Cited by 127Malaria Research and ControlClinical Laboratory Practices and Quality ControlPharmaceutical Quality and Counterfeiting

Challenges in Routine Implementation and Quality Control of Rapid Diagnostic Tests for Malaria–Rufiji District, Tanzania

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McMorrow, Meredith L., Masanja, M. Irene, Abdulla, Salim M. K., Kahigwa, Elizeus, Kachur, S. Patrick·2008·The American Journal of Tropical Medicine and Hygiene

Abstract

Rapid diagnostic tests (RDTs) represent an alternative to microscopy for malaria diagnosis and have shown high sensitivity and specificity in a variety of study settings. Current World Health Organization (WHO) guidelines for quality control of RDTs provide detailed instructions on pre-field testing, but offer little guidance for quality assurance once RDTs are deployed in health facilities. From September 2006 to April 2007, we introduced a histidine-rich protein II (HRP2)-based RDT (Paracheck) for suspected malaria cases five years of age and older in nine health facilities in Rufiji District, Tanzania, to assess sensitivity and specificity of RDTs in routine use at rural health facilities. Thick blood smears were collected for all patients tested with RDTs and stained and read by laboratory personnel in each facility. Thick smears were subsequently reviewed by a reference microscopist to determine RDT sensitivity and specificity. In all nine health facilities, there were significant problems with the quality of staining and microscopy. Sensitivity and specificity of RDTs were difficult to assess given the poor quality of routine blood smear staining. Mean operational sensitivity of RDTs based on reference microscopy was 64.8%, but varied greatly by health facility, range 18.8–85.9%. Sensitivity of RDTs increased with increasing parasite density. Specificity remained high at 87.8% despite relatively poor slide quality. Institution of quality control of RDTs based on poor quality blood smear staining may impede reliable measurement of sensitivity and specificity and undermine confidence in the new diagnostic. There is an urgent need for the development of alternative quality control procedures for rapid diagnostic tests that can be performed at the facility level.

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Crossref · 10.4269/ajtmh.2008.79.385

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Authors
McMorrow, M. L., Masanja, M. I., Abdulla, S. M. K., Kahigwa, E., & Kachur, S. P.
Affiliations
  • Ifakara Health Institute (TZ)
  • Malaria Branch, Division of Parasitic Diseases, National Center for Zoonotic Vector-borne and Enteric Diseases, US Centers for Disease Control and Prevention; Ifakara Health Research and Development Centre, Dares-Salaam, Tanzania
Corresponding author
McMorrow, Meredith L.
Venue
The American Journal of Tropical Medicine and Hygiene
Published
2008-09
Volume
79
Issue
3
Pages
385-390
ISSN
0002-9637 (ISSN-L)
OpenAlex
W4297888972
Cited by
127
References
15
Citations by year
2026: 1 · 2025: 3 · 2024: 2 · 2022: 2 · 2021: 4 · 2020: 4 · 2019: 5 · 2018: 5 · 2017: 6 · 2016: 8 · 2015: 10 · 2014: 12 · 2013: 16 · 2012: 10
FWCI
12.58
Type
journal article
Language
en
Open access
Locations
  • American Journal of Tropical Medicine and Hygiene (publishedVersion)
  • PubMed (publishedVersion)
  • IHI Repository (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • PubMed
Funders
National Institutes of Health (CC999999)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
Keywords
rapid diagnostic tests, malaria diagnosis, quality control, sensitivity and specificity, microscopy, parasite density, rural health facilities, Rufiji District
MeSH terms
Adult, Child, Child, Preschool, Humans, Infant, Malaria, Quality Control, Reagent Kits, Diagnostic, Sensitivity and Specificity, Tanzania, Time Factors

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