Latex agglutination test for rubella antibodies: report based on data from the College of American Pathologists surveys, 1983 to 1985.

In the College of American Pathologists (CAP) rubella survey program, 45% of laboratories rely on the latex agglutination (LA) card assay for detecting rubella immunoglobulin G (IgG) antibodies. By using CAP survey data over a 3-year period, we compared LA results with hemagglutination inhibition (HI) and enzyme immunoassay (EIA) results. EIA indices were used to classify results into three categories: nonimmune, EIA index of 0.300 or less; borderline, EIA index of 0.300 to 0.619; and immune, EIA index of 1.700 or greater. There was 91% or more agreement between LA, HI, and EIA for categories i and iii. In category ii, the response from LA users varied, depending on the level of antibody present in the survey samples; at an EIA index of 0.346, 81% reported nonimmune status, whereas at an EIA index of 0.619, 48% reported nonimmune status. Less than 10% indicated borderline status. In testing of samples in the same category, approximately 40%, using the HI method, reported titers of less than 1:8 (nonimmune status). Among EIA users, 97 to 99% regarded the specimens as nonimmune. On analysis of specimens in the borderline category, the LA test showed a pattern of sensitivity and specificity comparable to that reported with the HI technique, whereas the EIA method showed a greater degree of precision. The LA card assay provides a rapid screening test in which LA is read macroscopically, and the procedure differs considerably from the fully quantitative HI and EIA methods.(ABSTRACT TRUNCATED AT 250 WORDS)