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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

June 3, 2024CDC LOCSBy Admin

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)

May 31, 2024Laboratory WatchBy Admin

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 COLA Primer

May 29, 2024COLA PrimerBy Admin

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…

Primary HPV Testing in Cervical Cancer Screening (Part 4)

May 23, 2024Laboratory WatchBy Admin

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…

FDA Webinar About Final Rule Regarding Laboratory Developed Tests

May 13, 2024UncategorizedBy Admin

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,…

CDC Issues Alert for Adverse Effects Linked to Counterfeit or Mishandled Botulinum Toxin Injections

May 1, 2024CDC LOCSBy Admin

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…

Malaria Resurgence in the US: Understanding the Past and Preparing for the Future

April 25, 2024Laboratory WatchBy Admin

Medical Laboratory Professionals Week in 2024: A Salute to Unsung Heroes

April 14, 2024Laboratory WatchBy Admin

As April showers us with its vibrant blooms, the healthcare sector and the public shine a spotlight on a crucial yet often underrecognized group—medical laboratory professionals. The 49th Medical Laboratory Professionals Week (MLPW), running from April 14-20, 2024, is a tribute to these pivotal figures in healthcare and medicine, highlighting their vital contributions. The Rich…

Increase in Global and Domestic Measles Cases and Outbreaks: Ensure Children in the United States and Those Traveling Internationally 6 Months and Older are Current on MMR Vaccination

April 11, 2024CDC LOCSBy Admin

On March 18, 2024, the U.S. Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) message to inform clinicians and public health officials of an increase in global and U.S. measles cases and to provide guidance on measles prevention. Clinical laboratories should review the Lab Tools for Measles for information on…

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