scholarly journals External quality assessment of point-of-care International Normalized Ratio (INR) testing in Europe

2012 ◽  
Vol 50 (1) ◽  
Author(s):  
Anne Stavelin ◽  
Piet Meijer ◽  
Dianne Kitchen ◽  
Sverre Sandberg
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Point Of Care ◽  
International Normalized Ratio ◽  
External Quality

scholarly journals Preparation of Control Blood for External Quality Assessment of Point-of-Care International Normalized Ratio Testing in the Netherlands

2014 ◽  
Vol 141 (6) ◽  
pp. 878-883 ◽  
Author(s):  
Anton M. H. P. van den Besselaar ◽  
Charmane F. Abdoel ◽  
Davina Ardanary ◽  
Gert van de Kamp ◽  
Fanny A. C. Versluijs
Keyword(s):  
The Netherlands ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Point Of Care ◽  
International Normalized Ratio ◽  
External Quality

scholarly journals External Quality Assessment of Point-of-Care Methods: Model For Combined Assessment of Method Bias and Single-Participant Performance by the Use of Native Patient Samples and Noncommutable Control Materials

2013 ◽  
Vol 59 (2) ◽  
pp. 363-371 ◽  
Author(s):  
Anne Stavelin ◽  
Per Hyltoft Petersen ◽  
Una Ø Sølvik ◽  
Sverre Sandberg
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Point Of Care ◽  
International Normalized Ratio ◽  
Comparison Method ◽  
Case Scenario ◽  
External Quality ◽  
Target Values ◽  
Quality Specifications ◽  
Method Bias

BACKGROUND An important objective in external quality assessment (EQA) is to evaluate systematic deviations between methods. However, this is not possible when noncommutable control materials are used. The aim of this study was to develop an EQA model that incorporates a method bias evaluation using native patient samples into EQA schemes in which noncommutable materials are used. METHODS The model was applied twice in a point-of-care (POC) international normalized ratio survey among 1341 and 1578 participants. To estimate bias, about 100 native patient samples for each POC method were analyzed by a selected group of “expert” primary healthcare centers and on a designated comparison method. In addition, the expert centers as well as all the other EQA participants analyzed 2 noncommutable control materials, and method-specific target values were established. Both method bias and the deviation of a single-participant result from the method target value were evaluated against analytical quality specifications, making combined assessment possible. The best-case scenario occurred when both results were within the quality specifications. RESULTS Two POC methods fulfilled the quality specification for bias, whereas one did not. The best-case scenario was achieved by more than 90% of the participants using the methods with no bias, whereas none of the participants using the method with unacceptable bias achieved this result. CONCLUSIONS We propose an EQA model for which the bias of POC methods can be evaluated in situations in which commutable control materials are not available.

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.

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