INTENDED USE

The CMV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to CMV in whole blood, serum or plasma to aid in the diagnosis of CMV infection.

SUMMARY

Cytomegalovirus is a herpes virus. It is a leading etiological agent for congenital abnormalities and complications among those who receive massive blood transfusions and immunosuppressive therapy. About half of pregnant women who contract a primary infection spread the disease to their fetus. Infection during pregnancy may cause mental retardation, blindness, and/or deafness of the fetus.

PRINCIPLES

The CMV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of IgG and IgM antibodies to CMV in whole blood, serum or plasma specimens. In this test, mouse anti-human IgG and mouse anti-human IgM are coated in the test line regions of the test. During testing, the whole blood, serum or plasma specimen reacts with CMV antigen coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the mouse anti-human IgG or goat anti-human IgM on the membrane in the test line region. The presence of a colored line in the test line region indicates a positive result for CMV infection, while its absence indicates a negative result for that infection.
To serve as a procedural control, a colored line will always appear in the control line region of the strip indicating that proper volume of specimen has been added and membrane wicking has occurred.