The US Food and Drug Administration (FDA) has classified the recall of Ellume’s Covid-19 test as Class 1, marking it as the most serious kind of recall. Last month, the company recalled some batches of its COVID-19 Home Test due to increased rates of false-positive test results. The FDA received 35 reports of false-positive results associated with the over-the-counter antigen test. In December last year, the test received Emergency Use Authorization from the FDA for use in individuals aged two years and above to detect Covid-19 using a nasal sample. To date, 2,212,335 tests have been recalled in the US.
GoMeyra has entered a collaboration with Alliance Health to boost its Covid-19 testing capabilities. Alliance Health, with facilities in New York and Florida, US, provides walk-in, mobile, drive-through and onsite testing services. Use of GoMeyra’s Laboratory Information Management Solution (LIMS) is intended to help Alliance Health handle more samples. LIMS is a cloud-based system that offers fast processing times for Covid-19 reverse transcription-polymerase chain reaction (RT-PCR), antibody, antigen, rapid PCR as well as serology testing, GoMeyra said.
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Meridian Bioscience’s Revogene SARS-CoV-2 assay. The test is intended to qualitatively identify the SARS-CoV-2 virus using nasopharyngeal, anterior nasal, oropharyngeal as well as mid-turbinate nasal swab samples. With a positive percent agreement and a negative percent agreement of 97.7%, the test can deliver a positive result in just 47 minutes. The company plans to commence shipping of the molecular diagnostic tests before the end of 2021.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below formBy GlobalData