scholarly journals Quality Assessment of CoaguChek Point-of-Care Prothrombin Time Monitors: Comparison of the European Community-Approved Procedure and Conventional External Quality Assessment

2006 ◽  
Vol 52 (10) ◽  
pp. 1843-1847 ◽  
Author(s):  
L. Poller
Keyword(s):  
Quality Assessment ◽  
Prothrombin Time ◽  
European Community ◽  
External Quality Assessment ◽  
Point Of Care ◽  
External Quality

scholarly journals Accuracy of HbA1c as Monitored by External Quality Assessment and Compared With Patient Mean Values

2018 ◽  
Vol 12 (4) ◽  
pp. 771-779 ◽  
Author(s):  
Gunnar Nordin
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Point Of Care ◽  
Small Variation ◽  
Specific Method ◽  
External Quality ◽  
Swedish Population ◽  
Mean Values ◽  
Hba1c Test ◽  
Performance Specifications

Background: The accuracy and trueness of results from a laboratory test, such as the HbA1c test, should not be taken for granted but must be checked continuously. A tool for this is the participation in external quality assessment (EQA) for all laboratories performing the HbA1c-test. An additional possibility to detect changes in trueness is to monitor variations in patient cohort mean or median values that is not explained by changes in treatment or selection of patients. Methods: Results reported to an EQA scheme for HbA1c during 20 years have been extracted from Equalis database. The results are compared to current analytical performance specifications (APS) and to the mean HbA1c levels for the Swedish population of persons with type 2 diabetes. Results: The accuracy of the HbA1c test has improved during the period. The hospital lab methods used in Sweden now fulfil APS agreed by professional organizations in Sweden. The accuracy for point-of-care tests (POCT) methods vary over time and fulfil APS for some periods. The bias found for some of the methods might explain changes seen in patient mean values for HbA1c in Sweden during the period 2007-2017. Conclusions: The global standardization of HbA1c has resulted in an improved comparability for HbA1c-results worldwide. But even small variation in trueness for the methods in use might have important impact on mean HbA1c values for cohorts of patients. When a systematic error is observed for a specific method it is therefore essential that manufacturers correct the method without delay.

External quality assessment (EQA) for CoaguChek monitors

2010 ◽  
Vol 103 (05) ◽  
pp. 936-941 ◽  
Author(s):  
Joergen Jespersen ◽  
A. M. H. P. van den Besselaar ◽  
Felix van der Meer ◽  
Gualtiero Palareti ◽  
Armando Tripodi ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Point Of Care ◽  
Concerted Action ◽  
External Quality ◽  
Test Strips ◽  
Italian Studies ◽  
Large Numbers ◽  
Treatment Procedures ◽  
Eqa Schemes

SummaryAnticoagulant control facilities are being overwhelmed by requests for monitoring and large numbers of patients are not therefore receiving treatment. Procedures designed for point-of-care testing have therefore been developed, the most popular being the CoaguChek. The need for external quality assessment (EQA) of monitors used by patients in self-management has been stressed in a European Commission (EC) Directive. It would not however be feasible for all CoaguChek monitors to be enrolled in national or regional EQA schemes which take time to organise and analyse. The European Concerted Action on Anticoagulation (ECAA) has therefore evolved a simpler system. Its value has been assessed in collaboration with the European Concerted Action on Thrombosis (ECAT). 523 monitors were tested at nine clinics which asked patients to bring their CoaguChek instruments to be assessed with the ECAA/ECAT procedure based on a set of 5 plasma samples with certified international normalised ratios (INR). 15% or more deviation from the certified INR on a single certified plasma sample from the set was defined by the ECAA as the limit of acceptable performance. One hundred and six (20.3%) of the monitors tested showed significant deviation and higher than average incidence of significant INR deviations reported with one specific numbered lot of test strips. Recent ECAA/ECAT, Danish and Italian studies report regular EQA of CoaguChek monitors is essential. There is general agreement that this should be performed at reasonably frequent intervals, at six months or whenever there is a change of the manufacturer’s test strips.

scholarly journals External quality assessment schemes for glucose measurements in Germany: factors for successful participation, analytical performance and medical impact

2018 ◽  
Vol 56 (8) ◽  
pp. 1238-1250 ◽  
Author(s):  
Andreas Bietenbeck ◽  
Wolf J. Geilenkeuser ◽  
Frank Klawonn ◽  
Michael Spannagl ◽  
Matthias Nauck ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Measurement Errors ◽  
External Quality Assessment ◽  
Blood Glucose Concentration ◽  
Clinical Chemistry ◽  
Point Of Care ◽  
Important Variable ◽  
External Quality ◽  
Reciprocal Effect ◽  
Glucose Testing

Abstract Background: Determination of blood glucose concentration is one of the most important measurements in clinical chemistry worldwide. Analyzers in central laboratories (CL) and point-of-care tests (POCT) are both frequently used. In Germany, regular participation in external quality assessment (EQA) schemes is mandatory for laboratories performing glucose testing. Methods: Glucose testing data from the two German EQAs “Reference Institute for Bioanalytics” (RfB) and “INSTAND – Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien” (Instand) were analyzed from 2012 to 2016. Multivariable odds ratios (OR) for the probability to reach a “good” result were calculated. Imprecision and bias were determined and clinical risk of measurement errors estimated. Results: The device employed was the most important variable required for a “good” performance in all EQAs. Additional participation in an EQA for CL automated analyzers improved performance in POCT EQAs. The reciprocal effect was less pronounced. New participants performed worse than experienced participants especially in CL EQAs. Imprecision was generally smaller for CL, but some POCT devices reached a comparable performance. Large lot-to-lot differences occurred in over 10% of analyzed cases. We propose the “bias budget” as a new metric to express the maximum allowable bias that still carries acceptable medical risk. Bias budgets were smallest and clinical risks of errors greatest in the low range of measurement 60–115 mg/dL (3.3–6.4 mmol/L) for most devices. Conclusions: EQAs help to maintain high analytical performances. They generate important data that serve as the foundation for learning and improvement in the laboratory healthcare system.

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