Parvovirus B19 IgM Test System

Intended Use

The U.S. FDA-approved ZEUS ELISA Parvovirus IgM Test System is an enzyme-linked immunosorbent assay designed for the qualitative detection of IgM antibodies to human parvovirus B19 in human serum or plasma. This test, in conjunction with the ZEUS ELISA Parvovirus B19 IgG Test System, may be used for testing women of childbearing age to determine their serological status where there is a suspicion of exposure to human Parvovirus B19. Together, the results of these assays may be used to determine the overall serological status of the patient. The clinician should consider the results of these assays as presumptive for risk of fetal infection of human Parvovirus B19. The test is also intended for all patients as an aid in the diagnosis of fifth disease (erythema infectiosum). This test is intended for in vitro diagnostic use only.

Registration/Clearance

FDA Approved

CE Marked

Health Canada Licensed