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

Bietenbeck, Andreas; Geilenkeuser, Wolf-Jochen; Klawonn, Frank; Spannagl, Michael; Nauck, Matthias; Petersmann, Astrid; Thaler, Markus; Winter, Christof; Luppa, Peter B.

doi:10.1515/cclm-2017-1142

Cited by 15 publications

(10 citation statements)

References 30 publications

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“…The use of POCT in laboratory medicine is evolving at an increasing rate, with progressively more medical treatment decisions made based on it. Therefore, it is crucial to conduct EQAs to assess the accuracy and clinical reliability of POCT 29 . If an EQA is category I, the consistency of results between different measuring systems can be assessed using a true value, which would improve the harmonization and standardization of POCT.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, it is crucial to conduct EQAs to assess the accuracy and clinical reliability of POCT. 29 If an EQA is category I, the consistency of results between different measuring systems can be assessed using a true value, which would improve the harmonization and standardization of POCT. However, a main issue for EQA organizers is the scarcity of commutable EQA materials that are compatible with different POC instruments.…”

Section: Discussionmentioning

confidence: 99%

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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

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

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

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“…The quality of determination the blood glucose heavily influences the clinical quality of diagnosing and treating these patients [6]. POCT devices are more often affected by deranged QC results in external QA programs than measurements from analyzers within medical laboratories [7]. Due to the high impact of glucose determination in clinical settings and the known problems, it is important to maintain high quality in assessment of blood glucose measurements in POCT settings.…”

Section: Discussionmentioning

confidence: 99%

The extended internal QC (eIQC): a new practical approach for quality assurance in point-of-care glucose testing using the POCTopus Software – a pilot study

Meyer

Luppa

Cadamuro

2020

Journal of Laboratory Medicine

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BackgroundQuality assurance (QA) in point-of-care testing (POCT) is an important issue for organizing POCT structures within the healthcare sector. In Germany, only one device needs to participate in an external QA program, if the responsible core laboratory is supervising internal quality controls of all other identical POCT devices. This flexible definition of quality control (QC) testing is in line with the fundamentals of ISO 22870 and the ISO 15189, but can only be regarded as a minimum requirement.MethodsWe present a pilot study for an inexpensive new approach for additional POCT QC measurement similar to the external QA program within the medical laboratory using capillary glucose measurement as an example. This new system, referred to as “extended internal QC (eIQC)”, uses in-house generated QC material from leftover full blood from routine diagnostics. We provide information on calculation of target values and acceptance ranges and preliminary data on stability and comparison between POCT and core laboratory testing (COBAS 8000). Additionally, we simulated the approach using three devices within the laboratory as surrogate for three POCT sites. In this pilot study, measurements of QC material beyond the mandatory QA plan are structured and optimized through the use of the POCTopus Software solution.ResultsQC material was easily generated including specification of target values. The software aided in automatized processing of the samples. The software showed limitations in evaluation and monitoring without relevant use of resources. We found a significant bias between measurements on POCT and COBAS 8000 instruments.ConclusionsThe presented new approach for additional QAs for POCT enables POCT coordinators to establish an additional safety and QC level. Further software improvements are required. Further studies are needed for validation and comparison measurements between methods. Overall, this approach offers great potential for POCT structures seeking higher quality standards.

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“…This is because the initial pK a of phenyl boronic acid is ~8.8. After binding to glucose, the pK a value will drop by 2-4 pH units [30]. The polymers have been exploited by us to regulate the ion transfer through the glass nanopore [29].…”

Section: Introductionmentioning

confidence: 99%

Boronic Acid‐containing Stimuli‐responsive Polymers Modified Nanopores for Label‐free Dual‐signal‐output Detection of Glucose

Zheng

Zhu

2021

Electroanalysis

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Herein, a dual-signal-output glass nanopore system was developed for sensing glucose. Upon binding glucose, the boronic acid-containing stimuli-responsive polymer underwent a wettability switch and pKa shift. When the polymer was immobilized on the inner wall of nanopore, the nanopore offered a sensitive method for evaluating glucose by ion rectification. Besides, due to the electrostatic assembly of cationic pyrene onto the glucosebound anionic polymer, the pyrene excimer emission was observed. By separating the substrate binding and fluorescence reporting process, this work avoided the fluorescence labeling of the target and nanopore, thus simplifying the design of dual-signal-output nanopore for potential point-of-care test.

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

Abstract: 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.

Cited by 15 publications

References 30 publications

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

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

The extended internal QC (eIQC): a new practical approach for quality assurance in point-of-care glucose testing using the POCTopus Software – a pilot study

Boronic Acid‐containing Stimuli‐responsive Polymers Modified Nanopores for Label‐free Dual‐signal‐output Detection of Glucose

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