WHO external quality assurance scheme for malaria nucleic acid amplification testing. Operational manual

Nucleic-acid amplification (NAA)-based assays are increasingly being used in the context of malaria epidemiological surveys and research, particularly as diagnostic endpoints in clinical trials of vaccine and drug candidates. New methods are also being developed for various applications, including tools to be used in the context of malaria elimination efforts. Because NAA-based tests (NAATs) have superior sensitivity compared to microscopy and rapid diagnostic tests (RDTs), they are particularly useful for detecting low-density (<100 parasites/μL) infections, which are often asymptomatic but contribute to malaria transmission.

The purpose of the WHO malaria NAAT EQA scheme is to offer an independent and periodic means for clinical, reference and research laboratories to verify the quality of their NAA-based malaria diagnostic methods and to monitor performance over time.