Quality Control Materials for Cardiac Troponin Testing

Abstract

A method for the preparation of a cardiac troponin quality control sample of a mammal to determine the accuracy and/or precision of a cardiac troponin assay over time is provided. The method comprises the steps of: i) preparing a cardiac troponin concentrate from a pool of biological samples obtained from a population of the mammal having a troponin concentration of greater than 75% of an upper analytical limit of the assay; ii) obtaining a cardiac troponin base material comprising whole blood, plasma or serum of the mammal which is interference-free and disease-free; and iii) combining a quantity of the troponin concentrate with the base material to yield a quality control sample having a target concentration. Quality control samples may be provided in kits which provide a set of samples having particular concentrations which essentially correspond with lower detectable limits of an assay, upper limits of normal, as well as concentrations which define risk stratification cutoffs and other diagnostic cutoffs.

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