Accuracy of a rapid diagnostic test based on antigen detection for the diagnosis of cutaneous leishmaniasis in patients with suggestive skin lesions in Morocco

Issam Bennis, Kristien Verdonck, Nora El Khalfaoui, Myriam Riyad, Hajiba Fellah, Jean-Claude Dujardin, Hamid Sahibi, Souad Bouhout, Gert Van der Auwera, Marleen Boelaert

Research output: Contribution to journalA1: Web of Science-article

Abstract

In rural areas in Morocco, diagnosing cutaneous leishmaniasis (CL) can be challenging. We evaluated the accuracy of a rapid diagnostic test (RDT) based on antigen detection, CL Detect Rapid Test™ (Inbios International Inc., Seattle, WA), in this setting. We consecutively recruited patients with new skin ulcers in nine primary health centers. We took a dental broach sample for the RDT and two other tissue samples by scraping the border and center of the lesion with a scalpel and smearing it on a slide. We duplicated each smear by pressing a clean slide against it and processed the slides by using microscopy, polymerase chain reaction (PCR) internal transcribed spacer 1, and kDNA minicircle PCR. In a subgroup with positive PCR, the Leishmania species was identified using PCR-restriction fragment length polymorphism and PCR-sequencing of hsp70 genes. A participant with positive microscopy and/or PCR was considered a confirmed CL case. We computed sensitivity (Se) and specificity (Sp) of the RDT compared with this reference standard (ClinicalTrials.gov registration: NCT02979002). Between December 2016 and July 2017, we included 219 patients, 50% of them were under 18 years old. Rapid diagnostic test Se was 68% [95% confidence interval (CI): 61-74], Sp 94% [95% CI: 91-97], positive predictive value 95% [95% CI: 92-98], and negative predictive value 64% [95% CI: 58-70]. Despite its low Se, this novel RDT is a useful addition to clinical management of CL in Morocco, especially in isolated localities. Rapid diagnostic test-positive lesions can be treated as CL; but when RDT negative, microscopy should be performed as a second step. The Se of the RDT can probably be optimized by improving the sampling procedure.

Original languageEnglish
JournalAmerican Journal of Tropical Medicine and Hygiene
Volume99
Issue number3
Pages (from-to)716-722
Number of pages7
ISSN0002-9637
DOIs
Publication statusPublished - 2018

Keywords

  • ISOTHERMAL AMPLIFICATION LAMP
  • POLYMERASE-CHAIN-REACTION
  • MOLECULAR DIAGNOSIS
  • CLINICAL-SAMPLES
  • PCR
  • ASSAY

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