An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials

Danilenko, Uliana; Vesper, Hubert W.; Myers, Gary L.; Clapshaw, Patric A; Camara, Johanna E.; Miller, W. Greg

doi:10.1515/cclm-2019-0732

Cited by 31 publications

(15 citation statements)

References 6 publications

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“…Secondly, the use of pools instead of native samples may not be optimal in the commutability assessments. However, having strictly followed the CLSI C37-A recommendations for their preparation, we are confident that our pools may reasonably behave as individual patient samples [29]. Thirdly, using the IFCC statistical approach for evaluating commutability of reference materials, an indeterminate conclusion was frequently observed.…”

Section: Discussionmentioning

confidence: 85%

Trueness evaluation and verification of inter-assay agreement of serum folate measuring systems

Braga

Frusciante²,

Ferraro³

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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BackgroundDefinitive data to establish if the use of the WHO International Standard (IS) 03/178 as a common calibrator of commercial measuring systems (MSs) has improved the harmonization of serum total folate (tFOL) measurements to a clinically suitable level are lacking. Here, we report the results of an intercomparison study aimed to verify if the current inter-assay variability is acceptable for clinical application of tFOL testing.MethodsAfter confirming their commutability, the IS 03/178 and National Institute for Standards and Technology SRM 3949 L1 were used for evaluating the correctness of traceability implementation by manufacturers and the MSs trueness, respectively. The inter-assay agreement was verified using 20 patient pools. The measurement uncertainty (U) of tFOL measurements on clinical samples was also estimated. An outcome-based model for defining desirable performance specifications for bias and imprecision for serum tFOL measurements was applied.ResultsThe majority of evaluated MSs overestimated the WHO IS value of +5% or more with the risk to produce an unacceptably high number of false-negative results in clinical practice. The mean inter-assay CV on all pools and on those with tFOL values >3.0 μg/L (n = 15) was 12.5% and 7.1%, respectively. In neither case the goal of 3.0% was fulfilled. The residual bias resulted in an excessive U of tFOL measurement on clinical samples.ConclusionsThe implementation of traceability of tFOL MSs to the WHO IS 03/178 is currently inadequate, resulting in an inter-assay variability that does not permit the use of a common threshold for detecting folate deficiency.

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Section: Discussionmentioning

confidence: 85%

Trueness evaluation and verification of inter-assay agreement of serum folate measuring systems

Braga

Frusciante²,

Ferraro³

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…We are aware that using pools instead of a panel of native samples may not represent an optimal approach and theoretically can result in non-commutability problems. However, having strictly followed the CLSI C37-A recommendations for their preparation [22,23], we are confident that our pools may reasonably behave as individual clinical samples.…”

Section: Discussionmentioning

confidence: 99%

“…For each of the six enzymes, three fresh-frozen human serum pools with different catalytic concentrations were prepared using leftover samples, following recommendations from the Clinical Laboratory and Standards Institute (CLSI) C37-A guideline and its recently released update [22,23]. Catalytic concentrations of pools were distributed across the reportable range for each enzyme measurement, i.e.…”

Section: Preparation and Value Assignment Of Serum Poolsmentioning

confidence: 99%

Traceability validation of six enzyme measurements on the Abbott Alinity c analytical system

Aloisio

Frusciante

Pasqualetti

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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AbstractBackgroundLaboratory professionals should independently verify the correct implementation of metrological traceability of commercial measuring systems and determine if their performance is fit for purpose. We evaluated the trueness, uncertainty of measurements, and transferability of six clinically important enzyme measurements (alanine aminotransferase [ALT], alkaline phosphatase [ALP], aspartate aminotransferase [AST], creatine kinase [CK], γ-glutamyltransferase [γGT], and lactate dehydrogenase [LDH]) performed on the Abbott Alinity c analytical system.MethodsTarget values and associated uncertainties were assigned to three pools for each enzyme by using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference measurement procedures (RMPs) and the pools were then measured on the Alinity system. Bias estimation and regression studies were performed, and the uncertainty associated with Alinity measurements was also estimated, using analytical performance specifications (APS) derived from biological variability of measurands as goals. Finally, to validate the transferability of the obtained results, a comparison study between two Alinity systems located in Milan, Italy, and Bydgoszcz, Poland, was carried out.ResultsCorrect implementation of traceability to the IFCC RMPs and acceptable measurement uncertainty fulfilling desirable (ALP, AST, LDH) or optimal APS (ALT, CK, γGT) was verified for all evaluated enzymes. An optimal alignment between the two Alinity systems located in Milan and Bydgoszcz was also found for all enzyme measurements.ConclusionsWe confirmed that measurements of ALT, ALP, AST, CK, γGT, and LDH performed on the Alinity c analytical system are correctly standardized to the IFCC reference measurement systems and the system alignment is consistent between different platforms.

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“…The results of these screening analyses were provided to NIST and were used as target estimates using the RMPs. Solomon Park Research Laboratories acquired 200 mL of serum from each donor using the Clinical Laboratory Standard Institute (CLSI) C37-A protocol [49,50]. Each 200-mL single-donor sample was subsampled into 400 vials each containing 0.5 mL of serum.…”

Section: Single-donor Serum Samplesmentioning

confidence: 99%

Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) Intercomparison Study 2 — Part 1 liquid chromatography – tandem mass spectrometry (LC-MS/MS) assays — impact of 3-epi-25-hydroxyvitamin D3 on assay performance

et al. 2021

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An interlaboratory comparison study was conducted by the Vitamin D Standardization Program (VDSP) to assess the performance of liquid chromatographytandem mass spectrometry (LC-MS/MS) assays used for the determination of serum total 25hydroxyvitamin D (25(OH)D), which is the sum of 25-hydroxyvitamin D 2 (25(OH)D 2 ) and 25-hydroxyvitamin D 3 (25(OH)D 3 ). A set of 50 single-donor samples was assigned target values for concentrations of 25(OH)D 2 , 25(OH)D 3 , 3-epi-25hydroxyvitamin D 3 (3-epi-25(OH)D 3 ), and 24R,25-dihydroxyvitamin D 3 (24R,25(OH) 2 D 3 ) using isotope dilution liquid chromatographytandem mass spectrometry (ID LC-MS/MS). VDSP Intercomparison Study 2 Part 1 includes results from 14 laboratories using 14 custom LC-MS/MS assays. Assay performance was evaluated using mean % bias compared to the assigned target values and using linear regression analysis of the test assay mean results and the target values. Only 53% of the LC-MS/MS assays met the VDSP criterion of mean % bias ≤ |±5%|. For the LC-MS/MS assays not meeting the ≤ |±5%| criterion, four assays had mean % bias of between 12 and 21%. Based on multivariable regression analysis using the concentrations of the four individual vitamin D metabolites in the 50 single-donor samples, the performance of several LC-MS/MS assays was found to be influenced by the presence of 3-epi-25(OH)D 3 . The results of this interlaboratory study represent the most comprehensive comparison of LC-MS/MS assay performance for serum total 25(OH)D and document the significant impact of the lack of separation of 3-epi-25(OH)D 3 and 25(OH)D 3 on assay performance, particularly with regard to mean % bias. KeywordsTotal serum 25-hydroxyvitamin D (25(OH)D) . 25-Hydroxyvitamin D 3 (25(OH)D 3 ) . 25-Hydroxyvitamin D 2 (25(OH)D 2 ) . 3-epi-25-Hydroxyvitamin D 3 (3-epi-25(OH)D 3 ) . 24R,25-Dihydroxyvitamin D 3 (24R,25(OH) 3 D 3 ) . Liquid chromatographytandem mass spectrometry (LC-MS/MS) * Stephen A. Wise

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An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials

Cited by 31 publications

References 6 publications

Trueness evaluation and verification of inter-assay agreement of serum folate measuring systems

Trueness evaluation and verification of inter-assay agreement of serum folate measuring systems

Traceability validation of six enzyme measurements on the Abbott Alinity c analytical system

Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) Intercomparison Study 2 — Part 1 liquid chromatography – tandem mass spectrometry (LC-MS/MS) assays — impact of 3-epi-25-hydroxyvitamin D3 on assay performance

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