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Title
Guidance for the Deployment of the Emergency Use Approval (EUA) Zika Virus Tests
Memo #
16-16-CLIA
Posting Date
2016-03-25
Fiscal Year
2016
Summary
• Deployment of the EUA Zika Virus Tests: The Centers for Medicare & Medicaid Services (CMS) is providing guidance regarding the deployment of the EUA Zika Virus Tests, approved by the Clinical Laboratory Improvement Amendments (CLIA), to State and local Public Health Laboratories (PHLs) by the Centers for Disease Control and Prevention (CDC). • The Tests: Two Zika virus tests with corresponding protocols have been developed by the CDC for use by State PHLs and have received EUA by the FDA. • Surveyor Guidance: If test kits are noted during surveys, Regional Offices (ROs) must confirm that the Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) and/or the Trioplex Real Time RT-PCR (rRT-PCR) Assay was verified by each laboratory per the CDC protocol, and that corresponding CLIA policies and procedures are in place to ensure readiness and compliance in the event of an outbreak. • CDC Directions to State PHLs: Upon receipt of the Zika virus test system and corresponding instructions and information, State PHLs will verify the developed test specifications in their laboratory per the CDCs guidance.
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