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A Multicenter Pivotal Clinical Trial of a Urine Malaria Test (UMT) for the Rapid Diagnosis of Plasmodium falciparum Malaria

Thursday, 10th of November 2016

A Multicenter Pivotal Clinical Trial of a Urine Malaria Test (UMT) for the Rapid Diagnosis of Plasmodium falciparum Malaria

1. Wellington A. Oyibo, PhD1*,
2. Nnenna Ezeigwe, MBBS, FMCPH2,
3. Godwin Ntadom, MBBS, MPH2,
4. Oladipo O. Oladosu, PhD1,
5. Kaitlin Rainwater, PhD, MPH3,
6. Wendy O´Meara, PhD4,
7. Evaezi Okpokoro, MBBS, MPH5 and
8. William Brieger, DSc3

- Author Affiliations

1.      ¹ANDI Centre of Excellence for Malaria Diagnosis, International Malaria Microscopy Training & RDT QA Programme & WHO/TDR/FIND Malaria Specimen Bank Site, College of Medicine, University of Lagos, PMB 12003, Lagos, Nigeria

2.      ²National Malaria Elimination Program, Federal Ministry of Health, Abia Plaza, First Avenue, Off Ahmadu Bello Way, Central Business District, Abuja, Nigeria

3.      ³Johns Hopkins University School of Public Health, 615 N. Wolfe Street, Baltimore, Maryland 21205, USA

4.      ⁴Duke University School of Medicine, 201 Trent Drive, Durham, North Carolina 27710, USA.

5.      ⁵Institute of Human Virology Nigeria, Plot 252, Herbert Macaulay Way, Central Business District, Abuja, Nigeria

 

ABSTRACT below; full text is at http://jcm.asm.org/content/early/2016/11/03/JCM.01431-16.full.pdf+html

Background: The need to expand malaria diagnosis alongside policy requirements for mandatory testing before treatment motivates exploration of non-invasive 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 Plasmodium falciparum (Pf) malaria diagnosis in febrile patients.

Methods: Matched urine and fingerprick blood from participants ≥2 years with fever (axillary temperature ≥37.5°C) or history of fever in the preceding 48 hours were tested with UMT and microscopy (as gold standard). BinaxNOW® (Pf/Pan) blood RDT was done to assess relative performance. Urinalysis and Rheumatoid Factor (RF) tests were conducted to evaluate possible interference. Diagnostic performance characteristics were computed at 95% CI.

Results: Of 1,800 participants screened, 1,691 were enrolled; 566 (34%) were febrile, 1,125 (66%) afebrile; test positivity among enrolled participants: 341 (20%) by microscopy, 419 (25%) UMT, 676 (40%) BinaxNow Pf and 368 (22%) BinaxNow Pan. UMT sensitivity among febrile patients (for whom the test is indicated) was 85% and specificity 84%. Among febrile children ≤5 years, UMT sensitivity was 93%, specificity 83%. Area under receiver-operator characteristic curve (AUC) of UMT (0.84) was not significantly different from Binax Pf (0.86) or Binax 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 concentration in urine were associated with lower UMT specificity.

Conclusion: UMT performance was comparable to BinaxNOW Pf/Pan tests, and is a promising tool to expand malaria testing in public and private healthcare settings where there are challenges to blood-based malaria diagnosis testing.

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• ↵* Corresponding author | woyibo@unilag.edu.ng

Copyright © 2016 Oyibo et al.