TY - JOUR
T1 - The microINR portable coagulometer
T2 - analytical quality and user-friendliness of a PT (INR) point-of-care instrument
AU - Larsen, Pia Bükmann
AU - Storjord, Elin
AU - Bakke, Åsne
AU - Bukve, Tone
AU - Christensen, Mikael
AU - Eikeland, Joakim
AU - Haugen, Vegar Engeland
AU - Husby, Kristin
AU - McGrail, Rie
AU - Mikaelsen, Solveig Meier
AU - Monsen, Grete
AU - Møller, Mette Fogh
AU - Nybo, Jan
AU - Revsholm, Jesper
AU - Risøy, Aslaug Johanne
AU - Skålsvik, Unni Marie
AU - Strand, Heidi
AU - Teruel, Reyes Serrano
AU - Theodorsson, Elvar
PY - 2017
Y1 - 2017
N2 - 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.
AB - 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.
U2 - 10.1080/00365513.2016.1277433
DO - 10.1080/00365513.2016.1277433
M3 - Journal article
C2 - 28150507
SN - 0036-5513
VL - 77
SP - 115
EP - 121
JO - Scandinavian Journal of Clinical & Laboratory Investigation
JF - Scandinavian Journal of Clinical & Laboratory Investigation
IS - 2
ER -