Guidelines for certification of International Normalized Ratio (INR) for vitamin K antagonists monitoring according to the EN ISO 22870 standards

• Published in: Annales de biologie clinique (Paris) Vol. 76; no. 3; p. 271
• Main Authors: Brionne-François, Marie, Bauters, Anne, Mouton, Christine, Voisin, Sophie, Flaujac, Claire, Le Querrec, Agnès, Lasne, Dominique
• Format: Journal Article
• Language: English; French
• Published: France 01.05.2018
• Subjects: point of care testing; EN ISO 22 870 standard; INR; POCT; international normalized ratio; haemostasis
• ISSN: 1950-6112
• DOI: 10.1684/abc.2018.1332

Point of care testing (POCT) must comply with regulatory requirements according to standard EN ISO 22870, which identify biologists as responsible for POCT. INR for vitamin K antagonists (VKAs) monitoring is a test frequently performed in haemostasis laboratories. Bedside INR is useful in emergency room, in particular in case of VKAs overdosage but also for specific populations of patients like paediatrics or geriatrics. INR POCT devices are widely used at home by the patients for self-testing, but their use in the hospital by the clinical staff for bedside measurement is growing, with devices which now comply with standard for POCT accreditation for hospital use. The majority of point of care devices for INR monitoring has shown a good precision and accuracy with results similar to those obtained in laboratory. With the aim to help the multidisciplinary groups for POCT supervision, the medical departments and the biologists to be in accordance with the standard, we present the guidelines of the GFHT (Groupe français d'étude sur l'hémostase et la thrombose, subcommittee "CEC et biologie délocalisée") for the certification of POCT INR. These guidelines are based on the SFBC guidelines for the certification of POCT and on the analysis of the literature to ascertain the justification of clinical need and assess the analytical performance of main analysers used in France, as well as on a survey conducted with biologists.