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UrduWith the first home collection test kit for COVID-19 now authorized by the FDA, AACC is warning that more evidence is needed before the country can rely on home-based kits.
Tag: Aacc
AACC Launches Free Video Series to Help Explain COVID-19 Testing
To address some of the confusion surrounding COVID-19 testing, AACC today launched a video series in which leading laboratory experts answer common questions about tests for the pandemic. From persistent supply shortages to the emergence of antibody tests, these videos quickly answer the questions that patients and the general public have been asking.
Lab Experts Can Fill Gaps in FDA Regulation by Validating COVID-19 Antibody Tests
Now that diagnostic companies can sell COVID-19 antibody tests without FDA authorization, healthcare teams should work closely with clinical laboratory experts to ensure that these tests are thoroughly validated and used appropriately. A new opinion piece in AACC’s Clinical Chemistry journal emphasizes that this is critical to minimizing the risk of inaccurate results from these tests, which could have potentially life-threatening consequences.
AACC Commends Congress for Including Funding for Testing Improvements in the Latest Coronavirus Relief Package
AACC commends Congress for responding to the concerns of the clinical laboratory community and including $25 billion in the Paycheck Protection Program and Health Care Enhancement Act that is broadly marked for expanding the nation’s coronavirus testing capacity.
AACC Announces 2020 Award Winners; Celebrates Achievements in Laboratory Medicine
AACC, a global scientific and medical professional organization dedicated to better health through laboratory medicine, is pleased to announce the recipients of the 2020 AACC and AACC Academy Awards. Through this annual awards program, AACC and its academy recognize individuals worldwide for exceptional research and service in the field of laboratory medicine, and strive to raise awareness that clinical laboratory testing is vital to quality patient care.
The Federal Government Must Act on Supply Chains to Enable COVID-19 Testing in High Volumes
With shortages of test components and swabs, labs still face huge obstacles to COVID-19 testing. With new White House guidelines reliant on more testing, AACC is urging the administration to find and coordinate resources so lab experts can do their jobs.
The Need for FDA to Regulate Poorly Performing Commercial COVID-19 Tests Should Not Hinder Laboratory-Developed Tests
In the wake of FDA’s decision to loosen its emergency use authorization criteria for COVID-19 tests, reports have now been surfacing about unreliable commercial COVID-19 serological tests. While this is a major concern, AACC wants to emphasize that these problematic commercial tests are not the same as laboratory-developed tests–and that we still strongly support FDA’s decision to step back from regulating lab-developed tests for COVID-19.
Novel Research in AACC’s Clinical Chemistry Journal Shows That Vitamin D Supplements Do Not Prevent Osteoporotic Fractures
A first-of-its-kind study published in AACC’s Clinical Chemistry journal has found that low vitamin D levels alone do not cause osteoporotic fractures. This research could resolve the longstanding debate over whether vitamin D supplements prevent these fractures, and indicates that members of the general population should not rely on vitamin D by itself for this purpose.
AACC Reschedules 2020 AACC Annual Scientific Meeting & Clinical Lab Expo to December to Ensure a Healthy and Safe Meeting Experience for Attendees
AACC is pleased to announce that the organization will be able to preserve the complete 2020 AACC Annual Scientific Meeting & Clinical Lab Expo experience for its attendees by moving the meeting to December 13-17, 2020. After carefully monitoring the ongoing global crisis caused by the COVID-19 outbreak, the association’s leadership determined that rescheduling is the best way to safeguard the health of meeting attendees, partners, and staff, which is AACC’s number one priority.
AACC Applauds the Senate for Updating Its Legislation to Ensure that All Patients Have Access to COVID-19 Testing
AACC applauds the U.S. Senate for responding to the concerns of the clinical laboratory community and revising the Coronavirus Aid, Relief, and Economic Security (CARES) Act to ensure that it provides insurance coverage for all COVID-19 tests, regardless of whether or not they are performed under an FDA emergency use authorization (EUA).
When Mothers Receive Fentanyl Epidurals During Labor, the Fentanyl Gets Passed on to Their Babies
Breaking research in AACC’s The Journal of Applied Laboratory Medicine shows that the fentanyl in epidurals can pass on to babies during labor. While the infants in this study did not experience adverse effects from this fentanyl transfer, this information is crucial to ensuring that new mothers don’t get falsely accused of fentanyl abuse, which can have dire social repercussions for mother and child.
AACC Launches Directory of U.S. Labs That Are Performing COVID-19 Testing
To facilitate rapid identification of COVID-19 cases, AACC has launched a directory of U.S. clinical laboratories that are, or will be, performing testing for SARS-CoV-2, the virus that causes COVID-19. This directory is designed to help healthcare providers quickly find laboratories that can diagnose patients suspected to have COVID-19.
AACC Urges Congress to Ensure That All COVID-19 Tests Are Covered by Insurance Now That FDA Has Released Guidance That Will Expand Testing Access
On March 16, FDA updated its guidance on COVID-19 testing to allow clinical labs to create and perform COVID-19 tests without pursuing FDA emergency use authorization (EUA). AACC commends this decision, which will help speed the expansion of COVID-19 testing at this crucial time. However, the association remains concerned that the Families First Coronavirus Response Act does not provide coverage for COVID-19 tests unless the tests are performed under an EUA. AACC urges Congress to rectify this problem before passing the bill so that all patients will have access to coronavirus testing.
Families First Coronavirus Response Act Would Prohibit Insurers from Paying for Some COVID-19 Tests
AACC greatly values the work that the U.S. House of Representatives has done to support American families in the midst of the coronavirus outbreak and is supportive of the goals of H.R. 6201, the Families First Coronavirus Response Act. However, we are concerned that the language as currently drafted does not provide coverage for COVID-19 tests performed prior to those tests receiving Emergency Use Authorization (EUA) from the Food & Drug Administration (FDA).
New Legislation Would Jeopardize Patient Access to Medical Tests Across the Board by Restricting Policy that Removed Barriers to Coronavirus Testing
On March 5, U.S. House and Senate lawmakers introduced the VALID Act, which would give the Food and Drug Administration (FDA) new, expansive powers to regulate laboratory developed tests—tests that are already regulated by the Centers for Medicare and Medicaid Services (CMS) and are subject to stringent personnel, quality control, and proficiency testing requirements. This bill promotes duplicative, costly federal regulations for clinical laboratories that will result in decreased patient access to essential medical tests. AACC urges Congress not to act on this bill until its impact on healthcare can be thoroughly evaluated.
AACC Statement on New FDA Guidance That Allows Certified Labs to Perform Coronavirus Testing
AACC thanks the FDA for being responsive to the concerns of the clinical laboratory community and amending the coronavirus guidance to allow CMS-certified labs to develop and implement new tests for coronavirus prior to FDA approval.
As U.S. Struggles to Get Coronavirus Testing Up and Running, AACC Calls on FDA to Allow Clinical Labs to Develop Their Own Tests for the Virus
In a letter to the Food and Drug Administration (FDA), AACC is urging the agency to allow clinical laboratories to develop coronavirus tests without going through FDA review. Lifting this regulatory requirement is key to ensuring that all patients have access to high-quality coronavirus testing and that healthcare workers have the tools they need to control the spread of this disease in the U.S.
Two New Rapid Coronavirus Tests Could Play Key Role in Efforts to Contain Growing Epidemic
Breaking research in AACC’s Clinical Chemistry journal shows that two new tests accurately diagnose coronavirus infection in about 1 hour. These tests could play a critical role in halting this deadly outbreak by enabling healthcare workers to isolate and treat patients much faster than is currently possible.
AACC CEO Janet B. Kreizman to Retire in the Second Quarter of 2020
AACC today announced that its CEO, Janet B. Kreizman, will retire in the second quarter of 2020. “For the past 7 years, Janet has been a strategic leader for the organization, strengthening the association’s position as the leading voice and hub for laboratory medicine professionals dedicated to advancing quality patient care and improved health outcomes,” said AACC President Dr. Carmen L. Wiley.
New AACC Guidance Document Outlines How Healthcare Professionals Can Prevent the Widespread Supplement Biotin From Interfering With Medical Tests
Biotin’s upsurge in popularity has led to a parallel rise in incidents of this health supplement interfering with critical medical tests. A new guidance document from AACC urges clinicians and laboratory experts to collaborate to prevent this potentially harmful test interference, and to ensure that patients taking biotin receive high quality care.
New Blood Test Could Help Elderly Concussion Patients With Internal Head Bleeding to Get Diagnosed, Treated Faster
Novel research shows that a blood test can differentiate elderly concussion patients with brain tissue damage from those without it. This finding, published in the special brain health collection of AACC’s The Journal of Applied Laboratory Medicine, could help ensure that elderly patients with severe concussions receive crucial treatment for their injuries.
Novel Research That Could Advance Testing, Treatment for Concussions Showcased in the January Issue of AACC’s The Journal of Applied Laboratory Medicine
In a special brain health collection, AACC’s The Journal of Applied Laboratory Medicine highlights the innovative clinical tests that laboratory medicine experts are developing to improve care for concussions.
Breaking Research in AACC’s Clinical Chemistry Journal Debunks the Claim That Vitamin D and Fish Oil Supplements Reduce Inflammation
One of the many advertised benefits of vitamin D and fish oil supplements is that they reduce systemic inflammation, which in turn could help prevent certain chronic illnesses. However, a first-of-its-kind study published in AACC’s journal Clinical Chemistry has discovered that these two supplements do not actually reduce inflammation in healthy individuals, a finding that could help consumers make more informed choices about which supplements they decide to take.
The Journal of Applied Laboratory Medicine Is Now Indexed in PubMed
AACC, a global scientific and medical professional organization dedicated to better health through laboratory medicine, is pleased to announce that its peer-reviewed publication The Journal of Applied Laboratory Medicine has been accepted for indexing in PubMed, one of the largest and most respected databases of medical research in the world.
AACC’s Journals, Clinical Chemistry and The Journal of Applied Laboratory Medicine, to Be Published through Oxford University Press
AACC, a global scientific and medical professional organization dedicated to better health through laboratory medicine, is pleased to announce a publishing partnership with Oxford University Press for its peer-reviewed journals, Clinical Chemistry and The Journal of Applied Laboratory Medicine. Both journals will join Oxford University Press’s world-class science portfolio starting in January 2020. The partnership will increase researchers’ and healthcare practitioners’ access worldwide to the important science published in the journals.
Briefing: Point-of-Care Testing—Bringing the Lab to the Patient
Point-of-care testing is transforming healthcare: this type of testing helps patients get diagnosed and treated faster, and also makes it easier for patients in remote areas to have access to medical testing. Join AACC and leading experts in laboratory medicine for a discussion about what lies ahead for point-of-care testing and what needs to happen so that all patients can benefit from quality testing of this kind.
Expert Talks on Direct-to-Consumer Genetic Testing, Precision Medicine, and Breast Cancer Treatment Draw Nearly 20,000 Attendees to the 71st AACC Annual Scientific Meeting
AACC welcomed thousands of medical professionals and healthcare leaders to the 71st AACC Annual Scientific Meeting & Clinical Lab Expo from August 4-8. The meeting featured pioneering advances in medical testing that will help patients get the right diagnoses and the care they need.