WHO malaria nucleic acid amplification test external quality assessment scheme: results of distribution programmes one to three
Open Access
- 30 March 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Malaria Journal
- Vol. 19 (1), 1-12
- https://doi.org/10.1186/s12936-020-03200-0
Abstract
The World Health Organization (WHO) recommends parasite-based diagnosis of malaria. In recent years, there has been surge in the use of various kinds of nucleic-acid amplification based tests (NAATs) for detection and identification of Plasmodium spp. to support clinical care in high-resource settings and clinical and epidemiological research worldwide. However, these tests are not without challenges, including lack (or limited use) of standards and lack of reproducibility, due in part to variation in protocols amongst laboratories. Therefore, there is a need for rigorous quality control, including a robust external quality assessment (EQA) scheme targeted towards malaria NAATs. To this effect, the WHO Global Malaria Programme worked with the UK National External Quality Assessment Scheme (UK NEQAS) Parasitology and with technical experts to launch a global NAAT EQA scheme in January 2017. Panels of NAAT EQA specimens containing five major species of human-infecting Plasmodium at various parasite concentrations and negative samples were created in lyophilized blood (LB) and dried blood spot (DBS) formats. Two distributions per year were sent, containing five LB and five DBS specimens. Samples were tested and validated by six expert referee laboratories prior to distribution. Between 37 and 45 laboratories participated in each distribution and submitted results using the online submission portal of UK NEQAS. Participants were scored based on their laboratory’s stated capacity to identify Plasmodium species, and individual laboratory reports were sent which included performance comparison with anonymized peers. Analysis of the first three distributions revealed that the factors that most significantly affected performance were sample format (DBS vs LB), species and parasite density, while laboratory location and the reported methodology used (type of nucleic acid extraction, amplification, or DNA vs RNA target) did not significantly affect performance. Referee laboratories performed better than non-referee laboratories. Globally, malaria NAAT assays now inform a range of clinical, epidemiological and research investigations. EQA schemes offer a way for laboratories to assess and improve their performance, which is critical to safeguarding the reliability of data and diagnoses especially in situations where various NAAT methodologies and protocols are in use.Keywords
Funding Information
- Department of Foreign Affairs and Trade, Australian Government
This publication has 34 references indexed in Scilit:
- An innovative tool for moving malaria PCR detection of parasite reservoir into the fieldMalaria Journal, 2013
- Comparative evaluation of published real-time PCR assays for the detection of malaria following MIQE guidelinesMalaria Journal, 2013
- Real-Time Quantitative Reverse Transcription PCR for Monitoring of Blood-Stage Plasmodium falciparum Infections in Malaria Human Challenge TrialsThe American Journal of Tropical Medicine and Hygiene, 2012
- A real-time, quantitative PCR method using hydrolysis probes for the monitoring of Plasmodium falciparum load in experimentally infected human volunteersMalaria Journal, 2011
- Submicroscopic Infection inPlasmodium falciparum–Endemic Populations: A Systematic Review and Meta‐AnalysisThe Journal of Infectious Diseases, 2009
- The MIQE Guidelines: Minimum Information for Publication of Quantitative Real-Time PCR ExperimentsClinical Chemistry, 2009
- Establishment of the 1st World Health Organization International Standard for Plasmodium falciparum DNA for nucleic acid amplification technique (NAT)-based assaysMalaria Journal, 2008
- Detection of Four Plasmodium Species by Genus- and Species-Specific Loop-Mediated Isothermal Amplification for Clinical DiagnosisJournal of Clinical Microbiology, 2007
- Sensitive and Inexpensive Molecular Test for Falciparum Malaria: Detecting Plasmodium falciparum DNA Directly from Heat-Treated Blood by Loop-Mediated Isothermal Amplification,Clinical Chemistry, 2006
- Detection of Four Plasmodium Species in Blood from Humans by 18S rRNA Gene Subunit-Based and Species-Specific Real-Time PCR AssaysJournal of Clinical Microbiology, 2004