The site of the Media Sphera Publishers contains materials intended solely for healthcare professionals.
By closing this message, you confirm that you are a certified medical professional or a student of a medical educational institution.

Lantman M.S.

On behalf of the European Federation of Clinical Chemistry

Çubukçu H.C.

On behalf of the European Federation of Clinical Chemistry

Boursier G.

On behalf of the European Federation of Clinical Chemistry

Panteghini M.

On behalf of the European Federation of Clinical Chemistry

Bernabeu-Andreu F.A.

On behalf of the European Federation of Clinical Chemistry

Milinkovic N.

On behalf of the European Federation of Clinical Chemistry

Brguljan P.M.

On behalf of the European Federation of Clinical Chemistry

Linko S.

On behalf of the European Federation of Clinical Chemistry

Brugnoni D.

On behalf of the European Federation of Clinical Chemistry

O’Kelly R.

On behalf of the European Federation of Clinical Chemistry

Kroupis C.

On behalf of the European Federation of Clinical Chemistry

Lohmander M.

On behalf of the European Federation of Clinical Chemistry

Šprongl L.

On behalf of the European Federation of Clinical Chemistry

Vanstapel F.

On behalf of the European Federation of Clinical Chemistry

Thelen M.

On behalf of the European Federation of Clinical Chemistry

An approach for determining allowable between reagent lot variation

Authors:

Lantman M.S., Çubukçu H.C., Boursier G., Panteghini M., Bernabeu-Andreu F.A., Milinkovic N., Brguljan P.M., Linko S., Brugnoni D., O’Kelly R., Kroupis C., Lohmander M., Šprongl L., Vanstapel F., Thelen M.

More about the authors

Journal: Laboratory Service. 2022;11(3): 54‑63

Read: 1054 times


To cite this article:

Lantman MS, Çubukçu HC, Boursier G, et al. . An approach for determining allowable between reagent lot variation. Laboratory Service. 2022;11(3):54‑63. (In Russ.)
https://doi.org/10.17116/labs20221103154

References:

  1. International Organization for Standardization. Medical laboratories — Practical guidance for the estimation of measurement uncertainty. ISO/TS 20914:2019;2019.
  2. Infusino I, Panteghini M. Measurement uncertainty: friend or foe? Clin Biochem. 2018;57:3-6. 
  3. Braga F, Pasqualetti S, Aloisio E, Panteghini M. Theinternalquality control in the traceability era. Clin Chem Lab Med. 2020;59: 291-300. 
  4. Schoenmakers CHH, Naus AJM, Vermeer HJ, van Loon D, Steen G. Practical application of sigma metrics QC procedures in clinical chemistry. Clin Chem Lab Med. 2011;49:1837-1843.
  5. Katzman BM, Ness KM, Algeciras-Schimnich A. Evaluationof the CLSI EP26-A protocol for detection of reagent lot-to-lot differences. Clin Biochem. 2017;50:768-771. 
  6. CLSI. User evaluation of between-reagent lot variation. CLSI guideline EP26-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2013.
  7. CLSI. Verification of Comparability of Patient Results Within One Health Care System. CLSI guideline EP31-A-IR. Wayne, PA: Clinical and Laboratory Standards Institute; 2012.
  8. Thompson S, Chesher D. Lot-to-lot variation. Clin Biochem Rev. 2018;39:51-60. 
  9. Kristensen GBB, Meijer P. Interpretation of EQA results and EQA-based trouble shooting. Biochem Med. 2017;27:49-62. 
  10. Don-Wauchope AC. Lot change for reagents and calibrators. Clin Biochem. 2016;49:1211-1212.
  11. Miller W, Erek A, Cunningham TD, Oladipo O, Scott MG, Johnson RE. Commutability limitations influence quality control results with different reagent lots. Clin Chem. 2011;57:76-83. 
  12. Kim S, Chang J, Kim S-K, Park S, Huh J, Jeong T-D. Samplesizeand rejection limits for detecting reagent lot variability: analysis of the applicability of the Clinical and Laboratory Standards Institute (CLSI) EP26-A protocol to real-world clinical chemistry data. Clin Chem Lab Med. 2020;59:127-138. 
  13. Thaler MA, Iakoubov R, Bietenbeck A, Luppa PB. Clinically relevant lot-to-lot reagent difference in a commercial immunoturbidimetric assay for glycated hemoglobin A1c. Clin Biochem. 2015;48:1167-1170.
  14. Vos SJB, Visser PJ, Verhey F, Aalten P, Knol D, Ramakers I, et al. Variability of CSF Alzheimer’s disease biomarkers: implications for clinical practice. PLoS One. 2014;9:e100784.
  15. Sasaki M, Sasaki K. Significanceofthecontrolserummeasurement in infectious disease tests — a case of lot-to-lot variation of anti-HIV antibody assay kit. Rinsho Byori. 2002;50:717-720. 
  16. Algeciras-Schimnich A, Bruns D, Boyd J, Bryant S, Fortune K, Grebe S. Failure of current laboratory protocols to detect lot-to- lot reagent differences: findings and possible solutions. Clin Chem. 2013;59:1187-1194.
  17. Liu J, Tan CH, Loh TP, Badrick T. Detecting long-term drift in reagent lots. Clin Chem. 2015;61:1292-1298.
  18. International Organization for Standardization. In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples. ISO 17511:2020.
  19. Braga F, Panteghini M. The utility of measurement uncertainty in medical laboratories. Clin Chem Lab Med. 2020;58:1407-1413.
  20. Braga F, Panteghini M. Performance specifications for measurement uncertainty of common biochemical according to Milan models. Clin Chem Lab Med. 2021;59:1362-1368.
  21. Cotlove E, Harris EK, Williams GZ. Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. 3. Physiological and medical implications. Clin Chem. 1970;16:1028-1032.
  22. EFLM Biological Variation. Accessed 01 Dec 2021. https://biologicalvariation.eu
  23. Kristensen GBB, Christensen NG, Thue G, Sandberg S. Between-lot variation in external quality assessment of glucose: clinical importance and effect on participant performance evaluation. Clin Chem. 2005;51:1632-1636.
  24. Jansen RTP, Cobbaert CM, Weykamp C, Thelen M. The quest for equivalence of test results: The pilgrimage of the Dutch Calibration 2.000 program for metrological traceability. Clin Chem Lab Med. 2018;56:1673-1684.
  25. Calleja J. Parallel processing and maintaining adequate alignment between instruments and methods. Clin Biochem Rev. 2008; 29:71-77. 
  26. Miller WG, Greenberg N. Harmonization and standardization: where are we now? J Appl Lab Med. 2021;6:510-521. 
  27. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance). 2017. Accessed 02 Aug 2021. https://data.europa.eu/eli/reg/2017/746/oj/eng
  28. Ngo A, Gandhi P, Miller WG. Frequency that laboratory tests influence medical decisions. J Appl Lab Med. 2017;1:410-414. 
  29. Georgiou A, Sezgin G, Li L, Wilson R, McCaughey EJ, Lindeman R, et al. Who gets a laboratory test in hospital, why, and how often? A retrospective observational study of 4 Australian hospitals. J Appl Lab Med. 2019;4:343-354. 
  30. Barber J, Guo M, Nguyen LT, Thomas R, Turin TC, Vaska M, et al. Sociodemographic correlates of clinical laboratory test expenditures in a major Canadian city. Am J Clin Pathol. 2017;148:91-96. 
  31. Hardwick DF. Pathology — medicine’s search for meaning in the new millennium. Hum Pathol. 2002;33:1. 
  32. Vacellio E. Australian Government Department of Health. Examination of variation in hospital pathology investigations by diagnosis-related groups and associations with outcomes and costs: report to Commonwealth of Australia. Sydney: Department of Health, Quality Use Pathology Committee. Report to Commonwealth of Australia, Department of Health, Quality Use of Pathology Committee. Australian Institute of Health Innovation, Macquarie University; 2015.
  33. Braga F, Infusino I, Panteghini M. Performancecriteriafor combined uncertainty budget in the implementation of metrological traceability. Clin Chem Lab Med. 2015;53:905-912. 
  34. Loh TP, Sandberg S, Horvath A. Lot-to-lot reagent verification: challenges and possible solutions. Clin Chem Lab Med. 2022;60:675-680. 

Email Confirmation

An email was sent to test@gmail.com with a confirmation link. Follow the link from the letter to complete the registration on the site.

Email Confirmation

We use cооkies to improve the performance of the site. By staying on our site, you agree to the terms of use of cооkies. To view our Privacy and Cookie Policy, please. click here.