title: [Guidelines for certification of Activated clotting time (ACT) according to the EN ISO 22870 standards].
abstract: Point of care testing (POCT) must comply with regulatory requirements according to standard EN ISO 22870, which identify biologists as responsible for POCT. Activated clotting time (ACT) is mandatory to monitor on whole blood, anticoagulation achieved by unfractionated heparin during cardiopulmonary bypass (CPB) or cardiac catheterization. This test has no equivalent in the laboratory. With the aim to help the multidisciplinary groups for POCT supervision when they have to analyse the wish of medical departments to use ACT and to help the biologists to be in accordance with the standard, we present the guidelines of the GEHT (Groupe d'étude d'hémostase et thrombose) subcommittee "CEC et Biologie délocalisée" for the certification of ACT. 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 analyzers used in France, as well as on a survey conducted with French and Belgian biologists.
authors.affiliation: Laboratoire d'hématologie, Hôpital Necker, Paris, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Lasne
authors.affiliation: Laboratoire d'hématologie A, Hôpital cardiologique, Lille, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Bauters
authors.affiliation: Laboratoire d'hématologie, CHU Côte de Nacre, Caen, France.
authors.forename: Agnès
authors.initials: A
authors.lastname: Le Querrec
authors.affiliation: Laboratoire d'hématologie, Hôpital Necker, Paris, France.
authors.forename: Carole
authors.initials: C
authors.lastname: Bourdin
authors.affiliation: Laboratoire d'hématologie, Hôpital Rangueil, Toulouse, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Voisin
mesh_terms: D000068:Accreditation; D001777:Blood Coagulation; D006348:Cardiac Surgical Procedures / Q000295:instrumentation / Q000379:methods / Q000592:standards; D002568:Certification; D005602:France; D006487:Hemostasis; D006801:Humans; D016343:Monitoring, Intraoperative / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D012015:Reference Standards; D013927:Thrombosis / Q000097:blood* / Q000175:diagnosis; D014914:Whole Blood Coagulation Time / Q000295:instrumentation / Q000592:standards
keywords: ACT; EN ISO 22 870 standard; activated clotting time; point of care testing