BIOLABO

! www.biolabo.fr BIO-CK APTT Kaolin

MANUFACTURER: Reagent for the determination of activated partial thromboplastin time (APTT) in human plasmas
BIOLABO S.A.S
Les Hautes Rives REF 13560 R1 6 x 3 mL
! ! 02160, Maizy, France!
REF 13570 R1 6 x 10 mL

|
TECHNICAL SUPPORT AND ORDERS IVD
Tel: (33) 03 23 25 15 50
Made In France
support@biolabo.fr I: corresponds to significant modifications!
Latest revision: www.biolabo.fr

!
I INTENDED USE I REAGENTS PREPARATION
Reagent for chronometric determination of activated partial Vial R1:
thromboplastin time (APTT) in human plasmas to investigate intrinsec Reconstitute immediately with the volume of demineralized water
coagulation pathway except platelets and to monitor heparin therapy. indicated.
Laboratory professional use (manual or automated method).
Mix gently until complete dissolution
GENERALITIES (1)
STABILITY AND STORAGE
BIO-CK Reagent is a basic coagulation screening test, useful to
Stored away from light, well caped in the original vial at 2-8°C, and
investigate the intrinsic coagulation pathway (factors XII, XI, IX, VIII, X,
used as described, reagents are stable:
V, II and I) except the platelets.
Unopened:
The main application of the APTT is to monitor heparin therapy. · Until expiry date stated on the label of the kit
APTT is also used to detect congenital and acquired deficiencies Once opened:
related to the factors mentioned above. · Reconstitute immediately the contents of vial R1.
Prolonged APTT may require further investigations related to congenital · Transfer requested quantity, well recap vials and store at 2-8°C
or acquired deficiencies. · Working reagent is stable for 30 days at 2-8°C
Don’t use working reagent after expiry date.
PRINCIPLE (4)
SPECIMEN COLLECTION AND HANDLING (1) (7)
The BIO CK reagent contains a standardised amount of cephalin
· Careful venepuncture:
(platelet substitute) and a factor XII activator (Kaolin). The reactional
· Blood/anticoagulant ratio: 4.5 mL of blood for 0.5 mL of trisodium
mixture in contact with CaCl2 solution 0,025M involves the
citrate 2 H2O 0.109 M.
recalcification of the plasma and the start of clotting reaction. The use of
· Avoid blood drawing with a syringe that could result in the formation
Kaolin minimizes reading time and optimizes the optical detection. of micro-clots.
· Centrifuge for 10 minutes at 2500 g as soon as possible and run the
REAGENTS (3) assay within 3 hours following the blood collection.
R1 BIO-CK Freeze dried Reagent · Use plastic disposable test tubes to store plasmas refrigerated before
testing.
Cephalin (Rabbit cerebral tissues) · Patient’s specimen on heparin therapy: centrifuge and run the assay
within 1 hour following the blood collection.
Kaolin
· Simultaneously prepare a pool of at least 6 freshly drawn normal
According to 1272/2008 regulation, this reagent is not classified as plasmas as reference.
dangerous.
LIMITS (1) (2) (4) (5)
SAFETY CAUTIONS
· Traumatic venepuncture may contaminate specimen with tissue
· Refer to current Material Safety Data Sheet available on request or on thromboplastin and shorten APTT
www.biolabo.fr · A difficult draw may also interfere with PTT used for heparin
· Verify the integrity of the contents before use. monitoring by neutralizing the heparin effect in sample due to release
· Waste disposal: Respect legislation in force in the country. of Platelets Factor 4 (PF4).
· All specimens or reagents of biological origin should be handled as · Heparin, depending on its origin and composition (calcium or sodium
potentially infectious. Respect legislation in force in the country. salt) has a different influence on the sensitivity of reagent.
Any serious incident that has occurred in connection with the device is · Mishrahi and al. indicate an easy procedure to determine the
notified to the manufacturer and the competent authority of the Member sensitivity of the method used in each laboratory and to inform the
State in which the user and/or patient is based. clinician in order to optimize the posology.
For a more comprehensive review of factors affecting this assay refer to
MATERIAL REQUIRED BUT NOT PROVIDED the publication of Young D.S.
1. Medical analysis laboratory equipment
2. Automated or semi-automated coagulation analyzer
3. Demineralised water for preparation of reagent
4. REF 13565: Calcium chloride 0.025 M

APTTK_220E_IFU_13560-13570_V03_20231214
CALIBRATION (4) REFERENCE INTERVALS (1) (5) (6)
Results are method dependent. Reference range varies with reagent-instrument combinations and with
The validity of the result depends on the time counting, the respect of local conditions (population…).
reagent/specimen ratio and temperature. In general: lower limit of normal 20-25 sec, upper limit < 35 sec
Reference plasma time: Use normal human plasmas collected from Therefore, each laboratory should determine its reference intervals on
healthy individual, either men or women aged from 18 to 55, not taking a panel of normal plasmas.
any medication and giving blood voluntarily.
In this case, generally, a value is considered as normal if within mean
value +/- 2 standards deviations (+/-2SD).
QUALITY CONTROL For example, 58 normal plasmas have been tested on SOLEA 100:
REF 13961 Control Plasmas Level 1 6 X 1 mL The observed mean is 31.1 sec and standard deviation 1.6 sec
The APTT is normally prolonged in new-borns/infant.
REF 13962 Control Plasmas Level 2 6 X 1 mL
The APTT gradually decreases into adult range by 6 months
REF 13963 Control Plasmas Level 3 6 X 1 mL
Or PROCEDURE
REF 13971 Coatrol 1 6 x 1 mL Manual method on semi-automate BIO SOLEA2, BIO SOLEA4
REF 13972 Coatrol 2 6 x 1 mL Pre-warm Calcium chloride 0.025 M REF 13565 at 37°C
· External quality control program. Well homogenised Reagent R1 0.1 mL
It is recommended to control in the following cases: Specimen (Controls, Reference, Patients) 0.1 mL
· At least once a run
Mix, incubate exactly for 3 minutes at 37°C.
· At least once within 24 hours
· When changing vial of reagent REF 13565 : CaCl2 0.025 M 0.1 mL
· After maintenance operations on the instrument The automatic Countdown timer will start immediately after CaCl2
If control is out of range, apply following actions: addition and stop when the clot is formed.
1. Prepare a fresh control serum and repeat the test
Automated Procedure:
2. If control is still out of range, use a new vial of fresh calibrator
3. If control is still out of range, use a new vial of reagent and reassay Full detailed applications available on request.
If control is still out of range, please contact BIOLABO technical Notes:
support or your local Agent. 1. Performances have been validated on SOLEA100 and
Thrombolyzer Compact X.
I PERFORMANCES 2. With manual procedure performances must be validated by user.

On automatic analyser Thrombolyzer Compact X at 37°C. CALCULATION (5)

Precision: Results may be expressed as follows:
Within run Between run · In seconds (Patient time and Reference plasma time)
Level 1 Level 2 Level 3 Level 1 Level 2 Level 3
N = 20 N = 20 · In ratio (Patient time/Reference plasma time)
Mean (sec.) 34.8 50.2 65.7 Mean (sec.) 36.6 55.8 62.4
Note: Reference plasma time: see § Calibration
S.D. (sec.) 0.44 1.48 0.77 S.D. (sec.) 0.92 2.42 2.00
C.V. % 1.3 2.9 1.2 C.V. % 2.5 4.3 3.2
REFERENCES
On automatic analyser SOLEA 100 at 37°C: (1) Clinical Guide to Laboratory Test, 4th Ed., N.W. TIETZ (2006) p.46-47
(2) YOUNG D.S., Effect of Drugs on Clinical laboratory Tests, 4th Ed. (1995)
Precision:
p.3-447 à 3-448
Within run Between run (3) Bell W.N., Alton H.G., Nature, 1954, 174, 880-881.
Level 1 Level 2 Level 3 Level 1 Level 2 Level 3
N = 20 N = 20 (4) Struver G.P., Bittner D.L. Am. J. Clin. Path. 1962, 38, 473-481).
Mean (sec.) 34 51 62 Mean (sec.) 35 53 60 (5) Misrahi N., Manet L., Conard J., Samama M., Act. Pharm. Biol. Clin. 1981,
S.D. (sec.) 0.32 0.54 0.46 S.D. (sec.) 1.02 1.97 2.65 1, 81-85.
(6) LEVIN HILLMAN C.R., LUSHER J.M.: “Determining the sensitivity of
C.V. % 0.9 1.1 0.7 C.V. % 2.9 3.7 4.4
coagulation screening reagents: a simplified method”. Lab. Med., 13, 3, 162-
Comparison with commercially available reagent (same method): 165, 1982
(7) “Etude des différents paramètres intervenant dans les variables
191 plasmas located between 21 sec and 59 sec were tested: préanalytiques (revue de littérature) ». Sang Thromb. Vaiss., 10, p.5-18
y = 0.8749 x + 2.5946 r= 0.9316 (1998)

Interferences:
Turbidity No interference up to 0.543 abs
Total Bilirubin Positive interference from 143 µmol/L
Hemoglobin No interference up to 261 µmol/L
Other substances may interfere with the results (see § Limits)
Onboard stability:
30 days when kept 8 hours per days onboard (15-25°C) and remaining
time at 2-8°C

!
IVD H2O !
Manufacturer Expiry date In vitro diagnostic Storage temperature Dematerialized water Biological risk

REF LOT ®
Product Reference See Insert Batch number Store away from light Sufficient for Dilute with

APTTK_220E_IFU_13560-13570_V03_20231214