A rapid test for the qualitative detection of Strep A antigen in throat swab specimens.For professional in vitro diagnostic use only.

 

INTENDED USE

 

The Strep A Rapid Test Strip (Throat Swab) 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.

 

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 Rapid Test Strip (Throat Swab) 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.

 

PRINCIPLE

 

The Strep A Rapid Test Strip (Throat Swab) is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the test. After the test strip is immersed into a specimen, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. This mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a colored line in the test line region. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

 

Materials Provided

 

Test strips         

Strep A Reagent A (2M Sodium Nitrite)       

Strep A Reagent B (0.4M Acetic Acid)

Sterile swabs     

Workstation      

Package insert      

Test tubes

Materials Required But Not Provided

 

Timer

 

PRECAUTIONS

 

1. For professional in vitro diagnostic use only. Do not use after expiration date.

2. Do not eat, drink or smoke in the area where the specimens and kits are handled.

3. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.

4. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

5. Humidity and temperature can adversely affect results.

    

6. Do not use test if pouch is damaged.

7. Reagent B contains an acidic solution. If the solution contacts the skin or eye, flush with large volumes of water.

8. The positive and negative controls contain sodium azide (NaN3) as a preservative.

9. Do not interchange reagent bottle caps.

10. Do not interchange external control solution bottle caps.