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

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.