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Open Access Highly Accessed Research

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

Daniel TR Minja12*, Christentze Schmiegelow2, Mayke Oesterholt3, Pamela A Magistrado12, Stéphanie Boström7, Davis John4, Caroline Pehrson2, Daniel Andersen2, Philippe Deloron56, Ali Salanti2, Martha Lemnge1, Adrian JF Luty38, Michael Alifrangis2, Thor Theander2 and John PA Lusingu12

Author Affiliations

1 National Institute for Medical Research, Tanga Centre, Tanga, Tanzania

2 Centre for Medical Parasitology, Department of International Health, Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital, Copenhagen, Denmark

3 Department of Medical Microbiology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

4 Kilimanjaro Christian Medical Centre, Kilimanjaro, Tanzania

5 Institut de Recherche Pour le Développement (IRD), UMR 216 Mère et enfant face aux infections tropicales, Paris, France

6 Faculté de Pharmacie, Université Paris Descartes, Sorbonne Paris Cité, France

7 Department of Immunology, Wenner-Gren Institute, Stockholm University, Stockholm, Sweden

8 Present address: IRD, UMR 216 Mère et enfant face aux infections tropicales, Paris, France

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Malaria Journal 2012, 11:211  doi:10.1186/1475-2875-11-211

Published: 21 June 2012

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.

Keywords:
Rapid diagnostic tests (RDTs); Reliability; Sensitivity; Plasmodium falciparum; Pregnancy-Associated Malaria (PAM); Microscopy; Polymerase chain reaction (PCR); Sub-microscopic infections; Pregnancy outcomes; Tanzania