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Articles tagged with: Diagnostic assays/markers/tests/test kits (See also Screening tests) –

Hopes, fears as users switch to new troponin

December 2017—The questions that arise over the use of highly sensitive cardiac troponin are as riveting as, if less historically fraught than, the Jefferson-Hamilton debates over the shape of their newborn country. Who should lead—the states or a strong central government? Cardiologists or the emergency department? What cutoffs represent the right balance between admissions, referrals, and sending patients home? And will Lin-Manuel Miranda ever write a smash musical about this cardiac assay?

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.

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.

Advanced parameters offer faster, surer guidance to cancer care

September 2017—After a career spent studying malignancies in the bone marrow and monitoring the effects of chemotherapy on the bone marrow and neoplastic cells contained therein, Cheryl Hirsch-Ginsberg, MD, stepped out from the bone marrow realm and into the faster-paced world of high-volume hematology.

Hemophilia diagnosis: how to test, what to know

March 2017—True, hemophilia is no longer commonly known as the “royal disease” (as it was when several generations of European rulers suffered from it). But in a January webinar, Dorothy M. Adcock, MD, gave some royally important suggestions regarding the laboratory diagnosis of hemophilia A and B.

HbA1c in CVD treatment: farewell to one size fits all

March 2017—Anchor. Central pillar. Cornerstone. It would be hard to find a weighty synonym for “linchpin” that hasn’t been used to describe HbA1c’s role in diabetes diagnosis and management since 2010, when the assay was recognized by key standard-setting organizations as the equal of fasting glucose and oral glucose tolerance testing in diabetes and prediabetes testing.

Latest TB testing guide set forth by ATS, CDC, IDSA

March 2017—Testing for latent Mycobacterium tuberculosis infection and active tuberculosis disease remained relatively unchanged for many years. Screening for latent infection depended on an initial positive tuberculin skin test, and evidence for active TB required a positive culture for M. tuberculosis complex. New tests altered this picture in the past five years. For diagnosis of latent infection, interferon-gamma release assays have taken a major role. And nucleic acid amplification testing is becoming a mainstay for establishing a diagnosis of TB.

One bug or prix fixe? Respiratory pathogen testers weigh in

February 2017—With the number of rapid, accurate molecular assays for respiratory pathogens growing, microbiology laboratories have more options than ever. They include, among others, Meridian Bioscience’s Illumigene assays for group A Streptococcus and pertussis and its newest assay, Mycoplasma Direct, as well as Alere’s assays for influenza A/B, respiratory syncytial virus, and Streptococcus on its i molecular platform. No longer are laboratories limited to inaccurate rapid antigen tests, weeks-long culture, or multi-pathogen panels.

Buzz, prospects build for heparin-induced thrombocytopenia test

January 2017—U.S. physicians and laboratories are anticipating the early 2017 launch of the HemosIL HIT-Ab(PF4-H) assay, which detects antibodies associated with heparin-induced thrombocytopenia. The new test from Instrumentation Laboratory, Bedford, Mass., is the first fully automated, on-demand assay for HIT.

With metagenomic sequencing, no pathogen can hide

January 2017—Detecting pathogenic organisms with PCR has become a staple of the clinical microbiology laboratory, so much so that it seems like it has always been there. A more advanced molecular technique—unbiased metagenomic next-generation sequencing—will increasingly become a part of infectious disease diagnosis because it has several advantages over PCR. While it will be demanding to perform at first, it, too, may become a standard method in the clinical microbiology laboratory.

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