REF:

C2111 (Cassette)

INTENDED USE:

Group A Streptococcus Antigen Test Kit is a qualitative immunochromatographic assay that uses the double-antibody sandwich method to detect the group A streptococcus (GAS) antigen from throat swab specimen from patients who are suspected of GAS infection by a healthcare provider. Performance of the test is limited to laboratory professional use.

SUMMARY:

Group A streptococcus is an important public health threat as a cause of strep throat, scarlet fever, impetigo, necrotizing fasciitis, cellulitis, streptococcal toxic shock syndrome, rheumatic fever, post-treptococcal glomerulonephritis, a leading cause of acquired heart disease. GAS is a human-specific pathogen that is highly prevalent worldwide, causing 750 million infections per year. Death rates are high in streptococcal invasive infections, ranging from about 20% for necrotizing fasciitis to almost 100% for myositis. Laboratory diagnosis of group A streptococcal infection still relies primarily on culturing the bacteria from clinical specimens. This way it takes at least 18 to 48 hours to get accurate results. Group A Streptococcus Antigen Test Kit provides results in a short time with high diagnostic sensitivity and specificity and is specific to group A with no cross-reactivity to other groups of streptococci.