The microINR portable coagulometer: analytical quality and user-friendliness of a PT (INR) point-of-care instrument
2017 (English)In: Scandinavian Journal of Clinical and Laboratory Investigation, ISSN 0036-5513, E-ISSN 1502-7686, Vol. 77, no 2, 115-121 p.Article in journal (Refereed) Published
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((R))) (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 Olavs University Hospital, Trondheim, Norway (n=98) and from two PHCCs (n=88). Venous blood samples were analyzed under optimal conditions on the STA-R((R))Evolution with STA-SPA+reagent (Stago, France) (Owren method), and the results were compared to capillary measurements on the microINR((R)). The imprecision of the microINR((R)) 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((R)) did not meet the SKUP quality requirement for imprecision 5.0%. For INR amp;lt;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.
Place, publisher, year, edition, pages
TAYLOR & FRANCIS LTD , 2017. Vol. 77, no 2, 115-121 p.
International normalized ratio; point-of-care systems; point-of-care testing; quality control; warfarin
Health Care Service and Management, Health Policy and Services and Health Economy
IdentifiersURN: urn:nbn:se:liu:diva-136220DOI: 10.1080/00365513.2016.1277433ISI: 000395146100007PubMedID: 28150507OAI: oai:DiVA.org:liu-136220DiVA: diva2:1086247
Funding Agencies|SJCLI; Nordic Society for Clinical Chemistry (NFKK)2017-03-312017-03-312017-03-31