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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…
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…
On June 3, 2024, the U.S. Centers for Disease Control and Prevention (CDC), in collaboration with the State, Tribal, Local, and Territorial (STLT) public health agencies, has developed a multi-faceted enhanced summer influenza surveillance strategy that will be modified as new information becomes available or the situation changes warranting a revised approach.
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…
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…
Proficiency Testing (PT) is an important aspect of a laboratory’s overall assessment of quality. PT serves as an external check to verify the accuracy of a laboratory’s test results by providing an unknown specimen for analysis by the laboratory. This resource provides laboratories with requirements, processes, and procedures to achieve quality testing and meet CLIA…
Welcome back to our series on primary HPV testing in cervical cancer screening. Today, we turn our attention to the experts who have raised significant concerns about the American Cancer Society’s (ACS) 2020 guidelines advocating for HPV testing as the preferred screening strategy over other options. This topic has sparked a considerable amount of debate…
On May 14, 2024, the U.S. Food and Drug Administration (FDA) is hosting a webinar to discuss the final rule “Medical Devices; Laboratory Developed Tests” (LDTs). FDA will provide an overview of the final rule amending the FDA’s regulations to make it explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food,…
On April 23, 2024, CDC issued a Health Alert Network (HAN) message about the risks of counterfeit or mishandled botulinum toxin injections. CDC, the U.S. Food and Drug Administration (FDA) and state and local partners are investigating clusters of 22 people in 11 U.S. states reporting adverse effects after receiving injections with counterfeit botulinum toxin or…
