J Niederdöckl1, C-E Dempfle2, H-R Schönherr3, A Bartsch4, G Miles5, A Laggner1, A Pathil6. 1. Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria. 2. Coagulation Center Mannheim, Mannheim, Germany. 3. Internal Medicine, Hospital St. Vinzenz Zams, Zams, Austria. 4. Roche Diagnostics GmbH, Mannheim, Germany. 5. Roche Diagnostics Corporation, Indianapolis, IN, USA. 6. Gastroenterology, Intermediate and Intensive Care Unit, University Clinic Heidelberg, Heidelberg, Germany.
Abstract
INTRODUCTION: There are several clinical settings and patient conditions especially in intensive care units, emergency departments, and operating theaters, where the coagulation status of a patient must be known immediately and point-of-care (POC) systems are beneficial due to low time to result. METHODS: This noninterventional, single-blinded, multicenter study with prospectively collected whole blood samples was performed to evaluate the diagnostic accuracy of the CoaguChek PT Test (POC PT) and CoaguChek aPTT Test (POC aPTT) compared to standard laboratory testing in patients with suspected deficiencies of coagulation factors. RESULTS: In total, 390 subjects were included. Both POC PT and POC aPTT showed concordance with the laboratory PT and aPTT. Lot-to-lot variation was below 2% both for POC PT and for POC aPTT. The mean relative difference of capillary blood compared to venous blood was 0.2 % with POC PT and 8.4% with POC aPTT. The coefficients of variation for repeatability of POC PT using whole blood were found to be between 2% and 3.6%. CONCLUSION: Our findings suggest reliable quantitative results with this POC system to support on-site decision-making for patients with suspected deficiencies of coagulation factors in acute and intensive care.
INTRODUCTION: There are several clinical settings and patient conditions especially in intensive care units, emergency departments, and operating theaters, where the coagulation status of a patient must be known immediately and point-of-care (POC) systems are beneficial due to low time to result. METHODS: This noninterventional, single-blinded, multicenter study with prospectively collected whole blood samples was performed to evaluate the diagnostic accuracy of the CoaguChek PT Test (POC PT) and CoaguChek aPTT Test (POC aPTT) compared to standard laboratory testing in patients with suspected deficiencies of coagulation factors. RESULTS: In total, 390 subjects were included. Both POC PT and POC aPTT showed concordance with the laboratory PT and aPTT. Lot-to-lot variation was below 2% both for POC PT and for POC aPTT. The mean relative difference of capillary blood compared to venous blood was 0.2 % with POC PT and 8.4% with POC aPTT. The coefficients of variation for repeatability of POC PT using whole blood were found to be between 2% and 3.6%. CONCLUSION: Our findings suggest reliable quantitative results with this POC system to support on-site decision-making for patients with suspected deficiencies of coagulation factors in acute and intensive care.
Authors: Benjamin Lardinois; Michaël Hardy; Isabelle Michaux; Geoffrey Horlait; Thomas Rotens; Hugues Jacqmin; Sarah Lessire; Pierre Bulpa; Alain Dive; François Mullier Journal: J Clin Med Date: 2022-02-28 Impact factor: 4.241