title: Performance characteristics and utilization of rapid antigen test, DNA probe, and culture for detection of group a streptococci in an acute care clinic.
abstract: Group A streptococcus (GAS) antigen testing has become a routine point-of-care (POC) test in acute care settings. Concern about performance parameters (PP) of these tests as well as inappropriate antibiotic use has resulted in various recommendations regarding diagnosis of GAS. There were two objectives in this study. The first was to evaluate the rapid GAS antigen test presently in use (Thermo BioStar, Boulder, Colo.) and the GAS Direct probe test (Gen-Probe, San Diego, Calif.) compared to culture. The second was to define the optimal use of these technologies in a large acute care pediatric clinic. A total of 520 consecutive pediatric patients presenting with symptoms of pharyngitis at any of three Lahey Clinic acute care facilities were evaluated. Pharyngeal specimens were collected using a double-swab collection device (Copan, Corona, Calif.). One swab was used for the antigen test, the second was used for the probe test, and the pledget was placed in the collection device for culture on 5% sheep blood agar, incubated for 48 h anaerobically, and subsequently placed in Todd-Hewitt broth. After discrepant analysis, sensitivity, specificity, and positive and negative predictive values were as follows: 94.8, 100, 100, and 96.9% for the probe test and 86.1, 97.1, 93.7, and 93.4% for the antigen test, respectively. Sensitivity using an enhanced culture technique was 99.4% (163 of 164). False-positive (FP) antigen results were often seen from patients previously diagnosed and/or treated for GAS. No FP results were seen with the probe test. Colony counts for the false-negative (FN) antigen tests were higher than those for the FN probe tests. Compared to culture and DNA probe, the rapid antigen test (RAT) offered a result at the time of the patient's visit, with acceptable PP when prevalence of disease is high. Follow-up testing with the RAT of GAS patients who previously tested as positive should be avoided due to increased FP results. The probe test was comparable to culture in performance. Results indicate the probe test can be used as the primary test or as a backup to negative antigen tests. The probe test offers the advantage over culture of same-day reporting of a final result but, in contrast to a POC test, necessitates follow-up communication to the patient. Preliminary data show the specificity of the probe test to be greater than that of the RAT for patients previously diagnosed with GAS.
authors.affiliation: Department of Laboratory Medicine. Department of Pediatrics, Lahey Clinic Medical Center, Burlington, Massachusetts 01805, USA. kimberle_c_chapin@lahey.org
authors.forename: Kimberle C
authors.initials: KC
authors.lastname: Chapin
authors.forename: Patricia
authors.initials: P
authors.lastname: Blake
authors.forename: Claire D
authors.initials: CD
authors.lastname: Wilson
mesh_terms: D000293:Adolescent; D000553:Ambulatory Care; D000942:Antigens, Bacterial / Q000032:analysis*; D002648:Child; D002675:Child, Preschool; D003470:Culture Media; D015342:DNA Probes / Q000235:genetics*; D004275:DNA, Ribosomal / Q000032:analysis; D006801:Humans; D007118:Immunoassay; D007223:Infant; D007231:Infant, Newborn; D008163:Luminescent Measurements; D010372:Pediatrics; D010612:Pharyngitis / Q000382:microbiology; D011237:Predictive Value of Tests; D012335:RNA, Ribosomal / Q000235:genetics; D012680:Sensitivity and Specificity; D013290:Streptococcal Infections / Q000382:microbiology; D013297:Streptococcus pyogenes / Q000235:genetics / Q000254:growth & development* / Q000302:isolation & purification*; D013997:Time Factors
chemical_list: D000942:Antigens, Bacterial; D003470:Culture Media; D015342:DNA Probes; D004275:DNA, Ribosomal; D012335:RNA, Ribosomal