The microINR portable coagulometer: analytical quality and user-friendliness of a PT (INR) point-of-care instrument.
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.
a Department of Clinical Biochemistry , Slagelse Hospital , Slagelse, Denmark.
Pia Bükmann
PB
Larsen
b Department of Laboratory Medicine , Nordland Hospital , Bodø, Norway.|c Institute of Clinical Medicine, K.G. Jebsen TREC, UiT The Arctic University of Norway , Tromsø, Norway.
Elin
E
Storjord
d Department of Endocrinology , Stavanger University Hospital , Stavanger , Norway.
Åsne
Å
Bakke
e Department of Multidisciplinary Laboratory Medicine and Medical Biochemistry , Akershus University Hospital , Oslo , Norway.
Tone
T
Bukve
f Department of Clinical Biochemistry , University Hospital of Aarhus , Aarhus , Denmark.
Mikael
M
Christensen
g Department of Clinical Biochemistry , Oslo University Hospital , Oslo , Norway.
Joakim
J
Eikeland
h Department of Clinical Biochemistry , Haukeland University Hospital , Bergen , Norway.
Vegar Engeland
VE
Haugen
i Department of Multidisiplinary Laboratory Medicin and Medical Biochemistry , Akershus University Hospital , Oslo , Norway.
Kristin
K
Husby
f Department of Clinical Biochemistry , University Hospital of Aarhus , Aarhus , Denmark.
Rie
R
McGrail
j Department of Clinical Biochemistry , Sykehuset Innlandet , Lillehammer , Norway.
Solveig Meier
SM
Mikaelsen
k Noklus , Haraldsplass Deaconess Hospital , Bergen , Norway.
Grete
G
Monsen
l Department of Clinical Biochemistry , Herning Hospital , Herning , Denmark.
Mette Fogh
MF
Møller
m Department of Clinical Biochemistry , Aalborg University Hospital , Aalborg , Denmark.
Jan
J
Nybo
n Department of Clinical Biochemistry , Randers Regional Hospital , Randers , Denmark.
Jesper
J
Revsholm
k Noklus , Haraldsplass Deaconess Hospital , Bergen , Norway.|o Department of Global Public Health and Primary Care , University of Bergen , Bergen , Norway.
Aslaug Johanne
AJ
Risøy
b Department of Laboratory Medicine , Nordland Hospital , Bodø, Norway.
Unni Marie
UM
Skålsvik
i Department of Multidisiplinary Laboratory Medicin and Medical Biochemistry , Akershus University Hospital , Oslo , Norway.
Heidi
H
Strand
k Noklus , Haraldsplass Deaconess Hospital , Bergen , Norway.
Reyes Serrano
RS
Teruel
p Department of Clinical Chemistry and Department of Clinical and Experimental Medicine , Linköping University , Linköping, Sweden.
Elvar
E
Theodorsson
D000704:Analysis of Variance; D000925:Anticoagulants / Q000494:pharmacology; D057205:Automation, Laboratory / Q000295:instrumentation / Q000592:standards*; D001777:Blood Coagulation / Q000187:drug effects; D006801:Humans; D019934:International Normalized Ratio / Q000295:instrumentation*; D007755:Laboratories, Hospital; D009664:Norway; D019095:Point-of-Care Systems / Q000592:standards*; D011517:Prothrombin Time / Q000295:instrumentation*; D015203:Reproducibility of Results; D014859:Warfarin / Q000494:pharmacology
D000925:Anticoagulants; D014859:Warfarin
International normalized ratio; point-of-care systems; point-of-care testing; quality control; warfarin