Physician Practice

Guidance for the deployment of the Emergency Use Approval (EUA) Zika virus tests

Physician Practice Insider, April 19, 2016

Guidance for the deployment of the Emergency Use Approval (EUA) Zika virus testsOn March 25, CMS provided guidance regarding the deployment of the EUA Zika virus tests, approved by CLIA, to state and local Public Health Laboratories (PHL) by the CDC. 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. If test kits are noted during surveys, Regional Offices (RO) must confirm that the Zika Immunoglobulin M Antibody Capture Enzyme-Linked Immunosorbent Assay and/or the Trioplex Real Time RT-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. 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 CDC’s guidance.

View the survey and certification letter.

This article was originally published on Medicare Compliance Watch.

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