ArticlePLoS neglected tropical diseases2023
Evaluation of a diagnostic device, CL Detect rapid test for the diagnosis of new world cutaneous leishmaniasis in Peru.
Article in PLoS neglected tropical diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03762070 (Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru), which is not on this map. Cited by 6 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru
Who cites it
6 citing papers in PubMed, 9 citations in OpenAlex.
- Molecular diagnostics for cutaneous leishmaniasis: progress towards fulfilling the WHO target product profile.Parasitology · 2025Review
- Nanobiosensors for revolutionizing parasitic infections diagnosis: a critical review to improve global health with an update on future challenges prospect.European journal of medical research · 2025Review
- Instrument-Free Point-of-Care Diagnostic for Leishmania Parasites.Diagnostics (Basel, Switzerland) · 2024Article
- Sampling is decisive to determination of Leishmania (Viannia) species.PLoS neglected tropical diseases · 2024Article
- Evaluation of Less Invasive Sampling Tools for the Diagnosis of Cutaneous Leishmaniasis.Open forum infectious diseases · 2024Article
- Micro-costing from healthcare professional's perspective and acceptability of cutaneous leishmaniasis diagnostic tools in Morocco: A mixed-methods study.PLOS global public health · 2024Article
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCutaneous leishmaniasis (CL) is a neglected disease and a public health problem in Latin America. The diagnosis of CL in poor hyperendemic regions relies to large extent on the identification of amastigotes in Giemsa-stained smears. There is an urgent need for a rapid, sensitive and low cost diagnostic method for use in field conditions for CL as current modalities are not readily available. The primary objective of this study was to determine the sensitivity and specificity of the FDA-cleared CL Detect Rapid Test in Peru, using modified test procedures rather than the instructions-for-use, by 1) increasing the extraction time and 2) increasing the volume of the sample added to the test strip. CL Detect Rapid Test results were compared against microscopy and kDNA-PCR, for the diagnosis of CL in ulcerated lesions. In addition, we compared two collection methods the dental broach used and mentioned in the CL Detect insert and the standard less invasive and easier to conduct scrapping method. METHODOLOGY: Participants were patients who presented for medical consultation due to a suspected CL lesion. Four samples from the index lesion were collected using a dental broach, per package insert, and lancet scraping and tested by the modified CL Detect Rapid Test, microscopy, and PCR. PRINCIPAL
findingsA total of 156 subjects were eligible and evaluated. The modified CL Detect sensitivity was higher in specimens obtained by scraping (83.3%) than those from dental broach (64.2%). The specificity was lower in scrapings (77.8%) with a false positive rate of 22.2% compared with dental broach samples (91.7%) with a false positive rate of 8.3%. However, molecular analysis showed that all 8 false negative microscopy scrapings (those positive by modified CL Detect and negative by microscopy) were positive by kDNA-PCR, meaning that the modified CL Detect was more sensitive than microscopy.
conclusionsThese modifications to the package insert that resulted in a diagnostic sensitivity (83.3%) comparable to microscopy for species found in Peru may enable earlier anti-leishmanial drug treatment decisions based on a positive result from the CL Detect Rapid Test alone until further diagnostic tests like microscopy and PCR can be performed.
trial registrationNCT03762070; Clinicaltrials.gov.
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