American Screening, LLC, a leading local and global producer and supplier of diagnostic products and essential medical materials, is happy to introduce a COVID-19 IgG/IgM rapid test. The in-vitro immunoassay, which has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (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. Aside from being simple to administer, the test delivers results in about 15 minutes and has shown an impressively high level of accuracy.
“Governments around the world have designated testing as one of the top priorities in their efforts to arrest the spread of the novel coronavirus, which has caused unprecedented turmoil in social and economic systems. It is, therefore, vital to ensure that healthcare workers and medical facilities can access diagnostic tests in large quantities and obtain the kits as fast as possible. 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, LLC says.
The test is intended to provide qualitative detection and differentiation of IgM (Immunoglobulin M) and IgG (Immunoglobulin G) 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, as American Screening, LLC notes. 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, LLC 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.
American Screening, LLC was founded in 2004 by Ron Kilgarlin, who currently serves as the company’s CEO. Through his expertise in business management, medical devices, product development, distribution, and marketing, he has built the Shreveport, Louisiana-based enterprise into a leading provider of diagnostic tests and medical supplies to the United States, South America, Asia, Africa, Europe, and Australia. American Screening, LLC holds multiple certifications, among them the highly coveted one issued under MDSAP (Medical Device Single Audit Program). It has been granted only to a handful of companies, designating them as compliant with the requirements for quality management systems in multiple jurisdictions.
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