Herpes Simplex Virus I test in S/P IgG/IgM | HSV 130-1

INTENDED USE:

The kit is IVD rapid test for qualitative detection of HSV I lgG/lgM antibodies in human serum or urine samples. Herpes simplex virus (HSV) is the usual cause of orolabial infection (gingivostomatitis or herpes labialis), whereas HSV I is the major cause of genital infection. However,either virus can infect either location. Several modalities are available for the diagnosis of HSV infections.Serology can establish current and past infection with HSV. It has also been used in research studies of the epidemiology of HSV and is very useful in unusual clinical situations.

SUMMARY AND EXPLANATION:

The HSV I lgG/lgM Antibody Rapid Test Cassette (Colloidal Gold) is a qualitative membrane stripbased immunoassay for the detection of HSV I antibodies (lgG and lgM) in Serum/Urine. The test device consists of: 1)a burgundy colored conjugate pad containing HSV recombinant envelope antigens conjugated with Colloid gold (HSV conjugates) and rabbit lgG-gold conjugates,2)a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of lgM anti-HSV,T2 band is coated with antibody for the detection of lgG anti-HSV I, and the C band is pre-coated with goat anti rabbit lgG.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.lgG anti-HSV,if present in the specimen, will bind to the HSV conjugates.The immunocomplex is then captured by the reagent pre-coated on the T2 band,forming a burgundy colored T2 band, indicating an HSV lgG positive test result and suggesting a recent or repeat infection.lgM anti-HSV I if present in the specimen will bind to the HSV conjugates.The immunocomplex is then captured by the reagent coated on the T1 band,forming a burgundy colored T1 band,indicating an HSV lgM positive test result and suggesting a fresh infection. 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 lgG/rabbit lgG -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.