Produkte/Coagulation/Coag-o-test PT Liquid

Coag-o-test PT Liquid

PROTHROMBIN TIME REAGENT READY TO USE

Cat. No.: coag105  Size: 12 x 4 ml
Cat. No.: coag103  Size: 12 x 2 ml
Cat. No.: coag104  Size:  6 x 2 ml

DIMDI-Reg.-Nr.: DE/CA22/1116-153-IVD

PRODUCT NAME
Coag-o-test PT Liquid

INTENDED USE
(For In Vitro Diagnostic Use Only)
Coag-o-test PT Liquid is a rabbit brain thromboplastin without the necessity to reconstitute it .

SUMMARY AND BACKGROUND
Coag-o-test PT Liquid thromboplastin is a rabbit brain extract, which contains tissue factor, lipids and calcium ions. This reagent is used for determination of Prothrombin Time (PT). The PT according to Quick is a sensitive screening test for the extrinsic coagulation pathway. Coag-o-test PT as a reagent for PT is highly sensitive to vitamin K antagonists, decreased level of factors in extrinsic pathway (factor II, V, VII, and X), hereditary or acquired coagulation disorders and liver failure.
Therefore, the PT with Coag-o-test PT Liquid is used for presurgical screening and monitoring for oral anticoagulant therapy (OAT).

PRINCIPLE
Coag-o-test PT Liquid, as a calcium thromboplastin, when added to patient’s plasma induces the formation of fibrin clot, which is measurable manually, or with optical or mechanical coagulation analysers.

ACTIVE INGREDIENTS
Coag-o-test PT Liquid is a ready to use, tissue thromboplastin from rabbit brain with stabilizers.
Which contains calcium ions and sodium azide as preservative.

PRECAUTIONS

  • Coag-o-test PT Liquid, due to its ingredients should be handled with care, observing the precautions recommended for biohazardous material!
  • The product 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.
  • According to the present knowledge the reagent does not contain any particles, which can spread from animal to human!

PREPARATION
The product does not need any special preparative step. Keep the thromboplastin 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. Using of stirring bar is necessary.

SPECIMENS
Coag-o-test PT Liquid 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 DIA-TIMER
Coag-o-test PT Liquid test is a one-stage PT 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.

  1. Bring the bottle of Coag-o-test PT Liquid thromboplastin to 37°C.
  2. Add 50 μl plasma (control or patient’s) to the test tube.
  3. Incubate plasma at 37°C for 2 minutes.
  4. Add 100 μl Coag-o-test PT Liquid thromboplastin and simultaneously start the timer.
  5. 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 any other coagulometer, please follow the instructions of the manual.

STORAGE AND STABILITY
Coag-o-test PT Liquid reagent in intact vial is stable until the expiration date given on the vial, when stored at 2-8°C. Stability after opening in the original vial: 48 hours at 37°C, 4 days at 18-25 °C, 7 days at 2-8°C. Do not freeze!

EXPECTED RESULTS
Coag-o-test PT Liquid test results can be reported in the following units:

  1. Seconds, which means the observed clotting time.
  2. Ratio, which means the clotting time of the sample divided by the clotting time of the normal plasma pool.
  3. Percentage, which means the proportional part of the normal PT activity, which is calculable from the calibration curve. We recommend to use the master curve enclosed in the box.´
  4. International Normalized Ratio (INR), which means the ratio raised to the power of International Sensitivity Index (ISI).
    The lot and method dependent ISI value is provided on the separated sheet.

The International Committee on Thrombosis Haemostasis (ICTH) and the International Committee for Standardisation in Haematology (ICSH) have recommended the INR as a comparable dimension of PT results.
The normal range that is the second of the prothrombin time at healthy persons is influenced by several factors (age, gender, hematocrit etc.). In general the INR is considered as normal between 0,9-1,3. The pathological range begins at 1,6 INR.

LIMITATIONS
Person installing the reagent must be a trained laboratory professional.

MATERIALS REQUIRED BUT NOT PROVIDED

  • Normal and pathological controls for quality control (Coag-o-trol I-II; Cat. No.: coag118).
  • Optical or mechanical coagulation analyser for measuring.

BIBLIOGRAPHY

  1. Quick AJ: A study of the coagulation defect in haemophilia and in Jaundice. Am J Med Sci; 190:501; 1935.
  2. WHO Expert Committee on Standardisation: WHO Technical Report Series. No.889; 1999.
  3. van den Besselaar AMHP: The significance of the international normalized ratio for oral anticoagulant therapy. JIFCC; 3:146; 1991.
  4. Poller L: Therapeutic ranges for oral anticoagulation in different thromboembolic disorders. Ann Hematol; 64:52; 1992.
  5. Colman RW, Hirsh J: Haemostasis and Thrombosis. 4th. Edition; Lippincott-Williams-Wilikins; Phialdephia; 2001.


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