INTENDED USE The One Step RV IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Rubella (Virus) in Whole Blood /Serum / Plasma to aid in the diagnosis of RV infection. The test is based on immunochromatography and can give a result within 15 minutes. PRINCIPLE The One Step RV IgG/IgM Test is a qualitative membrane strip based immunoassay for the detection of RV antibodies (IgG and IgM) in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing RV recombinant envelope antigens conjugated with Colloid gold (RV 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 T1 band is pre-coated with the antibody for the detection of IgM anti-RV, T2 band is coated with antibody for the detection of IgG anti-RV, 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. IgG anti-RV, if present in the specimen, will bind to the RV conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a RV IgG positive test result and suggesting a recent or repeat infection. IgM anti-RV if present in the specimen will bind to the RV conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a RV IgM 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 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. Storage and Stability Store as packaged in the sealed pouch at room temperature or refrigerated (4-30â?? or 40-86â??). The test device is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use.
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