American Screening, Shreveport, La, has added a covid-19 IgG/IgM rapid test to its inventory. The in vitro immunoassay, which has been granted emergency use authorization (EUA) by the FDA, is designed for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is easy to administer and delivers results in about 15 minutes and has shown a high level of accuracy. “Our team has worked tirelessly during the pandemic to minimize supply chain disruptions and maintain essential products in stock while also adding new items. By making the covid-19 IgG/IgM rapid test available in our store, we are proudly contributing to the fight against this disease and supporting efforts to resolve the public health crisis to the best of our ability,” American Screening says. The test is intended to provide qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, serum, or plasma. Healthcare professionals can use it as an aid in identifying people with an adaptive immune response to covid-19, which would indicate a past or recent infection. Clinical evaluation has shown the test to be highly accurate. For IgM detection, the overall confidence interval is 95%, while relative sensitivity, relative specificity, and overall agreement are 93.7%, 99.1%, and 97.7%, respectively. The confidence interval is the same for IgG detection, whereas the respective figures for relative sensitivity, relative specificity, and overall agreement are 98.8%, 98.7%, and 98.7%. Since this fast and accurate test does not require extra equipment, it is suitable for application at points of care. American Screening is keen to emphasize that the product is designed exclusively for professional use, and its emergency approval grants authorization only to laboratories with a moderate or high complexity license extended under the Clinical Laboratory Improvement Amendments (CLIA) regulations. For more information, visit American Screening.
