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Chemistry of Biotin-Streptavidin and the Growing Concern of an Emerging Biotin Interference in Clinical Immunoassays.
ACS Omega ( IF 3.7 ) Pub Date : 2019-12-18 , DOI: 10.1021/acsomega.9b03013 John H T Luong 1 , Sandeep K Vashist 2, 3
ACS Omega ( IF 3.7 ) Pub Date : 2019-12-18 , DOI: 10.1021/acsomega.9b03013 John H T Luong 1 , Sandeep K Vashist 2, 3
Affiliation
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Overconsumption of biotin (5-100 mg daily) as a supplement by the general population poses a significant problem for clinical immunoassays (IAs) based on biotin-streptavidin (SA) interactions. This affinity pair has been exploited in immunoassays because of its avidity, sensitivity, specificity, and stability. The elevated biotin level in plasma varies from patient to patient, and its severe interference cannot easily be predicted and quantified. Thus, immunoassay manufacturers must investigate the biotin interference in the developed immunoassays to satisfy the threshold of 3510 ng/mL (14 367 nM), as stipulated by the FDA. There is no concrete solution to circumvent the biotin interference without extra costs and technical difficulties, albeit different strategies have been attempted. They include the IA format with biotinylated reagents prebound to streptavidin, the removal of biotin from the specimen, sample treatment, and biotin interference-free assays. The general public has been instructed to stop taking biotin supplements for 48 h or even weeks before the test, depending on the specific test, dose, and frequency of biotin uptake. As lab-based techniques cannot accommodate an enormous number of public samples, a rapid analytical procedure for biotin is urgently needed to quantify for its interference in immunoassays.
中文翻译：
生物素-链霉亲和素的化学以及临床免疫测定中新出现的生物素干扰的关注。
一般人群过度摄取生物素（每天5-100 mg）作为补充品，对基于生物素-链霉亲和素（SA）相互作用的临床免疫测定（IAs）构成了重大问题。由于其亲和力，敏感性，特异性和稳定性，这种亲和力对已经在免疫分析中得到了利用。血浆中生物素水平的升高因患者而异，并且其严重干扰难以轻易预测和量化。因此，免疫分析制造商必须在已开发的免疫分析中调查生物素的干扰，以满足FDA规定的阈值3510 ng / mL（14 367 nM）。尽管尝试了不同的策略，但没有任何额外的成本和技术难题来解决生物素干扰的具体解决方案。它们包括IA格式，其中预结合有链霉亲和素的生物素化试剂，从标本中去除生物素，样品处理和生物素无干扰测定。已指示普通公众在测试前48小时甚至几周内停止服用生物素补充剂，具体取决于具体测试，剂量和生物素摄取频率。由于基于实验室的技术无法容纳大量的公共样本，因此迫切需要一种生物素的快速分析程序，以量化其对免疫测定的干扰。
更新日期：2020-01-14
中文翻译：
生物素-链霉亲和素的化学以及临床免疫测定中新出现的生物素干扰的关注。
一般人群过度摄取生物素（每天5-100 mg）作为补充品，对基于生物素-链霉亲和素（SA）相互作用的临床免疫测定（IAs）构成了重大问题。由于其亲和力，敏感性，特异性和稳定性，这种亲和力对已经在免疫分析中得到了利用。血浆中生物素水平的升高因患者而异，并且其严重干扰难以轻易预测和量化。因此，免疫分析制造商必须在已开发的免疫分析中调查生物素的干扰，以满足FDA规定的阈值3510 ng / mL（14 367 nM）。尽管尝试了不同的策略，但没有任何额外的成本和技术难题来解决生物素干扰的具体解决方案。它们包括IA格式，其中预结合有链霉亲和素的生物素化试剂，从标本中去除生物素，样品处理和生物素无干扰测定。已指示普通公众在测试前48小时甚至几周内停止服用生物素补充剂，具体取决于具体测试，剂量和生物素摄取频率。由于基于实验室的技术无法容纳大量的公共样本，因此迫切需要一种生物素的快速分析程序，以量化其对免疫测定的干扰。
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