Description
Status_Strep_A_Flip_CLSI Sheet
Status_Strep_A_Flip_Package Insert
Unit: 1 Box
Regulatory Status: CLIA Waived
Contents: (25) Test Cassettes, (1) positive control, (1) negative control, (25) Throat Swabs, Package Insert, Procedure Card
Determinations: Streptococcus A
Test Strip Storage Requirements: 35° F – 86° F (Refrigeration Not Required)
Collection Method: Throat Swab
The Status® Strep A Flip is a rapid immunochromatographic assay for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. The test is intended for use in physician’s offices, hospitals and
clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection (1).
Group A streptococcus is one of the most significant human pathogens causing acute pharyngitis, tonsillitis, impetigo, and scarlet fever (1). It is very important to differentiate streptococcal infection from other etiologic agents (e.g., viral,
mycoplasmal, or chlamydial) so that appropriate therapy may be initiated. Classical methods for identification require 18–48 hours culture time for throat swab specimens or other exudates to produce results showing bacitracin susceptible beta-hemolytic streptococci. Rapid diagnosis and timely treatment of group A streptococcal pharyngitis infections will reduce the severity of symptoms and further complications such as rheumatic fever and glomerulonephritis (2-6).
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