CONTROL PLASMAS FOR COAGULATION TESTS
Cat. No.: coag118 Size: 20 x 1 ml
DIMDI Reg.-Nr.: DE/CA22/1116-21-IVD
(For In Vitro Diagnostic Use Only)
Coag-o-trol I-II kit is intended for normal and abnormal quality control for the following haemostasis screening tests: prothrombin time (PT), activated partial thromboplastin time´(APTT), fibrinogen and thrombin time (TT).
It does not provide as control for accuracy!
SUMMARY AND BACKGROUND
The performance of daily quality control (QC) of haemostasis screening tests is highly recommended for security reasons. The industrial QC materials contain preservatives, stabilizers for lyophilisation, which distort their original biological nature. For this reason they serve to check the repeatability and reproducibility of the measuring system.
To check the accuracy of the reported result join and perform external quality assurance program in regular intervals.
The Coag-o-trol I-II are freeze-dried, pooled human plasma with stabilizer. The Coag-o-trol II is a modified form of the normal Coag-o-trol I, imitating pathological condition of ill patients.
Coag-o-trol I-II due to its ingredients should be handled with care, observing the precautions recommended for biohazardous material!
Do not use controls beyond the expiration date printed on the label!
Avoid microbial contamination of controls or erroneous results may occur.
Eachl lot of these controls tested by the presence of the antibody to HIV, hepatitis C and hepatitis B surface antigen and found to be negative.
The reagent is dissolved with distilled water (1ml). Keep it at 18-25°C for 30 minutes. Swirl the vial gently before use and do not shake. Avoid the contact of fluid with the stopper.
INSTRUCTION FOR USE
The Coag-o-trol I-II are to be used as that of patients’ plasmas as investigated with haemostasis screening tests.
Compare the measured value with the declared one on the separated sheet. The computed result has to be inside of the reference range declared.
The get the exact mean is not obligatory.
STORAGE AND STABILITY
Coag-o-trol I-II in intact vial is stable until the expiration date given on the vial, when stored at 2-8°C. Stability after reconstitution in the originalvial: four hours at 22° C.
The control ranges for each of the parameters may vary from lot to lot. See the specific ranges in the separated sheet.
MATERIALS REQUIRED BUT NOT PROVIDED
Coag-o-trol I-II are recommended to control the following haemostasis screening tests:
Prothrombin time (Coag-o-test PT10; Cat. No.: coag102; Coag-o-test PT15; Cat. No.: coag100)
Activated partial thromboplastin time (Coag-o-test
PTT; Cat. No.: coag106, coag107)
FIB; Cat. No.: coag111, coag112)
Thrombin time test (Coag-o-test
TT; Cat. No.: coag110)
WHO Expert Committee on Standardisation: WHO Technical Report Series. No.889; 1999.