Strep A Rapid Test description:

"Export Use Only"
OneStep Strep A Rapid Test is a qualitative group A streptococcal antigen rapid test. The test is a rapid, in vitro assay. It is intended for professional use to help diagnose Strep A infection in hospital and clinical laboratories.





Materials provided with Strep A RapiCard InstaTest Kits:
1. OneStep Strep A RapiCard InstaTest device
2. Extraction Reagent 1 (2 M Sodium Nitrite)
3. Extraction Reagent 2 (1 M Acetic Acid)
4. Individually packaged sterile rayon-tipped swabs or solid shafts

Materials required but not provided:
1. Specimen collection container
2. Throat swab for specimen collection
3. Clock or timer





Strep A Rapid Test Background Information
Beta-hemolytic group A streptococcus is the most common cause of upper respiratory infection in human. The most commonly occurring disease is pharyngitis. The highest morbidity is usually found in children. The infection can lead to serious complication, including rheumatic fever and acute glomerulonephritis. Rapid diagnosis and appropriate antibiotic therapy appear to be the best means of preventing these complications. The traditional means of detecting group A streptococcal infection involves 24-48 hour culture of throat swab specimens or other exudates, confirming beta-hemolysis, and showing susceptibility to bacitracin. This long process of diagnosis often causes physicians to administer therapy without first knowing the etiologic agent involved. Strep A RapiCard Test detects group A streptococcus by immunological means. It utilize the antibodies that recognize the specific antigens from cell walls of the group A streptococcus. The test result can be obtained within 10 minutes.





Strep A Rapid Test Principle
OneStep Strep A Rapid Test is a sandwich immunoassay. The carbohydrate antigen of group A streptococcus is extracted by chemical extraction first. The extracted antigen then is transferred to sample pad, it moves through the conjugate pad and mobilizes gold anti-Strep A polyclonal antibody conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with anti-Strep A polyclonal antibody that is coated on the test region. If Strep A antigen is lower than detection level in the sample, the area will remain colorless. The sample continues to move to the control area where Goat anti-rabbit IgG antibody will capture gold-antibody conjugate to form a pink to purple color, indicating the test is working and the result is valid. For additional details please refer to the instructions for use.





Notable features of the Strep A RapiCard InstaTest:
-Reliable and inexpensive
-Convenient and easy-to-understand directions
-Clear preparation procedures
-Simple and safe specimen collection directions
-Comprehensive package of required materials and components
-Rapid and accurate test results-10 minutes




See Strep A RapiCard InstaTest Product Insert for specific details on preparation, procedures, quality control, and interpretation of test results.

Diagnostic Automation Inc. also offers other Infectious Diseases Rapid tests, and Infectious Diseases ELISA test kits. For more information about Rapid tests, CLIA tests, IFA kits, or ELISA test kits, please contact our Customer Service Representatives at 818-591-3030 .