A disease can only be diagnosed and treated with prior testing. This process uses the so-called diagnostic tests, which identify a viral infection through a saliva or blood sample. In recent months, there has been a surge in public awareness about antibody (serology) testing due to the novel coronavirus pandemic, with health experts and medical professionals highlighting the importance of these tests for informing research and policy decisions. As one of the biggest and most trusted suppliers of diagnostic products, American Screening, LLC considers it its duty and privilege to support efforts for safeguarding the public health, making its contribution through providing an extensive inventory of top-quality, accurate, and affordable solutions. Its vast selection of products includes a number of essential antibody tests, the most recent addition being the CLIA-waived COVID-19 rapid serology kit.
The FDA (US Food and Drug Administration) explains on its website that serological tests detect antibodies present in the blood when the body is responding to a specific infection. The severity and unprecedented socio-economic impact of the current pandemic have made testing a key weapon in the fight against SARS-CoV-2 (COVID-19), both in terms of curbing the spread of the virus and obtaining actionable data to support the development of effective vaccines and treatments. The representatives of American Screening, LLC say they are immensely pleased to have added a COVID-19 IgG/IgM rapid test to their inventory. This in-vitro immunoassay is designed 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. The test was granted Emergency Use Authorization (EUA) by the FDA, is simple to run, delivers results in about 15 minutes, and boasts an impressive accuracy.
While COVID-19 is currently the dominant global concern from a public health perspective, there are other viruses that have presented persistent challenges worldwide in recent decades due to their epidemic proportions. Among them is HIV (human immunodeficiency virus), which triggered the AIDS (acquired immunodeficiency syndrome) epidemic in the 1980s and remains one of the most serious public health problems in some regions of the world. The HIV 1/2 antibody test offered by American Screening, LLC is highly accurate (greater than 99% agreement with confirmatory Western blot) and delivers results within 20 minutes. In addition, it is CLIA-waived for oral fluid, fingerstick, and venipuncture whole blood, which makes testing possible in non-traditional environments, such as outreach programs and mobile clinics.
Another essential serology test stocked by American Screening, LLC is the one designed to detect antibodies produced in response to the presence of HCV (hepatitis C virus). The first to be approved by the FDA, this rapid test works with fingerstick and venipuncture whole blood, providing results in 20 minutes with more than 98% accuracy. American Screening, LLC also carries test kits that help medical professionals diagnose conditions linked to H. Pylori (a bacterium responsible for gastrointestinal disorders, most commonly ulcers) or the presence of thyroid peroxidase (TPO) antibodies (which indicate an autoimmune thyroid disease).
Since its launch in 2004, American Screening, LLC has steadily built its reputation by prioritizing product quality and customer service, growing over the years to become an ISO13485 contract manufacturer and premier distributor of diagnostic tests and essential medical supplies to the United States, South America, Asia, Africa, Europe, and Australia. Its rigorous adherence to the highest operational standards has been acknowledged through multiple certifications, including one under the Medical Device Single Audit Program (MDSAP) – an honor awarded to only a handful of companies. This certification designates American Screening, LLC as compliant with the quality management requirements of numerous 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