Wendy S Baker1, Kathleen J Albright2, Megan Berman2, Heidi Spratt1, Peggy A Mann3, Jaime Unabia4, John R Petersen5. 1. University of Texas Medical Branch, Department of Preventive Medicine and Community Health, Galveston, TX, 77555-1150, United States. 2. University of Texas Medical Branch, Departments of Internal Medicine, Galveston, TX, 77555-1167, United States. 3. University of Texas Medical Branch, Department of Clinics Administration & Support, League City, TX 77573-1210, United States. 4. University of Texas Medical Branch, Pathology, Galveston, TX 77555-0652, United States. 5. University of Texas Medical Branch, Pathology, Galveston, TX 77555-0652, United States. Electronic address: jrpeters@utmb.edu.
Abstract
BACKGROUND: In this study we examined the difference in patient INR values as measured by the POCT CoaguChek XS device and central laboratory Stago Evolution and Siemens BCS XP analyzers. METHODS: This study composed of 100 warfarin therapy patients and 20 coagulation normal subjects, showed that the difference between the POCT and clinical laboratory values increased with increasing INR and was exacerbated by the use of different thromboplastin reagents by the POCT and central lab. RESULTS: The CoaguChek XS and on-site Stago analyzers which used human recombinant (ISI=1.01) and rabbit brain thromboplastin (ISI=1.25), respectively, showed reasonable agreement for INR<3.0 (k=0.62) but significant difference for INR≥3.0 (k=0.10). In contrast, the CoaguChek XS and Siemens BCS XP, which both employed human recombinant thromboplastin (BCS ISI=1.02), showed greater agreement for the complete range INR values (INR<3.0 k=0.84; INR≥3.0 k=0.70). ECAA Poller calibrant data showed the automated instruments were performing as expected, indicating that ISI calibrations were correct but insufficient to standardize the INR values for the different thromboplastin methods across the full range of measured INRs. Central lab verification of POCT INR>5.0 with the Stago Evolution prevented adverse treatment events for the warfarin therapy patients in the six months preceding and following this investigation.
BACKGROUND: In this study we examined the difference in patient INR values as measured by the POCT CoaguChek XS device and central laboratory Stago Evolution and Siemens BCS XP analyzers. METHODS: This study composed of 100 warfarin therapy patients and 20 coagulation normal subjects, showed that the difference between the POCT and clinical laboratory values increased with increasing INR and was exacerbated by the use of different thromboplastin reagents by the POCT and central lab. RESULTS: The CoaguChek XS and on-site Stago analyzers which used human recombinant (ISI=1.01) and rabbit brain thromboplastin (ISI=1.25), respectively, showed reasonable agreement for INR<3.0 (k=0.62) but significant difference for INR≥3.0 (k=0.10). In contrast, the CoaguChek XS and Siemens BCS XP, which both employed human recombinant thromboplastin (BCS ISI=1.02), showed greater agreement for the complete range INR values (INR<3.0 k=0.84; INR≥3.0 k=0.70). ECAA Poller calibrant data showed the automated instruments were performing as expected, indicating that ISI calibrations were correct but insufficient to standardize the INR values for the different thromboplastin methods across the full range of measured INRs. Central lab verification of POCT INR>5.0 with the Stago Evolution prevented adverse treatment events for the warfarin therapy patients in the six months preceding and following this investigation.
Authors: Ramona C Dolscheid-Pommerich; Sarah Dolscheid; Lars Eichhorn; Birgit Stoffel-Wagner; Ingo Graeff Journal: PLoS One Date: 2018-01-10 Impact factor: 3.240
Authors: Wendy S Baker; Kathleen J Albright; Heidi Spratt; Megan Berman; Peggy A Mann; Jaime Unabia; John R Petersen Journal: Data Brief Date: 2017-11-07