Quality assessment in point-of-care coagulation testing

Area of Science:

• Clinical diagnostics
• Medical devices
• Hematology

Background:

• Point-of-care (POC) testing in hemostasis is rapidly expanding worldwide.
• Applications include operating theaters and monitoring oral anticoagulant therapy using international normalized ratio (INR) devices.
• Quality control and assessment are critical for POC hemostasis devices.

Purpose of the Study:

• To review issues related to internal quality control and external quality assessment for POC hemostasis devices.
• To describe data from external quality assessment (EQA) exercises for POC-INR devices.
• To present the use of split samples comparing POC devices with conventional laboratory methods.

Main Methods:

• Review of quality control and external quality assessment principles for POC hemostasis testing.
• Analysis of data from EQA exercises involving multiple POC-INR device users.
• Comparison of patient samples analyzed by POC devices and conventional laboratory methods using split samples.

Main Results:

• External quality assessment data from various POC-INR devices were analyzed.
• Split sample analysis demonstrated the performance of POC devices against laboratory standards.
• The study highlights the importance of robust quality control measures for POC hemostasis testing.

Conclusions:

• POC hemostasis testing, particularly INR monitoring, requires rigorous quality control and external assessment.
• EQA data and split sample analyses are essential for validating POC device performance.
• Ensuring accuracy and reliability of POC devices is crucial for patient management in anticoagulant therapy.