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May 2016

Making a smooth pivot to point-of-care IQCP

May 2016—Practically speaking, there’s a limit to the number of balls a human can juggle. And there’s probably a limit to how complex a quality control plan a point-of-care testing coordinator can handle. Last year, many POC coordinators felt that the Centers for Medicare and Medicaid Services would be pushing that limit pretty hard with its new Individualized Quality Control Plan.

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Early days, early detection, early treatment for HIV

May 2016—In 1985, when the first test for HIV—then called human T-cell lymphotropic virus type III—became available, it was approved for screening blood products but not for diagnostic use. A diagnostic test for antibody to HIV-1 was soon approved. Over the subsequent 30-plus years, further iterations of HIV screening tests have been made, with increasing sensitivity and specificity and a shorter window to detection. Fifth-generation tests are now under review. CAP TODAY asked Eileen Burd, PhD, D(ABMM), to discuss the evolution of HIV diagnostics and algorithms for using them and to give a qualitative evaluation of the pending fifth-generation assay.

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Metastatic cancer of unknown primary: diagnostic challenges

May 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. Case report No. 11, which begins here, comes from Cooper Medical School at Rowan University and Cooper University Hospital, Camden, NJ.

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Heart biopsy the first step on a complex path

May 2016—The stories are haunting: a young, seemingly healthy athlete collapses on the playing field and dies. For Joseph Maleszewski, MD, section head of cardiovascular pathology, Mayo Clinic, Rochester, Minn., these deaths also seem sadly familiar, especially given his work with the NCAA on such cases. “Every community, it seems, has a story,” says Dr. Maleszewski, who is also associate professor, laboratory medicine and pathology, and associate professor, medicine. “A child died on the basketball court, on the football field, while running track. These young athlete deaths are not uncommon at all—or even young nonathlete deaths.”

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With high-sensitivity troponins, watching and waiting continue

May 2016—Laboratories and hospitals in the U.S. continue to look forward to high-sensitivity troponin assays. Judd E. Hollander, MD, says all he’s heard for the past five years is that an assay will be out at the end of the year. “And once you get halfway through the year, it will be out next year,” says Dr. Hollander, chair of the Department of Emergency Medicine and associate dean of strategic health initiatives at Sidney Kimmel Medical College of Thomas Jefferson University.

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FilmArray ME panel—clinical trial to 1st clinical test

May 2016—The BioFire FilmArray meningitis/encephalitis (ME) panel received FDA clearance last October, and in November Jennifer Dien Bard, PhD, D(ABMM), of Children’s Hospital Los Angeles, presented the results of the multicenter clinical evaluation of the panel, in a webinar produced by CAP TODAY in collaboration with BioFire. The panel’s use in the clinical setting will reduce turnaround time and may, pending further studies, have a positive impact on patient care and outcomes, said Dr. Dien Bard, director of the clinical microbiology and virology laboratories at Children’s Hospital LA.

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Cytopathology in Focus: Paris System: a new paradigm for urinary cytology

May 2016—The Paris System Working Group has proposed and published a standardized reporting system that redefines the primary purpose of urinary cytology: the detection of high-grade urothelial carcinoma (HGUC).1 A program to address standardization of urine cytology reporting was conceived at the 18th International Congress of Cytology in Paris in May 2013 where a number of people of like interest assembled and formed the Paris System Working Group.

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