Results of the performance verification of the CoaguChek XS system

Abstract Background This is the first paper reporting a performance verification study of a point-of-care (POC) monitor for prothrombin time (PT) testing according to the requirements given in chapter 8 of the International Organization for Standardization (ISO) 17593:2007 standard “ Clinical labora...

Full description

Saved in:
Bibliographic Details
Published in:Thrombosis research 2008-01, Vol.123 (2), p.381-389
Main Authors: Plesch, W, Wolf, T, Breitenbeck, N, Dikkeschei, L.D, Cervero, A, Perez, P.L, van den Besselaar, A.M.H.P
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Anticoagulants - pharmacology
Anticoagulants - therapeutic use
Biological and medical sciences
Blood and lymphatic vessels
Blood Coagulation - drug effects
Cardiology. Vascular system
CoaguChek
Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous
Drug Monitoring - instrumentation
Drug Monitoring - methods
Female
Fundamental and applied biological sciences. Psychology
Hematology, Oncology and Palliative Medicine
Humans
International Normalized Ratio - standards
ISO 17593:2007 standard
Lymphatic system
Male
Medical sciences
Middle Aged
Oral Anticoagulation Monitoring
Performance Verification
Point-of-Care Systems - standards
Prothrombin Time - instrumentation
Prothrombin Time - methods
Reagent Strips
Recombinant Proteins - pharmacology
Reference Values
Self Care - instrumentation
Self Care - methods
Self-Testing and Self-Management
Thromboplastin - genetics
Thromboplastin - pharmacology
Time Factors
Vertebrates: cardiovascular system
Young Adult
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Abstract Background This is the first paper reporting a performance verification study of a point-of-care (POC) monitor for prothrombin time (PT) testing according to the requirements given in chapter 8 of the International Organization for Standardization (ISO) 17593:2007 standard “ Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy” . The monitor under investigation was the new CoaguChek XS system which is designed for use in patient self testing. Its detection principle is based on the amperometric measurement of the thrombin activity generated by starting the coagulation cascade using a recombinant human thromboplastin. Methods The system performance verification study was performed at four study centers using venous and capillary blood samples on two test strip lots. Laboratory testing was performed from corresponding frozen plasma samples with six commercial thromboplastins. Samples from 73 normal donors and 297 patients on oral anticoagulation therapy were collected. Results were assessed using a refined data set of 260 subjects according to the ISO 17593:2007 standard. Results Each of the two test strip lots met the acceptance criteria of ISO 17593:2007 versus all thromboplastins (bias − 0.19 to 0.18 INR; > 97% of data within accuracy limits). The coefficient of variation for imprecision of the PT determinations in INR ranged from 2.0% to 3.2% in venous, and from 2.9% to 4.0% in capillary blood testing. Capillary versus venous INR data showed agreement of results with regression lines equal to the line of identity. Conclusion The new system demonstrated a high level of trueness and accuracy, and low imprecision in INR testing. It can be concluded that the CoaguChek XS system complies with the requirements in chapter 8 of the ISO standard 17593:2007.
ISSN:0049-3848
1879-2472
DOI:10.1016/j.thromres.2008.04.021