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Parasitology

Multicenter Pivotal Clinical Trial of Urine Malaria Test for Rapid Diagnosis of Plasmodium falciparum Malaria

Wellington A. Oyibo, Nnenna Ezeigwe, Godwin Ntadom, Oladipo O. Oladosu, Kaitlin Rainwater-Loveth, Wendy O'Meara, Evaezi Okpokoro, William Brieger
Peter Gilligan, Editor
Wellington A. Oyibo
aANDI Centre of Excellence for Malaria Diagnosis, International Malaria Microscopy Training and Rapid Diagnostic Test Quality Assurance Programme, and WHO/TDR/FIND Malaria Specimen Bank Site, College of Medicine, University of Lagos, Lagos, Nigeria
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Nnenna Ezeigwe
bNational Malaria Elimination Program, Federal Ministry of Health, Abuja, Nigeria
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Godwin Ntadom
bNational Malaria Elimination Program, Federal Ministry of Health, Abuja, Nigeria
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Oladipo O. Oladosu
aANDI Centre of Excellence for Malaria Diagnosis, International Malaria Microscopy Training and Rapid Diagnostic Test Quality Assurance Programme, and WHO/TDR/FIND Malaria Specimen Bank Site, College of Medicine, University of Lagos, Lagos, Nigeria
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Kaitlin Rainwater-Loveth
cJohns Hopkins University School of Public Health, Baltimore, Maryland, USA
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Wendy O'Meara
dDuke University School of Medicine, Durham, North Carolina, USA
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Evaezi Okpokoro
eInstitute of Human Virology Nigeria, Abuja, Nigeria
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William Brieger
cJohns Hopkins University School of Public Health, Baltimore, Maryland, USA
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Peter Gilligan
UNC Health Care System
Roles: Editor
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DOI: 10.1128/JCM.01431-16
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ABSTRACT

The need to expand malaria diagnosis capabilities alongside policy requirements for mandatory testing before treatment motivates exploration of noninvasive rapid diagnostic tests (RDTs). We report the outcome of the first cross-sectional, single-blind clinical performance evaluation of a urine malaria test (UMT) for diagnosis of Plasmodium falciparum malaria in febrile patients. Matched urine and finger-prick blood samples from participants ≥2 years of age with fever (axillary temperature of ≥37.5°C) or with a history of fever in the preceding 48 h were tested with UMT and microscopy (as the gold standard). BinaxNOW (Pf and Pan versions) blood RDTs were done to assess relative performance. Urinalysis and rheumatoid factor (RF) tests were conducted to evaluate possible interference. Diagnostic performance characteristics were computed at 95% confidence intervals (CIs). Of 1,800 participants screened, 1,691 were enrolled; of these 566 (34%) were febrile, and 1,125 (66%) were afebrile. Among enrolled participants, 341 (20%) tested positive by microscopy, 419 (25%) were positive by UMT, 676 (40%) were positive by BinaxNOW Pf, and 368 (22%) were positive by BinaxNow Pan. UMT sensitivity among febrile patients (for whom the test was indicated) was 85%, and specificity was 84%. Among febrile children ≤5 years of age, UMT sensitivity was 93%, and specificity was 83%. The area under the receiver-operator characteristic curve (AUC) of UMT (0.84) was not significantly different from that of BinaxNOW Pf (0.86) or of BinaxNOW Pan (0.87), indicating that the tests do not differ in overall performance. Gender, seasons, and RF did not impact UMT performance. Leukocytes, hematuria, and urobilinogen concentrations in urine were associated with lower UMT specificities. UMT performance was comparable to that of the BinaxNOW Pf/Pan tests, making UMT a promising tool to expand malaria testing in public and private health care settings where there are challenges to blood-based malaria diagnosis testing.

  • Copyright © 2016 Oyibo et al.

This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license .

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Multicenter Pivotal Clinical Trial of Urine Malaria Test for Rapid Diagnosis of Plasmodium falciparum Malaria
Wellington A. Oyibo, Nnenna Ezeigwe, Godwin Ntadom, Oladipo O. Oladosu, Kaitlin Rainwater-Loveth, Wendy O'Meara, Evaezi Okpokoro, William Brieger
Journal of Clinical Microbiology Dec 2016, 55 (1) 253-263; DOI: 10.1128/JCM.01431-16

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Multicenter Pivotal Clinical Trial of Urine Malaria Test for Rapid Diagnosis of Plasmodium falciparum Malaria
Wellington A. Oyibo, Nnenna Ezeigwe, Godwin Ntadom, Oladipo O. Oladosu, Kaitlin Rainwater-Loveth, Wendy O'Meara, Evaezi Okpokoro, William Brieger
Journal of Clinical Microbiology Dec 2016, 55 (1) 253-263; DOI: 10.1128/JCM.01431-16
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KEYWORDS

Antigens, Protozoan
Chromatography, Affinity
Malaria, Falciparum
Point-of-Care Systems
health care provider
malaria
noninvasive malaria test
Plasmodium falciparum
point-of-care diagnosis
primary healthcare setting
rapid diagnostic test (RDT)
urine malaria test (UMT)

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