Problems and Practical Solutions in the External Quality Control of Point of Care Devices with Respect to the Measurement of Blood Glucose

Wood, W. G.

doi:10.1177/193229680700100203

Cited by 17 publications

(7 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The matrix effect (increase of the HbA1c values) was observed in the results provided by the users of the NycoCard devices participating in center 1 surveys. For practical (volume, stability, analytes concentrations) and ethical reasons, it is common to use processed blood during EQA surveys 24–27. The matrix effect observed with many quality control samples—and for which the explanation remains unclear—did not allow us to evaluate the accuracy of HbA1c devices.…”

Section: Discussionmentioning

confidence: 99%

Retrospective analysis of 55,769 HbA1c EQA results obtained from professional laboratories and medical offices participating in surveys organized by two European EQA centers over a nine‐year period

Morandi¹,

Deom²,

Kesseler³

et al. 2011

Clinical Laboratory Analysis

View full text Add to dashboard Cite

External Quality Assessment (EQA) is an essential tool for laboratories to monitor the performances of their analyses. It also allows a comparison of methods and types of laboratories (professional laboratories vs. medical offices). We, therefore, compared 55,769 HbA1c EQA results obtained between 1999 and 2008 by laboratories participating in EQA schemes organized by two European centers, Switzerland (center 1) and France (center 2). We used simple, nonparametrical statistics suited to EQA results to calculate the yearly and global precision performances. All the results, including the outliers, were included in the calculations. The best global precision performances were obtained by professional laboratories and medical offices using DCA POCT devices, followed by professional laboratories with the Integra, Hitachi, Cobas Mira, and HPLC groups of devices, and finally by both types of laboratories with the NycoCard POCT devices. When considering yearly precision performances, an overall improvement over time was observed for almost all diagnostic devices of center 1, whereas the trend was less clear for center 2. The HbA1c EQA results collected and analyzed over a 9-year period showed that the DCA POCT devices used either by professional laboratories or medical offices had better reproducibility than laboratory devices (other than POCT) and that a general improvement of yearly precision performances was observed, especially when frequent EQA schemes were organized.

show abstract

Section: Discussionmentioning

confidence: 99%

Retrospective analysis of 55,769 HbA1c EQA results obtained from professional laboratories and medical offices participating in surveys organized by two European EQA centers over a nine‐year period

Morandi¹,

Deom²,

Kesseler³

et al. 2011

Clinical Laboratory Analysis

View full text Add to dashboard Cite

show abstract

“…Several studies have shown that participation in an EQAS for POCT analyses is useful to improve analytical quality; e.g., for mononucleosis tests and urine dip-slide tests in Norway (8,9), for group A streptococcus tests in Finland (10) and in Switzerland (11), for hemoglobin tests in Belgium (12) and for blood glucose tests in Germany (13). The United Kingdom National External Quality Assessment Service (UKNEQAS) has reported their experience with EQAS for POCT INR over a 6-year period, and stated that this kind of control is both possible and necessary for health care professionals to obtain good analytical quality (14).…”

Section: Introductionmentioning

confidence: 99%

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

Stavelin

Meijer²,

Kitchen³

et al. 2012

Clinical Chemistry and Laboratory Medicine

View full text Add to dashboard Cite

Background: Point-of-care testing (POCT) of prothrombin time, expressed as International Normalized Ratio (INR), is widely used to monitor patients in oral anticoagulation treatment. Guidelines recommend that POCT users should participate in an external quality assessment (EQA) scheme whenever available. The aim of this study was to investigate which European countries provide EQA for POCT INR and to compare how these schemes are organized. Methods: Thirty European countries were invited to participate in this study. Those who reported that they provide EQA for POCT INR filled in a questionnaire dealing with different aspects of their schemes. Results: Nineteen countries reported that they do not provide EQA for POCT INR, while 12 organizations from nine countries reported that they provide this service. Most of these countries circulate lyophilized samples with for the participants unknown target values. Samples with certified INR values and procedures using split samples with fresh patient samples are also used. The acceptability limits vary from 15% to 30%, and the total number of samples circulated per year varies from 1 to 12. Most of the countries organize educational activities together with their schemes. Conclusions: This study demonstrates that there is a wide variation in the way EQA for POCT INR is performed in Europe and that there are many European countries that do not provide this service. Even though our findings indicate that EQA for POCT INR draws some challenges, especially in providing suitable control materials, participation in such schemes is considered useful.

show abstract

“…Particularly for EQAs, the lack of commutability of applied samples is internationally recognized as one of the major hurdles in achieving a Category I POC glucose testing, 6,19 as it often impedes interpretation. 20,21 Because evaluating the commutability of EQA materials requires consistent sample typology (capillary samples) and stringent requirements that are difficult to apply, a pragmatic evaluation approach is required to ensure the correct interpretation of results provided in POC EQA reports. The aim of this study was to assess the commutability of three types of EQA materials by two different approaches, and to define suitable EQA materials to evaluate and monitor the quality of POC glucose testing.…”

Section: Introductionmentioning

confidence: 99%

“…Category I is the most desirable, as programs in this category use commutable samples with target values established by a reference system, and can evaluate both individual laboratories and MPs for reproducibility, calibration traceability, and uniformity between laboratories and between MPs. Particularly for EQAs, the lack of commutability of applied samples is internationally recognized as one of the major hurdles in achieving a Category I POC glucose testing, 6,19 as it often impedes interpretation 20,21 …”

Section: Introductionmentioning

confidence: 99%

Commutability of external quality assessment materials for point‐of‐care glucose testing using the Clinical and Laboratory Standards Institute and International Federation of Clinical Chemistry approaches

Yan

Plebani

Sciacovelli

et al. 2020

Clinical Laboratory Analysis

View full text Add to dashboard Cite

Objectives The aim of this study was to assess the commutability of three external quality assessment (EQA) materials for point‐of‐care (POC) glucose testing using two approaches, to identify suitable EQA materials to evaluate and monitor the quality of POC testing. Methods Commercial control materials (CCMs), pooled human serum samples (PHSs), and homemade human whole‐blood samples (HWBs) were measured along with 33 individual clinical samples using five POC instruments and a Hitachi 7600 analyzer. Data were analyzed by Deming regression analysis with a 95% prediction interval as described in Clinical and Laboratory Standards Institute (CLSI) EP30‐A, and by difference in bias analysis as described by the International Federation of Clinical Chemistry (IFCC) Working Group on Commutability. Results Using the CLSI approach, HWBs, CCMs, and PHSs were commutable with five, one, and two instruments, respectively. With the IFCC approach, HWBs were commutable with two instruments, while CCMs and PHSs were largely inconclusive or non‐commutable on five instruments. Conclusions HWBs were commutable on all instruments by the CLSI approach and may be a suitable EQA material for POC testing. Although some results differed between the IFCC and CLSI approaches, both indicated that HWBs were far superior to CCMs and PHSs in commutability.

show abstract

Problems and Practical Solutions in the External Quality Control of Point of Care Devices with Respect to the Measurement of Blood Glucose

Cited by 17 publications

References 10 publications

Retrospective analysis of 55,769 HbA1c EQA results obtained from professional laboratories and medical offices participating in surveys organized by two European EQA centers over a nine‐year period

Retrospective analysis of 55,769 HbA1c EQA results obtained from professional laboratories and medical offices participating in surveys organized by two European EQA centers over a nine‐year period

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

Commutability of external quality assessment materials for point‐of‐care glucose testing using the Clinical and Laboratory Standards Institute and International Federation of Clinical Chemistry approaches

Contact Info

Product

Resources

About