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AACC.org // Clinical Laboratory News // CLN Magazine


Features

Critical Value Change
In January 2019, the American Diabetes Association in its annual standards of medical care in diabetes released new guidance on classifying level 2 hypoglycemia. Although the healthcare community generally hews closely to ADA standards, this move has been met with some doubt and disagreement among clinical laboratorians.
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Molecular Point-of-Care Testing in Clinical Laboratories
By cutting down turnaround times from weeks to hours, increasing sensitivity and specificity of viral detection, and allowing for quantification of viral load, molecular microbiology has revolutionized the virology field making molecular POCT increasingly advantageous in resource-limited settings.
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Ask the Expert

How Europe’s New IVD Regulations Will Impact Labs
In 2022, the European Union (EU) is going to implement new in vitro diagnostic regulations that are far more extensive than the current ones. Health expert, Natalie J. Kennel answers how clinical labs serving EU citizens can prepare for the change.
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Bench Matters

Secrets for Success in Managing Point-of-Care Testing Quality Assurance
Key elements for success in point-of-care testing quality assurance include focusing clearly on quality indicators, harnessing technology, training and recertifying current operators, and fostering proactive collaboration among users supported by trained POCT personnel. Laboratory professionals at University of Minnesota Medical Center share strategies for ensuring POCT competency and quality assurance…
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Federal Insider

Industry Playbook

Laboratory Stewardship

When Lab Testing Offered for Free Is Not Really Free
A free or reduced-rate test is a clinical test offered by a reference laboratory to some or all patients at no charge or at a reduced charge. Experts dive into research that shows how clinical laboratories can ensure free, high-quality testing for patients without any hidden costs.
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Regulatory Roundup

FDA Continues to Fine-Tune Regulation of SARS-CoV-2 Serology Tests
With a flood in SARS-CoV-2 serology tests, the FDA released a revised guidance requiring manufacturers to submit an EUA within 10 business days. With the new restrictions, the FDA created a public list of SARS-CoV-2 serology tests that can no longer be marketed under the terms of the agency’s current…
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The Sample

Phosphate-Buffered Saline Reliable for Transporting SARS-CoV-2 Samples
In light of continuing shortages of viral transport media during the COVID-19 pandemic, the FDA has authorized laboratories to consider testing alternative transport media for use with SARS-CoV-2 samples. Researchers at Rutgers Robert Wood Johnson Medical School found successful results when testing phosphate-buffered saline as a transport medium.
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