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# FDA Issues Abbott EUA for Monkeypox Test
- URL: https://www.fdaweb.com/fda-issues-abbott-eua-for-monkeypox-test/
- Published: 2022-10-07T12:00:00.000Z
- Updated: 2026-09-14T18:02:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152926

FDA has issued Abbott Molecular an emergency use authorization for its Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. This is the first commercial test kit to be authorized for detection of monkeypox, the [agency says](https://content.govdelivery.com/accounts/USFDA/bulletins/3311f43?ref=fdaweb.com). It is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures, and testing is limited to CLIA-certified laboratories that meet the requirements to perform moderate or high complexity tests.