BACKGROUND Biotin and streptavidin are commonly used reagents in clinical immunoassays. Several cases of biotin interference with immunoassay testing for patients taking biotin supplements have been reported, yet, not all analytes and platforms susceptible to biotin interference have been characterized. The objectives of this study are to characterize biotin interference with 21 immunoassays using the Ortho Clinical Diagnostics Vitros 5600, evaluate a biotin-depletion method, and apply risk mitigation strategies for biotin interference during routine clinical testing at our institution. METHODS Residual serum without and with increasing concentrations of exogenous biotin were used to evaluate biotin interference with 21 immunoassays using the Vitros 5600. Biotin-depletion was evaluated by comparing measured analyte concentrations in serum with and without exogenous biotin and streptavidin-microparticle pretreatment. Focused education for healthcare professionals about biotin interference was performed in February 2018. Samples with suspected biotin interference were investigated using this biotin-depletion method, and analyte testing by alternate methodology for select samples. RESULTS Exogenous biotin in serum caused dose-dependent negative biases in 15 immunometric assays, and dose-dependent positive biases in 6 competitive immunoassays. Streptavidin-microparticle pretreatment of serum containing exogenous biotin demonstrated recoveries 100 ± 15% of expected values for all 21 analytes. Physicians identified 21 samples suspicious for biotin interference over 11 months, and streptavidin-microparticle pretreatment verified 11 cases of biotin interference. CONCLUSIONS Analytical bias caused by biotin interference is dependent on biotin concentration but independent of analyte concentration for immunometric methods using the Vitros 5600, and dependent on both biotin and analyte concentration for competitive immunoassays. Multi-disciplinary education and a lab streptavidin-microparticle pretreatment method help mitigate risk of erroneous results due to biotin interference for patient safety.

中文翻译：

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在大型学术医疗中心进行21种Vitros 5600免疫测定中生物素干扰的表征以及减轻患者安全的风险。

背景技术生物素和抗生蛋白链菌素是临床免疫测定中常用的试剂。已经报道了几例服用生物素补充剂的患者进行免疫测定测试而引起生物素干扰的情况，但是，并非所有易受生物素干扰的分析物和平台均已表征。这项研究的目的是使用Ortho Clinical Diagnostics Vitros 5600进行21种免疫测定来表征生物素干扰，评估一种生物素消耗方法，并在我们机构的常规临床测试过程中采用降低风险的策略来抑制生物素。方法使用未添加外源生物素和增加外源生物素浓度的残留血清，通过Vitros 5600进行21种免疫测定来评估生物素的干扰。通过比较在有或没有外源生物素和链霉亲和素微粒预处理的情况下血清中分析物的浓度，评估生物素的消耗。于2018年2月对医疗保健专业人员进行了有关生物素干扰的重点教育。使用这种生物素消耗方法对怀疑有生物素干扰的样品进行了调查，并通过替代方法对选定样品进行了分析物测试。结果血清中的外源性生物素在15种免疫测定中引起剂量依赖性负偏差，在6种竞争性免疫测定中引起剂量依赖性正偏差。含有外源生物素的血清的链霉亲和素微粒预处理表明，所有21种分析物的回收率均为预期值的100±15％。医师在11个月内鉴定出21个可疑生物素干扰样品，链霉亲和素微粒预处理证实了11例生物素干扰素。结论由生物素干扰引起的分析偏倚取决于生物素浓度，但对于使用Vitros 5600的免疫测定方法而言，与分析物浓度无关，而对于竞争性免疫测定，也取决于生物素和分析物浓度。多学科教育和实验室链霉亲和素微粒预处理方法有助于降低由于生物素干扰而导致错误结果的风险，以确保患者安全。