Commutability of control materials for external quality assessment of serum apolipoprotein A-I measurement

2018 ◽  
Vol 56 (5) ◽  
pp. 789-795 ◽  
Author(s):  
Jie Zeng ◽  
Tianqi Qi ◽  
Shu Wang ◽  
Tianjiao Zhang ◽  
Weiyan Zhou ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Human Serum ◽  
External Quality Assessment ◽  
Prediction Intervals ◽  
External Quality ◽  
Apolipoprotein A ◽  
Deming Regression ◽  
Measurement Results ◽  
Fresh Frozen ◽  
Materials Used

AbstractBackground:The aim of the current study was to evaluate the commutability of commercial control materials and human serum pools and to investigate the suitability of the materials for the external quality assessment (EQA) of serum apolipoprotein A-I (apo A-I) measurement.Methods:The Clinical and Laboratory Standards Institute (CLSI) EP14-A3 protocol was used for the commutability study. Apo A-I concentrations in two levels of commercial control materials used in EQA program, two fresh-frozen human serum pools (FSPs) and two frozen human serum pools prepared from residual clinical specimens (RSPs) were measured along with 50 individual samples using nine commercial assays. Measurement results of the 50 individual samples obtained with different assays were pairwise analyzed by Deming regression, and 95% prediction intervals (PIs) were calculated. The commutability of the processed materials was evaluated by comparing the measurement results of the materials with the limits of the PIs.Results:The FSP-1 was commutable for all the 36 assay pairs, and FSP-2 was commutable for 30 pairs; RSP-1 and RSP-2 showed commutability for 27/36 and 22/36 assay pairs, respectively, whereas the two EQA materials were commutable only for 4/36 and 5/36 assay pairs, respectively.Conclusions:Non-commutability of the tested EQA materials has been observed among current apo A-I assays. EQA programs need either to take into account the commutability-related biases in the interpretation of the EQA results or to use more commutable materials. Frozen human serum pools were commutable for most of the assays.

scholarly journals The Importance of Commutability of Reference Materials Used as Calibrators: The Example of Ceruloplasmin

2013 ◽  
Vol 59 (9) ◽  
pp. 1322-1329 ◽  
Author(s):  
Ingrid Zegers ◽  
Robert Beetham ◽  
Thomas Keller ◽  
Joanna Sheldon ◽  
David Bullock ◽  
...  
Keyword(s):  
Reference Material ◽  
Quality Assessment ◽  
Reference Materials ◽  
External Quality Assessment ◽  
Serum Samples ◽  
External Quality ◽  
Measurement Results ◽  
Materials Used ◽  
The Uk ◽  
Good Linear Correlation

BACKGROUND Different methods for ceruloplasmin tend to give different results in external quality assessment schemes. During the production of the certified reference material ERM-DA470k/IFCC discrepant measurement results were also found for ceruloplasmin measured with different methods, and consequently the protein could not be certified in the material. METHODS We performed a commutability study with 30 serum samples and the reference materials ERM-DA470, ERM-DA470k/IFCC, and ERM-DA472/IFCC, using 6 different methods. Data were analyzed according to the CLSI Guideline C53-A to assess whether the reference materials had the same behavior as the serum samples with respect to measurement results obtained with combinations of the methods used. RESULTS Measurement results from different methods showed a good linear correlation for the serum samples. ERM-DA470 showed marked noncommutability for certain combinations of methods. ERM-DA470k/IFCC and ERM-DA472/IFCC were commutable for more combinations of methods. The lack of commutability of ERM-DA470 for certain combinations of methods correlates with results from the UK National External Quality Assessment Service showing discrepancies between results from these methods. For serum stored in the presence of sodium azide the results from different methods are essentially equivalent. CONCLUSIONS Ceruloplasmin in ERM-DA470 is a fully documented example of a situation in which, due to lack of commutability, the use of a common material for calibration did not lead to harmonization .

Traceable assigned values in external quality assessment schemes compared to those obtained by alternative procedure: a case study for Cu, Se and Zn in serum

2015 ◽  
Vol 30 (1) ◽  
pp. 148-153 ◽  
Author(s):  
Marina Patriarca ◽  
Cas Weykamp ◽  
Josiane Arnaud ◽  
Robert L. Jones ◽  
Patrick J. Parsons ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
International Standards ◽  
Alternative Procedure ◽  
External Quality ◽  
Testing Laboratories ◽  
Measurement Results

International standards for the recognition of the competence of testing laboratories require that measurement results should be traceable to a conventionally agreed reference.

Baseline Assessment of 25-Hydroxyvitamin D Reference Material and Proficiency Testing/External Quality Assurance Material Commutability: A Vitamin D Standardization Program Study

2017 ◽  
Vol 100 (5) ◽  
pp. 1288-1293 ◽  
Author(s):  
Karen W Phinney ◽  
Christopher T Sempos ◽  
Susan S-C Tai ◽  
Johanna E Camara ◽  
Stephen A Wise ◽  
...  
Keyword(s):  
Vitamin D ◽  
Quality Assurance ◽  
Reference Material ◽  
Quality Assessment ◽  
Human Serum ◽  
Proficiency Testing ◽  
External Quality Assessment ◽  
External Quality ◽  
Hydroxyvitamin D ◽  
25 Hydroxyvitamin D

Abstract The Vitamin D Standardization Program (VDSP) coordinated a study in 2012 to assess the commutability of reference materials and proficiency testing/external quality assurance materials for total 25-hydroxyvitamin D [25(OH)D] in human serum, the primary indicator of vitamin D status. A set of 50 single-donor serum samples as well as 17 reference and proficiency testing/external quality assessment materials wereanalyzed by participating laboratories that used either immunoassay or LC-MS methods for total 25(OH)D. The commutability test materials included National Institute of Standards and Technology Standard Reference Material 972a Vitamin D Metabolites in Human Serum as well as materials from the College of AmericanPathologists and the Vitamin D External Quality Assessment Scheme. Study protocols and data analysis procedures were in accordance with Clinical and Laboratory Standards Institute guidelines. The majority of the test materials were found to be commutable with the methods used in this commutability study. These results provide guidance for laboratories needing tochoose appropriate reference materials and select proficiency or external quality assessment programs and will serve as a foundation for additional VDSP studies.

scholarly journals Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0253324
Author(s):  
Shunli Zhang ◽  
Fei Cheng ◽  
Hua Wang ◽  
Jiangping Wen ◽  
Jie Zeng ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Human Serum ◽  
External Quality Assessment ◽  
Thyroid Stimulating Hormone ◽  
Clinical Samples ◽  
Systematic Bias ◽  
Serum Samples ◽  
Bias Analysis ◽  
External Quality ◽  
Human Sera

Background This study aimed to assess the comparability among assays using freshly frozen human sera and external quality assessment (EQA) data in China. Methods Twenty-nine serum samples and two commercial EQA materials, obtained from the National Center for Clinical Laboratories (NCCL), were analyzed in triplicate using eight routine TSH assays. The commutability of commercial EQA materials (NCCL materials) was evaluated in accordance with the CLSI EP30-A and IFCC bias analysis. Median values obtained for the NCCL EQA materials were used to determine the systematic and commutability-related biases among immunoassays through back-calculation. The comparability of TSH measurements from a panel of clinical samples and NCCL EQA data was determined on the basis of Passing–Bablok regression. Furthermore, human serum pools were used to perform commutable EQA. Results NCCL EQA materials displayed commutability among three or five of seven assay combinations according CLSI or IFCC approach, respectively. The mean of systematic bias ranged from -13.78% to 9.85% for the eight routine TSH assays. After correcting for systematic bias, averaged commutability-related biases ranged between -42.26% and 12.19%. After correction for systematic and commutability -related biases, the slopes indicating interassay relatedness ranged from 0.801 to 1.299 using individual human sera, from 0.735 to 1.254 using NCCL EQA data, and from 0.729 to 1.115 using pooled human serum EQA(the commutable EQA). Conclusions The harmonization of TSH measurement is challenging; hence, systematic and commutability-related biases should be determined and corrected for accurate comparisons among assays when using human individual serum and the commercial EQA materials.

scholarly journals Commutability of a Whole-Blood External Quality Assessment Material for Point-of-Care C-Reactive Protein, Glucose, and Hemoglobin Testing

2019 ◽  
Vol 65 (6) ◽  
pp. 791-797 ◽  
Author(s):  
Tone Bukve ◽  
Sverre Sandberg ◽  
Wenche S Vie ◽  
Una Sølvik ◽  
Nina G Christensen ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Whole Blood ◽  
External Quality Assessment ◽  
Point Of Care ◽  
C Reactive Protein ◽  
External Quality ◽  
Reactive Protein ◽  
Target Value ◽  
Reference Target ◽  
Deming Regression

Abstract BACKGROUND The optimal situation in external quality assessment (EQA) is to use commutable materials. No previous study has examined the commutability of a whole-blood material for point-of-care (POC) testing. The aim of this study was to determine the commutability of the Norwegian Quality Improvement of Laboratory Examinations (Noklus) organization's “in-house” whole-blood EQA material for C-reactive protein (CRP), glucose, and hemoglobin for frequently used POC instruments in Norway and to determine the possibility of using a common target value for each analyte. METHODS The study was performed according to the Clinical and Laboratory Standards Institute guidelines. The EQA material was pooled stabilized EDTA venous whole-blood containing different concentrations of the analytes. The EQA material and native routine patient samples were analyzed using 17 POC and 3 hospital instruments. The commutability was assessed using Deming regression analysis with 95% prediction intervals for each instrument comparison. RESULTS The EQA material was commutable for all CRP and hemoglobin POC instruments, whereas for glucose the material was commutable for all POC instruments at the lowest concentration analyzed [126.0 mg/dL (7.0 mmol/L)] and for 3 POC instruments at all of the concentrations analyzed. CONCLUSIONS Noklus EQA participants using CRP and hemoglobin POC instruments now receive results that are compared with a reference target value, whereas the results for participants using glucose POC instruments are still compared with method-specific target values. Systematic deviations from a reference target value for the commutable glucose POC instruments can be calculated, and this additional information can now be offered to these participants and to the manufacturers.

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