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Validation and verification of a new assay are integral components of implementation of any test in a clinical laboratory. To reduce potential biosafety risks and enhance laboratory safety for handling patient specimens that may contain monkeypox virus (MPXV), laboratories may consider implementing one or more methods to inactivate MPXV during nucleic acid amplification testing (NAATs).

The American Society for Microbiology has developed guidelines outlining general considerations for laboratories seeking to include MPXV inactivation protocols in their NAAT testing, whether for MPXV or other pathogens such as herpes simplex virus (HSV) or varicella zoster virus (VZV). The recommendations for completing a test performance evaluation when modifying an existing qualitative NAAT to include viral inactivation steps are included. It also provides a link to the ASM’s MPXV white paper for general biosafety considerations. These guidelines will prove helpful to laboratories that are handling specimens and performing molecular virology testing including MPXV, HSV, and VZV.

This guideline was developed on behalf of the American Society for Microbiology Clinical and Public Health Microbiology Committee, Laboratory Practices Subcommittee. 

Contact Information  

ASM's Clinical and Public Health Microbiology Committee,