Commutability of a whole-blood external quality assessment material for point-of-care C-reactive protein, glucose, and hemoglobin testing

Bukve, Tone

doi:10.1016/j.cca.2019.03.1365

Cited by 4 publications

(5 citation statements)

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“…41 Commutability relates to the ability of the analyzer to provide measurement results using such quality control materials that, in a method comparison, show the same relationship as, for example, using standard samples (eg, human blood panels). This is not always the case, as recently published by Bukve et al, 42 so that the POCT12-A3 recommendation to assess the commutability of such material should be acknowledged.…”

Section: Discussionmentioning

confidence: 96%

Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems

Freckmann

Baumstark

Jendrike

et al. 2020

J Diabetes Sci Technol

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Background: Measurement accuracy has been assessed for many different blood glucose monitoring systems (BGMS) over the years by different study groups. However, the choice of the comparison measurement procedure may impact the apparent level of accuracy found in such studies. Materials and Methods: Measurement accuracy of 18 different BGMS was assessed in a setting based on ISO 15197 using two different comparison methods in parallel: a glucose oxidase (GOD)-based and a hexokinase (HK)-based method. Accuracy limits of ISO 15197 were applied, and additional analyses were performed, including bias, linear regression, and mean absolute relative difference (MARD) to assess the impact of possible differences between comparison methods on the apparent level of accuracy. Results: While ≈80% of BGMS met the accuracy criteria of ISO 15197 when compared with the respective manufacturers’ reference measurement procedure, only two-thirds did so against both comparison methods. The mean relative bias ranged from −6.6% to +5.7% for the analysis against the GOD-based method and from −11.1% to +1.3% for the analysis against the HK-based method, whereas MARD results ranged from 3.7% to 9.8% and from 2.3% to 10.5%, respectively. Results of regression analysis showed slopes between 0.85 and 1.08 (GOD-based method) and between 0.81 and 1.01 (HK-based method). Conclusions: The results of this study indicate that there are systematic differences between the reference measurement procedures used for BGMS calibration as well as for system accuracy assessment. Because of the potential impact on therapy of patients with diabetes resulting from these differences, further steps toward harmonization of the measurement procedures’ results are important.

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Section: Discussionmentioning

confidence: 96%

Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems

Freckmann

Baumstark

Jendrike

et al. 2020

J Diabetes Sci Technol

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“…Commutability assessments of the three EQA materials were first performed using the CLSI EP30‐A approach, which analyzes samples with the pair MPs and determines if the materials fall within the 95% PI. Bukve et al 31 recently demonstrated that whole‐blood EQA material was commutable on three POC glucose instruments using this approach. Our study showed that HWBs were commutable on all five POC instruments at all three concentrations analyzed, while CCMs and PHSs were commutable on one and two instruments at all three levels, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…The results also displayed good linear correlation in each comparison.Commutability assessments of the three EQA materials were first performed using the CLSI EP30-A approach, which analyzes samples with the pair MPs and determines if the materials fall within the 95% PI. Bukve et al31 recently demonstrated that whole-blood EQA material was commutable on three POC glucose…”

mentioning

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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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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“…The commutability is a property required to provide an EQAS program classified as category 1 or 2, and without proven commutability the key benefit of assessment of traceability of the result to a reference system is lost, 36 as shown by comparing the results obtained from traditional schemes using both serum matrix control materials 37,38 and whole‐blood control materials 39 . The commutability of some whole‐blood EQAS control materials has been recently evaluated using the new IFCC approach, pursued for point of care testing, including only Hb as hematologic parameter 35‐40 . Conversely, at least to our knowledge, the commutability property of control materials used for hematologic analyzers alignment is not usually verified.…”

Section: Discussionmentioning

confidence: 99%

Standardization and harmonization in hematology: Instrument alignment, quality control materials, and commutability issue

Vidali¹,

Carobene

Esposito

et al. 2020

Int J Lab Hematology

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Introduction In the hub and spoke laboratory network, the number of hematology analyzers (HAs) within each core center has increased, and the control of HAs alignment is becoming necessary requirement to ensure analytical quality. In this scenario, HA alignment can be assessed by analyzing the same control material used for internal quality control on multiple HAs, assuming its commutability. The aim of the study was to verify the applicability of a protocol for the alignment of HAs based on control material rather than on fresh whole‐blood samples. Methods The alignment of five HAs was evaluated for red (RBC, Hb, MCV, RET), white (WBC, NE, LY, MO, EO, BA, IG), and platelet (PLT) series parameters, following a protocol by SIBioC, using human sample (HS) and quality control material (QC), after the verification of commutability, according to the IFCC protocol. Maximum bias was derived from biological variation data. Results A complete alignment between instruments was confirmed for the majority of the parameters investigated both for HS and QC material. Partial misalignments or inconcludent results were instead evident for MCV, MO, EO, BA, and IG. Interestingly, QC material was found to be not commutable for LY, MO, and BA. Conclusion The alignment of hematologic analyzers for main cell population parameters may be verified with both QC and HS, displaying consistent results and interpretation. The evaluation for some white series parameters (EO, BA, and IG) is critical, and particular attention must be paid to the values of the material used for the alignment.

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Commutability of a whole-blood external quality assessment material for point-of-care C-reactive protein, glucose, and hemoglobin testing

Cited by 4 publications

References 0 publications

Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems

Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems

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

Standardization and harmonization in hematology: Instrument alignment, quality control materials, and commutability issue

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