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The test targets antibodies for the viral spike protein and can characterize a vaccine-induced immune response.
The proposed order is intended to give patients more timely access to the tests by moving them from Class III to Class II and providing special controls.
The test detects the presence of two biomarkers within a single cell associated with HPV infections that can progress to cervical cancer.
The test is designed to detect and differentiate SARS-CoV-2, influenza A, and influenza B and runs on the company's benchtop Cobas Liat system.
Federal mandates requiring frequent SARS-CoV-2 testing for nursing home employees and significant purchases of rapid antigen tests from HHS have raised concerns about capacity.
The new report said that point-of-care testing could rise to 70 million tests per month, or more, by October based on manufacturers' announced market entry plans.
Healthcare providers need multiplexed tests that can differentiate the flu from the coronavirus so they can treat patients quickly and appropriately.
The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.
The RT-PCR test runs on Roche's automated Cobas 6800/8800 systems and is also available in countries accepting the CE mark.
The point-of-care test provides results in 15 minutes and can be used for both symptomatic and asymptomatic patients.