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Annual Report

J Lab Med Qual Assur 2014; 36(4): 171-189

Published online December 31, 2014

https://doi.org/10.15263/jlmqa.2014.36.4.171

Copyright © Korean Association of External Quality Assessment Service.

Annual Report on External Quality Assessment of Immunoassay Testing in Korea (2013)

Hyon-Suk Kim and Young Lan Kim, as Immunoassay Subcommittee, The Korean Association of Quality Assurance for Clinical Laboratories

Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea

Correspondence to:Hyon-Suk Kim
Department of Laboratory Medicine, Yonsei University College of Medicine, 50-1 Yonseiro, Seodaemun-gu, Seoul 120- 752, Korea
Tel: +82-2-2228-2443
Fax: +82-2-364-1583
E-mail: kimhs54@yuhs.ac

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Two external quality assessment trials were conducted on 13 test proteins spanning 4 test categories, in 2013. The first trial was initiated on May 6, 2013, and the second trial of immunoassay tests was conducted on November 12, 2013. The trials analysed tumour markers, thyroid hormones, bone marker carboxy-terminal collagen crosslinks (CTX), and the cardiac marker troponin (troponin T [Tn-T] or troponin I [Tn-I]) used in standard immunoassay testing. Three new markers, i.e., thyroglobulin, CTX, and Tn-T/Tn-I were introduced in 2013 to replace 5 existing marker immunoproteins (immunoglobulin G, immunoglobulin M, immunoglobulin A, complement (C)3, and C4). External quality surveys of 13 immunoassay test items were conducted with the aid of 8 control materials. The tested markers included 6 tumour markers (alpha-fetoprotein, carcinoembryonic antigen, carcinoma antigen 125, carbohydrate antigen 19-9), human chorionic gonadotrophin, and prostate specific antigen), 5 thyroid markers (thyroid hormone 3 [T3], T4, thyroid stimulating hormone, free T4, and thyroglobulin), and 1 bone resorption marker CTX. The newly adopted cardiac marker troponin was also included in this study. Five homemade pooled sera and 3 commercial sera were used as the control sera. The thyroid hormones, novel bone marker CTX, and troponin controls were analysed using the MAS Tri-point Liquimmune level 3 (Medical Analysis System, Inc., USA), Elecsys PreciControl Varia, and Elecsys PreciControl Troponin (Roche, Germany), respectively. The external quality assessment was analyzed by the Immunoassay Subcommittee in 685 institutions in the first trial survey (response rate 97.9%) and 678 institutions in the second survey (95.9%). A consistent improvement was observed in the quality of the participating laboratories, particularly in the peer group results. In addition, three new immunoassay markers, thyroglobulin, CTX, and Tn-T/Tn-I, were introduced to the standard assay systems by the Immunoassay Subcommittee. (J Lab Med Qual Assur 2014;36:171-189)

Keywords: Immunoassay, Quality assurance, External quality assessment, Data collection

  1. Kim HS, Kim YL, Park J, Kwon OH, Kim DA, Kim JQ, et al. Annual report on external quality assessment in immunoassay in Korea (2009). J Lab Med Qual Assur 2010;32:103-14.
  2. Kim HS, Kim YL, Park J, Kwon OH, Kim DA, Kim JQ, et al. Annual report on external quality assessment of immunoassay subcommittee in Korean clinical laboratory survey (2008). J Lab Med Qual Assur 2009;31: 105-24.
  3. Feldkamp CS, Carey JL. Standardization of immunoassay methodologies. In: Rose NR, Hamilton RG, Detrick B, editors. Manual of clinical laboratory immunology. 6th ed. Washington (DC): ASM Press, 2002: 1215-26.
  4. Holmes EW. Establishment and verification of reference values. In: Rose NR, Hamilton RG, Detrick B, editors. Manual of clinical laboratory immunology. 6th ed. Washington (DC): ASM Press, 2002: 1271-81.
    Pubmed
  5. Howanitz PJ, Howanitz JH. Quality assurance. In: Rose NR, Hamilton RG, Detrick B, editors. Manual of clinical laboratory immunology. 6th ed. Washington (DC): ASM Press, 2002: 1227-38.
  6. Bock JL. The new era of automated immunoassay. Am J Clin Pathol 2000;113:628-46.
    Pubmed CrossRef
  7. Cembrowski GS, Carey RN. Adding value to proficiency testing programs. Clin Chem 2000;46:7-8.
    Pubmed
  8. Kwon OH, Lim HS, Kim HS, Kim DA, Kim YK, Kim JQ, et al. Annual report on external quality assessment in immunoassay in Korea (1999). J Lab Med Qual Assur 2000;22:101-26.
  9. Kim HS, Kim DW, Kim JS, Kim TY, Park MH, Park AJ, et al. Annual report on external quality assessment in immunoserology in Korea (1994). J Lab Med Qual Assur 1995;17:35-64.
  10. Cha YJ, Kwon SY, Kim TY, Kim JR, Kim HS, Park MH, et al. Annual report on external quality assessment in immunoserology in Korea (2007). J Lab Med Qual Assur 2008;30:49-74.
  11. Cha YJ, Kwon SY, Kim TY, Kim JR, Kim HS, Park MH, et al. Annual report on external quality assessment in immunoserology in Korea (2009). J Lab Med Qual Assur 2010;32:45-68.
  12. Jenny RW, Jackson-Tarentino KY. Causes of unsatisfactory performance in proficiency testing. Clin Chem 2000;46:89-99.
    Pubmed
  13. College of American Pathologists. Standards for laboratory accreditation 2013 edition. http://www.cap.org(Accessed December 2, 2014).
  14. Miyai K, Price CP. Problems for improving performance in immunoassay. J Int Fed Clin Chem 1992;4:154-63.
    Pubmed
  15. Ritchie RF. Immunoanalytical standardization: a global science. Scand J Clin Lab Invest Suppl 1991;205:3-10.
    Pubmed CrossRef
  16. Whicher JT. Calibration is the key to immunoassay but the ideal calibrator is unattainable. Scand J Clin Lab Invest Suppl 1991;205:21-32.
    Pubmed CrossRef
  17. Tahlan A, Barrowcliffe T, Das RG, Shin J, Wood D. WHO technical workshop on stability of reference materials for biological medicines and in vitro diagnostics, Geneva, Switzerland, 28-29 November 2005. Biologicals 2007;35:361-5.
    Pubmed CrossRef

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