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The Clinitek Novus Automated Urine Analyzer uses dry-pad urine chemistry technology and a cassette test format to provide a variety of chemistry strip tests.
The tests are semi-quantitative, meaning that they estimate the quantity of a patient's antibodies produced against infection, the FDA said.
Plummeting testing for routine care activities due to COVID-19 had a negative revenue impact in all regions during the third quarter, according to the firm's CFO.
According to the registry's first dataset, more than 65 million tests have been manufactured and shipped across the US.
The firms supporting the new lab include Thermo Fisher Scientific, Canon Medical, and Siemens Healthineers, all of which will contribute their know-how and technologies to the effort.
A comparison of four antibody tests available for coronavirus testing in the UK revealed that only the Siemens Healthineers assay met sensitivity requirements.
Horiba received clearance for its Yumizen C1200 CRP reagent used to measure C-reactive protein for evaluation of infections, tissue injury, and inflammatory disorders.
The firm developed the total antibody test for use on its Dimension analyzers alongside its development for its Advia Centaur and Atellica analyzers.
Quidel received funding to develop a four-analyte antigen test to run on the firm's Sofia 2 point-of-care multiplex platform.
Hologic received clearance for a change to a probe reagent in the Aptima Combo 2 assay to detect variants of Chlamydia trachomatis that have emerged recently.