Reliability of point‐of‐care prothrombin time testing in a community clinic: a randomized crossover comparison with hospital laboratory testing

Abstract

Summary. The success in achieving therapeutic international normalized ratio (INR) targets in the control of warfarin using a whole-blood point-of-care testing (POCT) monitor (CoaguChek) in a community clinic was compared with hospital laboratory coagulometer prothrombin time (PT) testing in a randomized crossover study. Forty-six patients were randomized into two groups. At each visit, capillary blood was taken for the POCT monitor and venous blood for the laboratory coagulometer. In Group 1, for 6 months, dosage was based on the CoaguChek and for the second 6 months on the coagulometer. In the second group, the order was reversed. Dosages were determined using the dawn ac computer programme. Success was assessed by the percentage of time patients were maintained within the INR targets. Agreement between laboratory and monitor INR, and patient satisfaction were also assessed. Results with the POCT monitor compared well with the hospital coagulometer. Time in INR target range between the groups was similar, with 60AE9% on the POCT monitor and 59AE3% with the laboratory coagulometer in Group 1 and in Group 2, respectively, 64AE3% and 63AE4% with no significant difference in mean INR. An INR above 4AE0 gave some discrepant results. International Sensitivity Index calibrations of the two test systems indicated that the INRs were dependable. Patient questionnaires showed greater satisfaction with community POCT monitoring.

Home prothrombin time monitoring: A literature analysis

“…In a recent report, the accuracy of this device, when compared to laboratory methods, showed a mean INR bias of negative 0.025, with the least amount of bias at INRs between 2.0 and 3.0 [52]. Another study demonstrated that there was no significant difference between the geometric mean INRs obtained from the CoaguChek system and laboratory systems [53]. Tripodi et al [47] evaluated the ISI calibration of this device based on an IRP and found it to be extremely close to that adopted by the manufacturer for both whole blood and plasma.…”

The impact of non‐vitamin K antagonist oral anticoagulants (NOACs) on anticoagulation therapy in rural Australia

“…There have been few RCTs in this area and none have investigated all the areas covered in this Trial or at the scale of this Trial either in terms of the number of practices, the number of patients or the number of pathology tests included. 8,18,33,34,[58][59][60] No past trials and very few observational studies 16,17 have investigated the influence of geographic location on PoCT. The results of the PoCT Trial should provide a sound evidence base as to whether PoCT (for the three conditions) should be implemented by the government in Australian general practice.…”

“…44 Four of the RCTs investigated PoCT with another intervention. 8,18,21,34,58,59 The geographical setting included the United Kingdom (n=13) 8,16,18,21,33,[60][61][62][63][64][65][66][67] , Australia (n=7) 17,23,47,[68][69][70][71] , USA (n=5) 44,58,[72][73][74] , Belgium (n=2) 34,59 , Sweden (n=1) 75 and Ireland (n=1). 76 A description of the 29 studies included in the review is reported in Table 13 and Table 14.…”

Controle do tempo de protrombina em sangue capilar e venoso em pacientes com anticoagulação oral: correlação e concordância

“…Various studies have proven the good correlation between the Coaguchek S™ system and laboratory measurements 3,13,14 . Medical centers like the Mayo Clinic have used the technology of these devices to manage their patients 6 .…”

“…This test is very easy to perform and can be conducted anywhere including the patient's home, primary care facilities or hospitals 3,4 . These devices use microfluid technology and various detection methods to generate a prothrombin time measurement eliminating the need to draw peripheral venous blood.…”