productThis company’s rapid Strep A dispstick test, which was 510(k) cleared earlier this year, has now been CLIA-waived. The throat-swab test gives results in five minutes.
     The overall sensitivity of this company’s test is 97%. During clinical studies, the test was able to accurately detect a high percentage of rare and low colonization positives.
     Available for use in physician offices, the speed and accuracy of this test allows physicians to make treatment decisions while the patient is in the office. Quicker diagnosis and treatment can help reduce the risk of complications and the spread of the infection.
     The test may be stored at room temperature and has a long shelf life. The kit contains all materials required for testing. Positive and negative control solutions are included.
Acon Laboratories
Keywords: rapid test, waived test, strep