Evaluation of the Strep A OIA® assay versus culture methods: ability to detect different quantities of Group A Streptococcus

Abstract

The Strep A OIA® assay by Biostar (Boulder, Co., USA) is a unique optical immunoassay system for the rapid detection of Group A streptococcal carbohydrate. As part of a community-based pediatric cohort study of Group A Streptococcus (GAS) persistence following antibiotic therapy of pharyngitis, the performance of the Strep A OIA® assay was compared with the amount of growth from standard throat swab culture methods. A total of 363 throat swabs taken over the course of the study was evaluated from 248 children between 2 and 18 years of age. Two culture methods were performed: an agar plate with the throat swab using Columbia agar base with 5% sheep blood incubated under an anaerobic environment for 48 h and Todd–Hewitt broth (THB) enhancement. The Strep A OIA® was then performed. A total of 144 of 363 (39.7%) samples was positive for GAS by one or more of the laboratory tests across study visits: agar culture detected 132 of 144 (91.7%), THB culture detected 128 of 144 (88.9%), and the Strep A OIA® assay detected 129 of 144 (89.6%). Complete agreement among all three laboratory tests was found for 333 of 363 (91.7%) of the samples. Agar culture results were comparable to THB cultures with a sensitivity of 96.9%, specificity of 96.6%, a positive predictive value of 93.9%, and a negative predictive value of 98.3%. Although the performance of the Strep A OIA® assay had similar specificity (96.5%) and positive predictive value (93.8%) compared with the combined results of the two culture methods, the sensitivity (89.0%) and negative predictive value (93.6%) were lower. A significant difference ( p < 0.001) was found in the ability of the Strep A OIA® assay to detect agar culture–positive swabs that had a light growth (1+ or 2+) (63.0%) versus a moderate (3+) or heavy (4+) growth (98.1%) of GAS. Although the Strep A OIA® assay allows GAS throat swab results to be reported an average of 24 h sooner than either of the cultures, the rapid assay was not as sensitive in detecting light growth GAS-positive cultures.