Evaluation of point of care tests for the diagnosis of cutaneous leishmaniasis in Suriname

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.

Accuracy of diagnostic tests for American tegumentary leishmaniasis: a systematic literature review with meta‐analyses

“…Mello et al [32] performed imprint and scraping of the inner and outer edges and found low sensitivity values in both procedures. Schallig et al [39] analysed the Detect TM Rapid Test (CL Detect) and Loopamp TM Leishmania Detection Kit (Loopamp) for ATL detection in Suriname. The first rapid test showed low sensitivity and specificity values, whereas the second presented higher values for both measures, especially when the reference standard was PCR.…”

“…After reading of the titles and abstracts, 3334 studies were excluded because they did not meet the inclusion criteria. After full reading of the remaining 53 studies, 15 papers were excluded and 38 were included in the systematic review [10,20–56]. Of these, 27 were conducted in Brazil, 3 in Colombia and 2 in Ecuador.…”

Access to prompt diagnosis: The missing link in preventing mental health disorders associated with neglected tropical diseases

“…This RDT allows diagnosing CL in primary healthcare facilities as it only requires obtaining a sample from the lesion using a small dental broach; the results are available in less than an hour and can be interpreted the same way as results from a malaria RDT. As shown in different studies, the specificity of the CL Detect RDT is good, but its sensitivity is low [18–20]. Nevertheless, the CL Detect can significantly improve access to CL diagnosis in endemic regions.…”

Loop-Mediated Isothermal Amplification Allows Rapid, Simple and Accurate Molecular Diagnosis of Human Cutaneous and Visceral Leishmaniasis Caused by Leishmania infantum When Compared to PCR

“…A molecular diagnostic test that presents less limitations for implementation is the loop-mediated isothermal amplification (LAMP), a robust method that allows for the rapid, sensitive, and specific amplification of target DNA using less sophisticated equipment [ 8 ]. A LAMP test developed by Eiken Chemical Co., Ltd., Tokyo, Japan (Loopamp™ Leishmania Detection Kit), which is a dry reagent-based test, simple to operate and that does not require a cold chain, has been shown to be useful in the diagnosis of CL and VL in different endemic areas [ 9 , 10 , 11 , 12 ]. In a previous study, we demonstrated the analytical performance of Loopamp™ Leishmania detection kit [ 13 ].…”