CL Detect™ Rapid Test for Cutaneous Leishmaniasis
FDA Cleared for In Vitro Diagnostic Use
The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four month old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL.
The CL Detect™ Rapid Test is intended to aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.
- US FDA Cleared
- CE Marked
- Sensitivity in non-endemic population: 96%.
- Sensitivity and Specificity in endemic population: 100% and 84% respectively.
- Kit includes 25 tests, controls, buffers and sterile dental broaches.
| Catalog No. | Format | Quantity/Kit | Time to Result | Sample Type | Storage | Shelf Life |
|---|---|---|---|---|---|---|
| CL025 | ICT (strip) | 25 tests | 30-40 minutes | Skin lesions | Room Temperature (20℃ -30℃) | 24 months |