Point of Care INR testing devices: performance of the Roche CoaguChek XS and XS Plus in the UK NEQAS BC external quality assessment programme for healthcare professionals: four years’ experience
Abstract:Utilisation of an EQA programme for POC devices in primary care is feasible and necessary. Our data suggest for those health professionals using EQA, the reliability and accuracy of INR testing matches the quality of laboratory testing.
“…Some form of external assessment of INRs obtained with POCT devices is recommended (Fitzmaurice et al , ; MHRA, ). For healthcare professionals, EQA is available and established for several POCT devices (Tripodi et al , ; Kitchen et al , , ). The SMART (Self‐management of anticoagulation: a randomized trial) study (McCahon et al , ) explored three different models of EQA for PST/PSM: (1) enrolment in a proficiency testing programme, with EQA material provided directly to the patient for testing; (2) comparison of fingerstick samples with a master POCT device, itself controlled through participation in a proficiency testing programme and (3) comparison of a fingerstick sample with a venous sample tested with a laboratory system.…”
“…Some form of external assessment of INRs obtained with POCT devices is recommended (Fitzmaurice et al , ; MHRA, ). For healthcare professionals, EQA is available and established for several POCT devices (Tripodi et al , ; Kitchen et al , , ). The SMART (Self‐management of anticoagulation: a randomized trial) study (McCahon et al , ) explored three different models of EQA for PST/PSM: (1) enrolment in a proficiency testing programme, with EQA material provided directly to the patient for testing; (2) comparison of fingerstick samples with a master POCT device, itself controlled through participation in a proficiency testing programme and (3) comparison of a fingerstick sample with a venous sample tested with a laboratory system.…”
“…The variations of CoaguChek XS and CoaguChek XS Plus were outstandingly low, mean CV 3.3%, range 2.2–6.1% (Table ), while the CVs (after excluding outliers) of these instruments reported in the UK NEQAS varied from 12 to 15.8% . This substantial difference may be explained by different type of the majority of participating centers, that is, hospital laboratories, in our study and general practice in the other, due to the fact that laboratory personnel have better skill in performance of testing.…”
External quality assessment for POCT INR in Thailand is feasible using the ECAA plasmas as control materials. The results therefore appear encouraging to other developing countries to establish their own EQA schemes.
“…18 In the latter scheme period (2010-2011), CVs were 10.6% to 18.9% for CoaguChek XS Plus users, and a mean of 7.5% of CoaguChek XS users were more than 15% from the median of INRs determined from all user results. 18 There are several differences between the Netherlands and the UK schemes. One difference is in the removal of any outliers.…”
Section: Discussionmentioning
confidence: 91%
“…One possible explanation for the greater proportion of "out with consensus" results in the UK scheme may be variable fluid transfer by some participants in the reconstitution and recalcification of the lyophilized samples. 18 In the Netherlands scheme, participants were requested to use an accurate pipette for adding calcium chloride solution.…”
The control blood samples were useful for external quality assessment in the Netherlands. The participants' performance with the CoaguChek XS system improved with time, demonstrating the value of external quality assessment.
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