Coag-o-test TT
THROMBIN TIME REAGENT
Cat. No.: coag110 Size: 12 x 3 ml
DIMDI-Reg.-Nr.: DE/CA22/1116-156-IVD
PRODUCT NAME
Coag-o-test TT
INTENDED USE
(For In Vitro Diagnostic Use Only)
Coag-o-test TT is a thrombin reagent for Thrombin Time determinations.
SUMMARY AND BACKGROUND
The Thrombin Time (TT) test is designed for the assessment of fibrin formation. The TT is only effected by factors that interfere with thrombin or fibrinogen. The TT is only elevated in DIC (FDPs interfere with polymerisation), low fibrinogen levels, dysfibrinogemia and heparin (very sensitive). The TT remains normal in deficiencies of factor XIII.
PRINCIPLE
The TT test is performed by adding thrombin to plasma. The added thrombin directly clots fibrinogen.
ACTIVE INGREDIENTS
Coag-o-test TT is a freeze-dried, human thrombin in buffered medium with calcium and stabilizer.
PRECAUTIONS
Coag-o-test TT due to its ingredients should be handled with care, observing the precautions recommended for biohazardous material!
The reagent contains sodium azide. It can form metallic azides, which may be potentially explosive in metal plumbing. Execute proper precaution!
Specimens, samples and all materials coming into contact with them should be handled as if capable of transmitting infection and disposed of with proper precautions.
Do not use the reagent beyond the expiration date printed on the label!
Avoid microbial contamination of the reagent or erroneous results may occur.
Each lot of this reagent tested by the presence of the antibody to HIV, hepatitis C and hepatitis B surface antigen and found to be negative.
All reagents, waste and utilized disposable laboratory equipments should be considered as hazardous waste. Their handling and disposal should be done according to the valid hazardous material processing regulation.
PREPARATION
Coag-o-test TT reagent is dissolved with distilled water.
Amount is indicated on the label. Keep the reagent 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.
SPECIMENS
Coag-o-test TT requires freshly, decalcified plasma. To obtain it, mix nine parts of freshly drawn venous blood with one part trisodium citrate. Mix the blood carefully and centrifuge plasma before testing. Refer to National Committee for Clinical Laboratory Standards (NCCLS) guidelines H3-A3 and H21-A3.
INSTRUCTION FOR USE ON A COAGULOMETER
Coag-o-test TT test is a TT test, which is suitable for manual techniques according to the protocol detailed below and for automated assays according to the instructions outlined in the instrument manual. Duplicate determinations are recommended.
Bring the sufficient volume of Coag-o-test TT reagent to room temperature.
Add 100μl plasma (control or patient’s) to the test tube.
Incubate plasma at 37°C for 2 minutes.
Add 100μl Coag-o-test TT reagent and simultaneously start the timer.
Determine the coagulation time.
Normal and pathological controls are recommended for verified measuring. Each laboratory should establish its own quality control program.
In case of determination by automated coagulometer, please follow the instructions of the manual.
STORAGE AND STABILITY
Coag-o-test TT reagent 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: three days at 22°C, five days at 15°C and seven days at 2-8°C. Do not freeze!
EXPECTED RESULTS
Coag-o-test TT test results can be reported in second, which means the observed clotting time.
The normal range of thrombin time at healthy persons is less than 30 seconds.
LIMITATIONS
Person installing the reagent must be a trained laboratory professional.
MATERIALS REQUIRED BUT NOT PROVIDED
BIBLIOGRAPHY
Latallo ZS: Thrombin clotting assays. In Bang NU, Beller FK, Deutsch E, Mammen EF: Thrombosis and Bleeding Disorders: Theory and Methods. Academic Press, New York; 183; 1971.
