Produkte/Coagulation/Coag-o-test PT5

Coag-o-test PT5

PROTHROMBIN TIME REAGENT

Cat. No.: coag100  Size: 10 x 5 ml
Cat. No.: coag101  Size: 5 x 5 ml

DIMDI-Reg.-Nr.: DE/CA22/1116-152-IVD

PRODUCT NAME
Coag-o-test PT5

INTENDED USE
(For In Vitro Diagnostic Use Only)
Coag-o-test PT5 is a rabbit brain thromboplastin with own solvent for Prothrombin Time determinations.

SUMMARY AND BACKGROUND
Coag-o-test PT5 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 PT5 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 PT5 is used for presurgical screening and monitoring for oral anticoagulant therapy (OAT).

PRINCIPLE
Coag-o-test PT5, 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 PT5 is a freeze-dried, tissue thromboplastin from rabbit brain with stabilizers.
Solvent is a buffer, which contains calcium ions and sodium azide as preservative.

PRECAUTIONS

  • Coag-o-test PT5, due to its ingredients should be handled with care, observing the precautions recommended for biohazardous material!
  • The solvent 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!
  • 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 PT5 reagent is dissolved with the entire contents of one vial Solvent of the same lot. 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 PT5 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 PT5 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 sufficient volume of Coag-o-test PT5 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 Dia-PT 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 PT5 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: 8 hours at 37°C, 1 day at 22°C, 2 days at 16°C and 12 days at 2-8°C. Do not freeze!

EXPECTED RESULTS
Coag-o-test PT5 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.

  img/page/needfull/Tabelle-unten1.jpg

img/page/needfull/ce-zeichen.gif Hersteller:

img/page/needfull/bgt-logo-neu.gif
Von-Langen-Weg 10
D-48565 Steinfurt
Tel.: 02551/4090  Fax.: 02551/1298
Web: www.biogentechnologies.de



 
  © 2006-2017 by Guenter Keul GmbH - www.keul.de  
Duales System interseroh  
EN ISO 13485:2012
zertifiziertes System