Products/Coagulation/Cal-o-trol COAG
Cal-o-trol COAGCALIBRATOR PLASMA Cat. No.: coag119 Size: 12 x 1 ml DIMDI-Reg.-Nr.: DE/CA22/1116-162-IVD PRODUCT NAME
Cal-o-trol COAG INTENDED USE
(For In Vitro Diagnostic Use Only)
Cal-o-trol COAG is intended for calibration of haemostasis screening test SUMMARY AND BACKGROUND
The PT test results can be reported in percentage, which means the proportional part of the normal PT activity (theoretical 100%), which is calculable from the calibration curve. The percentage depends on the applied lot of the thromboplastin and calibration material.
Therefore the percentage is not considered as a reported form of the result proper for the standardisation. It is possible to use the same calibration curve as long as the same lot is in use. ACTIVE INGREDIENTS
The Cal-o-trol COAG is freeze-dried, pooled human plasma with stabilizer. PRECAUTIONS Cal-o-trol COAG due to its ingredients should be handled with care, observing the precautions recommended for biohazardous material!´ Do not use the calibrator beyond the expiration date printed on the label! Avoid microbial contamination of the calibrator or erroneous results may occur. Each donor unit used in the preparation of this calibrator tested by the presence of the antibody to HIV, hepatitis C and hepatitis B surface antigen and found to be negative.
PREPARATION
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
Follow the manual carefully of concerned coagulometer. Perform the calibration with this calibrator material according to the prescription.
Theoretical background: The different calibration plasma manufactured by different companies may provide different prothrombin activity and fibrinogen concentration due to activity loss during the processing. STORAGE AND STABILITY
Cal-o-trol COAG in intact vial is stable until the expiration date given on the vial, when stored at 2-8°C. Stability after reconstitution in the original vial: four hours at 22°C. EXPECTED RESULTS
The calibrator values for PT may vary from lot to lot. See the specific values in the separated sheet. MATERIALS REQUIRED BUT NOT PROVIDED Prothrombin time reagent to calibrate (Coag-o-test PT5; Cat. No.: coag100, coag101; Coag-o-test PT10; Cat. No.: coag102) Imidazol buffer for dilution (Coag-o-test IMIDAZOL,Cat. No.: coag115) Fibrinogen reagent (Coag-o-test FIB; Cat. No.: coag111,coag112) Normal and pathological controls for quality control (Coag-o-trol I-II; Cat. No.: coag118).
BIBLIOGRAPHY WHO Expert Committee on Standardisation: WHO Technical Report Series. No.889; 1999.
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