The importance of analytical quality specifications for biomarker assays currently used in acute cardiac care.

It is very important that cardiac biomarkers on which clinically relevant decisions will rest are measured with highly reliable assays. Adequate studies are needed before new methods can be implemented in the laboratory routine, and only well‐documented assays should be considered for clinical use. Therefore, it is critical that, as new biomarkers are proposed, quality specifications are developed. Only after appropriate analytical quality specifications are addressed, the issues pertaining to methodological differences that result in non‐harmonized concentration values, and clinical interpretation of biomarker concentrations will be reconciled. Today, the technology to address many analytic problems is at hand, but commitment on the part of manufacturers and their customers in the laboratory and clinical communities is essential. The design control loop is not closed until the finished in vitro diagnostic system is adequately validated to meet the customer needs, including analytical quality specifications. It is essential to determine the attributes and performance characteristics of relevant competitive systems and their degree of acceptance by clinical laboratories in order to demonstrate that user needs are definitely met. The responsibility of defining and implementing these issues must be a shared responsibility among laboratorians, clinicians, industry, and regulatory agencies on an international front. To date, two sets of quality specifications have been published, one for cardiac troponin assays and one for B‐type natriuretic peptide assays. Both address analytical factors, such as calibrator characterization, antibody specificity, assay sensitivity and imprecision, and interferents, as well as preanalytical factors, such as sample type and stability. It would be ideal if regulatory agencies, such as FDA in the United States, accept these criteria for premarket approval clearance applications. [ABSTRACT FROM AUTHOR]