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Standardization of the APTT test. Current status
Insights
Standardizing the partial thromboplastin time (PTT) test improves reliability in detecting clotting defects and managing anticoagulation. A human brain phospholipid preparation (71/25) serves as a key reference material for PTT testing.
Area of Science:
- Hematology
- Clinical Chemistry
- Coagulation Diagnostics
Background:
- The partial thromboplastin time (PTT) is a common coagulation test for assessing intrinsic clotting system defects.
- Current PTT testing involves variable reagents and techniques, highlighting the need for standardization.
- Key PTT applications include screening for bleeding disorders, monitoring heparin therapy, and managing oral anticoagulant treatment.
Purpose of the Study:
- To address the need for a standardized reference preparation for the partial thromboplastin time (PTT) test.
- To evaluate the reliability of a proposed international reference material for PTT testing.
Main Methods:
- Preparation of a large batch of lyophilized human brain phospholipid (71/25) as a provisional international reference material.
- Calibration of secondary reference preparations using the primary master preparation (71/25).
- Conducting collaborative studies to compare the standardized PTT extract with commercial extracts.
Main Results:
- Collaborative studies demonstrated enhanced reliability of the standardized PTT extract compared to commercial alternatives.
- The reference preparation (71/25) proved effective in calibrating secondary materials for widespread use.
- Results indicated improved consistency across different PTT testing applications.
Conclusions:
- The provisional international reference preparation (71/25) has shown significant promise for standardizing PTT testing.
- These findings suggest the potential to establish an international standard for the activated partial thromboplastin time (APTT).
- Standardization of PTT reagents and techniques is crucial for accurate coagulation diagnostics.
Abstract:
The partial thromboplastin time (PTT) which is used as an overall measure of the intrinsic clotting system, is the commonest coagulation test employed in routine laboratories apart from the prothrombin time. The main functions of the test are: - 1. to screen intrinsic coagulation defects; 2. to control heparin administration; 3. in the control of oral anticoagulant treatment. Many different preparations of phospholipid of human, animal and vegetable origin are used as PTT reagents. In addition, different activators, incubation times, concentrations of calcium chloride and test dilutions of plasma and phospholipid are recommended for routine laboratory use. The need to standardise both reagents and technique has been emphasised in many reports. To meet the need for a reference preparation for the PTT test, a large batch of phospholipid material of human brain origin, designated 71/25, was prepared in the National (UK) Reference Laboratory in lyophilised form in 1971 and proposed as a provisional international reference material. This primary master preparation has been used to calibrate subsequent batches of secondary reference preparations distributed to hospitals in the UK and overseas. Results of a number of collaborative studies have demonstrated the greater reliability of the standardised PTT extract compared with commercial extracts used at the same centres in the three aspects of PTT testing. The conclusion to be drawn from these extensive studies of the laboratory and clinical application of the provisional international reference preparation (71/25) is that we may now be in a position to define an acceptable international standard for the APTT.
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