The Importance of Laboratory Developed Tests in Diagnosing COVID-19

Laboratory developed tests play a vital role in getting patients accurate diagnoses and effective care, and at no time has their importance been clearer than during the current pandemic. In this briefing, AACC’s leading experts in laboratory medicine will discuss why laboratory developed tests are crucial to fighting the coronavirus, as well as the regulatory barriers that nearly prevented labs from developing and introducing these tests for the virus.

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AACC Urges Congress to Fund Laboratory Training Programs to Better Prepare the U.S. for Future Pandemics

In the face of a chronic shortage of professionals who are qualified to perform clinical laboratory tests—including those for COVID-19—AACC released a position statement today calling on Congress to provide federal funding to expand clinical laboratory training programs. This will help to ensure that labs have the staffing they need to deliver timely, accurate test results, particularly during public health emergencies such as the current coronavirus pandemic.

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AACC and CDC Partner to Improve Cardiovascular Disease Testing Around the World

AACC, a global scientific and medical professional organization dedicated to better health through laboratory medicine, is pleased to announce a new collaboration with the Centers for Disease Control and Prevention (CDC) and the CDC Foundation that aims to expand lipid testing in resource-limited countries. Improving access to this essential testing could help reduce the high worldwide mortality rate from cardiovascular disease by enabling patients to get treated for this condition earlier.

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A New Test Could Identify COVID-19 Patients Who Are at Risk for Severe Illness

A novel study in AACC’s Clinical Chemistry journal shows that a new test for SARS-CoV-2 viral proteins known as antigens could determine which COVID-19 patients are most likely to become critically ill. This test could help improve management of COVID-19 by enabling hospitals to ensure that these patients have access to intensive care.

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AACC Honors Senator Roy Blunt for His Dedication to Improving Pediatric Medical Testing

AACC, a global scientific and medical professional organization dedicated to better health through laboratory medicine, is pleased to announce that Senator Roy Blunt (R-Missouri) is the recipient of AACC’s Outstanding Legislator Award for the 116th Congress. This award recognizes Sen. Blunt for his tireless efforts to improve children’s healthcare by advancing the development of pediatric reference intervals.

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AACC Welcomes HHS Decision to Clarify Federal Regulation of Laboratory Developed Tests

AACC welcomes a decision from the Department of Health and Human Services that the Food and Drug Administration does not have authority to regulate laboratory developed tests (LDTs) without formal notice-and-comment rulemaking.

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Labs Still Do Not Have Supplies for COVID-19 Testing, AACC Survey Finds

A new survey of U.S. clinical laboratories conducted by AACC has found that nearly half of all responding labs still do not have the supplies they need to run COVID-19 tests. AACC presented these findings to the White House Coronavirus Task Force today in a letter that calls on the federal government to take a more active role in alleviating this problem, so that labs can increase their testing capacity in the midst of the virus’s latest surge.

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AACC Is Honored to Participate in a New Federal Initiative to Improve COVID-19 Testing Across the U.S.

We at AACC would like to thank Assistant Secretary for Health Admiral Brett P. Giroir, MD, for his leadership in establishing the National Testing Implementation Forum to address the persistent challenges that the U.S. is facing with COVID-19 testing and for inviting us to participate in this initiative.

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The Impact Factor of AACC’s Clinical Chemistry Journal Increases to 7.292

AACC, a global scientific and medical professional organization dedicated to better health through laboratory medicine, is pleased to announce that the impact factor of its journal, Clinical Chemistry, has risen to 7.292 in the 2019 Clarivate Analytics Journal Citation Reports. This impact factor places Clinical Chemistry in the top 4.2% of 12,838 ranked academic journals and speaks to the significant influence of the science it publishes on laboratory medicine and patient care.

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To Prepare the U.S. for Future Pandemics, AACC Calls on Congress to Enact 4 Recommendations

In response to the Senate health committee’s white paper on preparing for future pandemics, AACC sent a letter to committee leadership detailing four key steps the government should take to ready the U.S. for the next outbreak. AACC urges the health committee to address these recommendations in future pandemic legislation, as they are crucial to preventing another public health crisis like the one COVID-19 has caused.

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AACC Launches a New Competition to Support Innovative Research in Diagnostic Testing

AACC, a global scientific and medical professional organization dedicated to better health through laboratory medicine, is pleased to announce a new competition that will support cutting-edge research that could significantly improve diagnostic testing and patient care. Winners of the competition will each receive a sample set from AACC’s Universal Sample Bank, which includes blood samples from hundreds of healthy individuals that were collected to aid medical studies.

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AACC Releases Guidance Document on Using Point-of-Care Tests to Improve Patient Care

AACC has issued a new guidance document detailing best practices that hospitals and other healthcare institutions should follow when running a point-of-care testing program. As point-of-care tests emerge for more and more conditions—including COVID-19—the guidance emphasizes that it is essential for laboratory professionals and clinicians to collaborate on point-of-care testing programs to ensure this testing benefits patients.

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To Prevent a Second Wave of COVID-19, AACC Calls on Senate to Include 5 Recommendations in Upcoming Coronavirus Bill

Now that the latest coronavirus relief package, known as the Heroes Act, has moved forward to the U.S. Senate, AACC has sent a letter to Senate leadership outlining five key recommendations that will improve COVID-19 testing capacity across the U.S. AACC urges the Senate to ensure these recommendations are addressed within the Heroes Act, as they are critical to preventing a second wave of the pandemic.

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AACC Issues Recommendations on the Use of COVID-19 Antibody Tests

To ensure the proper use of antibody testing for the novel coronavirus, AACC today issued a public statement detailing the role these tests should play in the management of COVID-19 patients and in the development of public health policy. In particular, the organization emphasizes that healthcare professionals and policymakers should work closely with laboratory experts on antibody testing to ensure that these tests are validated, used appropriately, and interpreted correctly.

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Not All FDA-Authorized COVID-19 Antibody Tests Are Equally Reliable

A first-of-its-kind study published today in AACC’s Clinical Chemistry journal compared the performance of two COVID-19 antibody tests and found that—even though both tests are FDA authorized—one produced more incorrect results than the other. These findings could help healthcare professionals and researchers to better select antibody tests, which are essential to both treating COVID-19 patients and determining the full extent of the outbreak.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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).

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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.

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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.

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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.

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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).

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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