In vitro diagnostics are crucial tools for disease surveillance. Serological immunoassays, for example, can indicate whether someone has had a viral infection — particularly important during this ...

As more and more COVID-19 data are collected, the clearer our picture of the novel disease becomes. One of the most important pieces of the puzzle (though we stress that it is nevertheless only one ...

Molecular test, or nucleic acid amplification, has been recommended by the FDA for the diagnosis of the COVID-19 virus. Nucleic acid amplification testing necessitates the collection of respiratory ...

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Shuren, Stenzel push back on serology tests; FDA touts accomplishments for 2020; IMDRF ...

MADISON, Wis.--(BUSINESS WIRE)--Promega Corporation today announced the launch of its new serological antibody test for COVID-19 to detect the presence of antibodies against the SARS-CoV-2 virus. A ...

Testing for COVID-19 continues to be too little too late in the United States. Many groups are working on closing the testing gap, by innovating new tests for both the presence of the virus and ...

WALTHAM, Mass.--(BUSINESS WIRE)-- PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, announced today that the U.S. Food and Drug Administration (FDA) has ...

A fascinating new preprint discusses the potential for customized serologic testing in individuals who have or have not been vaccinated against the severe acute respiratory syndrome coronavirus 2 ...

As debate intensifies about how and when the country can resume regular life, immunity testing widely seen as essential for that reopening is mired in the same competition and chaos that marred ...

The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their ...

A new test that boasts nearly 100% accuracy has recently been approved, but debate still surrounds how useful such tests might be for both populations and individuals. Dale Smith is a former Associate ...