Smartphone Tests Detect Frontotemporal Dementia
Cognitive tests administered through a smartphone mobile application (app) accurately and reliably detected frontotemporal lobar degeneration (FTLD), also known as frontotemporal dementia (FTD), an observational study showed. The smartphone tests had moderate to excellent internal consistency and test-retest reliability (intraclass correlation coefficient range of 0.77-0.95), according to Adam Staffaroni, PhD, of the University of California […]
House Committee Wrestles With Lab Test Regulation
Members of a House committee mostly agreed that laboratory-developed tests need more oversight, but were divided Thursday on how best to approach the topic. The issue at hand was a proposed rule from the FDA that would require medical facilities that use lab tests developed in-house to get the tests approved by the FDA, something […]
Lab Tests That Escape FDA Oversight May Come Under Agency Review
The FDA issued its long-awaited proposal for regulating laboratory developed tests (LDTs) on Friday. The proposed rule would amend FDA regulations to make explicit that in vitro diagnostic products (IVDs) are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. The agency also wants […]
Direct-to-Consumer Lab Tests Raise Ethical Questions, Researchers Say
Direct-to-consumer (DTC) laboratory tests — for the thyroid, hormonal biomarkers, or diabetes and hemoglobin A1c, for example — often had unclear terms of sale and vague privacy policies, a qualitative study showed. Of 21 U.S. companies that offered DTC lab tests, less than half declared compliance with the Health Insurance Portability and Accountability Act (HIPAA), […]
FDA Reviewers Have Concerns About Artificial Womb Trials in Humans
FDA staff raised concerns that need to be addressed prior to potential human tests of artificial womb technology (AWT), a device that simulates a womb for extremely premature infants, as detailed in briefing documents released ahead of a Pediatric Advisory Committee meeting next week. AWT devices are intended to treat extremely premature infants, who have […]
At-Home Test Performance Declined During Omicron
The performance of certain at-home rapid antigen tests declined during Omicron, Dutch researchers found. From December 2021 to February 2022, sensitivities for three commonly used tests in the Netherlands dropped, though only the decline with Clinitest was statistically significant: Flowflex: 87% to 80.9% MPBio: 80% to 73% Clinitest: 83.1% to 70.3% Adding an oropharyngeal swab […]
Can I Use My Expired At-Home COVID Tests?
People who stocked up on at-home COVID-19 tests during this past winter’s Omicron surge may have expired test kits on hand. But before tossing them in the trash, check to see if their shelf-life has been extended, as the FDA has updated expiration dates for some tests based on new data. Among those tests are […]
Women’s heart attacks are often missed: This gene may help explain why
When diagnostic tests for the heart were first created, scientists at the time did not fully consider that no two bodies are the same, especially between the sexes. According to University of Florida College of Nursing associate professor Jennifer Dungan, many of the current symptom profiles and lab tests for heart disease do not accurately […]
How Do They Test for ADHD in Adults? 7 Diagnostic Steps
Doctors may conduct several tests to detect attention deficit hyperactivity disorder (ADHD) in adults. Learn about how ADHD in adults is diagnosed There is no specific test that can detect attention deficit hyperactivity disorder (ADHD) in adults. However, doctors can confirm a diagnosis of adult ADHD based on multiple tests and evaluations. According to the […]
Home-based flu tests as accurate as rapid diagnostic testing in clinical settings: Study findings underscore imperative of expanding test access and lowering costs
Home-based, self-administered tests for influenza are comparable in accuracy to rapid diagnostic tests in clinical settings, according to a recently published, peer-reviewed study. “Home tests are a valuable tool to support the management of influenza and other respiratory infections,” said Matthew J. Thompson, professor of global health and family medicine at the University of Washington […]