INTENDED USE The StrongStep^® Strep A Rapid Test Device is a rapid immunoassay for the qualitative detection of Group A Streptococcal (Group A Strep) antigen from throat swab specimens as an aid to the diagnosis of Group A Strep pharyngitis or for culture confirmation. INTRODUCTION Beta-haemolytic Group B Streptococcus is a major cause of upper respiratory infections in humans. The most commonly occurring Group A Streptococcal disease is pharyngitis. The symptoms of this, if left untreated, can become more severe and further complications such as acute rheumatic fever, toxic shocklike syndrome and glomerulonephritis can develop. Rapid identification can facilitate clinical management to prevent disease progression. Conventional methods used to identify Group A Streptococcus involve the isolation and subsequent identification of the organisms, which can take 24-48 hours to complete. The StrongStep^® Strep A Rapid Test Device detects Group A Streptococci directly from throat swabs so that more rapid results are achieved. The test detects bacterial antigen from swabs, therefore it is possible to detect Group A Streptococcus, which may fail to grow in culture. PRINCIPLE The Strep A Rapid Test Device has been designed to detect Group A Streptococcal antigen through visual interpretation of color development in the internal strip. The membrane was immobilized with Rabbit anti Strep A antibody on the test region. During the test, the specimen is allowed to react with another rabbit anti-Strep A antibody colored particals conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough Strep A antigens in specimens, a colored band will form at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred. STORAGE AND STABILITY ■ The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch. ■ The test must remain in the sealed pouch until use. ■ Do not freeze. ■ Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.Instructions