A practical approach for the validation and clinical implementation of a high-sensitivity cardiac troponin I assay across a North American city

摘要

Objectives Despite several publications on the analytical performance of high-sensitivity cardiac troponin (hs-cTn) assays, there has been little information on how laboratories should validate and implement these assays into clinical service. Our study provides a practical approach for the validation and implementation of a hs-cTn assay across a large North American City. Design and methods Validation for the Abbott ARCHITECT hs-cTnI assay (across 5 analyzers) consisted of verification of limit of blank (LoB), precision (i.e., coefficient of variation; CV) testing at the reported limit of detection (LoD) and within and outside the 99th percentile, linearity testing, cTnI versus hs-cTnI patient comparison within and between analyzers (Passing and Bablok and non-parametric analyses). Education, clinical communications, and memorandums were issued in advance to inform all staff across the city as well as a selected reminder the day before live-date to important users. All hospitals switched to the hs-cTnI assay concurrently (the contemporary cTnI assay removed) with laboratory staff instructed to repeat samples previously measured with the contemporary cTnI assay with the hs-cTnI assay only by physician request. Results Across the 5 analyzers and 6 reagent packs the overall LoB was 0.6ng/L ( n =60) with a CV of 33% at an overall mean of 1.2ng/L ( n =60; reported LoD=1.0ng/L), with linearity demonstrated from 45,005ng/L to 1.1ng/L. Precision testing with a normal patient-pool QC material (mean range across 5 analyzers was 3.9–4.4ng/L) yielded a range of CVs from 7% to 10% (within-run) and CVs from 7% to 18% (between-run) with the high patient-pool QC material (mean range across 5 analyzers was 29.6–36.3ng/L) yielding a range of CVs from 2% to 5% (within-run) and CVs from 4% to 8% (between-run). There was agreement between hs-cTnI versus cTnI with the patient samples (slope ranges: 0.89–1.03; intercept ranges: 1.9–3.8ng/L), however, the median CV on patient samples <100ng/L across the analyzers was 5.6% for hs-cTnI versus 18.7% for the contemporary assay ( p <0.001). Following the switch to hs-cTnI testing, no requests for repeat measurements were received. Conclusions Validation and implementation of hs-cTnI testing across multiple sites requires collaboration within the laboratories and between hospital laboratories and clinical staff. Highlights ? City-wide analytical validation of a high-sensitivity cardiac troponin assay. ? Practical approach to hs-cTnI validation and clinical implementation. ? Clinical support and communication are important for a successful implementation. ? New QC practices and comparability testing for hs-cTnI monitoring.