ArticleMalaria journal2015
Quality assurance of malaria rapid diagnostic tests used for routine patient care in rural Tanzania: microscopy versus real-time polymerase chain reaction.
Article in Malaria journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed, 12 citations in OpenAlex.
- Prototype Positive Control Wells for Malaria Rapid Diagnostic Tests: Prospective Evaluation of Implementation Among Health Workers in Lao People's Democratic Republic and Uganda.The American journal of tropical medicine and hygiene · 2017Trial
- When Diagnosis Meets Reality: Operational Performance of Routine Malaria Diagnostics Against Molecular Evidence in Southwestern Saudi Arabia.Journal of tropical medicine · 2026Article
- AIDMAN: An AI-based object detection system for malaria diagnosis from smartphone thin-blood-smear images.Patterns (New York, N.Y.) · 2023Article
- Malaria diagnostic methods with the elimination goal in view.Parasitology research · 2022Review
- Article
- Deep Learning Based Automatic Malaria Parasite Detection from Blood Smear and its Smartphone Based Application.Diagnostics (Basel, Switzerland) · 2020Article
- Article
- External quality assessment in resource-limited countries.Biochemia medica · 2017Article
- Recombinant human G6PD for quality control and quality assurance of novel point-of-care diagnostics for G6PD deficiency.PloS one · 2017Article
- The development of malaria diagnostic techniques: a review of the approaches with focus on dielectrophoretic and magnetophoretic methods.Malaria journal · 2016Review
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Authors and funding
8 authors at 3 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe World Health Organization (WHO) recommends parasitologic confirmation of suspected malaria cases before treatment. Due to the limited availability of quality microscopy services, this recommendation has become scalable following increased use of antigen-detecting malaria rapid diagnostic tests (RDTs) in many malaria-endemic countries. This study was carried out to monitor quality of RDT performance in selected health facilities using two quality assurance (QA) methods: reference microscopy and detection of parasite DNA by real-time quantitative polymerase chain reaction (qPCR) on dried blood spots (DBS).
methodsBlood samples for QA were collected from patients undergoing RDT for diagnostic confirmation of malaria during two to three consecutive days per month in 12 health facilities in rural Tanzania. Stained blood smears (BS) were first examined at the district hospitals (BS1) and then at a reference laboratory (BS2). Discordant BS1 and BS2 results prompted a third examination. Molecular analysis was carried out at the Ifakara Health Institute laboratory in Bagamoyo.
resultsMalaria RDTs had a higher positivity rate (6.5%) than qPCR (4.2%) or microscopy (2.9% for BS1 and 2.5% for BS2). Poor correlation was observed between RDT and BS results: BS1 (K = 0.5), BS2 (K = 0.43) and qPCR (K = 0.45), challenging the utility of these tests for RDT QA. In addition, many challenges related to qPCR processing were recorded and long delays in obtaining QA test results for both microscopy and qPCR.
conclusionsOverall there was limited agreement among the three diagnostic approaches and neither microscopy nor qPCR appear to be good QA options for RDTs under field conditions.
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