New Colorimetric Test for Rapid Diagnosis of Streptococcal Pharyngitis: A Warning

Abstract
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

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