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November 2017

Next-gen troponin: out of the gate, into labs

November 2017—The story of highly sensitive cardiac troponin, as written by Dr. Seuss, would provide a small twist. In this version, the Grinch doesn’t steal Christmas. Rather, he keeps delaying it, quarter after quarter, year after year. “I remember maybe seven years ago, Roche told me their assay was coming. It’s coming, it’s coming, it’s coming,” laughs Sihe Wang, PhD, medical director and section head, clinical biochemistry, Cleveland Clinic, and clinical chemistry professor, Cleveland State University.

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Benefits and bumps of shifting to Beaker

November 2017—If they were located in the Land of Oz, laboratories selecting a laboratory information system might not have to make a choice between full functionality and seamless integration with their electronic medical record system. They could just follow the helpful advice of the Scarecrow to Dorothy at a crossroads: “Go both ways.”

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LIS niche modules flourish amid IT consolidation

November 2017—“There’s an app for that” was a common, if flippant, catch phrase to suggest that a software solution had already been devised for just about every need (at least until 2010, when Apple trademarked the catch phrase). In the laboratory industry today, you are likely to hear more references to software’s “functionality,” but the concept is the same. While debate continues over whether best-of-breed products or comprehensive information technology systems should rule the laboratory, health care IT companies have developed a profusion of modules or ancillary applications—sometimes packaged with an LIS, sometimes sold separately—to fill software gaps.

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With syphilis rates rising sharply, syphilis tests a focus

November 2017—Syphilis is making a comeback. Nearly 28,000 cases of primary and secondary syphilis, the most infectious stages of the disease, were reported in the U.S. in 2016—a 17.6 percent jump over 2015 and the highest reported rate since 1993. Cumbersome, subjective nontreponemal assays and the lack of a gold standard screening method lend complexity to the diagnostic process. But new nontreponemal assay options, including the first FDA-cleared fully automated treponemal/nontreponemal dual assay, may help stem the rising tide.

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From the President’s Desk: CAP17—No match for being there, 11/17

November 2017—My sister Jean had a Chatty Cathy doll; you pulled a cord in the back of her neck and she would say one of a handful of things (“Would you like some tea?”). Chatty Cathy was Jean’s favorite for a while, supplanting her much-loved Raggedy Ann. The coup lasted just long enough to make it plain that the new kid on the block didn’t have much to say for herself. She was kind of stiff and controlling, really. Raggedy Ann was a much better listener. Making up stories with her was a lot more fun.

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AMP case report: Follicular lymphoma of gallbladder, November 2017

November 2017—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. The following report comes from Western University and London Health Sciences Centre, London, Ontario, Canada. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

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Clinical Pathology Abstracts, 11/17

November 2017—Performance of virological testing for early infant diagnosis: a systematic review: The World Health Organization recommends that HIV-exposed infants receive virological testing for HIV infection between four and six weeks of age and treatment with antiretroviral (ARV) therapy as soon as the diagnosis is made. Despite efforts to expand mother-to-child transmission prevention programs, only an estimated 50 percent of HIV-exposed infants are tested within the first two months of life.

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Newsbytes, 11/17

November 2017—Software-validation products: finding a glitch before it’s a hitch: The idiom “time is of the essence” isn’t lost on Lisa Adams, senior information technology systems analyst at Banner Health and a believer in the need for speed when identifying software glitches and errors.

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Q&A column, 11/17

November 2017—A laboratory owns chemistry analyzers from company X. Company X recommends that its customers use company X’s calibration material to perform their linearity studies, starting with the highest concentration and using the chemistry analyzer’s autodilution feature to provide a total of four measurable concentrations and a final zero point. Does this protocol fulfill CAP checklist requirements?

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Put It on the Board, 11/17

November 2017—Study finds biotin interference; FDA clears Flu A/B/RSV assay on Hologic’s Panther Fusion; FDA clears Abbott’s Alinity ci-series; Sysmex introduces CyFlow Antibodies for flow cytometry; Test approved for screening Zika in blood donations; New insights into female reproductive tract development

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Letters, 11/17

Biotin pharmacokinetic study results: In Anne Paxton’s September 2016 article, “Beauty fad’s ugly downside: test interference,” I stated a commitment from Roche to reduce possible interferences, including biotin, and provide clear test labeling to ensure that physicians and laboratories can mitigate risk.

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Multiplexed inherited cancer reference material, 7/17

July 2017—SeraCare Life Sciences launched the industry’s first multiplexed inherited cancer reference material for inherited disease testing by next-generation sequencing, according to the company. The Seraseq Inherited Cancer DNA Mix reference materials were developed to validate the ability of synthetic reference materials to address technically challenging variants.

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