La'ulu Sonia L, Slev Patricia R, Roberts William L
ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, United States.
Clin Chim Acta. 2007 Feb;376(1-2):88-95. doi: 10.1016/j.cca.2006.07.018. Epub 2006 Jul 25.
Measurement of thyroid peroxidase autoantibodies (TPOAb) is useful in diagnosing patients with autoimmune thyroid disease. Measurement of thyroglobulin autoantibodies (TgAb) is used to detect potential interferences with thyroglobulin immunoassays and in limited situations for the diagnosis of autoimmune thyroid disease.
The limit of detection, imprecision, reference interval, method comparison and diagnostic concordance for the ADVIA Centaur, ARCHITECT i2000, AxSYM, Immulite 2000, Modular E170 (TPOAb only), and UniCel DxI 800 (TgAb only) methods were evaluated. The Advantage was used as the comparison method.
Total imprecision ranged from 2.6% to 14.9% for TgAb and 2.1% to 15.8% for TPOAb. Passing-Bablok slopes ranged from 0.51 to 10.4 (TgAb) and 1.05 to 7.12 (TPOAb) with correlation coefficients of 0.48 to 0.82 (TgAb) and 0.66 to 0.78 (TPOAb). Assay cutoffs were adjusted using a common set of reference interval samples. Concordance with the Advantage assay using the new cutoffs was found to be improved and ranged from 68.5% to 84.7% (TgAb) and 77.5% to 84.7% (TPOAb).
Although all assays generally performed well, assay concordance for a negative or positive result ranged from 54.2 to 84.7%. Quantitative agreement between methods was generally poor and methods could not be used interchangeably. Additional standardization efforts are required to improve inter-method agreement.
甲状腺过氧化物酶自身抗体（TPOAb）的检测有助于诊断自身免疫性甲状腺疾病患者。甲状腺球蛋白自身抗体（TgAb）的检测用于检测对甲状腺球蛋白免疫测定的潜在干扰，并在有限情况下用于自身免疫性甲状腺疾病的诊断。
评估了ADVIA Centaur、ARCHITECT i2000、AxSYM、Immulite 2000、Modular E170（仅用于TPOAb）和UniCel DxI 800（仅用于TgAb）方法的检测限、不精密度、参考区间、方法比较和诊断一致性。将Advantage用作比较方法。
TgAb的总不精密度范围为2.6%至14.9%，TPOAb的总不精密度范围为2.1%至15.8%。Passing-Bablok斜率范围为0.51至10.4（TgAb）和1.05至7.12（TPOAb），相关系数为0.48至0.82（TgAb）和0.66至0.78（TPOAb）。使用一组共同的参考区间样本调整检测临界值。发现使用新临界值与Advantage检测的一致性有所提高，范围为68.5%至84.7%（TgAb）和77.5%至84.7%（TPOAb）。
尽管所有检测方法总体表现良好，但阴性或阳性结果的检测一致性范围为54.2%至84.7%。方法之间的定量一致性普遍较差，不能互换使用。需要进一步的标准化努力来提高方法间的一致性。
