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The microINR portable coagulometer: analytical quality and user-friendliness of a PT (INR) point-of-care instrument.
Larsen, Pia Bükmann; Storjord, Elin; Bakke, Åsne; Bukve, Tone; Christensen, Mikael; Eikeland, Joakim; Haugen, Vegar Engeland; Husby, Kristin; McGrail, Rie; Mikaelsen, Solveig Meier; Monsen, Grete; Møller, Mette Fogh; Nybo, Jan; Revsholm, Jesper; Risøy, Aslaug Johanne; Skålsvik, Unni Marie; Strand, Heidi; Teruel, Reyes Serrano; Theodorsson, Elvar.
Afiliación
  • Larsen PB; a Department of Clinical Biochemistry , Slagelse Hospital , Slagelse, Denmark.
  • Storjord E; b Department of Laboratory Medicine , Nordland Hospital , Bodø, Norway.
  • Bakke Å; c Institute of Clinical Medicine, K.G. Jebsen TREC, UiT The Arctic University of Norway , Tromsø, Norway.
  • Bukve T; d Department of Endocrinology , Stavanger University Hospital , Stavanger , Norway.
  • Christensen M; e Department of Multidisciplinary Laboratory Medicine and Medical Biochemistry , Akershus University Hospital , Oslo , Norway.
  • Eikeland J; f Department of Clinical Biochemistry , University Hospital of Aarhus , Aarhus , Denmark.
  • Haugen VE; g Department of Clinical Biochemistry , Oslo University Hospital , Oslo , Norway.
  • Husby K; h Department of Clinical Biochemistry , Haukeland University Hospital , Bergen , Norway.
  • McGrail R; i Department of Multidisiplinary Laboratory Medicin and Medical Biochemistry , Akershus University Hospital , Oslo , Norway.
  • Mikaelsen SM; f Department of Clinical Biochemistry , University Hospital of Aarhus , Aarhus , Denmark.
  • Monsen G; j Department of Clinical Biochemistry , Sykehuset Innlandet , Lillehammer , Norway.
  • Møller MF; k Noklus , Haraldsplass Deaconess Hospital , Bergen , Norway.
  • Nybo J; l Department of Clinical Biochemistry , Herning Hospital , Herning , Denmark.
  • Revsholm J; m Department of Clinical Biochemistry , Aalborg University Hospital , Aalborg , Denmark.
  • Risøy AJ; n Department of Clinical Biochemistry , Randers Regional Hospital , Randers , Denmark.
  • Skålsvik UM; k Noklus , Haraldsplass Deaconess Hospital , Bergen , Norway.
  • Strand H; o Department of Global Public Health and Primary Care , University of Bergen , Bergen , Norway.
  • Teruel RS; b Department of Laboratory Medicine , Nordland Hospital , Bodø, Norway.
  • Theodorsson E; i Department of Multidisiplinary Laboratory Medicin and Medical Biochemistry , Akershus University Hospital , Oslo , Norway.
Scand J Clin Lab Invest ; 77(2): 115-121, 2017 04.
Article en En | MEDLINE | ID: mdl-28150507
Regular measurement of prothrombin time as an international normalized ratio PT (INR) is mandatory for optimal and safe use of warfarin. Scandinavian evaluation of laboratory equipment for primary health care (SKUP) evaluated the microINR portable coagulometer (microINR®) (iLine Microsystems S.L., Spain) for measurement of PT (INR). Analytical quality and user-friendliness were evaluated under optimal conditions at an accredited hospital laboratory and at two primary health care centres (PHCCs). Patients were recruited at the outpatient clinic of the Laboratory of Medical Biochemistry, St Olav's University Hospital, Trondheim, Norway (n = 98) and from two PHCCs (n = 88). Venous blood samples were analyzed under optimal conditions on the STA-R®Evolution with STA-SPA + reagent (Stago, France) (Owren method), and the results were compared to capillary measurements on the microINR®. The imprecision of the microINR® was 6% (90% CI: 5.3-7.0%) and 6.3% (90% CI: 5.1-8.3) in the outpatient clinic and PHCC2, respectively for INR ≥2.5. The microINR® did not meet the SKUP quality requirement for imprecision ≤5.0%. For INR <2.5 at PHCC2 and at both levels in PHCC1, CV% was ≤5.0. The accuracy fulfilled the SKUP quality goal in both outpatient clinic and PHCCs. User-friendliness of the operation manual was rated as intermediate, defined by SKUP as neutral ratings assessed as neither good nor bad. Operation facilities was rated unsatisfactory, and time factors satisfactory. In conclusion, quality requirements for imprecision were not met. The SKUP criteria for accuracy was fulfilled both at the hospital and at the PHCCs. The user-friendliness was rated intermediate.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tiempo de Protrombina / Sistemas de Atención de Punto / Relación Normalizada Internacional / Automatización de Laboratorios Tipo de estudio: Guideline Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Scand J Clin Lab Invest Año: 2017 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tiempo de Protrombina / Sistemas de Atención de Punto / Relación Normalizada Internacional / Automatización de Laboratorios Tipo de estudio: Guideline Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Scand J Clin Lab Invest Año: 2017 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Reino Unido