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Applications Mindray BS-300 en 06-07-2010
Applications Mindray BS-300 en 06-07-2010
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:
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 25 15 Substrate: 0 Upper: 0 Ratio: 0
Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number
BIOLABO REAGENTS 04
www.biolabo.fr ALBUMIN
MANUFACTURER: BCG Method
BIOLABO SA,
02160, MAIZY, FRANCE |
REF 80002 R1 2 x 200 mL R2 1x 5 mL
IVD : IN VITRO DIAGNOSTIC USE
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50
Fax : (33) 03 23 256 256
Principle: 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:
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 15 Substrate: 0 Upper: 5 Ratio: 0
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 50 Substrate: 0 Upper: 0 Ratio: 0
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
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 40
Reaction: 0 50 Substrate: 0 Upper: 0 Ratio: 3
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
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 5 15 Substrate: 0 Upper: 0 Ratio: 0
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
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.
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 15 Substrate: 0.85 Upper: 0 Ratio: 0
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.
Response
Incubation: 5 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 50 Substrate: 0 Upper: 0 Ratio: 0
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.
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 5 20 Substrate: 0 Upper: 0 Ratio: 0
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
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 11 Substrate: 0 Upper: 0 Ratio: 0
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
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 2 -- 15 Substrate: 0.85 Upper: 0 Ratio: 0
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
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 20 Substrate: 0 Upper: 0 Ratio: 0
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
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)
Response
Incubation: 25 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0
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
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)
Response
Incubation: 5 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 5 Substrate: 0 Upper: 0 Ratio: 0
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
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”.
Response
Incubation: 5 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 15 Substrate: 0 Upper: 0 Ratio: 0
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
Response
Incubation: 1 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 2.5 Ratio: 0
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
Response
Incubation: 0 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 5 Substrate: 0 Upper: 2.5 Ratio: 0
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
Response
Incubation: 0 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 2.5 Ratio: 0
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
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.
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.
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 20 Substrate: 0 Upper: 0 Ratio: 0
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
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:
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).
Response
Incubation: 25 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0
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
Calibration: Calibration :
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.
Response
Incubation: 25 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0
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.
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 25 25 Substrate: 0 Upper: 0 Ratio: 0
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
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.
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 10 25 Substrate: 0 Upper: 0 Ratio: 0
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
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 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.
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
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.
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 10 Substrate: 0 Upper: 0 Ratio: 0
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.
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:
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 10
Reaction: 3 13 Substrate: 0 Upper: 0 Ratio: 20
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
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.
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 18 Substrate: 0 Upper: 0 Ratio: 0
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.
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 0 Ratio: 0
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)
Use R1 enclosed in the kit as R1* and R2*. Utiliser R1 du kit comme R1* et R2*.
Response
Incubation: 1 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 16 Substrate: 0 Upper: 2.5 Ratio: 0
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
Response
Incubation: 15 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0
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
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.
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 13 Substrate: 0 Upper: 0 Ratio: 0
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
Response
Incubation: 0 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 2.5 Ratio: 0
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
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 0 Ratio: 0
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.
Response
Incubation: 0 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 10 Substrate: 0 Upper: 2.5 Ratio: 0
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
Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 30 Substrate: 0 Upper: 0 Ratio: 0
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
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 50 Substrate: 0 Upper: 0 Ratio: 0
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.
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 0 Ratio: 0
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
Response
Incubation: 10 Antigen Check: no Lower: -2.5 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 2.5 Ratio: 0
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.
Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 10 Substrate: 0 Upper: 0 Ratio: 0
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
Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 3 10 Substrate: 0 Upper: 0 Ratio: 0
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
Response
Incubation: 0 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: 0 25 Substrate: 0 Upper: 0 Ratio: 0
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
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:
Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0
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
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.
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:
Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0
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
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.
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:
Response
Incubation: 1 Antigen Check: no Lower: 0 Volume S.: 0
Reaction: -1 25 Substrate: 0 Upper: 0 Ratio: 0
Manufacturer Use by IVD: In vitro diagnostic Temperature limitation REF: Catalogue number See insert LOT: Batch number