Strep A Rapid Test Device (DTS342)

Regulatory status: For research use only, not for use in diagnostic procedures.

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throat swab specimens
Intended Use
The Strep A Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.
Store as packaged in the sealed pouch either at room temperature or refrigerated (2 -30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
Performance Characteristics

The following organisms were tested at 1.0 x 107 organisms per test and were all found to be negative when tested with the Strep A Rapid Test Device. No mucoid-producing strains were tested.
Group B Streptococcus Neisseria meningitidis Serratia marcescens
Group F Streptococcus Neisseria sicca Klebsiella pneumoniae
Streptococcus pneumoniae Branhamella catarrhalis Bordetella pertussis
Streptococcus mutans Group C Streptococcus Neisseria gonorrhea
Staphylococcus aureus Group G Streptococcus Neisseria subflava
Corynebacterium diphtheria Streptococcus sanguis Hemophilus influenza
Candida albicans Enterococcus faecalis
Pseudomonas aeruginosa Staphylococcus epidermidis
POL Studies
Three physicians' offices were used to conduct an evaluation of the Strep A Rapid Test Device. Personnel with various educational backgrounds performed the testing. Each physician's office tested a randomly coded panel of samples consisting of negative (20), low
positive (20), and medium positive (20) for three days. The results obtained had a 96% correlation with the expected results.
General Description
Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigen that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis. Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess. Traditional identification procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 hours or longer.
The Strep A Rapid Test Device is a rapid test to qualitatively detect the presence of Strep A antigen in throat swab specimens, providing results within 5 minutes. The test utilizes antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen.


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