Proficiency testing/external quality assurance for the PFA-100(®)

Area of Science:

• Clinical chemistry
• Haematology
• Diagnostic assay development

Background:

• The Platelet Function Analyser-100 (PFA-100®) is a key instrument for primary haemostasis screening.
• External Quality Assurance (EQA) is crucial for maintaining testing quality but faces logistical challenges for platelet function tests.

Purpose of the Study:

• To develop and validate a novel EQA process for PFA-100® testing.
• To overcome logistical hurdles in EQA for platelet function analysis.

Main Methods:

• A new method involving formulated test tubes and participant-collected whole blood was created for local evaluation.
• Multiple EQA exercises were conducted over four years, simulating various haemostasis defects.

Main Results:

• The novel EQA process demonstrated reproducible closure time (CT) results for PFA-100®.
• Coefficients of variation (CVs) were comparable to those using native whole blood.
• Participant interpretations of test results were generally consistent with expectations.

Conclusions:

• A feasible and reproducible EQA process for PFA-100® platelet function testing has been established.
• This method provides a valuable tool for monitoring and enhancing laboratory performance in haemostasis testing.