Novel Influenza A Virus Biosafety Guidance Update

On June 6, 2024, the U.S. Centers for Disease Control and Prevention (CDC) updated the laboratory biosafety guidelines for handling and processing specimens associated with Novel Influenza A viruses webpage to include additional information about risk assessment and mitigation, diagnostic testing, and decontamination and waste management. The risk posed by Novel Influenza A viruses to the public…

CDC Enhanced Summer 2024 Influenza Surveillance Strategy

On June 6, 2024, the Administrator of the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced a temporary exemption for H5 avian influenza viruses from the requirements of the select agent and toxin regulations for a period of three years utilizing the exemption authority under 9 C.F.R. §121.5(f). This exemption replaces all…

Enforcement Discretion Granted for the Use of Conjunctival Swabs with the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Kit

On May 24, 2024, the U.S. Food and Drug Administration (FDA) granted enforcement discretion for the use of conjunctival swabs as an acceptable specimen type with the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Kit. Laboratories may now submit conjunctival swabs from patients that meet Epidemiologic criteria AND either Clinical OR Public…

Primary HPV Testing in Cervical Cancer Screening (Part 5)

Welcome back to our ongoing series about the role of HPV testing in the early detection of cervical cancer. In this installment, we delve into the complex issues surrounding false negatives and false positives in primary HPV testing.  The Challenge of False Negatives  While HPV tests have significantly improved in sensitivity compared to traditional cytology-based…