Report of the IFCC Working Group for Standardization of Thyroid Function Tests; Part 1: Thyroid-Stimulating Hormone

被引:105
作者
Thienpont, Linda M. [1 ]
Van Uytfanghe, Katleen [1 ]
Beastall, Graham [2 ]
Faix, James D. [4 ]
Ieiri, Tamio [3 ]
Miller, W. Greg [5 ]
Nelson, Jerald C. [6 ]
Ronin, Catherine [7 ]
Ross, H. Alec [8 ]
Thijssen, Jos H. [9 ]
Toussaint, Brigitte [10 ]
机构
[1] Univ Ghent, Fac Pharmaceut Sci, Analyt Chem Lab, B-9000 Ghent, Belgium
[2] Royal Infirm, Dept Clin Biochem, Glasgow G31 2ER, Lanark, Scotland
[3] Dokkyo Univ, Sch Med, Dept Clin Lab Med, Mibu, Tochigi 32102, Japan
[4] Stanford Med Sch, Palo Alto, CA USA
[5] Virginia Commonwealth Univ, Dept Pathol, Richmond, VA USA
[6] Loma Linda Univ, Sch Med, Dept Med, Loma Linda, CA 92354 USA
[7] CNRS, Neurobiol Lab, Marseille, France
[8] Radboud Univ Nijmegen, Med Ctr, Dept Chem Endocrinol, NL-6525 ED Nijmegen, Netherlands
[9] Univ Med Ctr Utrecht, Lab Endocrinol, Utrecht, Netherlands
[10] Commiss European Communities, Joint Res Ctr, Inst Reference Mat & Measurements, Geel, Belgium
关键词
PREVALENCE; DISEASE; THYROTROPIN; DYSFUNCTION; GUIDELINES; ASSAYS;
D O I
10.1373/clinchem.2009.140178
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
BACKGROUND: Laboratory testing of serum thyroid-stimulating hormone (TSH) is an essential tool for the diagnosis and management of various thyroid disorders whose collective prevalence lies between 4% and 8%. However, between-assay discrepancies in TSH results limit the application of clinical practice guidelines. METHODS: We performed a method comparison study with 40 sera to assess the result comparability and performance attributes of 16 immunoassays. RESULTS: Thirteen of 16 assays gave mean results within 10% of the overall mean. The difference between the most extreme means was 39%. Assay-specific biases could be eliminated by recalibration to the overall mean. After recalibration of singlicate results, all assays showed results within the biological total error goal (22.8%), except for 1 result in each of 4 assays. For a sample with a TSH concentration of 0.016 mIU/L, 6 assays either did not report results or demonstrated CVs >20%. Within-run and total imprecision ranged from 1.5% to 5.5% and 2.5% to 7.7%, respectively. Most assays were able to match the internal QC targets within 5%. Within-run drifts and shifts were observed. CONCLUSIONS: Harmonization of TSH measurements would be particularly beneficial for 3 of the 16 examined assays. These data demonstrate that harmonization may be accomplished by establishing calibration traceability to the overall mean values for a panel of patient samples. However, the full impact of the approach must be further explored with a wider range of samples. Although a majority of assays showed excellent quality of performance, some would benefit from improved within-run stability. (C) 2010 American Association for Clinical Chemistry
引用
收藏
页码:902 / 911
页数:10
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