Ratnam S, Gadag V, West R, Burris J, Oates E, Stead F, Bouilianne N
Public Health Laboratory, Faculty of Medicine, Memorial University of Newfoundland, St. John's, Canada.
J Clin Microbiol. 1995 Apr;33(4):811-5. doi: 10.1128/jcm.33.4.811-815.1995.
Four commercially available enzyme immunoassay (EIA) kits were evaluated in comparison with the plaque reduction neutralization (PRN) test for detection of measles virus antibody. The EIA kits, Enzygnost (Behring), Diamedix, Vidas (bioMerieux Vitek), and Measlestat (Biowhittaker), were assessed with two PRN cutoff titers: a PRN titer of 8, the lowest detectable antibody level by the PRN test under the test conditions, and a titer of 120, which has been shown to be the minimum protective antibody titer. At a PRN cutoff titer of 8, the sensitivity was 88.2, 91.1, 74.6, and 69.8% for Behring, Diamedix, Vidas, and Biowhittaker EIA tests, respectively, with negative predictive values ranging from 22.7 to 45.5%. The specificity was 93.8% for Diamedix and 100% for the rest. At a PRN cutoff titer of 120, the sensitivity and specificity, respectively, were 100 and 90.7% (Behring), 98.2 and 58.8% (Diamedix), 90.6 and 94.5% (Vidas), and 85.7 and 96.4% (Biowhittaker). At this PRN cutoff titer, the negative predictive values of all EIA tests improved considerably, ranging from 70.7 to 100%. The EIA results showed an excellent association with PRN results when the PRN titers of the test samples were either < 8 or > 1,052. Discrepancies occurred especially when testing samples having PRN titers in the range of 8 to 120, indicating lack of sensitivity of the EIA tests in detecting measles virus antibody at low levels. Maternally derived measles virus antibody at this level has been shown to interfere with measles vaccine response in children and hence has implications from the standpoint of measles immunization. The ready availability, ease of operation, and rapid turnaround time are strong plus points of the EIA kits, and they could be useful in a clinical laboratory setting for routine application, but they may have limited use in vaccine-related studies and seroepidemiological surveys.
对四种市售酶免疫测定(EIA)试剂盒进行了评估,并与蚀斑减少中和(PRN)试验比较以检测麻疹病毒抗体。使用两种PRN临界滴度评估了EIA试剂盒Enzygnost(贝林)、Diamedix、Vidas(生物梅里埃维泰克)和Measlestat(生物惠特克):PRN滴度8,这是试验条件下PRN试验可检测到的最低抗体水平;以及滴度120,已证明这是最低保护性抗体滴度。在PRN临界滴度为8时,贝林、Diamedix、Vidas和生物惠特克EIA试验的敏感性分别为88.2%、91.1%、74.6%和69.8%,阴性预测值范围为22.7%至45.5%。Diamedix的特异性为93.8%,其余的为100%。在PRN临界滴度为120时,敏感性和特异性分别为:贝林100%和90.7%、Diamedix 98.2%和58.8%、Vidas 90.6%和94.5%、生物惠特克85.7%和96.4%。在此PRN临界滴度下,所有EIA试验的阴性预测值都有显著提高,范围为70.7%至100%。当试验样品的PRN滴度<8或>1052时,EIA结果与PRN结果显示出极好的相关性。当检测PRN滴度在8至120范围内的样品时,尤其会出现差异,这表明EIA试验在检测低水平麻疹病毒抗体时缺乏敏感性。已证明此水平的母源麻疹病毒抗体可干扰儿童的麻疹疫苗反应,因此从麻疹免疫的角度来看具有重要意义。EIA试剂盒随时可用、操作简便且周转时间快,这些都是其显著优点,它们在临床实验室环境中可用于常规应用,但在疫苗相关研究和血清流行病学调查中的用途可能有限。