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Challenges in Routine Implementation and Quality Control of Rapid Diagnostic Tests for Malaria–Rufiji District, Tanzania
Open accessAbstract
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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“However, blood film microscopy is time-consuming and needs significant technical skills, good-quality reagents, and clean slides; thus, its accuracy is of highly variable quality in sub-Saharan African hospitals [7-10].”
From Reliability of rapid diagnostic test for diagnosing peripheral and placental malaria in an area of unstable malaria transmission in Eastern Sudan (2013) · cites this paper as [10]
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Sarrassat, S., Lalou, R., Cissé, M., et al. (2011) · Malaria Journal · doi:10.1186/1475-2875-10-285 · Cited by 2
“In Tanzania, within routine practice, their sensitivity was evaluated between 19% and 86% [25].”
BackgroundRauf, A. (2014) · Journal of Pharmaceutical Research International · doi:10.9734/bjpr/2014/8910 · Cited by 2
“A similar suggestion by caregivers that blood test is for HIV/AIDS and not malaria have been reported also in Uganda and Tanzania [34,35].”
Malaria rapid diagnostic tests : Laboratory aspects in the diagnostic setting
Gillet, P. (2011) · Research Publications (Maastricht University) · doi:10.26481/dis.20110622pg · Cited by 1
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“ral malaria-endemic regions despite some reported cases of its imprecision as early malarial clinical features vary and are nonspecific hence, its sole utilization becomes quite challenging and unreliable (7).”
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“E nos últimos cinco artigos (McMORROW et al, 2008, METZGER et al, 2008, LAURENT et al, 2010, METZGER et al, 2011, ENDESHAW et al, 2012) os testes rápidos não foram considerados confiáveis ou não puderam ser comparados adequadamente à microscopia da gota espessa, demonstrando que a acurácia do teste…”
BackgroundAIMING AT MALARIA ELIMINATION IN ZANZIBAR
Shakely, D. (2015) · Figshare · Cited by 1
INFLUENCE OF HEALTH SYSTEMS IN MALARIA CASE MANAGEMENT AS PART OF MALARIA CONTROL IN
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Konec valky v severnich Cechach: Novy denik
Cornwall, M. (2007) · ePrints Soton (University of Southampton)
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Diagnostic Accuracy of Rapid Diagnostic Kits Test for Diagnosis of Malaria
Zafar, M. A., Khalid, S., & Munir, T. (2021) · Pakistan Journal of Medical and Health Sciences · doi:10.53350/pjmhs2115102826
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Metadata
- 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)
- PMC
- PMC5801444
- 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
- green
- www.ncbi.nlm.nih.gov
- 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 › Health Professions › Medical Laboratory Technology › 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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