Diagnostic performance of CL Detect rapid-immunochromatographic test for cutaneous leishmaniasis: a systematic review and meta-analysis

Abstract

Background Sensitive, robust, and fast point-of-care tests are needed for cutaneous leishmaniasis (CL) diagnosis. The recently developed CL Detect rapid test (InBios) for detecting Leishmania peroxidoxin antigen has been evaluated in several studies. However, diagnostic performances were controversial. Therefore, this systematic review and meta-analysis aimed to determine the pooled sensitivity and specificity of CL Detect for CL diagnosis. Methods PubMed, Scopus, EMBASE, ScienceDirect, and Google Scholar were sources of articles. We included studies reporting the diagnostic accuracy of CL Detect and CL-suspected patients in the English language. The methodological qualities of the included studies were appraised using the quality assessment of diagnostic accuracy studies-2 (QUADAS‐2). Meta-analysis was conducted using Stata 14.2 and R software. Results A total of 9 articles were included. The study sample size ranged from 11 to 274. The sensitivities of the individual studies ranged from 23 to 100%, and the specificities ranged from 78 to 100%. Pooled sensitivity and specificity were 68% (95% CI, 41–86%) and 94% (95% CI, 87–97%), respectively. AUC displayed 0.899. Pooled sensitivity was lower (47%, 95% CI, 34–61%) when PCR was used as a reference than microscopy (83%, 95% CI, 39–97%). Pooled sensitivity was lower (48%, 95% CI, 30–67%) for all lesion durations compared to ≤ 4 months (89%, 95% CI, 43–99%). Conclusions CL Detect has poor sensitivity and does not meet the minimal sensitivity of 95% of target product profiles designed for CL point-of-care tests. Currently, the CL Detect test looks unsuitable for CL diagnosis, despite its high specificity. Findings are limited by the low number of studies available. Further large-scale studies are recommended. Systematic review registration PROSPERO CRD42022323497.

Micro-costing from healthcare professional’s perspective and acceptability of cutaneous leishmaniasis diagnostic tools in Morocco: A mixed-methods study

“…Nevertheless, recent guidance from the WHO Diagnostic Technical Advisory Group for neglected tropical diseases (NTDs) highlights the need to develop new point-of-care tests for Cutaneous Leishmaniasis (CL). The currently available CL Detect Rapid Test fails to meet the requisite diagnostic performance standards of reaching 95% sensitivity for point-of-care waiting for the next generation of CL-RDT based on antigen detection that should differentiate between L.tropica, L.major, and other species [1,29,30].…”

“…The psychosocial burden prevalent in some areas, where there is an urgent need to minimise scarring through prompt treatment, underscores the importance of using diagnostic tools like the current CL Detect Rapid Test (CL RDT). With its high specificity, as indicated by the review's pooled analysis showing an overall specificity of 94% [87-97%], the CL RDT or similar rapid diagnostic tools can provide quick answers, essential for ruling out CL [30]. This is especially relevant in Morocco, reflecting a pattern observed in Sri Lanka, where, for the L. donovani species, the RDT demonstrated a sensitivity of 36% but a specificity of 100% [25].…”