Fajardo E M, Fernández J L, Solís R L, Portuondo B, Heredia L, Noroña M, Urquiza H, Amat M
Carlos J. Finlay Biologicals Production Company, Havana, Cuba.
Bull Pan Am Health Organ. 1996 Mar;30(1):9-17.
This article describes a combination of methods--a solid-phase enzyme-linked immunosorbent assay (ELISA) combined with an ultramicroanalytical system (UMAS)--that can be used to measure tetanus antitoxin activity in human sera or plasma. The test, which is rapid and permits analysis of 78 samples of serum per reaction plate with a volume of 10 microL of diluted serum per sample, is proposed as an alternative to the traditional biologic assay in mice based on seroneutralization of a known dose of tetanus toxin. The study reported here compared these two procedures, using them both to evaluate 100 sera from the Clinical Laboratory of the General Calixto García Hospital in Havana, Cuba. The two sets of results showed a high degree of correlation (r = 0.99) when subjected to linear regression analysis (95% CI = 0.985-0.993). These and other findings indicate that the cheap and rapid ultramicroELISA method can perform certain tasks for which the slower and costlier traditional assay is not well suited, such as field evaluation of tetanus toxoid vaccines and identification of hyperimmune plasmas appropriate for use in producing specific antitetanus immunoglobulin.
本文介绍了一种方法组合——固相酶联免疫吸附测定法(ELISA)与超微分析系统(UMAS)相结合的方法,可用于测定人血清或血浆中的破伤风抗毒素活性。该检测方法快速,每个反应板可分析78份血清样本,每份样本稀释血清体积为10微升,被提议作为基于已知剂量破伤风毒素血清中和作用的传统小鼠生物学检测方法的替代方法。本文报道的研究比较了这两种方法,用它们对来自古巴哈瓦那卡利克斯托·加西亚综合医院临床实验室的100份血清进行评估。两组结果经线性回归分析(95%可信区间=0.985 - 0.993)显示高度相关(r = 0.99)。这些及其他研究结果表明,廉价且快速的超微ELISA方法能够完成一些传统检测方法不太适合的任务,比如破伤风类毒素疫苗的现场评估以及鉴定适合用于生产特异性抗破伤风免疫球蛋白的高免疫血浆。