title: Clinical evaluation of the sensitivity and specificity of a commercially available enzyme immunoassay for detection of rubella virus-specific immunoglobulin M.
abstract: A solid-phase capture antigen enzyme immunoassay (Rubazyme-M) was evaluated for sensitivity and specificity on sera from 1,200 blood donors, 51 patients with rubella, 2 infants with congenital rubella, 104 patients with other infections, and 126 patients with immunological abnormalities. The sensitivity was 100% for sera tested between days 3 and 40 after the onset of symptoms of rubella virus infection. Rubella virus-specific immunoglobulin M was detected at birth in sera from congenitally infected infants and persisted for several months. Positive Rubazyme-M responses were observed in some patients in the absence of rubella diagnosis (one blood donor, three other infections, and two immunological abnormalities), providing a test specificity of 99.6%. None of 67 patients with rubella virus-specific immunoglobulin G antibody and high levels of rheumatoid factor were positive in the test.
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000032:analysis*; D000918:Antibody Specificity; D001782:Blood Donors; D005069:Evaluation Studies as Topic; D006801:Humans; D007124:Immunoenzyme Techniques; D007075:Immunoglobulin M / Q000032:analysis*; D007231:Infant, Newborn; D007239:Infections / Q000276:immunology; D008297:Male; D012409:Rubella / Q000151:congenital / Q000276:immunology; D012412:Rubella virus / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D007075:Immunoglobulin M