Typhoid IgG/IgM Rapid Test
FOR IN VITRO DIAGNOSTIC USE ONLY
INTENDED USE
The Typhoid IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-Salmonella typhi (S. typhi) IgG and IgM in human whole blood/serum/plasma . It is intended to be used as a screening test and as an aid in the diagnosis of infection with S. typhi. Any reactive specimen with the Typhoid IgG/IgM Rapid Test must be confirmed with alternative testing method(s)..
PRINCIPLE OF THE PROCEDURE
The Typhoid IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant S. typhoid H antigen and O antigen conjugated with colloid gold (Typhoid conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T2 band is pre-coated with monoclonal anti-human IgG for the detection of IgG anti-S. typhi, T1 band is pre-coated with reagents for the detection of IgM anti-S. typhi, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. Anti-S. typhi IgG if present in the specimen will bind to the Typhoid conjugates. The immunocomplex is then captured on the membrane by the precoated anti-human IgG antibody, forming a burgundy colored T2 band, indicating a S. typhi IgG positive test result.Anti-S. typhi IgM if present in the specimen will bind to the Typhoid conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a burgundy colored T1 band, indicating a S. typhi IgMSDF positive test result. Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.
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