Evaluation of a Sensitive Copeptin Assay for Clinical Measurement

Background: Copeptin, a marker of vasopressin production, has been introduced for earlier diagnosis of acute myocardial infarction and other clinical emergencies.We evaluated the analytical performance of a new generation copeptin assay in an inter-laboratory trial. Methods: Precision, linearity range, carry-over contamination, the limit of blank and an inter-laboratory comparison trial for the copeptin US KRYPTOR assay were performed on the B•R•A•H•M•S KRYPTOR compact PLUS.Results: The intra-assay imprecision (CVs) was 12.6-2.2%and total imprecision over five days was 12.3-4.3%between 3.1 and 18.2 pmol/L.The assay had excellent linearity between 7-222 pmol/L.The limit of blank was 2.5 pmol/L and the limit of detection was 3.2 pmol/L, but was dependent on the analyte-free material used.No significant difference between sample type, such as serum or different types of plasma or reagent lots, was noted.The copeptin results remained unchanged upon five repeated freeze-thaw cycles.A set of patient samples with a mean copeptin concentration of 2.1-61 pmol/L run at two separate sites showed close correlation (r 2 =0.99, slope=1.01,intercept=0.35),indicating comparable results across laboratories. Conclusion:The new ultrasensitive copeptin KRYPTOR assay shows excellent inter-lab precision, opening up the possibility for international guidelines to exclude acute myocardial infarction.