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 R Brieger

Research output: Contribution to journalArticle

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 crosssectional, 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 Binax- NOW 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.

Original languageEnglish (US)
Pages (from-to)253-263
Number of pages11
JournalJournal of Clinical Microbiology
Volume55
Issue number1
DOIs
StatePublished - Jan 1 2017

Fingerprint

Falciparum Malaria
Malaria
Clinical Trials
Urine
Fever
Rheumatoid Factor
Routine Diagnostic Tests
Microscopy
Urobilinogen
Mandatory Testing
Urinalysis
Hematuria
Fingers
Area Under Curve
Leukocytes
Public Health

Keywords

  • Health care provider
  • Malaria
  • Noninvasive malaria test
  • Plasmodium falciparum
  • Point-of-care diagnosis
  • Primary healthcare setting
  • Rapid diagnostic test (RDT)
  • Urine malaria test (UMT)

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

Multicenter pivotal clinical trial of urine malaria test for rapid diagnosis of Plasmodium falciparum malaria. / Oyibo, Wellington A.; Ezeigwe, Nnenna; Ntadom, Godwin; Oladosu, Oladipo O.; Rainwater-Loveth, Kaitlin; O'Meara, Wendy; Okpokoro, Evaezi; Brieger, William R.

In: Journal of Clinical Microbiology, Vol. 55, No. 1, 01.01.2017, p. 253-263.

Research output: Contribution to journalArticle

Oyibo, WA, Ezeigwe, N, Ntadom, G, Oladosu, OO, Rainwater-Loveth, K, O'Meara, W, Okpokoro, E & Brieger, WR 2017, 'Multicenter pivotal clinical trial of urine malaria test for rapid diagnosis of Plasmodium falciparum malaria', Journal of Clinical Microbiology, vol. 55, no. 1, pp. 253-263. https://doi.org/10.1128/JCM.01431-16
Oyibo, Wellington A. ; Ezeigwe, Nnenna ; Ntadom, Godwin ; Oladosu, Oladipo O. ; Rainwater-Loveth, Kaitlin ; O'Meara, Wendy ; Okpokoro, Evaezi ; Brieger, William R. / Multicenter pivotal clinical trial of urine malaria test for rapid diagnosis of Plasmodium falciparum malaria. In: Journal of Clinical Microbiology. 2017 ; Vol. 55, No. 1. pp. 253-263.
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