JAMA · 1997
Optical immunoassay test for group A beta-hemolytic streptococcal pharyngitis. An office-based, multicenter investigation.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Gerber M A, Tanz R R, Kabat W, Dennis E, Bell G L, Kaplan E L, Shulman S T
Аннотация
OBJECTIVE: To compare the accuracy of an optical immunoassay (OIA) for the rapid diagnosis of group A streptococcal pharyngitis with blood agar plate (BAP) culture.
DESIGN: Blinded comparison with criterion standard.
SETTING: A total of 6 private pediatricians' offices, 3 in Connecticut and 3 in Chicago, III.
PATIENTS: A total of 2113 consecutive patients with acute pharyngitis, 983 in Connecticut and 1130 in Chicago.
MAIN OUTCOME MEASURES: The sensitivities and specificities of OIA and BAP culture (both performed and interpreted in the office) were determined using a research laboratory's interpretation of a combination of BAP culture and Todd-Hewitt broth (THB) culture of transport tube pledget as criterion standard.
RESULTS: Among patients in Connecticut, the sensitivities of the OIA and BAP culture were 94% and 89%, respectively (P=.004), while the specificities were 96% and 99%, respectively (P=.001). Among patients in Chicago, the sensitivities of the OIA and BAP culture were 79% and 72%, respectively (P<.001), while the specificities were 89% and 99%, respectively (P<.001). In each of the 6 pediatricians' offices, the OIA was more sensitive than the BAP culture. Combining the data from Connecticut and Chicago, the overall sensitivities of the OIA and BAP culture were 84% and 78%, respectively (P<.001), while the specificities were 93% and 99%, respectively (P<.001).
CONCLUSIONS: The results of this comprehensive office-based investigation suggest that with adequately trained personnel, negative OIA test results may not always need to be routinely confirmed with BAP cultures.
DESIGN: Blinded comparison with criterion standard.
SETTING: A total of 6 private pediatricians' offices, 3 in Connecticut and 3 in Chicago, III.
PATIENTS: A total of 2113 consecutive patients with acute pharyngitis, 983 in Connecticut and 1130 in Chicago.
MAIN OUTCOME MEASURES: The sensitivities and specificities of OIA and BAP culture (both performed and interpreted in the office) were determined using a research laboratory's interpretation of a combination of BAP culture and Todd-Hewitt broth (THB) culture of transport tube pledget as criterion standard.
RESULTS: Among patients in Connecticut, the sensitivities of the OIA and BAP culture were 94% and 89%, respectively (P=.004), while the specificities were 96% and 99%, respectively (P=.001). Among patients in Chicago, the sensitivities of the OIA and BAP culture were 79% and 72%, respectively (P<.001), while the specificities were 89% and 99%, respectively (P<.001). In each of the 6 pediatricians' offices, the OIA was more sensitive than the BAP culture. Combining the data from Connecticut and Chicago, the overall sensitivities of the OIA and BAP culture were 84% and 78%, respectively (P<.001), while the specificities were 93% and 99%, respectively (P<.001).
CONCLUSIONS: The results of this comprehensive office-based investigation suggest that with adequately trained personnel, negative OIA test results may not always need to be routinely confirmed with BAP cultures.