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The U.S. Centers for Disease Control and Prevention (CDC) continues to distribute an FDA 510k-cleared IVD influenza A(H5) assay to state and jurisdictional public health laboratories to test patients for influenza A(H5) virus. CDC is also aware of recent development and use of IVDs offered as LDTs independent of state and jurisdictional public health laboratories…
On November 18, 2024, The Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Advisory to provide information about the first case of clade I mpox diagnosed in the United States and recommendations to clinicians about preventing, diagnosing, treating and reporting mpox cases. On November 15, 2024, the California Department of Public…
Welcome back to our ongoing series on the use of primary HPV testing in cervical cancer screening. In this installment, we aim to shed light on the issues of false negatives and false positives that can occur with primary HPV testing. False Negative HPV Results The advent of HPV tests has undoubtedly transformed cervical cancer…
The global effort to eradicate Guinea worm disease, or dracunculiasis, is nearing a historic milestone, thanks to decades of persistent, community-driven initiatives that have dramatically reduced human cases. However, recent challenges, particularly the rise of infections in domestic animals like dogs, threaten to reverse this progress. These setbacks underscore the unpredictable nature of disease eradication…
Breast cancer remains a leading cause of morbidity and mortality worldwide. In the U.S., one in eight women is expected to develop breast cancer in their lifetime. Laboratory testing is indispensable in the diagnosis and management of this disease. In recognition of National Breast Cancer Awareness Month, observed each October, this blog highlights the key…
On October 3, 2024, the U.S. Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Advisory about the confirmed outbreak of Marburg virus disease (MVD) in the Republic of Rwanda. As of October 2, 2024, 36 laboratory-confirmed cases and 11 deaths have been reported in the Republic of Rwanda, including at…
Chagas disease, caused by the Trypanosoma cruzi parasite and transmitted by triatomine insects, or “kissing bugs,” affects over 6 million people worldwide, leading to around 10,000 deaths annually. Despite its global impact, awareness of Chagas disease remains low, especially in the United States. Two Phases of Chagas Disease Chagas disease progresses through two distinct phases:…
