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The real-time RT-PCR multiplex test is intended for the simultaneous detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus.
Issued last week, the guidance said insurers were not required to reimburse such testing, which could impact coverage in schools, workplaces, and other settings.
Recent guidance from HHS has improved data collection by clarifying which testing data all laboratories must report, including demographic data.
Roche will have non-exclusive access to SpeeDx's existing tests and technology to enable expansion of diagnostic products for antibiotic resistance in STIs.
Warrior Diagnostics' RT-PCR test detects SARS-CoV-2 RNA in nasopharyngeal swab samples and uses the same primers and probes as the CDC SARS-CoV-2 test.
The system detects Zika virus IgM antibodies in human serum, potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens.
Some of the additional data required includes the patient's age, race, ethnicity, sex, and residence zip code, along with info about the ordering provider.
CDC Director Robert Redfield told a congressional subcommittee about the test, for which the center plans to seek Emergency Use Authorization from the FDA.
The recommendations are intended to improve testing capacity for SARS-CoV-2 by providing ways to combat testing supply shortages and expanding funding, among other steps.
A professor of pathology and laboratory medicine, Gregory Tsongalis has published a paper detailing his lab's work on SARS-CoV-2 testing and the challenges faced.