Steve Kitchen1, Ulrich Geisen2, Janos Kappelmayer3, Peter Quehenberger4, Anna Lowe1, Robert Jones1, Gabrielle Miles5, Jana G Boehm6, Gergely Rozsnyai7. 1. Sheffield Haemostasis and Thrombosis Centre, Sheffield, UK. 2. Institute for Clinical Chemistry and Laboratory Medicine, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany. 3. Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary. 4. Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria. 5. Roche Diagnostics Inc., Indianapolis, Indiana. 6. Roche Diagnostics GmbH, Mannheim, Germany. 7. Roche Diagnostics International Ltd, Rotkreuz, Switzerland.
Abstract
INTRODUCTION: New laboratory methods to measure haemostatic function require careful assessment before routine use. We evaluated the analytical performance of four new coagulation assays for the measurement of fibrinogen by Clauss assay, prothrombin time-derived fibrinogen, thrombin time and D-dimer levels. METHODS: The four assays were evaluated on the cobas t 711 and cobas t 511 analysers at four centres in Europe. Analytical performance and method comparisons with other commercially available assays were performed according to Clinical and Laboratory Standards Institute guidelines (EP09-A3, EP05-A3) using residual anonymized human sodium citrate (3.2% [0.109M]) plasma samples. Lot-to-lot variability and the equivalency of each assay on the cobas t 711 and cobas t 511 analysers were also assessed. RESULTS: Overall, coefficients of variance were ≤4.1% and ≤8.6% for within-run precision and total reproducibility, respectively. Method comparison experiments showed good or acceptable agreement for each assay compared with their respective comparator method, and equivalency was demonstrated for the two cobas t platforms (Pearson's correlation coefficient ≥0.991). A high level of consistency was observed between lots for all four assays (Pearson's correlation coefficient ≥0.994). CONCLUSION: This multicentre study demonstrates excellent analytical performance for four new coagulation assays on the cobas t 711 and cobas t 511 analysers.
INTRODUCTION: New laboratory methods to measure haemostatic function require careful assessment before routine use. We evaluated the analytical performance of four new coagulation assays for the measurement of fibrinogen by Clauss assay, prothrombin time-derived fibrinogen, thrombin time and D-dimer levels. METHODS: The four assays were evaluated on the cobas t 711 and cobas t 511 analysers at four centres in Europe. Analytical performance and method comparisons with other commercially available assays were performed according to Clinical and Laboratory Standards Institute guidelines (EP09-A3, EP05-A3) using residual anonymized humansodium citrate (3.2% [0.109M]) plasma samples. Lot-to-lot variability and the equivalency of each assay on the cobas t 711 and cobas t 511 analysers were also assessed. RESULTS: Overall, coefficients of variance were ≤4.1% and ≤8.6% for within-run precision and total reproducibility, respectively. Method comparison experiments showed good or acceptable agreement for each assay compared with their respective comparator method, and equivalency was demonstrated for the two cobas t platforms (Pearson's correlation coefficient ≥0.991). A high level of consistency was observed between lots for all four assays (Pearson's correlation coefficient ≥0.994). CONCLUSION: This multicentre study demonstrates excellent analytical performance for four new coagulation assays on the cobas t 711 and cobas t 511 analysers.
Authors: Steve Kitchen; Moniek de Maat; Michael Nagler; Robert Jones; Anna Lowe; John Burden; Kai Groneberg; Gergely Rozsnyai Journal: Blood Coagul Fibrinolysis Date: 2020-10 Impact factor: 1.061