The agency’s EUA grants permission for Cepheid’s test to be used in high- and moderate-complexity CLIA-certified laboratories as well as in certain patient care settings.
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The test is highly specific to covid-19 and targets several regions of the viral genome to minimize the impact on performance should there be possible future mutations.
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If authorized, the new tests would increase the potential capacity to screen for covid-19 by thousands of tests per day.
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The virus was detectable for up to 3 hours in aerosols, up to 4 hours on copper, up to 24 hours on cardboard, and up to 3 days on plastic and stainless steel.
Read MoreSection 1135 authority includes the ability to grant state and territorial Medicaid agencies a wider range of flexibilities. States may now submit Section 1135 waiver requests that will remove administrative burdens and expand access to needed services.
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