Comparison of Visuwell enzyme immunoassay to culture for detection of group A Streptococcus in throat swab specimens.

A microwell enzyme immunoassay (Visuwell) for direct detection of Group A streptococcal antigen from throat swab specimens has been developed. It incorporates urease conjugated antibody as the detector and is easily interpreted by a yellow to purple color change. Throat specimens obtained on rayon-tipped swabs were transported moist in modified Stuarts medium and cultured before being tested in Visuwell (n = 585, prevalence 17.1%, sensitivity 88%, specificity 92.4%, predictive value positive 70.4%, predictive value negative 97.4%, and accuracy 91.6%). In instances of discrepancy between culture and Visuwell, throat swab extracts were tested in a latex agglutination test. In 21 of 37 instances of Visuwell-positive, culture-negative specimens, latex agglutination was positive. Throat specimens obtained using double rayon swabs and transported to the laboratory dry had one swab cultured and the other tested in Visuwell (n = 280, prevalence 20.4%, sensitivity 75.4%, specificity 88.3%, predictive value positive 62.3%, predictive value negative 93.4%, and accuracy 85.7%). When 1+ culture positive specimens were considered negative, a sensitivity of 97.6% was obtained. In 14 of 26 instances of Visuwell-positive, culture-negative specimens, latex agglutination was positive. Cross-reaction with organisms other than Group A Streptococcus found in the oropharynx was negligible in Visuwell. Limit of detection of Group A streptococcal antigen was equivalent for Visuwell and latex agglutination.