CTK Biotech, USA Leishmania Ab Rapid 50 Test (strip)

The OnSite  Leishmania Ab Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies including IgG and IgM to the subspecies of Leishmania donovani (L. donovani), the Visceral leishmaniasis causative protozoans, in human serum or plasma.

• No equipment required
• Simple procedure
• Detects both IgG and IgM to L. donovani
• Utilizes rK39  antigen to achieve high sensitivity and specificity
• IgM: Sensitivity: 91.2%, Specificity: 99.5%
• IgG: Sensitivity: 92.9%, Specificity: 99%
• Cost-effective products available in strip format
• 24 Months shelf life at 2-30 °C

Each kit contains:

• Individually sealed foil pouches containing:
  • One strip device
  • One desiccant
• 5 µL capillary tubes
• Sample diluent (2 bottles, 5 mL/bottle)
• One package insert (instruction for use)

TEST PRINCIPLE  : The OnSite Leishmania Ab Rapid Test is a lateral flow chromatographic immunoassay. The test strip consists of: 1) a burgundy colored conjugate pad containing protein A conjugated with colloidal gold (Protein A conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with a proprietary recombinant L. donovani  antigen 39, and the C band is pre-coated with chicken anti-protein A Ab. When an adequate volume of test specimen is dispensed into the sample pad of the strip, the specimen migrates by capillary action across the strip.  Anti- L. donovani Ab if present in the specimen will bind to the Protein A conjugates. The immunocomplex is then captured on the membrane by the pre-coated antigen, forming a burgundy colored T band, indicating a L. donovani Ab positive test result. Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of anti-protein A – Protein A conjugates regardless of the presence of any antibodies to L. donovani antigen. Otherwise, the test result is invalid and the specimen must be retested with another device