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生物素对即时检验hCG定性检测设备干扰情况的评估。

Assessment of biotin interference with qualitative point-of-care hCG test devices.

作者信息

Williams Grace R, Cervinski Mark A, Nerenz Robert D

机构信息

Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States; The Geisel School of Medicine at Dartmouth, Hanover, NH, United States.

Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States; The Geisel School of Medicine at Dartmouth, Hanover, NH, United States.

出版信息

Clin Biochem. 2018 Mar;53:168-170. doi: 10.1016/j.clinbiochem.2018.01.018. Epub 2018 Jan 31.

DOI:10.1016/j.clinbiochem.2018.01.018
PMID:29395091
Abstract

Biotin is commonly used as a dietary supplement for the claimed benefits of promoting healthy hair and nail growth and is available without a prescription at doses up to 10mg/capsule. Biotin-mediated interference in immunoassay testing is an emerging issue for clinical laboratories and previous studies have indicated that biotin at regularly encountered doses may interfere with these assays. In this study, we evaluated the effect of supplemental biotin on seven POC urine hCG test devices using purified biotin and urine collected from four volunteers consuming 10mg biotin/day. Six of the seven devices showed no evidence of biotin interference as each device's control line remained clearly detectable at all biotin concentrations tested. However, the QuickVue device control line demonstrated a marked decrease in intensity when used to test solutions containing >5μg/mL biotin. The absence of a control line during patient testing has the potential to delay care due to the generation of an invalid test result and lead to additional unnecessary testing. It is not realistic to measure urinary biotin concentrations in every patient undergoing qualitative urine hCG testing but biotin supplementation should be considered if repeat testing on a patient sample generates an invalid test result.

摘要

生物素通常作为一种膳食补充剂使用,因其宣称具有促进头发和指甲健康生长的功效,且无需处方即可获得,每粒胶囊剂量可达10毫克。生物素对免疫分析检测的干扰是临床实验室中一个新出现的问题,先前的研究表明,常规剂量的生物素可能会干扰这些检测。在本研究中,我们使用纯化的生物素和从四名每天服用10毫克生物素的志愿者收集的尿液,评估了补充生物素对七种即时检验尿液人绒毛膜促性腺激素(hCG)检测设备的影响。七种设备中的六种未显示生物素干扰的迹象,因为在所有测试的生物素浓度下,每种设备的控制线仍清晰可测。然而,当使用QuickVue设备检测含有>5μg/mL生物素的溶液时,其控制线强度显著降低。在患者检测过程中没有控制线可能会因产生无效检测结果而延误治疗,并导致额外的不必要检测。对每个进行定性尿液hCG检测的患者测量尿液生物素浓度是不现实的,但如果对患者样本进行重复检测产生无效检测结果,则应考虑生物素补充的情况。

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