Application of five frozen human-pooled serum samples assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference procedure in a traceability investigation of γ-glutamyltransferase catalytic concentration measurements in China

Xia, Chang-Yu; Tong, Qing; Wang, Qingtao; Tang, Zhu-ling; Qi, Lili; Shan, Changliang; Zhang, Man; Wang, Xuejing; Li, Haixia; Xu, Guobin

doi:10.1258/acb.2009.009210

Cited by 7 publications

(7 citation statements)

References 16 publications

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“…Several examples in literature show that the application of the metrological traceability approach works well in harmonizing enzyme results in clinical samples [27,28].…”

Section: Introductionmentioning

confidence: 99%

Progress and impact of enzyme measurement standardization

Infusino

Frusciante

Braga

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has established reference measurement procedures (RMPs) for the most popular enzymes. Manufacturers should assign values to commercial calibrators traceable to these RMPs to achieve equivalent results in clinical samples, independent of reagent kits, instruments, and laboratory where the measurement is carried out. The situation is, however, far from acceptable. Some manufacturers continue to market assays giving results that are not traceable to internationally accepted RMPs. Meanwhile, end-users often do not abandon assays with demonstrated insufficient quality. Of the enzyme measurements, creatine kinase (CK) is satisfactorily standardized and a substantial improvement in performance of marketed γ-glutamyltranspeptidase (GGT) assays has been demonstrated. Conversely, aminotransferase measurements often exceed the desirable analytical performance because of the lack of pyridoxal-5-phosphate addition in the commercial reagents. Measurements of lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and α-amylase (AMY) still show major disagreement, suggesting the need for improvement in implementing traceability to higher-order references. This is mainly the result of using assays with different analytical selectivities for these enzymes. The definition by laboratory professionals of the clinically acceptable measurement uncertainty for each enzyme together with the adoption by EQAS of commutable materials and use of an evaluation approach based on trueness represent the way forward for reaching standardization in clinical enzymology.

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“…Several examples in literature show that the application of the metrological traceability approach works well in harmonizing enzyme results in clinical samples [27,28].…”

Section: Introductionmentioning

confidence: 99%

Progress and impact of enzyme measurement standardization

Infusino

Frusciante

Braga

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…Furthermore, a proof-of-concept study should properly be performed to obtain convincing evidence that the standardization works by improving result comparability in clinical setting, in order to justify costs required to recalibrate assays due to manufacturing process changes, communications to regulatory agencies, etc. (49) .…”

Section: Role and Duties Of Diagnostic Manufacturersmentioning

confidence: 99%

Implementation of standardization in clinical practice: not always an easy task

Panteghini

2012

Clinical Chemistry and Laboratory Medicine (CCLM)

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As soon as a new reference measurement system is adopted, clinical validation of correctly calibrated commercial methods should take place. Tracing back the calibration of routine assays to a reference system can actually modify the relation of analyte results to existing reference intervals and decision limits and this may invalidate some of the clinical decision-making criteria currently used. To maintain the accumulated clinical experience, the quantitative relationship to the previous calibration system should be established and, if necessary, the clinical decision-making criteria should be adjusted accordingly. The implementation of standardization should take place in a concerted action of laboratorians, manufacturers, external quality assessment scheme organizers and clinicians. Dedicated meetings with manufacturers should be organized to discuss the process of assay recalibration and studies should be performed to obtain convincing evidence that the standardization works, improving result comparability. Another important issue relates to the surveillance of the performance of standardized assays through the organization of appropriate analytical internal and external quality controls. Last but not least, uncertainty of measurement that fi ts for this purpose must be defi ned across the entire traceability chain, starting with the available reference materials, extending through the manufacturers and their processes for assignment of calibrator values and ultimately to the fi nal result reported to clinicians by laboratories.

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“…Methods for detecting serum GGT include (a) a reference method recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) 7 which shows accurate measurement results, but the operation is tedious, time‐consuming, costly, and cannot be automated, making it unsuitable for routine detection of clinical patients samples, and (b) conventional measurement systems with simple operation, low‐cost, automation, and wide use. However, the results of conventional measurement systems are often inconsistent; Xia Cet al 8 showed deviation was as high as 14.2% compared to IFCC reference procedure and coefficients of variation between systems as high to 11.6%. Additionally, some systems are not consistent in the level of medical decision‐making 9 .…”

Section: Introductionmentioning

confidence: 99%

Comparability of four clinical laboratory measurement methods for GGT and commutability of candidate reference materials

Zhang

Wang

2020

Clinical Laboratory Analysis

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Background This study was conducted to evaluate the progress in the standardization of the gamma‐glutamyl transferase (GGT) to achieve metrological traceability of routine in vitro diagnosis (IVD) medical devices. Methods We collected 25 single fresh frozen serum samples for GGT analysis. Candidate reference materials (RMs), calibrators, internal quality controls (IQC), and external quality assessment (EQA) materials from the National Center for Clinical Laboratory (NCCL), Beijing Center for Clinical Laboratory (BCCL), and College of American Pathologists (CAP) were randomly added to these serum samples. A total of 42 samples were examined using IFCC reference method and four different IVD medical devices to perform the comparability and commutability study. Results The four IVD medical devices achieved trueness assessment within the measurement range. Linear analysis showed the agreement of Siemens ADVIA 2400, Hitachi 7600‐020/BioSino, Beckman AU 5800, and Roche Cobas 501 with the reference method. These assay pairs were comparable at the medical decision levels. The GGT in‐house candidate RMs, and Beckmann and Roche calibrators were all within the limits of the 95% prediction intervals, the commutability of BioSino calibrators was indeterminate, and some internal and external quality controls were not commutable for comparisons of certain IVD medical devices vs the reference method. Conclusions By comparing with the reference method, we found that performance of GGT conventional measurement systems to be traceable to the higher order references was improved. The commutable materials for calibration and trueness controls of routine methods were significant to promote the standardization of GGT analysis.

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Application of five frozen human-pooled serum samples assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference procedure in a traceability investigation of γ-glutamyltransferase catalytic concentration measurements in China

Cited by 7 publications

References 16 publications

Progress and impact of enzyme measurement standardization

Progress and impact of enzyme measurement standardization

Implementation of standardization in clinical practice: not always an easy task

Comparability of four clinical laboratory measurement methods for GGT and commutability of candidate reference materials

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