol.: 200 R2 vol.: 0 Lin limit: 25

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 5 20 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 10 Full Name: AMYLASE PNP G7
Upper: 0.6 Upper 0 Upper: 2000 Print No. : entered by user.

For more details, see packing insert. Version : 19-02-2010

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 10
www.biolabo.fr AMYLASE
MANUFACTURER: CNPG3 Method
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 99523 R1 1 × 105 mL R2 20 x 5 mL
REF 99123 R1 8 × 30 mL R2 8 x 30 mL IVD : IN VITRO DIAGNOSTIC USE
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

MINDRAY BS-300

Principle: Performance characteristics:


Kinetic photometric test. Linearity: the assay is linear up to 2000 IU/L (33 µKat/L)
Reaction direction: increase in absorbance. Detection limit: approximately 6 IU/L (0.1 µKay/L).

Reagents preparation: Calibration:


REF 99523: Once opened add promptly 5 mL of reagent R1 It is recommended to verify the theoretical factor (K=6356) with
(Buffer) to the contents of vial R2 (Substrate). BIOLABO-Multicalibrator REF 95015 or a multiparametric
REF 99123 and 99223: Once opened add promptly the calibrator traceable to a reference method or material.
contents of vial R2 (Substrate) into vial R1 (Buffer).
To avoid contamination with salivary amylase, do not pipette by Quality Control:
mouth. BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL)
Mix gently and wait for complete dissolution before using BIOLABO EXATROL-P (pathological values) REF 95011
reagents (approximately 2 minutes). (10 x 5 mL)
Vial R2 : Use a non-sharp instrument to remove aluminium cap. or any assayed control sera referring to the same method.

Stability and storage: Expected values:


Store at 2-8 °C away from light.
Unopened: Reagents are stable until expiry date stated on the
label. α-AMYLASE at 37°C
Once reconstituted, working reagent is stable at least for 15 IU/L µKat/L
days at 18-25° C and for 90 days at 2-8° C.
Serum 22-80 0.38-1.36
Discard any reagent if cloudy or if reagent blank at 405 nm
is > 0.600.
Urines (37°C) : 24-408 IU/24 hours (0.41-6.94 µKat/24 hours)
Specimen collection and handling:
Unhemolysed serum or heparinized plasma.
a-amylase activity is stable in serum/plasma for :
at least 7 days at room temperature and 1 month at 2-8° C.
Urines: Adjust pH to alkalin range before storage.
a-amylase activity is stable in urines for 7 days at 2-8° C.
In case of delay in transporting urines to the laboratory, use a
preservative as merthiolate (thimerosal) 0.24mM or 0.1 g/L.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: AMYLCNPG3 Method: Kinetic Direction Ascend


Unit: IU/L Decimals: 1 Prim. Wave: 405 Sec. Wave: 0
Sample vol.: 7 R1 vol.: 280 R2 vol.: 0 Lin. limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 11 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 6 Full Name: AMYLCNPG3
Upper: 0 Upper 0 Upper: 2000 Print No. : entered by user.

For more details, see packing insert.


Version AT 80106 09 12 2005
Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 11
www.biolabo.fr AST/TGO (single vial)
MANUFACTURER: IFCC Method
BIOLABO SA,
02160, MAIZY, FRANCE
REF 80025 R1 20 x 10 mL REF 80125 R1 8 x 30 mL
|
IVD : IN VITRO DIAGNOSTIC USE
REF 80225 R1 10 x 125 mL REF 80325 R1 6 x 200 mL
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

MINDRAY BS-300 - Validated

Principle: Performance characteristics:

Kinetic photometric test Linearity: The assay is linear up to 350 IU/L


Reaction direction: decrease in absorbance Detection limit: approximately 3 IU/L

Reagents preparation: Calibration:

Add promptly to the contents of the vial the amount of It is recommended to verify the theoretical calibration factor
demineralised water stated on the label. (K =3492) with BIOLABO-Multicalibrator REF 95015 or a
Mix gently and wait for complete dissolution before using multiparametric calibrator traceable to a reference method or
reagent (approximately 2 minutes). material.
REF 80025: Use a non-sharp instrument to remove aluminium
cap. Quality Control:

Stability and storage: BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL)
BIOLABO EXATROL-P (pathological values) REF 95011
Store at 2-8°C away from light. (10 x 5 mL) or any assayed control sera referring to the same
Unopened: Reagent is stable until expiry date stated on the method.
label.
Once opened: working reagent is stable at least for 60 days Expected values:
when free from contamination.
Discard any reagent if cloudy or if absorbance at 340 nm AST
is < 1.000. IU/L à 30°C IU/L à 37°C
Specimen collection and handling: Newborn 25-75 39-117

Unhemolysed serum or heparinised plasma. Infant 15-60 23-94


AST is stable in serum or plasma for: Adult 8-20 13-21
24 hours at room temperature.
28 days at 2-8° C.
at least for 1 year at -20° C
Adding pyridoxal phosphate (0.1 mM) improves stability at room
temperature to 7 days.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: GOT Method: Kinetic Direction Descend


Unit: U/I Decimals: 1 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 20 R1 vol.: 200 R2 vol.: 0 Lin. limit: 25

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 2 -- 15 Substrate: 0.85 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower : 1 Lower 0 Lower: 3 Full Name: GOT
Upper : 2.5 Upper 0 Upper: 350 Print No. : entered by user.

For more details, see packing insert. Version 19-02-2010

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 12
www.biolabo.fr BICARBONATE
MANUFACTURER: Enzymatic Method
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 99832 R1 8 x 30 mL R2 1 x 30 mL
IVD : IN VITRO DIAGNOSTIC USE
REF 99852 R1 6 x 100 mL R2 1 x 30 mL
TECHNICAL SUPPORT AND ORDERS
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

MINDRAY BS-300

Principle: Performance characteristics:


Determination of total CO2 by end point photometric test. Linearity: The reaction is linear up to 50 mEq/L
Reaction direction: decrease in absorbance Detection limit: approximately 3.0 mEq/L.

Reagents preparation: Calibration:


Reagent R1: Add promptly to the contents of vial R1 the amount Use Standard (vial R3) enclosed in the kit or any calibrator
of demineralised water stated on the label. traceable to a reference method or material.
Mix gently and wait for complete dissolution before use
( approx. 2 min)
To avoid CO2 contamination, use fresh demineralised water Quality Control:
Reagent R2: standard 50 mmol/L, are ready for use. Assayed control referring to the same method.
(*) R2 in programming test: fresh demineralised water.
Expected values:
Stability and storage:
Store at 2-8° C and away from light. BICARBONATE
Stored in the original vial and used as described in the Serum mEq/L mmol/L
packaging insert, reagents are stable until expiry date stated on
the label. Arterial 21-28 21-28
Once reconstituted, working reagent is stable at least for Venous 22-29 22-29
4 month when free from contamination. (well recap after use)
Discard any reagent if cloudy or if absorbance measured at Total CO2 concentration is approximately 10% higher than
340 nm < 1.000. Bicarbonate concentration.
Don’t use working reagent after expiry date stated on the label. The assay gives the concentration of CO2 which is the sum of
dissolved CO2 + Bicarbonate.
Specimen collection and handling:
Unhemolysed serum: Collect specimen anaerobically
Heparin is the preferred anticoagulant.
Do not store specimen more than 1 hour at 2-8° C.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: Bicarbonate Method: EndPoint Direction Descend


Unit: mEq/L Decimals: 0 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 4 R1 vol.: 100 (*)R2 vol.: 300 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 20 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0 Full Name: BICARBONATE
Upper: 0 Upper 0 Upper: 50 Print No. : entered by user.

(*): see § “reagents preparation”

for more details, , see packing insert.


Version AT 80001 24 02 2005

Manufacturer Use by IVD : In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT : Batch number
13
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 97443 R1 2 x 200 mL Total Bilirubin Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 Fax : (33) 03 23 256 256
R2 1 x 10 mL Nitrite Solution
|
IVD : IN VITRO DIAGNOSTIC USE
|
IVD : USAGE IN VITRO

Total Bilirubin Bilirubine totale


DCA method Méthode DCA

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

Reagents Preparation : Préparation des réactifs :

R1*: content of vial R1 (Ready for use) R1*: contenu du flacon R1 (prêt à l’emploi)
R2*: mix R1 (1 volume) and R2 (3 volumes) R2*: mélanger R1 (1 volume) et R2 (3 volumes)

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: BTDCA Method: EndPoint Direction Ascend


Unit: mg/dL / mg/L Decimals: 2/1 Prim. Wave: 546 Sec. Wave: 0
Sample vol.: 38 R1* vol.: 340 R2* vol.: 30 Lin. limit: 20

Response
Incubation: 25 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower : 0 Lower 0 Lower: 0 Full Name: Bilirubin T DCA
Upper : 0 Upper 0 Upper: 200 / 20 Print No. : entered by user.

R1* and R2* : see §Reagents Preparation / R1* et R2* : voir §Prépatation des réactifs.

Version : 17/02/2009
14
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 97553 R1 2 x 200 mL Direct Bilirubin Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 Fax : (33) 03 23 256 256
R2 1 x 10 mL Nitrite Solution
|
IVD : IN VITRO DIAGNOSTIC USE
|
IVD : USAGE IN VITRO

Direct Bilirubin Bilirubine Directe


DCA method Méthode DCA

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

Reagents Preparation: Préparation des réactifs :

R1*: content of vial R1 (Ready for use) R1*: contenu du flacon R1 (prêt à l’emploi)
R2*: content of vial R2 (Ready for use) R2*: contenu du flacon R2 (prêt à l’emploi)

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: BDDCA Method: EndPoint Direction Ascend


Unit: mg/dL / mg/L Decimals: 2/1 Prim. Wave: 546 Sec. Wave: 0
Sample vol.: 25 R1* vol.: 200 R2* vol.: 50 Lin. limit: 20

Response
Incubation: 5 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 5 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower : 0 Lower 0 Lower: 0 Full Name: Bilirubin D DCA
Upper : 0 Upper 0 Upper: 200 / 20 Print No. : entered by user.

R1* and R2* : see §Reagents Preparation / R1* et R2* : voir §Prépatation des réactifs.

Version : 17/02/2009
BIOLABO REAGENTS 15
www.biolabo.fr T o t a l a n d D i r e c t BILIRUBIN
MANUFACTURER: Sulfanilic acid method
BIOLABO SA,
02160, MAIZY, FRANCE |
IVD : IN VITRO DIAGNOSTIC USE
REF 80403 R1 1 x 200 mL R2 1 x 200 mL R3 1 x 20 mL
TECHNICAL SUPPORT AND ORDERS REF 80443 R1 1 x 200 mL R3 1 x 20 mL
Tel : (33) 03 23 25 15 50 REF 80553 R2 1 x 200 mL R3 1 x 20 mL
Fax : (33) 03 23 256 256

Preliminary MINDRAY BS-300

Principle: Calibration:
End point photometric test. Use the experimental factor, adjust with BIOLABO EXATROL-N
Reaction direction: increase in absorbance. (level I) REF 95010 (10 x 5 mL), BIOLABO EXATROL-P (level
II) REF 95011 (10 x 5 mL),
Reagents preparation : Or
R1 (BT): Contents of vial R1 is ready for use.
BIOLABO-Multicalibrator REF 95015 or any calibrator
R1 (BD): Contents of vial R2 is ready for use. traceable to a reference method or material.
R2*: Mix 1 volume of the contents of vial R1 (BT) or R2 (BD)
with 1 volume of the contents of vial R3. Quality Control:
BIOLABO EXATROL-N (level I) REF 95010 (10 x 5 mL)
Stability and storage: BIOLABO EXATROL-P (level II)) REF 95011 (10 x 5 mL)
Store at 2-8°C, in the original vial well capped and away from light.
or any assayed control sera referring to the same method.
• When used and stored as described in the insert, reagents
(vial R1, R2, R3) are stable, without contamination, until
expiry date stated on the label.
Expected values:
• R2*: Contents of vial R3 diluted in R1 or R2 is stable for 48 h.
• Discard any reagent blank measured at 546 nm is > 0.100. Total Bilirubin mg/dL [µmol/L]
Newborn Premature Full-term Premature Full-term
Specimen collection and handling: In cord < 2.0 < 2.0 [< 34] [< 34]
0-1 day < 8.0 1.4-8.7 [< 137] [24-149]
Unhemolysed serum or plasma.
1-2 days < 12.0 3.4-11.5 [< 205] [58-197]
Bilirubin is photolabile. Store the specimen away from light.
3-5 days < 16.0 1.5-12.0 [< 274] [26-205]
• Stability in the specimen: 4 to 7 days at 2-8°C.
2 days at room temperature.
Icteric or pediatric specimens: see § SPECIAL PROCEDURE.. Adult Total Bilirubin Direct Bilirubin
(and child > 5 mg/dL [µmol/L] mg/dl
days) [µmol/L]
Performance characteristics:
>5 days-60 years 0.3-1.2 [5-21] < 0.2 [< 3.4]
Linearity: the assay is linear up to 20 mg/dL (342 µmol/L) 60-90 years 0.2-1.1 [3-19] < 0.2 [< 3.4]
Detection limit: approximately 110 µg/dL (2 µmol/L) > 90 years 0.2-0.9 [3-15] < 0.2 [< 3.4]
Above, do not dilute specimen: perform Special procedure for
“Paediatric or icteric specimen”.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: BILI Method: EndPoint Direction Ascend


Unit: mg/dL Decimals: 1 Prim. Wave: 546 Sec. Wave:
Sample vol. : 30 R1 vol. : 285 R2* vol.: 30 Lin. limit: 20

Response
Incubation: 5 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 15 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower : 0 Lower 0 Lower: 0.1 Full Name: BILI DMSO
Upper : 0 Upper 0 Upper: 20 Print No. : entered by user.

For more details, see packing insert.


Version AT 80403 21 06 2007

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 04
www.biolabo.fr CALCIUM
MANUFACTURER: CPC Method
BIOLABO SA,
02160, MAIZY, FRANCE |
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
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256 MINDRAY BS-300 - Validated

Principle: Performances characteristics:


Linearity between 7.5 and 17.5 mg/dL (1.88 to 4.37 mmol/L).
Endpoint photometric test. Detection limit: approximately 0.16 mg/dL.
Reaction direction: increase in absorbance.
Calibration:
Reagents preparation: Use Standard enclosed in the Kit (vial R2),
Reagents are ready for use BIOLABO Multicalibrator REF 95015 or any calibrator
traceable to a reference method or material.
Stability and storage:
Store at 18-25° C in the original vial and away from light. Quality Control:
BIOLABO EXATROL-N (normal values) REF 95010
When used and stored as indicated, reagents are stable until (10 x 5 mL)
expiry date stated on the label of the kit. BIOLABO EXATROL-P (pathological values) REF 95011
Discard reagent if cloudy or if absorbance at 578 nm > 0.800. (10 x 5 mL) or any assayed control sera referring to the same
method.
Specimen collection and handling:
Serum or heparinised plasma. Do not use citrate, oxalate or Expected values:
EDTA. Blood obtained on fasting patient with minimal venous
occlusion and without exercise or after restoring circulation at
least for 1 minute. in serum :
24 h Urines : Acidify before assay with 20 to 30 mL HCl 6 N to Population mg/dL mmol/L
dissolve calcium salts. Premature 6.2-11.0 [1.55-2.75]
Mix well then dilute (1 + 2) with demineralised water before 0-10 days 7.6-10.4 [1.90-2.60]
performing the test. 10 days –24 months 9.0-11.0 [2.25-2.75]
Calcium is stable in serum for : 24 months –12 8.8-10.8 [2.20-2.70]
• at least 7 days at 2-8°C. years
• 6 months at -20°C. 12 years -18 years 8.4-10.2 [2.10-2.55]
Plastic and glass may adsorb calcium during storage, 18-60 years 8.6-10.0 [2.15-2.50]
especially with diluted solution.
60-90 years 8.8-10.2 [2.20-2.55]
Long-term freezing may lead to associated evaporation,
lyophilisation or coprecipitation with fibrin (i.e. heparinised > 90 years 8.2-9.6 [2.05-2.40]
plasma) or lipids.
in 24 h Urines : 100-300 mg/24 h (2.5-7.5 mmol/24 h).

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: Cal CPC Method: EndPoint Direction Ascend


Unit: mg/dL Decimals: 2 Prim. Wave: 578 Sec. Wave: 0
Sample vol.: 10 R1 vol.: 200 R2 vol.: 200 Line limit: 20

Response
Incubation: 1 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 2.5 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 7.5 Full Name: Calcium CPC
Upper: 0.4 Upper 0 Upper: 17.5 Print No. : entered by user.

For more details, see packing insert. Version: 20-02-2010

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
18
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS 300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 90004 R1 2 x125 mL R2 1 x 10 mL Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 Fax : (33) 03 23 256 256

|
IVD : IN VITRO DIAGNOSTIC USE
|
IVD : USAGE IN VITRO

C AL C I U M C AL C I U M
Arsenazo III Method M éth od e Arsen az o III

ENGLISH - Validated FRANÇAIS - Validé

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: CAA Method: EndPoint Direction Ascend


Unit: mg/dL / mg/L Decimals: 2/1 Prim. Wave: 630 Sec. Wave: 0
Sample vol.: 4 R1 vol.: 200 R2 vol.: 0 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 5 Substrate: 0 Upper: 2.5 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0.21 / 2.1 Full Name: Calcium Ars III
Upper: 0.4 Upper 0 Upper: 15.0 / 150 Print No. : entered by user.

Version : 20/02/2010
19
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 80005 R1 2 x 125 mL R2 1x 5 mL Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 Fax : (33) 03 23 256 256

|
IVD : IN VITRO DIAGNOSTIC USE
|
IVD : USAGE IN VITRO

Chloride Chlorures
Colorimetric Method Méthode Colorimétrique

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: Cl Method: EndPoint Direction Ascend


Unit: mEq/L Decimals: 0 Prim. Wave: 510 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 0 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 2.5 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 70 Full Name: Chloride
Upper: 0 Upper 0 Upper: 140 Print No. : entered by user.

Version : 17/02/2009
BIOLABO REAGENTS
www.biolabo.fr CHOLESTEROL 20
MANUFACTURER : CHOD-PAP Method
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 80106 R1 2 x 100 mL R2 2 x 100 mL R3 1 x 5 mL IVD : IN VITRO DIAGNOSTIC USE
REF 87356 R1 10 x 100 mL R2 10 x 100 mL R3 1 x 5 mL
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

MINDRAY BS-300

Principle: Performance characteristics:

End point photometric test. Linearity: the reaction is linear up to 500 mg/dL (12,9 mmol/L)
Reaction direction: increase in absorbance. Detection limit: approximately 1 mg/dL.

Reagents preparation: Calibration:

Add promptly the content of vial R2 (Enzymes) into vial R1 Use standard (Vial R3) enclosed in the kit, BIOLABO-
(Buffer). Multicalibrator REF 95015 or any calibrator traceable to
Mix gently until complete dissolution (approximately 2 minutes). reference method or material.
Vial R2: use a non-sharp instrument to remove aluminium cap.
Quality Control:
Stability and storage:
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL)
Store at 2-8°C away from light. BIOLABO EXATROL-P (pathological values) REF 95011
Unopened: Reagents are stable until expiry date stated on the (10 x 5 mL)
label. or any assayed control sera referring to the same method.
Once opened: working reagent is stable at least for 2 years.
Standard stability: Several weeks after opening (transfer the Expected values:
requested quantity, recap and store at 2-8° C.
Discard any reagent if cloudy or if absorbance of reagent blank
is > 0,400 at 510 nm. CHOLESTEROL
Serum or Plasma mg/dL mmol/L
Specimen collection and handling:
Recommended value < 200 < 5,18
Unhemolysed serum or Plasma (Heparin or EDTA)
Do not use oxalate, fluoride or citrate. Collect on fasting patient. low risk 200 - 239 5,18 - 6,19
Separate serum from cells within 2 hours. high risk ≥ 240 ≥ 6,22
Cholesterol is stable in the specimen for:
5-7 days at 2-8° C; 3 months at -20° C; many years at - 70° C.
Avoid repeated freezing and thawing.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: Cholesterol Method: EndPoint Direction Ascend


Unit: mg/dL Decimals: 0 Prim. Wave: 510 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 0 Lin. Limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 20 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower : 0 Lower 0 Lower: 1 Full Name: CHOLESTEROL
Upper : 0 Upper 0 Upper: 500 Print No. : entered by user.

for more details, , see packing insert.


Version AT 80106 09 12 2005

Manufacturer Use by IVD : In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT : Batch number
BIOLABO REAGENTS 22
www.biolabo.fr HDL CHOLESTEROL
MANUFACTURER : Direct Method
BIOLABO SA,
02160, MAIZY, FRANCE
REF 90206 200-250 tests R1 1 × 60 mL R2 1 × 20 mL
REF 90406 400-500 tests R1 2 × 60 mL R2 2 × 20 mL
|
TECHNICAL SUPPORT AND ORDERS
Tel : (33) 03 23 25 15 50 REF 90426 2000-2500 tests R1 4 × 150 mL R2 4 × 50 mL
Fax : (33) 03 23 256 256

MINDRAY BS-300 IVD : IN VITRO DIAGNOSTIC USE

Principle: Performances characteristics:

End point photometric test. The reaction is linear from 2.5 to 200 mg/dL
Reaction direction: increase in absorbance. (0.065 to 5.17 mmol/L).
Detection limit: approximately 2.5 mg/dL (0.065 mmol/L).
Reagents preparations:

Reagents are ready for use. Calibration:

Stability and storage: Do not use aqueous calibrator.


Use BIOLABO HDL-Cholesterol Calibrator REF 95406 or a
Store at 2-8° C away from light. calibrator of human origin traceable to reference method or
Unopened: Reagents are stable until expiry date stated on the material.
label.
Once opened, when free from contamination, reagents are stable Quality Control:
at least for 3 months at 2-8° C, 24 h at room temperature and 30
days on board of refrigerated analyser. Assayed control sera of human origin referring to the same
Discard any reagent if cloudy or if reagent blank > 0.100 at method :( accelerator selective detergent).
578 nm.
This Kit should be refrigerated during transport. Expected values:

Specimen collection and handling: HDL-Cholesterol mg/dL [mmol/L]

Specimens should be collected after 12-14h fasting. Low level (Risk factor) < 40 < 1.0
Plasma: collected on EDTA ot lithium/sodium heparinate. High level (Protective factor) > 60 > 1.5
Centrifuge and remove plasma from blood cells as soon as
possible. (within 3 hours).
Serum: Centrifuge and remove serum from clot as soon as
possible. (within 3 hours).
HDL Cholesterol is stable in specimen for 1 to 3 days at 2-8° C, 1
month at -20° C (Avoid repeated freezing and thawing).

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: HDLDIRECT Method: EndPoint Direction Ascend


Unit: mg/dL Decimals: 1 Prim. Wave: 578 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 100 Lin. limit: 20

Response
Incubation: 25 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower : 0 Lower 0 Lower: 2.5 Full Name: HLDDIRECT
Upper : 0 Upper 0 Upper: 200 Print No. : entered by user.

for more details, , see packing insert.


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
23
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 90416 R1 1 x 30 mL R2 1 x 10 mL Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 Fax : (33) 03 23 256 256
REF 90816 R1 2 x 30 mL R2 2 x 10 mL
|
IVD : IN VITRO DIAGNOSTIC USE
|
IVD : USAGE IN VITRO

LDL Cholesterol LDL Cholestérol


Direct Method Méthode Directe

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

Calibration: Calibration :

Do not use aqueous calibrator Ne pas utiliser de calibrateur aqueux.


- Use HDL / LDL / CK-MB Calibrator REF 95506 (2 x 2mL) - Utiliser le calibrateur HDL / LDL / CK-MB REF 95506
- Or a calibrator of human origin traceable to reference (2x2mL)
method or material. - ou tout calibrant d’origine humaine, raccordé sur une
The calibration frequency depends on proper instrument méthode ou un matériau de référence.

Quality Control: La fréquence de la calibration dépend de l’instrument

REF 95516 HDL / LDL / CK-MB Control, level 1 (2 x 2 mL) Contrôle de Qualité :
REF 95526 HDL / LDL / CK-MB Control, level 2 (2 x 2 mL).
or any assayed human control sera referring to the same REF 95516 Contrôle HDL / LDL / CK-MB Taux 1 (2 x 2 mL)
method REF 95526 Contrôle HDL / LDL / CK-MB Taux 2 (2 x 2 mL).
ou tout sérum de contrôle humain titre pour cette méthode.

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: LDLDIRECT Method: EndPoint Direction Ascend


Unit: mg/dL / g/L Decimals: 1 Prim. Wave: 546 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 100 Lin. limit: 20

Response
Incubation: 25 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower : 0 Lower 0 Lower: 2.5 Full Name: LDLDIRECT
Upper : 0 Upper 0 Upper: 900 / 9 Print No. : entered by user.

Version : 16/02/2009
BIOLABO REAGENTS 24
www.biolabo.fr CK-MB ISOENZYME
MANUFACTURER: Immunoinhibition Method
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 97217 R1 10 x 3 mL R2 1 x 30 mL
IVD : IN VITRO DIAGNOSTIC USE
REF 97317 R1 6 x 20 mL R2 8 x 30 mL
TECHNICAL SUPPORT AND ORDERS
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

MINDRAY BS-300
Principle: Performance characteristics:
Kinetic UV Photometric test.. Linearity: The reaction is linear up to 1000 IU/L
Reaction direction: increase in absorbance Detection limit: approximately 5 IU/L.

Reagents preparation: Calibration:


REF 97317: Add promptly the contents of vial R1 It is recommended to verify the calibration factor (K=6667) with
(Enzymes- Substrate) into vial R2 (Buffer). a calibrator traceable to a reference method or material.
REF 97217: Add promptly 3 mL of vial (Buffer) into vial R1 This factor takes into account that CK-MB activity =
(Enzymes-Substrate) 2 x CK-B activity.
Mix gently and wait for complete dissolution before using
reagents (approximately 2 minutes). Quality Control:
Vial R1: use a non-sharp instrument to remove aluminium cap. Assayed human control sera referring to the same method.

Stability and storage: Expected values:


Store at 2-8° C and away from light.
Stored in the original vial and used as described in the CK-MB
packaging insert, reagents are stable until expiry date stated on At 30°C At 37 °C
the label.
Once reconstituted, working reagent is stable at least for 7 days Serum < 16 < 25
when free from contamination.
Discard any reagent if cloudy or if absorbance at 340 nm CK-MB %: a ratio between 6 and 25% is consistent with acute
is > 0.700. myocardial infarction. In case of suspicion of myocardial
Don’t use working reagent after expiry date stated on the label. infarction, CK-MB values rise and afterwards return to normal in
48 hours.
Specimen collection and handling:
Unhemolysed serum: store at 2-8°C away from light. Use an
airtight container to prevent loss of CO2
Plasma is not recommended because anticoagulants as
heparine, EDTA, Citrate or fluoride interfere with the
determination.
If myocardial infarction is suspected, it is recommended to
collect patient after 6 hours, 12 hours and 24 hours. Minimum
requested number of collects is two: 12 hours and 24 hours
after symptoms appearance.
CK-MB activity in serum is stable for:
4 to 8 hours at room temperature, 1 to 2 days at 2-8°C or
1 month at -20°C.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: CK-MB Method: Kinetic Direction Ascend


Unit: mEq/L Decimals: 0 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 15 R1 vol.: 300 R2 vol.: 0 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 25 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0 Full Name: CK-MB
Upper: 0 Upper 0 Upper: 1000 Print No. : entered by user.

for more details, , see packing insert.


Version AT 97317 05 04 2005

Manufacturer Use by IVD : In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT : Batch number
25
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 92207 R1 20 × 3 mL R2 1 x 60 mL Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 REF 92307 R1 8 × 20 mL R2 8 x 20 mL Fax : (33) 03 23 256 256

|
IVD : IN VITRO DIAGNOSTIC USE
|
IVD : USAGE IN VITRO

C K - N AC C K - N AC
IFCC MonoReagent Method Méthode IFCC Monoréactif

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

Calibration: Calibration :
It is recommended to verify the factor (K=6666) with a Il est recommandé de vérifier le facteur (K=6666) à l’aide
multiparametric control traceable to a reference material or d’un sérum de contrôle multiparamétrique raccordé sur une
method. solution ou une méthode de référence.

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: CK-NAC Method: Kinetic Direction Ascend


Unit: UI/L Decimals: 0 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 12.5 R1 vol.: 250 R2 vol.: 0 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 10 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 10 Full Name: CK-NAC
Upper: 0 Upper 0 Upper: 1000 Print No. : entered by user.

Version : 16/02/2009
BIOLABO REAGENTS 26’
www.biolabo.fr CREATININE
MANUFACTURER: Kinetic Method - Bi-reagent
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 80107 R1 1 × 125 mL R2 1 × 125 mL R3 1 × 10 mL
IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50 Special Procedure "Icteric specimens"
Fax: (33) 03 23 256 256

MINDRAY BS-300 - Validated

Principle: Calibration:
Use standard (vial R3) enclosed in the kit,
Fixed time Kinetic photometric test. BIOLABO-Multicalibrator REF 95015 or any calibrator traceable
Reaction direction: increase in absorbance. to a reference method or material.

Reagents preparation: Quality Control:

Reagents are ready for use. BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL)
BIOLABO EXATROL-P (pathological values) REF 95011
Stability and storage: (10 x 5 mL) or any assayed control sera referring to the same
method.
Store at 18-25° C away from light.
Unopened: Reagents are stable until expiry date stated on the Expected values:
label.
Once opened, reagents are stable at least for 6 months when
Serum, Plasma mg/dL µmol/L
free from contamination.
Standard stability (vial R3): several weeks once opened Men 0.9 to 1.3 80 to 115
(transfer the requested quantity, recap and store at 18-25° C). Women 0.6 to 1.1 53 to 97
Discard any reagent if cloudy or if absorbance of working
reagent is > 0.300 at 510 nm. Interferences
Specimen collection and handling:
Haemolysis, bilirubin and lipemia may cause falsely negative
results.
Serum or heparinised plasma.
Ascorbic acid, glucose and some antibiotics interfere also with
Creatinine is stable in the specimen for 24 h at 2-8° C.
the determination of creatinine according to Jaffe method.
Freeze for longer storage.
Reading interval is the main determinant for the specificity of the
Jaffe reaction; some interferents act quickly (acetoacetate) and
Performances characteristics: others slowly (proteins). The majority of kinetic methods
recommend a reading interval between 30 and 150 seconds.
Linearity: The assay is linear up to 15 mg/dL (1327 µmol/L)
Detection limit: approximately 0.2 mg/dL.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: CREAT BI-R Method: Fixed Time Direction Ascend
Unit: mg/dL Decimals: 1 Prim. Wave: 510 Sec. Wave: 0
Sample vol.: 35 R1 vol.: 180 R2 vol.: 180 Line Limit: 20

Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 13 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0.2 Full Name: CREAT BI-R
Upper: 0 Upper 0.3 Upper: 15 Print No. : entered by user.

For more details, see packing insert. Version 19-02-2010

Manufacturer Use by IVD : In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT : Batch number
BIOLABO REAGENTS 26
www.biolabo.fr CREATININE
MANUFACTURER: Kinetic Method – Single reagent
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 80107 R1 1 × 125 mL R2 1 × 125 mL R3 1 × 10 mL
IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50
Fax: (33) 03 23 256 256
MINDRAY BS-300

Principle: Calibration:
Fixed time Kinetic photometric test. Use standard (vial R3) enclosed in the kit, BIOLABO-
Reaction direction: increase in absorbance. Multicalibrator REF 95015 or any calibrator traceable to
a reference method or material.
Reagents preparation:
Prepare working reagent as follows: Quality Control:
Mix vial R1 and vial R2 contents (1 volume/1 volume). BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL)
A graduated test-tube may be used. BIOLABO EXATROL-P (pathological values) REF 95011
(10 x 5 mL) or any assayed control sera referring to the same
Stability and storage: method.

Store at 18-25° C away from light. Expected values:


Unopened: Reagents are stable until expiry date stated on the
label.
Serum, Plasma mg/dL µmol/L
Once opened, reagents are stable at least for 6 months when
free from contamination. Men 0.9 to 1.3 80 to 115
Working reagent is stable at least for 30 days at 2-8° C. Women 0.6 to 1.1 53 to 97
Standard stability (vial R3): several weeks once opened
(transfer the requested quantity, recap and store at 18-25° C). Urines mg/kg/24h µmol/kg/24h
Discard any reagent if cloudy or if absorbance of working
Men 14 to 26 124 to 230
reagent is > 0.300 at 510 nm.
Women 11 to 20 97 to 177
Specimen collection and handling:
Serum or heparinised plasma. GFR (Glomerular filtration rate)
Urines: Dilute 1+19 with demineralised water and multiply the Adult < 40 years 120 (100 - 140) mL/min.
obtained results by the dilution factor or use special procedure
(with sample pre-dilution). Adult > 40 years Physiologically decreased approx. 1% per year.
Creatinine is stable in the specimen for 24 h at 2-8° C.
Freeze for longer storage. Interferences
Haemolysis, bilirubin and lipemia may cause falsely negative
Performances characteristics: results.
Linearity: The assay is linear up to 15 mg/dL (1327 µmol/L) Bilirubin: see Bi-reagent procedure.
Detection limit: approximately 0.2 mg/dL. Ascorbic acid, glucose and some antibiotics interfere also with
the determination of creatinine according to Jaffe method.
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.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: CREATININE Method: Fixed Time Direction Ascend


Unit: mg/dL Decimals: 1 Prim. Wave: 510 Sec. Wave: 0
Sample vol.: 20 R1 vol.: 200 R2 vol.: 0 Lin. Limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 10 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0.2 Full Name: CREATININE
Upper: 0 Upper 0 Upper: 15 Print No. : entered by user.

for more details, , see packing insert.


Version AT 80107 05 07 2007

Manufacturer Use by IVD : In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT : Batch number
BIOLABO REAGENTS 26’’
www.biolabo.fr CREATININE
MANUFACTURER: Kinetic Method
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 80107 R1 1 × 125 mL R2 1 × 125 mL R3 1 × 10 mL
IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 Special Procedure "Urines" with sample dilution
MINDRAY BS-300

Principle: Calibration:

Fixed time Kinetic photometric test. Use standard (vial R3) enclosed in the kit,
Reaction direction: increase in absorbance. BIOLABO-Multicalibrator REF 95015 or any calibrator traceable
to a reference method or material.
Reagents preparation: Do not dilute standard.

Prepare working reagent as following:


Mix vial R1 and vial R2 contents (1 volume/1 volume). A Quality Control:
graduated test-tube may be used
Normal and pathological urinary controls
Stability and storage: or any assayed urinary controls referring to the same method.
Controls should be diluted by the instrument as samples.
Store at 18-25° C away from light.
Unopened: Reagents are stable until expiry date stated on the Expected values:
label.
Once opened, reagents are stable at least for 6 months when
free from contamination. Urines mg/kg/24h µmol/kg/24h
Working reagent is stable at least for 30 days at 2-8° C.
Standard stability (vial R3): several weeks once opened Men 14 to 26 124 to 230
(transfer the requested quantity, recap and store at 18-25° C).
Discard any reagent if cloudy or if absorbance of working Women 11 to 20 97 to 177
reagent is > 0.300 at 510 nm.

Specimen collection and handling: GFR (Glomerular filtration rate)

Urines: collected during precisely timed intervals (4, 12 or Adult < 40 years 120 (100 - 140) mL/min.
24 hours).
Creatinine is stable in the specimen for 24 h at 2-8° C. Physiologically decreased approx. 1%
Freeze for longer storage. Adult > 40 years
per year.
Performances characteristics:

The assay is linear up to 15 mg/dL (1327 µmol/L)


Detection limit: approximately 0.2 mg/dL.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: CREAT U Method: Fixed Time Direction Ascend


Unit: mg/dL Decimals: 1 Prim. Wave: 510 Sec. Wave: 0
Sample vol.: 20 R1 vol.: 200 R2 vol.: 0 Line Limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 10
Reaction: 3 13 Substrate: 0 Upper: 0 Ratio: 20

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0.2 Full Name: CREAT U
Upper: 0 Upper 0 Upper: 15 Print No. : entered by user.

For more details, see packing insert.


Version AT80107 05 07 2007

Manufacturer Use by IVD : In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT : Batch number
27
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 80110 R1 8 × 30 mL R2 8 x 30 mL Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 REF 80210 R1 10 × 10 mL R2 10 x 10 mL Fax : (33) 03 23 256 256

|
IVD : IN VITRO DIAGNOSTIC USE
REF 80310 R1 10 × 100 mL R2 10 x 100 mL
|
IVD : USAGE IN VITRO

Gamma-GT Gamma-GT
GPNA Soluble GPNA Soluble

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

Calibration: Calibration :
It is recommended to verify the factor (K=4242) with a Il est recommandé de vérifier le facteur (K=4242) à l’aide
multiparametric control traceable to a reference material or d’un sérum de contrôle multiparamétrique raccordé sur une
method. solution ou une méthode de référence.

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: GGT Method: Kinetic Direction Ascend


Unit: UI/L Decimals: 0 Prim. Wave: 405 Sec. Wave: 0
Sample vol.: 12.5 R1 vol.: 250 R2 vol.: 0 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 18 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 4 Full Name: Gamma-GT
Upper: 0 Upper 0 Upper: 320 Print No. : entered by user.

Version : 17/02/2009
BIOLABO REAGENTS 28
www.biolabo.fr GLUCOSE
MANUFACTURER: GOD-PAP Method
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 80009 R1 1 × 500 mL R2 1 x 7,5 mL R3 1 x 5 mL
IVD : IN VITRO DIAGNOSTIC USE
REF 87109 R1 6 × 250 mL R2 6 x 3,75 mL R3 1 x 5 mL
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
MINDRAY BS-300 - Validated
Principle: Performances characteristics:
End point photometric test. Linearity: the assay is linear up to 500 mg/dL (28 mmol/L)
Reaction direction: increase in absorbance. Detection limit: approximately 10 mg/dL.

Reagents preparation: Calibration:


Using a volumetric flask, measure the volume of demineralised Standard enclosed in the kit (vial R3)
water stated on the label of the vial R1 (Enzymes-Buffer). or BIOLABO Multicalibrator REF 95015
Transfer the contents of vial R1 into the flask and mix gently or any calibrator traceable to a reference method or material.
until complete dissolution (approximately 2 minutes). Then add
the contents of vial R2 and mix gently. Quality Control:
Vial R1 and R2 : if appropiate, use a non-sharp instrument to BIOLABO EXATROL-N (normal values) REF 95010 (10 x
remove aluminium cap. 5 mL)
BIOLABO EXATROL-P (pathological values) REF 95011 (10 x
Stability and storage: 5 mL)
Store at 2-8° C away from light and in the original vial. or others assayed control sera referring to the same method.
Unopened: the reagents are stable until the expiry date stated
on the label. Expected values:
Once opened: working reagent is stable for at least 2 years at
2-8° C, when free from contamination. GLUCOSE
Standard stability (vial R3): Several weeks (transfer the
Serum or Plasma mg/dL mmol/L
requested quantity, recap and store at 2-8° C).
Discard any reagent if cloudy or if absorbance of working New-born, 1 day 40-60 2.2-3.3
reagent is >0.400 at 510 nm. New-born, >1 day 50-80 2.8-4.4
Children 60-100 3.3-5.6
Specimen collection and handling:
Serum or plasma: Separate promptly from blood cells to prevent Adult 74-106 4.1-5.9
glycolysis.
If fluorure is used as a preservative, a decrease of 9 mg/dL is
seen within the first 2 hours, then concentration stabilises. In CSF mg/dL mmol/L
Glucose is stable: Children 60-80 [3.3-4.4]
- in serum or heparinised plasma for 8 hours at 25°C or
72 hours at 2-8° C, Adult 40-70 [2.2-3.9]
- in plasma (fluoride or Iodoacetate) for 24 hours at room
temperature. In 24h Urines: 1-15 mg/dL [0.1-0.8 mmol/L]
CSF: process immediately to avoid falsely low results. < 0.5 g/24
Store at -20° C. hours [< 2.78 mmol/24 hours]
Urines: collect in dark bottle and store at 2-8° C. Preser ve 24h
urines with 5 mL glacial acetic acid or 5 g sodium benzoate or
sodium fluoride.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: GLUCOSE Method: End Point Direction Ascend


Unit: mg/dL Decimals: 1 Prim. Wave: 510 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 0 Lin. limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 10 Full Name: GLUCOSE
Upper: 0.4 Upper 0 Upper: 500 Print No.: entered by user.

For more details, see packing insert. Version: 20-02-2010

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
29
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 82200 R1 2 x 200 mL Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 Fax : (33) 03 23 256 256
REF 82250 R2 1x 50 mL
|
IVD : IN VITRO DIAGNOSTIC USE
REF 3502200 R2 2x 200 mL |
IVD : USAGE IN VITRO

Hemoglobin Hémoglobine
Colorimetric Method (Cyanmethemoglobin) Méthode Colorimétrique (Cyanméthémoglobine)

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

Reagents preparation: Reagents preparation:

REF 3502200: Ready for use REF 3502200: Prêt à l’emploi


REF 82200: To be diluted 1/10 with demineralised water. REF 82200: A diluer au 1/10 dans de l’eau déminéralisée
REF 82250: To be diluted 1/50 with demineralised water. REF 82250: A diluer au 1/50 dans de l’eau déminéralisée

Use R1 enclosed in the kit as R1* and R2*. Utiliser R1 du kit comme R1* et R2*.

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: Hb Method: EndPoint Direction Ascend


Unit: g/dL Decimals: 1 Prim. Wave: 546 Sec. Wave: 0
Sample vol.: 3 R1* vol.: 450 R2* vol.: 300 Line limit: 20

Response
Incubation: 1 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 16 Substrate: 0 Upper: 2.5 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0 Full Name: Hemoglobin
Upper: 0 Upper 0 Upper: 25 Print No. : entered by user.

R1* and R2* : refer to §Reagents Preparation / R1* et R2* : voir §Préparation des réactifs

Version : 17/02/2009
BIOLABO REAGENTS 30
www.biolabo.fr IRON / T. I. B. C.
MANUFACTURER: Direct Method (Ferene)
BIOLABO SA,
02160, MAIZY, FRANCE |
IVD : IN VITRO DIAGNOSTIC USE
REF 92108 R1 2 × 125 mL R2 1 × 5 mL R3 1 × 10 mL
TECHNICAL SUPPORT AND ORDERS
REF 92308 R1 1 × 60 mL R2 1 × 30 capsules
Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

MINDRAY BS-300 - Validated

Principle: Performance characteristics:


End point photometric test. Linearity: the assay is linear up to at least 1500 µg/dL
Reaction direction: increase in absorbance. (26 µmol/L)
Detection limit: approximately 11 µg/dL (2 µmol/L)
Reagents preparation :
Iron and T.I.B.C.: use BIOLABO REF 92108 to determine Calibration:
the concentration in specimens. Use standard (vial R3) enclosed in the kit,
R1: Contents of vial R1 is ready for use. BIOLABO-Multicalibrator REF 95015 or any calibrator traceable
to a reference method or material.
R2*: Mix 1 volume of the contents of vial R2 with 5 volumes of
TIBC: Sample = Supernatant
the contents of vial R1. Multiply the obtained result by 3 to take into account the
Use carefully cleaned material with HCL 0.1 N and well rinsed dilution factor (due to the preparation of the supernatant).
with distilled water. Give a special care to the quality of water,
reagents and/or specimens.
Quality Control:
Stability and storage: BIOLABO EXATROL-N (normal values) REF 95010 (10 x
5 mL)
Store at 2-8°C away from light.
BIOLABO EXATROL-P (pathological values) REF 95011
Unopened: Reagents are stable until expiry date stated on the (10 x 5 mL)
label. or any assayed control sera referring to the same method.
Once opened: Reagents are stable for at least 6 months at
2-8° C when free from contamination.
Expected values:
Standard stability (Vial R3): Several weeks (transfer the
requested quantity, recap and store at 2-8° C).
Discard reagents if cloudy or if absorbance of working reagent Serum Iron Concentration
(R1: 50 vol. + R2 : 1 vol.) is > 0.120 at 578 nm. Age (µg/dL) [µmol/L]
Specimen collection and handling: New-born 100-250 17.9 -44.8
Serum or heparinised plasma. Unhemolysed morning Infant 40-100 7.2 - 17.9
specimen. Draw blood before other specimens that require
anticoagulants. Do not use EDTA, Oxalate or citrate Children 50-120 9.0 - 21.5
Serum Iron is stable in specimen for: 4 days at room Men 65-175 11.6 - 31.3
temperature.1 week stored at 2-8°C.
TIBC (*): Use BIOLABO REF 92308 to prepare the Women 50-170 9.0 - 30.4
supernatant. Use the supernatant as sample.
TIBC : See packaging insert REF 92308

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: IRON Method: EndPoint Direction Ascend


Unit: µg/dL Decimals: 0 Prim. Wave: 578 Sec. Wave: 0
Sample vol.(*) : 45 R1 vol. : 250 R2* vol.: 30 Lin. limit: 20

Response
Incubation: 15 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower : 0 Lower 0 Lower: 11 Full Name: IRON
Upper : 0 Upper 0.1 Upper: 1500 Print No. : entered by user.

For more details, see packing insert. Version: 20-02-2010

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
31
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 92111 R1 10 x 15 mL R2 10 x 15 mL Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 REF 92011 R1 1 x 60 mL R2 20 x 3 mL Fax : (33) 03 23 256 256

|
IVD : IN VITRO DIAGNOSTIC USE
REF 92511 R1 10 x 50 mL R2 10 x 50 mL
|
IVD : USAGE IN VITRO

LDH LDH
SFBC modified Method Méthode SFBC Modifiée

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

Calibration: Calibration :
It is recommended to verify the factor (K=16190) with a Il est recommandé de vérifier le facteur (K=16190) à l’aide
multiparametric control traceable to a reference material or d’un sérum de contrôle multiparamétrique raccordé sur une
method. solution ou une méthode de référence.

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: LDH Method: Kinetic Direction Descend


Unit: UI/L Decimals: 0 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 5 R1 vol.: 250 R2 vol.: 0 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 13 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 20 Full Name: LDH
Upper: 0 Upper 0 Upper: 1500 Print No. : entered by user.

Version : 16/02/2009
32
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS REF 98212 R1 2 × 200 mL R2 1 x 5 mL ET COMMANDES
Tel: (33) 03 23 25 15 50 Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 Fax : (33) 03 23 256 256

|
IVD : IN VITRO DIAGNOSTIC USE
|
IVD : USAGE IN VITRO

Magnesium HS-HL Magnésium HS-HL


Calmagite Method Méthode Calmagite

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: MGHL Method: EndPoint Direction Ascend


Unit: mg/dL / mg/L Decimals: 2/1 Prim. Wave: 510 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 0 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 2.5 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0.23 / 2.3 Full Name: Magnesium HL
Upper: 0 Upper 0 Upper: 6.0 / 60.0 Print No. : entered by user.

Version : 17/02/2009
33
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS R1 2 × 250 mL R2 1 x 10 mL ET COMMANDES
Tel: (33) 03 23 25 15 50 Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256
REF 87212 R3 1 × 15 mL R4 1 x 15 mL Fax : (33) 03 23 256 256
R5 1 × 10 mL
|
IVD : IN VITRO DIAGNOSTIC USE
|
IVD : USAGE IN VITRO

Magnesium Magnésium
Calmagite Method Méthode Calmagite

ENGLISH - VALIDATED FRANÇAIS - VALIDE

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: MG Method: EndPoint Direction Ascend


Unit: mg/dL / mg/L Decimals: 2/1 Prim. Wave: 510 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 0 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0.6 Lower 0 Lower: 0.15 / 1.5 Full Name: Magnesium
Upper: 2.5 Upper 0 Upper: 4.0 / 40.0 Print No. : entered by user.

Version : 19/02/2010
34
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 80015 R1 2 x 125 mL R2 1x 5 mL Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 Fax : (33) 03 23 256 256

|
IVD : IN VITRO DIAGNOSTIC USE
|
IVD : USAGE IN VITRO

Phosphorus Phosphore
U.V. Method Méthode U.V.

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: Phosphorus Method: EndPoint Direction Ascend


Unit: mg/dL / mg/L Decimals: 2/1 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 5 R1 vol.: 250 R2 vol.: 0 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 10 Substrate: 0 Upper: 2.5 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0.7 / 7 Full Name: Inorg. Phosph
Upper: 0 Upper 0 Upper: 10 / 100 Print No. : entered by user.

Version : 16/02/2009
35
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 80016 R1 1 x 500 mL R2 1 x 500 mL Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 Fax : (33) 03 23 256 256
R3 1 x 5 mL
|
IVD : IN VITRO DIAGNOSTIC USE
|
IVD : USAGE IN VITRO

T O T AL P R O T E I N S PROTEINES TOTALES
Biuret Method Méthode Biuret

ENGLISH - Validated FRANÇAIS - Validé

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: Tot Prot Method: EndPoint Direction Ascend


Unit: g/dL / g/L Decimals: 2/1 Prim. Wave: 546 Sec. Wave: 0
Sample vol.: 4 R1 vol.: 200 R2 vol.: 200 Line limit: 20

Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 30 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0.2 / 2 Full Name: Tot Prot
Upper: 0 Upper 0.05 Upper: 10.0 / 100 Print No. : entered by user.

Version : 19/02/2010
BIOLABO REAGENTS
www.biolabo.fr PROTEINS U.S. 37
MANUFACTURER : Pyrogallol Red Method
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 97016 R1 2 × 113 mL R2 2 x 12 mL R3 1 x 3 mL IVD : IN VITRO DIAGNOSTIC USE

TECHNICAL SUPPORT AND ORDERS


Tel : (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Mindray BS-300 – Preliminary

Principle: Performances characteristics:


End point photometric test. The assay is linear up to 150 mg/dL in the conditions described
Reaction direction: increase in absorbance. opposite.
Detection limit: approximately 5 mg/dL
Reagents preparation:
Working reagent: Add the contents of vial R2 into vial R1 (or 1 vol of Calibration:
vial R2 + 9 vol of vial R1). Mix swirling to homogenise the working Use Standard enclosed in the kit (vial R3) or any calibrator traceable to
solution. a reference method or material.

Stability and storage: Quality Control:


On receipt, store standard (vial R3) at 2-8° C. Normal or pathological urinary / or CSF controls referring to the same
Store reagents (vial R1 and R2) at 18-25° C, in the original vial and method.
away from light.
Unopened: reagents are stable until expiry date stated on the label. Expected values:
Once reconstituted: Working reagent is stable at least for 1 year when
free from contamination. Urines (micturation): < 14.0 mg/dL
Standard stability R3 : several weeks (transfer the requested quantity,
close the vial and store at 2-8° C).
Discard reagent if cloudy or if absorbance of R1 at 578 nm is < 0.050 24 h Urines
or > 0.600.
at rest < 80 mg/24h
Specimen collection and handling: After intensive exercise < 250 mg/24h
Urines: Micturation or partial collection.
24 h Urines: Freshly collected urines, stored at 2-8° C. No preservative
requested. Centrifuge 10 minutes at 3000 RPM and adjust pH at 7.0. CSF: mg/dL
CSF: Freshly collected and centrifuged before analysis.
Avoid specimen containing blood. Premature 15-130
Newborn 40-120
Stability in Urines: over 1 year at -20° C. < 1 month 20-80
Stability in CSF: up to 72 h at 2-8° C, 6 months at -20° C, indefinitely
at -70° C. > 1 month 15-40

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: US PROTEIN Method: End Point Direction Ascend


Unit: mg/dL Decimals: 0 Prim. Wave: 578 Sec. Wave: 0
Sample vol.: 6 R1 vol.: 300 R2 vol.: 0 Lin. limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 50 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 5 Full Name: US PROTEINS
Upper: 0 Upper 0 Upper: 150 Print No.: entered by user.

For more details, see packing insert.


Version AT 97016 16 06 2006

Manufacturer Use by IVD : In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT : Batch number
BIOLABO REAGENTS 38
www.biolabo.fr TRIGLYCERIDES
MANUFACTURER: GPO Method
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 80019 R1 2 × 50 mL R2 2 x 50 mL R3 1 x 5 mL
IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS REF 87319 R1 10 × 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
MINDRAY BS-300 - Validated
Principle: Performances characteristics:
End point photometric test. Linearity: the assay is linear up to at least 700 mg/dL
Reaction direction: increase in absorbance. (7.9 mmol/L).
Detection limit: approximately 10 mg/dL
Reagents preparation:
Add promptly the contents of vial R2 (Enzymes) into vial R1 Calibration:
(buffer). Use Standard (vial R3) provided in the kit, BIOLABO-
Mix gently and wait for complete dissolution before using Multicalibrator
reagent (approximately 2 minutes). REF 95015 or any calibrator traceable to a reference method
Vial R2 : use a non-sharp instrument to remove aluminium cap. or material.
Mix gently and wait for complete dissolution before using
reagent. Quality Control:
BIOLABO EXATROL-N (normal values) REF 95010 (10 x
Stability and storage: 5 mL)
Store at 2-8° C in the original vial and away from l ight. BIOLABO EXATROL-P (pathological values) REF 95011 (10 x
Unopened: Reagents are stable until expiry date stated on the 5 mL)
label. or any assayed control sera referring to the same method.
Once reconstituted: Working reagent is stable for at least 1
year when free from contamination. Expected values:
Standard stability (vial R3) : Several weeks (transfer the
requested quantity, recap and store at 2-8° C). TRIGLYCERIDES
Discard any reagent if cloudy or if absorbance of working
reagent is > 0.200.at 510 nm. Serum or Plasma mg/dL mmol/L
Recommended values 35-160 0.40 - 1.82
Specimen collection and handling:
Serum or plasma (EDTA or Heparin) fasting > 12 hours.
Separate from blood cells within 2 hours.
Do not use oxalate, fluoride or citrate as anticoagulant.
Triglycerides are stable for:
5 to 7 days at 2-8° C, 3 months at -20° C and many years at
-70° C.
Avoid repeated freezing and thawing.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: TRIGLYCERIDES Method: End Point Direction Ascend


Unit: mg/dL Decimals: 0 Prim. Wave: 510 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 0 Lin. limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 10 Full Name: TRIGLYCERIDES
Upper: 0.2 Upper 0 Upper: 700 Print No.: entered by user.

For more details, see packing insert. 19-02-2010

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
39
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 80221 R1 1 x 125 mL R2 1 x 1,25 mL R3 1 x 31 mL R4 1 x 5 mL Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 Fax : (33) 03 23 256 256

|
IVD : IN VITRO DIAGNOSTIC USE
REF 80321 R1 1 x 500 mL R2 1 x 5 mL R3 1 x 125 mL R4 1 x 10 mL
|
IVD : USAGE IN VITRO

Urea Urée
Colorimetric Method Méthode colorimétrique

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

Reagents Preparation : Préparation des réactifs


R1: working reagent R1 + R2 (see packing insert, R1 : réactif de travail R1 + R2 (voir notice du coffret,
§ Reagents Preparation). § Préparation des réactifs)
R2: content of the vial R3 (1 volume) diluted in R2 : contenu du flacon R3 (1 volume) dilué dans de l’eau
demineralised water (3 volumes). déminéralisée (3 volumes)

Sample Preparation : Préparation de l’échantillon


To increase the linearity from 125mg/dL to 250mg/dL, it is Pour améliorer la linéarité de la réaction, de 1,25g/L à
possible to dilute the sample as follows : 2,5g/L, il est possible de diluer l’échantillon comme indiqué :
- Dilute the sample (1 volume) in NaCl (0.9%) (1 volume). - Diluer l’échantillon (1volume) dans du NaCl à 0,9%
(1 volume).

PARAMETRES DE DOSAGE à 37°C


ASSAY PARAMETERS AT 37°C PARAMETRAGE TESTS
TESTS PROGRAMMING

No. : Automatic Test: UCO Method: EndPoint Direction Ascend


Unit: mg/dL / g/L Decimals: 0/2 Prim. Wave: 578 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 300 Line limit: 20

Response
Incubation: 10 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 2.5 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 10 / 0.1 Full Name: Urea Color
Upper: 0 Upper 0 Upper: 125 / 1.25 Print No. : entered by user.

Version : 17/02/2009
BIOLABO REAGENTS 40
www.biolabo.fr UREA U.V.
MANUFACTURER: Kinetic Method
BIOLABO SA,
02160, MAIZY, FRANCE |
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
Mindray BS-300 - Validated
Principle : Performances characteristics :
2 points rate photometric test. Linearity: the assay is linear up to 300 mg/dL (50 mmol/L)
Reaction direction : decrease in absorbance. Detection limit: approximately 7 mg/dL (1.17 mmol/L)
Reagents preparation : Calibration :
Add promptly the contents of vial R2 (Enzymes-coenzyme) into Use standard (vial R3) enclosed in the kit, BIOLABO-
vial R1 (Buffer). Multicalibrator
Mix gently and wait for complete dissolution before using REF 95015 or any calibrator traceable to a reference method
reagent. (2 minutes) or material.
Vial R2 : use a non-sharp instrument to remove aluminium cap.
Quality Control :
Stability and storage : BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5
Store at 2-8° C in the original vial away from light . mL)
Unopened : Reagents are stable until expiry date stated on the BIOLABO EXATROL-P (pathological values) REF 95011 (10 x
label. 5 mL)
Once opened: Working reagent is stable for at least 1 month or any assayed control sera referring to the same method.
when free from
contamination. Expected values :
Standard stability (vial R3) : several weeks (transfer the Serum
requested quantity or plasma mg/dL mmol/L
recap, and store at 2-8° C).
Discard working reagent if cloudy or if absorbance is < 1.100 In Cord 45-86 7.5-14.3
at 340 nm. Premature 6-54 1.1-8.9
< 1 year 9-41 1.4-6.8
Specimen collection and handling :
Unhemolysed serum or heparinised plasma. Avoid fluoride or Children 11-39 1.8-6.4
ammonium 18-60 years 13-43 2.1-7.1
heparinate as anticoagulants which interfere with the assay. 60-90 years 17-49 2.9-8.2
Urea is stable in serum or plasma for 24 h at room
temperature, several days > 90 years 21-66 3.6-11.1
at 2-8° C, at least 2-3 months at -20° C.
24 h Urines : diluted 1 + 19 with demineralised water before Urines : 26-43 g/24h 0.43-0.71 mol/24h
assay and To calculate Blood Urea Nitrogen (BUN), multiply the value
multiply the obtained result by 20. of Urea (mg/dL) by 0.467.
Urea is stable in Urines for 4 days at 2-8° C.
Add antibacterial agent as Thymol to improve the stability.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: URUV Method: Fixed Time Direction Descend


Unit: mg/dL / g/L Decimals: 0 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 3 R1 vol.: 300 R2 vol.: 0 Lin. limit: 20

Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 10 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 1.1 Lower 0 Lower: 7 / 0.07 Full Name: URUV
Upper: 2.5 Upper 0 Upper: 150 / 1.5 Print No.: entered by user.

For more details, see packing insert. Version : 19-02-2010

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
41
BIOLABO REAGENTS REACTIFS BIOLABO
www.biolabo.fr www.biolabo.fr
MANUFACTURER:
BIOLABO SA, Mindray BS-300 FABRICANT :
BIOLABO SA,
02160, MAIZY, FRANCE 02160, MAIZY, FRANCE
TECHNICAL SUPPORT SUPPORT TECHNIQUE
AND ORDERS ET COMMANDES
Tel: (33) 03 23 25 15 50 REF 99032 R1 8 x 30 mL R2 8 x 30 mL R3 1 x 5 mL Tél : (33) 03 23 25 15 50
Fax: (33) 03 23 256 256 REF 99132 R1 10 x 100 mL R2 10 x 100 mL R3 1 x 5 mL Fax : (33) 03 23 256 256

|
IVD : IN VITRO DIAGNOSTIC USE
|
IVD : USAGE IN VITRO

UREA U.V. HL Hémoglobine


Kinetic Method High Linearity Méthode Cinétique Haute Linéarité

ENGLISH - PRELIMINARY FRANÇAIS - PROPOSITION

REFER TO PACKING INSERT SE REFERER A LA NOTICE DU COFFRET

ASSAY PARAMETERS AT 37°C PARAMETRES DE DOSAGE à 37°C


TESTS PROGRAMMING PARAMETRAGE TESTS

No. : Automatic Test: UHL Method: Fixed Time Direction Descend


Unit: mg/dL / g/L Decimals: 0 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 3 R1* vol.: 300 R2* vol.: 300 Lin. limit: 20

Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 10 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 7 / 0.07 Full Name: Urea UV HL
Upper: 0 Upper 0 Upper: 300 / 3.0 Print No.: entered by user.

R1* and R2*: use R1 enclosed in the kit / R1* et R2* : utiliser le réactif R1 du coffret

Version : 17/02/2009
BIOLABO REAGENTS 42
www.biolabo.fr URIC ACID
MANUFACTURER: Uricase Method
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 80351 R1 6 x 30 mL R2 6 x 30 mL R3 1 x 5 mL
IVD : IN VITRO DIAGNOSTIC USE
REF 80001 R1 2 x 100 mL R2 2 x 100 mL R3 1 x 5 mL
TECHNICAL SUPPORT AND ORDERS
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

MINDRAY BS-300 - Validated

Principle: Performance characteristics:


End point photometric test Linearity: The reaction is linear up to 25 mg/dL (1487.5 µmol/L).
Reaction direction: increase in absorbance Detection limit: approximately 0.3 mg/dL.

Reagents preparation: Calibration:


Add promptly the contents of vial R1 (Enzymes) into vial R2 Use Standard (vial R3) enclosed in the kit,
(Buffer). BIOLABO Multicalibrator REF 95015 or any calibrator traceable
Mix gently until complete dissolution before using reagent to a reference method or material.
(approximately 2 minutes).
Vial R1: Use a non-sharp instrument to remove aluminium cap.

Stability and storage:


Store at 2-8° C and away from light. Quality Control:
Unopened: Reagents are stable until expiry date stated on the
BIOLABO EXATROL-N (normal values) REF 95010 (10 x 5 mL)
label.
Once opened: Working reagent is stable at least for 1 month BIOLABO EXATROL-P (pathological values) REF 95011 (10 x
when free from contamination. 5 mL)
Standard stability (vial R3): Several weeks (transfer requested or any assayed control sera referring to the same method.
quantity, recap and store at 2-8 ° C).
Discard any reagent if cloudy or if absorbance measured at Expected values:
510 nm is > 0.100.
URIC ACID
Specimen collection and handling: Serum or Plasma mg/dl µmol/L
Unhemolysed serum or plasma (heparin or EDTA)
Urines: Dilute 1+9 in demineralised water before assay and Child (*) 2.0-5.5 119-327
multiply the obtained result by 10 or pre-dilute the sample with Men 3.5-7.2 208-428
the instrument. Women(**) 2.6-6.0 155-357
Uric acid is stable in the specimen for: (*) Higher value in newborn.
3 days at room temperature, 1 week at 2-8° C, 6 mon ths frozen (**) Lower during pregnancy.
at -20° C.
Add Na OH to keep urine alkaline and prevent uric acid Urines: 250-750 mg/24h 1.48-4.43 mmol/24h
precipitation.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: Uric Acid Method: EndPoint Direction Ascend


Unit: µmol/L Decimals: 0 Prim. Wave: 510 Sec. Wave: 0
Sample vol.: 5 R1 vol.: 200 R2 vol.: 0 Line limit: 20

Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 18 Full Name: URIC ACID
Upper: 0.1 Upper 0 Upper: 1190 Print No. : entered by user.

For more details, see packing insert. Version : 19-02-2010

Manufacturer Use by IVD : In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT : Batch number
BIOLABO REAGENTS 5
www.biolabo.fr RHEUMATOID FACTOR
MANUFACTURER: Turbidimetric Immunoassay
BIOLABO SA,
02160, MAIZY, FRANCE |
REF RF050E R1 1 x 50 mL R2 1 x 10 mL IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50 REF RF520E R1 5 x 20 mL R2 1 x 20 mL
Fax : (33) 03 23 256 256

MINDRAY BS-300 without Sample Dilution

Principle: Performances characteristics:

Turbidimetric Immunoassay method. The assay is linear up to 500 IU/mL.


Reaction direction: increase in absorbance. Detection limit: approximately 3 IU/mL

Reagents preparation: Calibration:

Liquid reagents, ready for use. To generate standard curve, use ready to use Standard Set
REF RF/CAL SET51 or Standard REF RF/CAL SH1 by
Stability and storage: successive 1:2 dilutions in saline (6 different levels are
recommended). Use saline as zero point.
Store at 2-8° C, away from light (Do not freeze).
Quality Control:
Unopened, reagents are stable until expiry date stated on the
label. Use BIOLABO RF Control REF RF/CONT1 or REF RF/CONT5
Once opened, when free from contamination, reagents (vial R1 or any assayed control serum referring to the same method.
and vial R2) are stable at least for 3 months at 2-8° C, 24 h at
room temperature and 30 days on the board of analysers. Expected values:

Specimen collection and handling: WHO Values: 0-20 IU/mL

Use fresh serum. This range is given as a guide only.


If the test can not be carried out on the same day, the serum Each laboratory should establish its own normal ranges for the
may be stored at 2-8°C for 24 hours. population that it serves.
If stored for a longer period, the sample should be frozen once
only.

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: RF Method: EndPoint Direction Ascend


Unit: IU/mL Decimals: 0 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 17 R1 vol.: 300 R2 vol.: 60 Lin. limit: 20

Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower : 0 Lower 0 Lower: 3 Full Name: RF
Upper : 0 Upper 0 Upper: 500 Print No. : entered by user.

for more details, , see packing insert,


Version AT RF 3rd 11 10 2007

Manufacturer Use by IVD : In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT : Batch number
BIOLABO REAGENTS 3
www.biolabo.fr ASLO
MANUFACTURER: Turbidimetric Immunoassay
BIOLABO SA,
02160, MAIZY, FRANCE |
REF ASLO050E R1 1 x 50 mL R2 1 x 7 mL IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50 REF ASLO620E R1 6 x 20 mL R2 1 x 15 mL
Fax : (33) 03 23 256 256

MINDRAY BS-300 without Sample Dilution

Principle: Calibration:

Turbidimetric Immunoassay method. To generate standard curve, use ready to use Standard Set
Reaction direction: increase in absorbance. REF ASLO/CAL SET41 or Standard REF ASLO/CAL SH1 by
successive 1:2 dilutions in saline (5 different levels are
Reagents preparation: recommended). Use saline as zero point.

Liquid reagents, ready for use. Quality Control:

Stability and storage: USE BIOLABO ASLO Control REF ASLO/CONT1 or


REF ASLO/CONT5 or any assayed control serum referring to
Store at 2-8° C, away from light (Do not freeze). the same method.

Unopened, reagents are stable until expiry date stated on the Expected values:
label.
Once opened, when free from contamination, reagents (vial R1 WHO Values: 0-200 IU/mL
and vial R2) are stable at least for 3 months at 2-8° C, 24 h at
room temperature and 30 days on the board of analysers. These values may vary with many factors (age, season, region).
Each laboratory should establish its own normal ranges for the
Specimen collection and handling: population that it serves.
Use fresh serum.
If the test can not be carried out on the same day, the serum
may be stored at 2-8°C for 48 hours.
If stored for a longer period, the sample should be frozen.

Performances characteristics:

The assay is linear between 12.5 to 400 IU/mL.


Detection limit: approximately 12.5 IU/mL

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No. : Automatic Test: ASLO Method: EndPoint Direction Ascend


Unit: IU/mL Decimals: 1 Prim. Wave: 578 Sec. Wave: 0
Sample vol.: 4 R1 vol.: 300 R2 vol.: 40 Lin. limit: 20

Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower : 0 Lower 0 Lower: 12.5 Full Name: ASLO
Upper : 0 Upper 0 Upper: 400 Print No. : entered by user.

for more details, , see packing insert,


Version AT ASLO 10 10 2007

Manufacturer Use by IVD : In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT : Batch number
BIOLABO REAGENTS 4
www.biolabo.fr CRP
MANUFACTURER: Turbidimetric Immunoassay
BIOLABO SA,
02160, MAIZY, FRANCE |
REF CRP620E R1 6 x 20 mL R2 1 x 10 mL
IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS
REF CRP050E R1 1 x 50 mL R2 1 x 5 mL
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256

MINDRAY BS-300 without Sample Dilution

Principle: Calibration:

Turbidimetric immunoassay. To generate Standard curve, use ready for use Standard Set
Reaction direction: increase in absorbance. REF CRP/CAL SET51 or Standard Super High
REF CRP/CAL SH1 by successive dilutions 1:2 in saline
Reagents preparation: (6 different levels are recommended). Use saline as zero point.

Liquid reagents, ready for use. Quality Control:

Stability and storage: BIOLABO CRP Control Low REF CRP/CONT L1 or


REF CRP/CONT L5.
Store at 2-8° C, away from light (Do not freeze). BIOLABO CRP Control High REF CRP/CONT H1 or
REF CRP/CONT H5 or any assayed control sera referring to the
Unopened reagents are stable until expiry date stated on the same method.
label.
Once opened, when free from contamination, reagents R1 and Expected values:
R2 are stable at least for 3 months at 2-8° C, 24 h at room
temperature and 30 days on the board of analyser. IFCC Value: < 0.5 mg/dL

Specimen collection and handling: These values are applicable only to adults between 20 and
60 years of age
Each laboratory should establish its own normal ranges for the
Use fresh serum. population that it serves.
If the test can not be carried out on the same day, the serum
may be stored at 2-8°C for 48 hours.
If stored for a longer period, the sample should be frozen.

Performance characteristics:

The assay is linear between 0.5 to 22 mg/dL.


Detection limit: approximately 0.5 mg/dL

ASSAY PARAMETERS AT 37°C


PROGRAMMING TESTS

No.: Automatic Test: CRP Method: EndPoint Direction Ascend


Unit: mg/dL Decimals: 1 Prim. Wave: 340 Sec. Wave: 0
Sample vol.: 20 R1 vol.: 333 R2 vol.: 33 Lin. limit: 20

Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0

R1 Blank Mix R Blank Linearity


Lower: 0 Lower 0 Lower: 0.5 Full Name: CRP
Upper: 0 Upper 0 Upper: 22 Print No. : entered by user.

for more details, , see packing insert,


version AT CRP 11 10 2007

Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number