RT Journal Article
SR Electronic
T1 New Colorimetric Test for Rapid Diagnosis of Streptococcal Pharyngitis: A Warning
JF Pediatrics
JO Pediatrics
FD American Academy of Pediatrics
SP 457
OP 459
VO 86
IS 3
A1 Gerber, Michael A.
A1 Facklam, Richard R.
A1 Randolph, Martin F.
A1 DeMeo, Kathleen K.
YR 1990
UL http://pediatrics.aappublications.org/content/86/3/457.abstract
AB During the last few years there has been a dramatic proliferation of rapid tests for the diagnosis of group A β-hemolytic streptococcal pharyngitis.1 It is important for physicians to realize that the Food and Drug Administration does not approve these diagnostic tests as it would approve a pharmacologic agent, but simply permits a manufacturer to sell the test. Consequently, unacceptably inaccurate rapid tests for group A streptococci have been marketed in the past and could potentially appear again at anytime. In 1986, we studied a new enzyme fluorescence procedure (Strep-A-Fluor, Bio-Spec Inc, Dublin, CA) for the rapid diagnosis of group A β-hemolytic streptococcal pharyngitis.2