Specimens collected prior to seroconversion may yield negative IgM or IgG antibody results, while specimens collected after IgM antibody levels have begun to decline may yield negative IgM antibody results. Follow-up testing of convalescent samples may be beneficial to establish infection status.
The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
Test results of specimens from immunocompromised patients may be difficult to interpret.
Testing should not be performed as a screening procedure for the general population. Testing should only be done when clinical evidence suggests the diagnosis of parvovirus B19-associated disease.
The performance of this test has not been established on neonates and immunocompromised patients.
Specimens containing antinuclear antibodies may produce equivocal or positive test results in the IgM assay.
Epstein-Barr virus-positive specimens may produce positive or equivocal test results in the IgM assay.
Assay performance characteristics have not been established for matrices other than serum.