As a premier domestic and international manufacturer and distributor of diagnostic products and essential medical supplies, American Screening, LLC is pleased to announce its inventory was supplemented with a COVID-19 IgG/IgM rapid test. This is an in-vitro immunoassay that was granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). It 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 not only simple to administer, it also delivers results in about 15 minutes with an impressive high level of accuracy.
According to American Screening, LLC governments around the world designated testing as their main priority in their efforts to halt the spread of the novel coronavirus that caused unparalleled turmoil in social and economic systems. The company adds that it is vital to ensure that healthcare workers and medical facilities can access diagnostic tests in large quantities and as fast as possible. Its team worked tirelessly during the pandemic to minimize supply chain disruptions and maintain essential products in stock while adding new items as well. The company is proud to contribute to the fight against the virus and the crisis by making the COVID-19 IgG/IgM rapid test available in their store.
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.
American Screening, LLC Now Offers COVID-19 Antibody Rapid Serology Tests: https://www.biospace.com/article/releases/american-screening-llc-now-offers-covid-19-antibody-rapid-serology-tests/
American Screening LLC Founder, Ron Kilgarlin, on Improved Efficiency in Decision-Making with Rapid Drug Tests: https://apnews.com/article/coronavirus-pandemic-business-technology-health-4984166f0d2a716baa5137741175445b