Rapid AIDS test ILE-402

leishmaniasisIgAIgG

Product Overview
The Leishmania Ab Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies (IgG, IgM, IgA) to Leishmania donovani subspecies in human serum, plasma or whole blood. The test is provided as a cassette device intended for professional in vitro diagnostic use; results are read visually according to the included instructions for use.

Background
Visceral leishmaniasis (Kala-azar) is a systemic infection caused by subspecies of Leishmania donovani. Transmission to humans occurs via Phlebotomus sandfly bites. In endemic regions the disease can be an opportunistic infection in immunocompromised patients, including those with AIDS. Serological screening supports clinical and epidemiological assessment but should be interpreted with clinical findings and confirmatory testing where required.

Kit Components

• 30 test devices, each individually foil-sealed (one cassette device per pouch).
• 30 plastic droppers (one per device) and desiccant included.
• Sample diluent: 1 bottle, 5 mL.
• One package insert (instructions for use).

Product Reference (from product table)
Product: Leishmania
Item No.: ILE-402
Description: Leishmania IgG test cassette
Specimen: WB/S/P (whole blood / serum / plasma)

Technical specifications

• Detection: Qualitative detection of antibodies (IgG, IgM, IgA) to Leishmania donovani subspecies.
• Intended specimens: Human serum, plasma, or whole blood.
• Format: Lateral flow immunoassay (cassette device).
• Kit configuration: 30 test devices per kit; devices individually foil-sealed with cassette, dropper and desiccant.
• Sample diluent: Provided (5 mL bottle).
• Manufacturer item number: ILE-402.
• Product description (manufacturer): Leishmania IgG test cassette.