Expected use
The kit is a rapid IVD test for the qualitative detection of IgG / IgM antibodies to HSV II in human serum or urine specimens. The herpes simplex virus (HSV) is the common cause of orolabial infection (gingivostomatitis or cold sores), while HSV II is the main cause of genital infection. However, any of the viruses can infect any location. There are several modalities available for the diagnosis of HSV infections. Serology can establish current and past HSV infection. It has also been used in HSV epidemiology research studies and is very useful in unusual clinical situations.
Summary and explanation
The HSV II IgG / IgM Rapid Antibody Test Cassette (Colloidal Gold) is a qualitative membrane strip-based immunoassay for the detection of HSV II antibodies (IgG and IgM) in serum / urine. The test device consists of: 1) a burgundy conjugate pad containing recombinant HSV envelope antigens conjugated to colloid gold (HSV conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip It contains two test bands (T1 and T2 bands) and one control band (C band). The T1 band is precoated with the antibody for the detection of anti-HSV IgM, the T2 band is coated with the antibody for the detection of anti-HSV II IgG and the C band is precoated with goat anti-rabbit IgG.
An adequate volume of test sample is dispensed into the sample well of the test cassette, the sample migrates by capillary action through the cassette. If anti-HSV IgG, if present in the sample, it will bind to HSV conjugates. The immune complex is then captured by the reagent precoated in the T2 band, forming a burgundy colored T2 band, indicating a positive HSV IgG test result and suggesting a recent or repeat infection. If present in the sample, IgM anti-HSV II will bind to HSV conjugates.
The immune complex is then captured by the reagent coating the T1 band, forming a burgundy T1 band, indicating a positive HSV IgM test result and suggesting recent infection. The absence of T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) that should show a burgundy band of the goat anti-rabbit IgG / rabbit IgG-gold conjugate immune complex regardless of color. development in any of the T bands. Otherwise, the test result is invalid and the sample must be retested with another device.
