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新开发的全自动免疫检测分析法

By LabMedica International staff writers
Posted on 28 Dec 2017
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图片:ARCHITECT i2000SR免疫分析仪(照片由Abbott提供)。
图片:ARCHITECT i2000SR免疫分析仪(照片由Abbott提供)。
二肽基肽酶-4(DPP-4)可以作为鉴别严重哮喘者的一个适宜生物标志物,这些人的白介素-13(IL-13)通路活性更大,因此可能受益于IL-13靶向治疗。
与健康个体相比,哮喘患者的支气管活检、唾液和支气管肺泡灌洗液中IL-13信使RNA(mRNA)表达增多,蛋白浓度增大,这支持了IL-13在一些类型的哮喘中发挥了一定病理生理学作用。
一个科学家团队与Abbott Laboratories(Abbott Park,IL,USA)的科学家合作,获得健康志愿者和哮喘及1型糖尿病受试者的血清样品。他们使用了DPP-4浓度评估法,从一项tralokinumab IIb期研究获得重度哮喘患者的样品,这些患者接受高剂量氟替卡松和沙美特罗联合用药仍未能控制住病情。其他样品采集自一项确证样品处理程序的预分析内部研究,由自我报告有哮喘、同意提供样品的志愿者提供。
该团队评估了检测的性能,还评估了所用分析方法的精密度、线性和灵敏度、常见内源性检测干扰物的影响,以及哮喘和抗糖尿病药物的影响。新的自动化IUO DPP-4免疫检测法由Abbott的ARCHITECT i系统进行。 DPP免疫检测的范围是109 ng/mL-580 ng/mL。该检测法全自动,每小时检测量为200次。
研究者报告,使用变异系数百分比确定的20天DPP-4浓度检测的总精密度不超过5%。稀释液分析,30-1305 ng/mL范围内呈线性;定量限为19.2 ng/mL。在预期的治疗浓度下,没有明显的内源性或药物干扰。评估了健康志愿者和哮喘或1型糖尿病患者的DPP-4浓度中位数,具备不同人口统计学特征的糖尿病和哮喘受试者该浓度仍相似。
作者得出结论,他们的分析显示,ARCHITECT DPP-4免疫检测是一种可靠而稳健的血清DPP-4浓度检测法。该检测法目前正在针对未控制住哮喘的受试者开展的tralokinumab III期研究中用于评估DPP-4作为预测性生物标志物的临床可用性。本研究已发表于2017年10月20日网络版的Practical Laboratory Medicine(实用检验医学)上。

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