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利用 Beckman DXI 800 分析仪与 Alinity i 分析仪的检测方法学一致性,鉴定并消除甲状腺功能检测中生物素干扰的方法。

Approach to Identify and Eliminate Biotin Interference in Thyroid Function Tests Using Beckman DXI 800 Analyzer by Taking Advantage of Assay Harmonization with Alinity i Analyzer.

机构信息

Department of Clinical Laboratory Sciences, University of Kansas Medical Center, Kansas City, KS, USA.

Department of Pathology and Laboratory Medicine, University of Kansas Medical Center, Kansas City, KS, USA

出版信息

Ann Clin Lab Sci. 2023 May;53(3):482-484.

Abstract

OBJECTIVE

We reported significant interference of biotin in FT3 and FT4 assays using Beckman DXI 800 analyzer. Recently we acquired Alinity i analyzer where TSH, FT3 and FT4 assays are not biotin based. We hypothesized that if thyroid function tests on DXI 800 and Alinity i are harmonized, then it is possible to eliminate biotin interference.

METHODS

We investigated assay harmonization by analyzing 35 specimens for TSH, FT4 and FT3 using both analyzers. We prepared one serum pool using left-over specimens where thyroid tests were ordered. Then aliquots of the pool were supplemented with various amounts of biotin followed by measuring thyroid function tests again.

RESULTS

We observed assay harmonization between both analyzers for TSH, FT3 and FT4 Tests. TSH assay was not affected in the presence of biotin, but FT3 and FT4 values were significantly elevated using DXI 800 analyzer. In contrast, TSH, FT3 and FT4 assays were not affected by biotin using Alinity i analyzer.

CONCLUSIONS

Elevated FT3 and FT4 using DXI 800 analyzer may be due to biotin interference which can be eliminated by observing normal values using Alinity i analyzer. However, normal or slightly elevated TSH with elevated FT3 and FT4 using both analyzers may indicate rare type of TSH producing tumor of pituitary, not biotin interference.

摘要

目的

我们曾报道过贝克曼 DXI 800 分析仪的生物素会对 FT3 和 FT4 检测造成显著干扰。最近我们购入了基于免疫测定法的雅培 Alinity i 分析仪,该分析仪的 TSH、FT3 和 FT4 检测均不依赖生物素。我们假设如果 DXI 800 和 Alinity i 的甲状腺功能检测结果能够实现一致化,那么消除生物素干扰是可行的。

方法

我们分析了 35 份标本,使用两台分析仪分别检测 TSH、FT4 和 FT3,以此来研究检测的一致性。我们用剩余的标本制备了一个血清池,这些标本均已检测了甲状腺功能。然后,我们从该血清池中取出等分样本,并向其中添加不同量的生物素,再次检测甲状腺功能。

结果

我们观察到两台分析仪的 TSH、FT3 和 FT4 检测结果具有一致性。在生物素存在的情况下,TSH 检测不受影响,但 DXI 800 分析仪会显著提高 FT3 和 FT4 的检测值。相比之下,Alinity i 分析仪不受生物素的影响。

结论

使用 DXI 800 分析仪检测到的 FT3 和 FT4 升高可能是由于生物素干扰所致,而通过 Alinity i 分析仪观察到正常的 FT3 和 FT4 值可以消除这种干扰。然而,使用两台分析仪均检测到正常或轻度升高的 TSH 以及升高的 FT3 和 FT4,可能提示存在垂体产生 TSH 的罕见肿瘤,而非生物素干扰。

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