Rapid typhoid test ITY-402

for infectious diseasesfor antibodiesIgG

Overview
The Typhoid IgG/IgM Rapid Test Cassette is a lateral flow immunoassay for the qualitative, simultaneous detection and differentiation of anti-Salmonella typhi IgG and IgM in human serum, plasma or whole blood. The device is intended for professional in vitro diagnostic use.

Intended use
Qualitative detection of specific IgG and IgM antibodies to S. typhi in human serum, plasma or whole blood to support clinical diagnosis where laboratory culture is not available or as an adjunct to other diagnostic methods.

Clinical background
Typhoid fever is caused by Salmonella typhi, a Gram-negative bacterium. Worldwide an estimated 17 million cases and 600,000 deaths occur annually. Patients with HIV have an increased risk of clinical infection. Co-infection or prior infection with H. pylori may increase susceptibility. Approximately 1–5% of infected individuals can become chronic carriers. Blood culture or bone marrow culture remain the diagnostic gold standard; serological tests are used where cultures cannot be performed.

Kit components

• Each foil pouch contains: one cassette device, one plastic dropper, one desiccant
• Sample diluent
• One package insert (instructions for use)

Product information
Product: Typhoid - Item No.: ITY-422 - Description: Typhoid IgG/IgM test cassette - Specimen: WB/S/P

Technical specifications

• Assay type: lateral flow immunoassay
• Analytes: anti-Salmonella typhi IgG and IgM
• Specimen types: Whole blood / Serum / Plasma (WB/S/P)
• Sample requirement: human serum or plasma; compatible with whole blood
• Packaging: individual foil pouch containing cassette, dropper and desiccant
• Product/Item No.: ITY-422

Usage notes
For professional in vitro diagnostic use only. Results are qualitative and should be interpreted within the clinical context; confirmatory testing by culture is recommended when possible. Follow the package insert for specimen handling, test procedure and storage conditions.