Plus, get ready for high sensitivity cardiac Troponin assays in practice.
Laboratory medicine experts discovered a new lipid biomarker panel to detect heart failure with reduced ejection fraction (HFrEF) even before symptoms present, with “much greater certainty than standard tests for this condition,” according to a January 5 press release from the American Association for Clinical Chemistry (AACC).
The January issue of the AACC’s journal, Clinical Chemistry focuses on cardiovascular disease and features research reflecting a “growing understanding of the molecular signatures of heart disease,” according to the press release, and a trend towards developing “more precise tests for the early diagnosis, monitoring, and targeted treatment.”
The study in question identified three new cardiac lipid biomarkers, a cardiac lipid panel (CLP), which “significantly improved diagnostic performance” when combined with the current standard biomarker approach for diagnosing heart failure, NT-proBNP.
The resulting biomarker panel, CLP + NT, correctly classified healthy controls and HFrEF patients with higher diagnostic performance, specificity and sensitivity.
From a long-term point of view, advances in laboratory medicine could spell both a significant increase in the quality of care as well as a significant reduction in costs—through reduced readmission rates, reduced length-of-stay, and more.
Of course, it may take some time for this particular innovation to reach clinical application—other biomarker assays, like high sensitivity cardiac Troponin (hs-cTn) assays—implications of which we’ve discussed before—have yet to pass FDA approval, and thus the “high sensitivity cardiac troponin era” has yet to begin in the U.S.
“The United States lags behind, unfortunately, in the ability to use these new tools,” said Allan Jaffe, MD in an interview with Mayo Clinic Talks on Medscape Cardiology.
Though, that era might begin soon—and providers should be prepared. Since companies are already supplying high sensitivity assays with significant volume in Europe, these vendors are “unlikely” to continue supplying conventional assays at reduced volumes following FDA approval of the new tests, says Dr Jaffe.
“The high sensitivity assays will replace all of the non-high-sensitivity assays… I think the uptake will be fairly rapid, and we will need to adjust,” says Dr Jaffe. Thankfully, costs should stay the same. “They are both relatively inexpensive,” he says.
But a clinical understanding of the assays will be important considering widespread implications, and soon. Experts expected FDA approval of at least one high sensitivity assay before the end of 2016, though the waiting continues.
For more information on hs-cTn assays: An AACC task force compiled a report on implementing high sensitivity cardiac Troponin assays in late 2014. AACC’s January issue of Clinical Chemistry also features a Q&A regarding best practices for monitoring cardiac Troponin in detecting myocardial injury.