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On June 11, 2024, BD Life Sciences sent a letter to inform BD BACTEC Blood Culture System Users that they may experience intermittent delays in supply of some BD BACTEC blood culture media bottles over the coming months. The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are working…
On June 25, 2024, CDC issued a Health Alert Network (HAN) message about an increased risk of dengue virus (DENV) infections in the United States in 2024. The CDC is actively implementing several strategies to address the increase in cases of dengue including expanding laboratory capacity to improve laboratory testing approaches. Information about clinical testing guidance for dengue and instructions…
As the healthcare landscape evolves, the need for rapid and accurate diagnostic tests has never been greater. Among these, the D-Dimer test is indispensable for diagnosing and excluding venous thromboembolism (VTE) such as deep vein thrombosis (DVT) and pulmonary embolism (PE). With growing awareness and technological advancements, the D-Dimer testing market is poised for substantial…
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…
