Shots: The US FDA has issued EUA for Abbott’s BinaxNOW COVID-19 Ag Card rapid test for the detection of COVID-19. The test will be available at $5 and can deliver results in 15mins. The test utilizes lateral flow technology and has demonstrated a sensitivity of 97.1% and specificity of 98.5% in a clinical study. Additionally, […]Read More
Shots: The US FDA has granted Emergency Use Authorization (EUA) for its rapid point-of-care BD Veritor SARS-CoV-2 Assay which allows the result in 15 mins evaluated in 20 sites across the US with 84% sensitivity and 100% specificity. Additionally, BD plans for increasing capacity to produce 2M tests per week by the end of September […]Read More
Shots: Sorrento has reported that its EUA is under review at the US FDA for its COVI-TRACK in vitro diagnostic test kit for the detection of IgG and IgM Abs in sera of patients exposed to the SARS-CoV-2 virus Following the issuance of an EUA, the COVI-TRACK test will be available for distribution to clinical […]Read More
Shots: Abbott’s SARS-CoV-2 IgG lab-based serology blood test is the fourth COVID-19 detection test to receive the FDA’ EUA based on Alinity i platforms, which is a next-generation immunoassay instrument offering efficiency to lab clinicians for running tests SARS-CoV-2 IgG lab-based serology blood test is a reliable test for customers and patients to detect Abs […]Read More
Shots: The US FDA has granted EUA for its COVID-19 Droplet Digital PCR (ddPCR) test that runs on Bio-Rad’s QX200 and QXDx ddPCR systems Due to its high sensitivity, the test is well-suited for screening upper respiratory samples in patients with a low viral load as compared to other quantitative PCR tests. The test provides […]Read More
Shots: 1Health.io and its lab partners have launched telehealth supervised self-collection kits for COVID-19 diagnosis. The company reports the availability of 50,000 FDA’s approved self-collection kit and ramp up ~ 300,000 test kits by May’2020 The company will initially release the supply of test kits to HCPD who want to remotely collect specimens from COVID-19 […]Read More
Shots: The new Elecsys anti-SARS-CoV-2 serology test supports the detection of Ab against SARS-CoV-2 in patients that are exposed to the virus which causes COVID-19. The detection of Ab helps to identify people infected by the virus, especially those who have been infected but did not show symptoms The Elecsys Anti-SARS-CoV-2 immunoassay is an in […]Read More
Shots: Abbott has launched its third COVID-19 test, a lab-based serology blood test to detect AB, IgG that identifies a person with COVID-19. The Ab testing will provide more understanding of the virus, including how long Ab stay in the body and if they provide immunity The serology test follows Abbott’s existing COVID-19 tests, including […]Read More
Shots: The US FDA has granted EUA to the BD’s molecular diagnostic test for COVID-19 that provides results in 2-3hrs. The BD SARS-CoV-2 Reagent Kit for BD MAX System has been CE marked to the IVD Directive (98/79/EC) The test is run on the BD MAX System to augment supply from existing collaboration with BioGX […]Read More
Shots: BioMedomic develops and manufactures the POC tests that will be available through BD and distributed exclusively by Henry Schein to the HCPs in the US The POC test detects Abs in the blood to confirm current or past exposure to COVID-19. The test has been clinically validated at several hospitals and clinical laboratories in […]Read More
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