Infection Disease Strep A Antigen Rapid Test with CE certificate uncut sheet

For professional in vitro diagnostic use only.

INTENDED USE

The Strep A Antigen Rapid Test 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.

PERFORMANCE CHARACTERISTICS

Table: Strep A Rapid Test vs. PCR Test

Relative Sensitivity: 94% (88%-98%)* Relative Specificity: 98% (96%-99%)*

Accuracy: 97% (96%-98%)* * 95% Confidence Intervals

Cross-Reactivity

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.

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.

SUMMARY

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.¹ Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess.² 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.^3,4

The Strep A Antigen Rapid Test 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.