INTENDED USE

The Tsutsugamushi(Scrub Typhus) IgG/IgM Rapid Test Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay for the qualitative detection of IgM/IgG anti-Tsutsugamushi in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Tsutsugamushi. Any reactive specimen with the Tsutsugamushi IgM/IgG Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY AND EXPLANATION THE TEST

The Tsutsugamushi(Scrub Typhus) IgG/IgM Rapid Test Kit (Colloidal Gold) utilizes recombinant antigens derived from its structure protein, it detects IgM anti-Tsutsugamushi in patient serum or plasma within 15 minutes. The test can be performed by untrained or minimally skilled personnel, without cumbersome laboratory equipment.

PRINCIPLE

The Tsutsugamushi(Scrub Typhus) IgG/IgM Rapid Test Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant antigen conjugated with colloid gold (Tsutsugamushi conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (M and G bands) and a control band (C band). The M band is pre-coated with monoclonal anti-human IgM for the detection of IgM anti-Tsutsugamushi , G band is pre-coated with reagents for the detection of IgG anti-Tsutsugamushi , 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-Tsutsugamushi IgM if present in the specimen will bind to the Tsutsugamushi conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored M band, indicating a Tsutsugamushi IgM positive test result.
Anti-Tsutsugamushi IgG if present in the specimen will bind to the Tsutsugamushi conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a burgundy colored G band, indicating a Tsutsugamushi IgG positive test result.
Absence of any test bands (M and G) 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 test bands. Otherwise, the test result is invalid and the specimen must be retested with another device.