J Lab Med Qual Assur.  2014 Dec;36(4):171-189. 10.15263/jlmqa.2014.36.4.171.

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

• Kim HS
• Kim YL
• Immunoassay Subcommittee, The Korean Association of Quality Assurance for Clinical Laboratories

• KMID: 2200397
• DOI: http://doi.org/10.15263/jlmqa.2014.36.4.171

Abstract

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.

Keyword

Immunoassay; Quality assurance; External quality assessment; Data collection

MeSH Terms

Bone Resorption
Carcinoembryonic Antigen
Chorion
Collagen
Complement System Proteins
Data Collection
Humans
Immunoassay*
Immunoglobulin A
Immunoglobulin M
Immunoproteins
Korea
Peer Group
Prostate
Thyroglobulin
Thyroid Gland
Thyroid Hormones
Thyrotropin
Troponin
Troponin I
Carcinoembryonic Antigen
Collagen
Complement System Proteins
Immunoglobulin A
Immunoglobulin M
Immunoproteins
Thyroglobulin
Thyroid Hormones
Thyrotropin
Troponin
Troponin I