Real-time RT-PCR, Home Collection, Multiple Targets, Screening, Pooling Letter Granting EUA Revision(s) (July 18, 2023).Letter Granting EUA Revision(s) (February 10, 2023).RT, LAMP, Over the Counter (OTC) Home Testing, Saliva, Screening, Multiple Targets Real-time RT-PCR, Home Collection, Saliva, Multiple Targets Michigan State University laboratories, Department of Medicine Olin Student Health Center “RT, LAMP, Over the Counter (OTC) Home Testing, Multiple Targets Authorized EUAs for Multi-analyte Respiratory Panel Tests are assigned the QLT product code.ĭiagnostic (Most Recent Letter of Authorization) and Date EUA Original Issue more likely to continue to perform well when new variants emerge.ĮUAs for standalone specimen collection devices, including home collection kits which do not include an assay in the EUA, will not have a target designation in the attribute column.Īuthorized Molecular Diagnostic Tests for SARS-CoV-2 are assigned the QJR product code.Īuthorized Home Collection Kits are assigned the QLW product code.designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome.Tests with "multiple targets" in the attribute column are: more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.designed to detect only one viral target on the SARS-CoV-2 genome.Tests with "single target" in the attribute column are: In addition to COVID-19 tests issued EUAs, there are molecular SARS-CoV-2 diagnostic tests that have been authorized through traditional premarket review pathways. To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the "Date EUA Issued or Last Updated" for the EUA.įor information on test EUAs that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD). Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests). For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. Test attributes are listed in the "Attributes" column. These emergency use authorizations (EUAs) have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. The table below includes information about authorized SARS-CoV-2 molecular diagnostic tests. Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2 EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests.Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing.Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2.Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2.IVDs for Management of COVID-19 Patients.Serology and Other Adaptive Immune Response Tests for SARS-CoV-2. ![]()
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