PEDIATRICS Vol. 86 No. 3 September 1990, pp. 457-459
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New Colorimetric Test for Rapid Diagnosis of Streptococcal Pharyngitis: A Warning

Michael A. Gerber MD1, Richard R. Facklam PhD2, Martin F. Randolph MD3, and Kathleen K. DeMeo BS3

1 Dept of Pediatrics, University of Connecticut Health Center, Farmington, CT
2 Centers for Disease Control, Atlanta, GA
3 Danbury, CT

During the last few years there has been a dramatic proliferation of rapid tests for the diagnosis of group A beta-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 beta-hemolytic streptococcal pharyngitis.2

Submitted on August 14, 1989
Accepted on November 8, 1989