Testsealabs Leishmania IgG/IgM Test
Short Description:
Fast & Accurate：Achieve reliable results in minutes.
Simple Operation：No complex equipment required.
High Accuracy：Lab-grade precision you can trust.
Clear Visual Readout：Results are easy to read and interpret.
Certified Quality Systems：Compliant with ISO 13485 and MDSAP.
Room-Temperature Stability：No cold chain needed—easy to transport and store.
Product Specification
| Principle | Chromatographic Immunoassay | Specimen | Whole Blood/Serum/Plasma |
| Reading Time | 15 minutes | QMS Certification | ISO 13485 and MDSAP |
| Storage Temperature | 4-30°C | Shelf life | 2 years |
| Format | Cassette | Specification | 25T/40T |
Intended Use
Leishmania IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibody(IgG and IgM) to the subspecies of the leishmania donovani (L.donovani), the visceral leishmaniasis causative protozoans in whole blood/serum/plasma.
Summary
Visceral leishmaniasis, or kala-azar, is a disseminated infection caused by several subspecies of the L.donovani. The disease is estimated by the world health organization (WHO) to affect approximately 12 million people in 88 countries. It is transmitted to humans by bites of the phlebotomus sandflies, which acquire infection from feeding on infected animals. Though it is a disease found in poor countries, in southern europe, it has become the leading opportunistic infection in AIDS patients. Identification of L. donovani organism from the blood, bone marrow, liver, lymph nodes or the spleen provides a definite mean of diagnosis. Serological detection of anti-L. donovani IgM is found to be an excellent marker for the acute visceral leishmaniasis. Tests used in clinic are included ELISA, fluorescent antibody or direct agglutination tests . Recently, utilization of L. donovani specific protein in the test has improved the sensitivity and specificity dramatically. Leishmania IgG/IgM Test is a simple, visual qualitative test that detects L. donovani antibody in human whole blood/serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes.
