Abstract
BackgroundCutaneous leishmaniasis (CL) is a serious health problem in Suriname. To expand the diagnostic options, two newly developed diagnostic tests, i.e. the rapid diagnostic test CL Detect™ Rapid Test (CL Detect) and the Loopamp™ Leishmania Detection Kit (Loopamp) were evaluated.MethodsDiagnostic test performance was compared to the routine diagnostic approach in place, i.e. clinical symptoms combined with microscopy, and to polymerase chain reaction (PCR), which was used as a reference standard. The study population (n = 93) was a typical representation of the CL affected population in Suriname and mainly infected with Leishmania guyanensis.ResultsCL Detect had a very low sensitivity compared to microscopy (36.7%) or PCR (35.8%), due to a high number of false negative results. The specificity of the CL Detect compared to microscopy and PCR was 85.7 and 83.3% respectively. Loopamp sensitivity was 84.8% compared to microscopy and 91.4% compared to PCR. The Loopamp test had a moderate specificity (42.9%) compared to microscopy, but a good specificity compared to PCR (91.7%).ConclusionThe CL Detect is not likely to be a good replacement for the routine diagnostic procedure for CL in Suriname. The high sensitivity of the easy to perform Loopamp enables the implementation of sensitive molecular diagnosis in resource limited settings.
Highlights
Cutaneous leishmaniasis (CL) is a serious health problem in Suriname
Nucleic acid amplification methods (NAAT), in particular polymerase chain reaction (PCR) or nucleic acid sequence based amplification (NASBA), are reported to have high sensitivity [7], but are difficult to implement in resource limited settings or as point of care (PoC) diagnostics [2, 8]
Diagnostic performance of the PoC tests The results of the individual diagnostic tests performed either in Suriname or The Netherlands were as follows
Summary
Cutaneous leishmaniasis (CL) is a serious health problem in Suriname. Leishmaniasis is a complex of disease caused by parasitic kinetoplastid flagellates of the genus Leishmania and manifests as three principal clinical forms, i.e. cutaneous leishmaniasis (CL), mucocutaneous leishmaniasis (MCL), In Suriname CL is endemic and a major concern to public health. The disease is generally known in Suriname as ‘bosyaws’ or ‘busi yasi’ - meaning ‘disease from the jungle’ – and is mainly caused by L. The diagnosis of CL is mainly based on a broad variety of clinical signs, but requires laboratory confirmation as these symptoms are not very specific. The laboratory diagnosis of CL is mainly based on microscopic examination of Giemsa’s stained skin scrapings or fine needle aspirates, but this approach is reported to have a low sensitivity [2]. Nucleic acid amplification methods (NAAT), in particular polymerase chain reaction (PCR) or nucleic acid sequence based amplification (NASBA), are reported to have high sensitivity [7], but are difficult to implement in resource limited settings or as (near) point of care (PoC) diagnostics [2, 8]
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