Uniformity in how cardiac troponin assays are analytically and clinically validated is needed to facilitate between assay comparisons, write Fred S. Apple, PhD, DABCC; Judd Hollander, MD; Alan H.B. Wu, PhD, DABCC; and Allan S. Jaffe, MD, FACB, in an opinion piece recently published in Clinical Chemistry. “We believe this could occur if companies worked together along with the clinical and laboratory communities to develop scientifically robust and consistent approaches.”
The group recently met with leaders of the Food and Drug Administration’s (FDA’s) Division of Chemistry and Toxicology Devices to discuss “concerns about the heterogeneity of analytical and clinical protocols used in studies for clearance of cardiac troponin assays,” the article explains.
“We, as experts, are frequently asked to help with the evaluation of new cardiac troponin assays and are aware of variability between the specific protocols used, which are difficult to understand, but which likely reflect differences in the various companies’ interpretations of what elements are mandated by the FDA,” the authors write. “We advocated to the FDA the use of standardized study protocols to reduce complexity and permit better comparisons among methods and provided suggestions to achieve these goals.”
The Clinical Chemistry article provides details about the authors’ extensive recommendations to FDA for unifying study protocols, which covered the following points and also apply to high-sensitivity cardiac troponin assays:
- Number of reference individuals for determination of a 99th-percentile upper reference limit.
- Limit of quantification.
- Total imprecision requirements.
- Enrollment of subjects for diagnostic studies.
- Patient adjudication processes.
- Clinical endpoints and time limits to assess outcomes.
Read details on the above recommendations online.