rapid test kit,
infectious disease diagnostic tests
A rapid test for the qualitative detection of Strep A antigens in throat swab specimens CE certified
The Strep A Rapid Test Cassette (Control Line in Blue) is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigens from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.
Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigens 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 Rapid Test Cassette is a rapid test to qualitatively detect the presence of Strep A antigens 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 antigens in a throat swab specimen.
How to use?
Allow the test, urine specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
Allow the test, reagents, throat swab specimen, and/or controls to reach room temperature (15-30℃) prior to testing.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). A positive result indicates that Strep A was detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Strep A present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). A negative result indicates that Strep A antigen is not present in the specimen, or is present below the detectable level of the test. The patient’s specimen should be cultured to confirm the absence of Strep A infection. If clinical symptoms are not consistent with results, obtain another specimen for culture.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Internal Quality Control
Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal positive procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
External Quality Control
It is recommended that a positive and negative external control be run every 25 tests, and as deemed necessary by internal laboratory procedures. External positive and negative controls are supplied in the kit. Alternatively, other Group A and non-Group A Streptococcus reference strains may be used as external controls. Some commercial controls may contain interfering preservatives; therefore, other commercial controls are not recommended.
Procedure for External Quality Control Testing
If the controls do not yield the expected results, do not use the test results. Repeat the test or contact your distributor.