Reliability of rapid diagnostic tests in diagnosing pregnancy-associated malaria in north-eastern Tanzania

Minja, Daniel TR; Schmiegelow, Christentze; Oesterholt, Mayke; Magistrado, Pamela A; Boström, Stéphanie; John, Davis; Pehrson, Caroline; Andersen, Daniel; Deloron, Philippe; Salanti, Ali; Lemnge, Martha; Luty, Adrian JF; Alifrangis, Michael; Theander, Thor; Lusingu, John PA

doi:10.1186/1475-2875-11-211

Cited by 37Malaria Research and ControlBiosensors and Analytical DetectionClinical Laboratory Practices and Quality Control

Reliability of rapid diagnostic tests in diagnosing pregnancy-associated malaria in north-eastern Tanzania

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Minja, Daniel TR, Schmiegelow, Christentze, Oesterholt, Mayke, Magistrado, Pamela A, Boström, Stéphanie, John, Davis, Pehrson, Caroline, Andersen, Daniel +7 more·2012·Malaria Journal

DOI 10.1186/1475-2875-11-211PMC PMC3459785

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Abstract

BACKGROUND: Accurate diagnosis and prompt treatment of pregnancy-associated malaria (PAM) are key aspects in averting adverse pregnancy outcomes. Microscopy is the gold standard in malaria diagnosis, but it has limited detection and availability. When used appropriately, rapid diagnostic tests (RDTs) could be an ideal diagnostic complement to microscopy, due to their ease of use and adequate sensitivity in detecting even sub-microscopic infections. Polymerase chain reaction (PCR) is even more sensitive, but it is mainly used for research purposes. The accuracy and reliability of RDTs in diagnosing PAM was evaluated using microscopy and PCR. METHODS: A cohort of pregnant women in north-eastern Tanzania was followed throughout pregnancy for detection of plasmodial infection using venous and placental blood samples evaluated by histidine rich protein 2 (HRP-2) and parasite lactate dehydrogenase (pLDH) based RDTs (Parascreen™) or HRP-2 only (Paracheck Pf® and ParaHIT®f), microscopy and nested Plasmodium species diagnostic PCR. RESULTS: From a cohort of 924 pregnant women who completed the follow up, complete RDT and microscopy data was available for 5,555 blood samples and of these 442 samples were analysed by PCR. Of the 5,555 blood samples, 49 ((proportion and 95% confidence interval) 0.9% [0.7 -1.1]) samples were positive by microscopy and 91 (1.6% [1.3-2.0]) by RDT. Forty-six (50.5% [40.5 - 60.6]) and 45 (49.5% [39.4 - 59.5]) of the RDT positive samples were positive and negative by microscopy, respectively, whereas nineteen (42.2% [29.0 - 56.7]) of the microscopy negative, but RDT positive, samples were positive by PCR. Three (0.05% [0.02 - 0.2]) samples were positive by microscopy but negative by RDT. 351 of the 5,461 samples negative by both RDT and microscopy were tested by PCR and found negative. There was no statistically significant difference between the performances of the different RDTs. CONCLUSIONS: Microscopy underestimated the real burden of malaria during pregnancy and RDTs performed better than microscopy in diagnosing PAM. In areas where intermittent preventive treatment during pregnancy may be abandoned due to low and decreasing malaria risk and instead replaced with active case management, screening with RDT is likely to identify most infections in pregnant women and out-performs microscopy as a diagnostic tool.

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There are few published data on the performance of RDT for diagnosing malaria during pregnancy, especially in areas of unstable malaria transmission.
“While RDT have been extensively evaluated in malaria among the non-pregnant population, there are few published data on the performance of RDT for diagnosing malaria during pregnancy, especially in areas of unstable malaria transmission [12-17].”
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 [17]

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Authors: Minja, D. T., Schmiegelow, C., Oesterholt, M., Magistrado, P. A., Boström, S., John, D., Pehrson, C., Andersen, D., Deloron, P., Salanti, A., Lemnge, M., Luty, A. J., Alifrangis, M., Theander, T., & Lusingu, J. P.
Affiliations: University of Copenhagen (DK)
Radboud University Medical Center (NL)
Stockholm University (SE)
Sorbonne Paris Cité (FR)
National Institute for Medical Research (TZ)
Corresponding author: Minja, Daniel TR
ORCID: Minja, Daniel TR
Schmiegelow, Christentze
Pehrson, Caroline
Andersen, Daniel
Deloron, Philippe
Salanti, Ali
Luty, Adrian JF
Alifrangis, Michael
Theander, Thor
Lusingu, John PA
Venue: Malaria Journal
Publisher: Springer Science and Business Media LLC
Published: 2012-06-21
Volume: 11
Issue: 1
Pages: 211-211
ISSN: 1475-2875 (ISSN-L)
DOI: 10.1186/1475-2875-11-211
PMC: PMC3459785
OpenAlex: W2140051057
Cited by: 37
References: 64
Citations by year: 2026: 1 · 2025: 2 · 2023: 1 · 2022: 3 · 2021: 1 · 2020: 4 · 2019: 3 · 2018: 3 · 2017: 4 · 2016: 1 · 2015: 4 · 2014: 2 · 2013: 7 · 2012: 1
FWCI: 4.32
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/2.0 (tdm)
Locations: Malaria Journal (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
IHI Repository (acceptedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
Funders: European Commission (200889)
Radboud Universiteit
Danish International Development Agency
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
Physical Sciences › Engineering › Biomedical Engineering › Biosensors and Analytical Detection
Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Keywords: rapid diagnostic tests, diagnostic accuracy, microscopy, HRP-2, lactate dehydrogenase, Plasmodium falciparum, placental malaria, malaria in pregnancy, northeastern Tanzania, adverse pregnancy outcomes, maternal mortality
MeSH terms: Adolescent, Adult, Antigens, Protozoan, Blood, Diagnostic Tests, Routine, Female, Humans, Malaria, Parasitology, Pregnancy, Pregnancy Complications, Infectious, Prospective Studies, Sensitivity and Specificity, Tanzania, Cohort Studies, Clinical Laboratory Techniques, Young Adult

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Reliability of rapid diagnostic tests in diagnosing pregnancy-associated malaria in north-eastern Tanzania

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