Ann Lab Med.  2023 Jan;43(1):104-107. 10.3343/alm.2023.43.1.104.

Proposed Model for Evaluating Real-world Laboratory Results for Big Data Research

• Kim S
• Cho EJ
• Jeong TD
• Park HD
• Yun YM
• Lee K
• Lee YW
• Chun S
• Min WK

• KMID: 2551611
• DOI: http://doi.org/10.3343/alm.2023.43.1.104

Figure

• 

  Fig. 1 EQA results reanalysis model for determining test results that are sufficiently reliable for big data research. *“Harmonized” refers to whether or not the laboratory test item is harmonized based on the “Harmonization Status of Measurand” on the ICHCLR website (https://www.harmonization.net/); †A convenient and effective method of evaluation is to use cumulative data of external quality assurance for each laboratory. For the harmonized tests, if the evaluation results are within the acceptable criteria, the laboratory results could be considered to be sufficiently reliable for big data research and data aggregation. For non-harmonized tests, if the evaluation results are within acceptable criteria, the laboratory results could be sufficiently reliable for big data research and data aggregation, but only within the peer group. Abbreviations: EQA, external quality assessment; ICHCLR, International Consortium for Harmonization of Clinical Laboratory Results.

• 

  Fig. 2 Five principles and two prerequisites for the proposed EQA results reanalysis model for evaluating test results suitable for big data research. Abbreviation: EQA, external quality assessment.

Reference

1. EurA1c Trial Group. 2018; EurA1c: the European HbA1c trial to investigate the performance of HbA1c assays in 2166 laboratories across 17 countries and 24 manufacturers by use of the IFCC model for quality targets. Clin Chem. 64:1183–92. DOI: 10.1373/clinchem.2018.288795. PMID: 29921723.

2. Thompson S, Chesher D. 2018; Lot-to-lot variation. Clin Biochem Rev. 39:51–60.

3. Thaler MA, Iakoubov R, Bietenbeck A, Luppa PB. 2015; Clinically relevant lot-to-lot reagent difference in a commercial immunoturbidimetric assay for glycated hemoglobin A1c. Clin Biochem. 48:1167–70. DOI: 10.1016/j.clinbiochem.2015.07.018. PMID: 26187005.

4. ICHCLR. The International Consortium for Harmonization of Clinical Laboratory Results. https://www.harmonization.net. Updated on Apr 2022.

5. Jeong TD, Cho EJ, Lee K, Lee W, Yun YM, Chun S, et al. 2021; Recent trends in creatinine assays in Korea: long-term accuracy-based proficiency testing survey data by the Korean Association of External quality assessment service (2011-2019). Ann Lab Med. 41:372–9. DOI: 10.3343/alm.2021.41.4.372. PMID: 33536355. PMCID: PMC7884186.

6. Kim S, Lee K, Park HD, Lee YW, Chun S, Min WK. 2021; Schemes and performance evaluation criteria of Korean Association of External Quality Assessment (KEQAS) for improving laboratory testing. Ann Lab Med. 41:230–9. DOI: 10.3343/alm.2021.41.2.230. PMID: 33063686. PMCID: PMC7591290.

7. Weykamp C, John G, Gillery P, English E, Ji L, Lenters-Westra E, et al. 2015; Investigation of 2 models to set and evaluate quality targets for hb a1c: biological variation and sigma-metrics. Clin Chem. 61:752–9. DOI: 10.1373/clinchem.2014.235333. PMID: 25737535. PMCID: PMC4946649.

8. IFCC (International Federation of Clinical Chemistry and Laboratory Medicine). IFCC network for standardization of HbA1c. Updated on May 2022. https://ifcchba1c.org/.