Annals of Laboratory Medicine

Korean Society for Laboratory Medicine (대한진단검사의학회)
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Evaluating the Commutability of Reference Materials for α-Fetoprotein: Accurate Value Assignment With Multiple Systems and Trueness Verification

  • Jianping Zhang (Department of Clinical Laboratory, Beijing Chaoyang Hospital, Capital Medical University, Beijing Center for Clinical Laboratories) ;
  • Jing Zhao (Department of Clinical Laboratory, Beijing Chaoyang Hospital, Capital Medical University, Beijing Center for Clinical Laboratories) ;
  • Qingtao Wang (Department of Clinical Laboratory, Beijing Chaoyang Hospital, Capital Medical University, Beijing Center for Clinical Laboratories) ;
  • Rui Zhang (Department of Clinical Laboratory, Beijing Chaoyang Hospital, Capital Medical University, Beijing Center for Clinical Laboratories) ;
  • Yuhong Yue (Department of Clinical Laboratory, Beijing Chaoyang Hospital, Capital Medical University, Beijing Center for Clinical Laboratories)
  • Received : 2023.11.14
  • Accepted : 2024.06.14
  • Published : 2024.11.01
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Abstract

Background: The accurate measurement of α-fetoprotein (AFP) is critical for clinical diagnosis. However, different AFP immunoassays may yield different results. Appropriate AFP reference materials (RMs) were selected and assigned accurate values for applications with external quality assessment (EQA) programs to standardize AFP measurements. Methods: Forty individual clinical samples and six different concentrations of candidate RMs (Can-RMs, L1-L6) were prepared by the Beijing Center for Clinical Laboratories. The Can-RMs were assigned target values by performing five immunoassays, using WHO International Standard 72/225 as a calibrator, and sent to 45 clinical laboratories in Beijing for AFP measurements. The commutability of all RMs was assessed based on CLSI and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) approaches. Analytical performance was assessed for compliance based on accuracy (total error, TE), trueness (bias), and precision (CV). Results: The Can-RMs were commutable for all immunoassays using the CLSI approach and for 6 of 10 assay combinations using the IFCC approach. RMs diluted in WHO RM 72/225 were commutable among all assays with the CLSI approach, except for serum matrix (Autolumo vs. Roche analyzer) and diluted water matrix (Abbott vs. Roche/Mindray analyzer), whereas some inconclusive and non-commutable results were found using the IFCC approach. The average pass rates based on the TE, bias, and CV were 91%, 81%, and 95%, respectively. Conclusions: The commutability of the RMs differed between both evaluation approaches. The Can-RMs exhibited good commutability with the CLSI approach, suggesting their suitability for use with that approach as commutable EQA materials with assigned values and for monitoring the performance of AFP measurements.

Keywords

Acknowledgement

This study was supported by the Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support (grant number ZYLX202137) and Beijing Chaoyang Hospital Science and Technology Innovation Fund (grant number 22kcjjzd-7).

References

  1. Gillespie JR and Uversky VN. Structure and function of alpha-fetoprotein: a biophysical overview. Biochim Biophys Acta 2000;1480:41-56. https://doi.org/10.1016/S0167-4838(00)00104-7
  2. Wong RJ, Ahmed A, Gish RG. Elevated alpha-fetoprotein: differential diagnosis – hepatocellular carcinoma and other disorders. Clin Liver Dis 2015;19:309-23. https://doi.org/10.1016/j.cld.2015.01.005
  3. Chang TS, Wu YC, Tung SY, Wei KL, Hsieh YY, Huang HC, et al. Alpha-fetoprotein measurement benefits hepatocellular carcinoma surveillance in patients with cirrhosis. Am J Gastroenterol 2015;110:836-44; quiz 845. https://doi.org/10.1038/ajg.2015.100
  4. Cao W, Chen Y, Han W, Yuan J, Xie W, Liu K, et al. Potentiality of α-fetoprotein (AFP) and soluble intercellular adhesion molecule-1 (sICAM-1) in prognosis prediction and immunotherapy response for patients with hepatocellular carcinoma. Bioengineered 2021;12:9435-51. https://doi.org/10.1080/21655979.2021.1990195
  5. Hanif H, Ali MJ, Susheela AT, Khan IW, Luna-Cuadros MA, Khan MM, et al. Update on the applications and limitations of alpha-fetoprotein for hepatocellular carcinoma. World J Gastroenterol 2022;28:216-29. https://doi.org/10.3748/wjg.v28.i2.216
  6. 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. 2020;ISO 17511:2020. https://www.iso.org/standard/69985.html
  7. Vesper HW and Thienpont LM. Traceability in laboratory medicine. Clin Chem 2009;55:1067-75. https://doi.org/10.1373/clinchem.2008.107052
  8. Yue Y, Zhang S, Xu Z, Chen X, Wang Q. Commutability of reference materials for α-fetoprotein in human serum. Arch Pathol Lab Med 2017;141:1421-7. https://doi.org/10.5858/arpa.2016-0441-OA
  9. Braga F, Pasqualetti S, Panteghini M. The role of external quality assessment in the verification of in vitro medical diagnostics in the traceability era. Clin Biochem 2018;57:23-8. https://doi.org/10.1016/j.clinbiochem.2018.02.004
  10. Jones GRD, Delatour V, Badrick T. Metrological traceability and clinical traceability of laboratory results - the role of commutability in external quality assurance. Clin Chem Lab Med 2022;60:669-74. https://doi.org/10.1515/cclm-2022-0038
  11. Braga F and Panteghini M. Commutability of reference and control materials: an essential factor for assuring the quality of measurements in laboratory medicine. Clin Chem Lab Med 2019;57:967-73. https://doi.org/10.1515/cclm-2019-0154
  12. Miller WG, Schimmel H, Rej R, Greenberg N, Ceriotti F, Burns C, et al. IFCC Working Group recommendations for assessing commutability part 1: general experimental design. Clin Chem 2018;64:447-54. https://doi.org/10.1373/clinchem.2017.277525
  13. Danilenko U, Vesper HW, Myers GL, Clapshaw PA, Camara JE, Miller WG. 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. Clin Chem Lab Med 2020;58:368-74. https://doi.org/10.1515/cclm-2019-0732
  14. CLSI. Characterization and qualification of commutable reference materials for laboratory medicine; approved guideline. 1st ed. CLSI EP30-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2010.
  15. Deprez L, Toussaint B, Zegers I, Schimmel H, Grote-Koska D, Klauke R, et al. Commutability assessment of candidate reference materials for pancreatic α-amylase. Clin Chem 2018;64:1193-202. https://doi.org/10.1373/clinchem.2018.289744
  16. Nilsson G, Budd JR, Greenberg N, Delatour V, Rej R, Panteghini M, et al. IFCC working group recommendations for assessing commutability part 2: using the difference in bias between a reference material and clinical samples. Clin Chem 2018;64:455-64. https://doi.org/10.1373/clinchem.2017.277541
  17. Trapé J, Botargues JM, Porta F, Ricós C, Badal JM, Salinas R, et al. Reference change value for alpha-fetoprotein and its application in early detection of hepatocellular carcinoma in patients with hepatic disease. Clin Chem 2003;49:1209-11. https://doi.org/10.1373/49.7.1209
  18. Trapé J, Franquesa J, Sala M, Domenech M, Montesinos J, Catot S, et al. Determination of biological variation of α-fetoprotein and choriogonadotropin (β chain) in disease-free patients with testicular cancer. Clin Chem Lab Med 2010;48:1799-801. https://doi.org/10.1515/CCLM.2010.343
  19. Coşkun A, Aarsand AK, Sandberg S, Guerra E, Locatelli M, Díaz-Garzón J, et al. Within- and between-subject biological variation data for tumor markers based on the European Biological Variation Study. Clin Chem Lab Med 2022;60:543-52. https://doi.org/10.1515/cclm-2021-0283
  20. Korchia J and Freeman KP. Total observed error, total allowable error, and QC rules for canine serum and urine cortisol achievable with the Immulite 2000 Xpi cortisol immunoassay. J Vet Diagn Invest 2022;34:246-57. https://doi.org/10.1177/10406387221076129
  21. Conformity assessment — General requirements for the competence of proficiency testing providers. 2023; ISO/IEC 17043:2023. https://www.iso.org/standard/80864.html
  22. Jennings I, Kitchen D, Kitchen S, Woods T, Walker I. The importance of commutability in material used for quality control purposes. Int J Lab Hematol 2019;41:39-45. https://doi.org/10.1111/ijlh.12918
  23. Miller WG, Jones GRD, Horowitz GL, Weykamp C. Proficiency testing/external quality assessment: current challenges and future directions. Clin Chem 2011;57:1670-80. https://doi.org/10.1373/clinchem.2011.168641
  24. Xing T, Liu J, Sun H, Gao Y, Ju Y, Liu X, et al. Commutability assessment of reference materials for homocysteine. Clin Chem Lab Med 2022;60:1562-9. https://doi.org/10.1515/cclm-2022-0388
  25. Guo Q, Wang J, Yi X, Zeng J, Zhou W, Zhao H, et al. Commutability of reference materials for alkaline phosphatase measurements. Scand J Clin Lab Invest 2020;80:388-94. https://doi.org/10.1080/00365513.2020.1747111
  26. Apple FS, Collinson PO, IFCC Task Force on Clinical Applications of Cardiac Biomarkers. Analytical characteristics of high-sensitivity cardiac troponin assays. Clin Chem 2012;58:54-61. https://doi.org/10.1373/clinchem.2011.165795
  27. Zhang TJ, Pu YG, Zhou HJ, Ma R, Zhang JT, Wang DG, et al. Application of IFCC reference assay in the evaluation of five glycosylated hemoglobin detection assays. Chin J Lab Med 2018;12:821-6.