用于评估口服脊髓灰质炎疫苗免疫反应的脊髓灰质炎病毒结合抑制ELISA：中和试验的一种可能替代方法。

Poliovirus-binding inhibition ELISA for evaluation of immune response to oral poliovirus vaccine: a possible alternative to the neutralization test.

作者信息

Ivanov A P, Dragunsky E M, Ivanova O E, Rezapkin G V, Potapova S G, Chumakov K M

机构信息

Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA.

出版信息

Hum Vaccin. 2005 May-Jun;1(3):102-5. doi: 10.4161/hv.1.3.1719. Epub 2005 May 5.

DOI:10.4161/hv.1.3.1719

PMID:17012865

Abstract

This study describes an ELISA variant (Binding Inhibition ELISA, BI ELISA) for the quantitative determination of neutralization-relevant antibodies to polioviruses. The test differs from previously described analogs by utilizing polyclonal immune reagents: capture antibodies and biotin-labeled detecting antibodies. The BI ELISA was compared with the conventional neutralization test (NT) by testing live Sabin and wild-type poliovirus strains. The comparison of 68 serum samples taken from Oral Poliovirus Vaccine (OPV) recipients showed 100% specificity and sensitivity for Sabin 1 and Sabin 2, and 100% sensitivity and 97% specificity for Sabin 3. Good correlations (r = 0.7, 0.77, 0.65 for Sabin 1, 2, 3, respectively) were demonstrated between the NT and BI ELISA results. These results indicate that the BI ELISA can be used as a reliable alternative to the NT for determination of neutralization-relevant antibodies to polioviruses in vaccinees and in large-scale sero-epidemiological studies.

摘要

本研究描述了一种用于定量测定脊髓灰质炎病毒中和相关抗体的酶联免疫吸附测定（ELISA）变体（结合抑制ELISA，BI ELISA）。该检测方法与先前描述的类似方法不同之处在于使用了多克隆免疫试剂：捕获抗体和生物素标记的检测抗体。通过检测活的萨宾株和野生型脊髓灰质炎病毒株，将BI ELISA与传统中和试验（NT）进行了比较。对取自口服脊髓灰质炎疫苗（OPV）接种者的68份血清样本进行比较，结果显示，对于萨宾1型和萨宾2型，BI ELISA的特异性和敏感性均为100%；对于萨宾3型，敏感性为100%，特异性为97%。NT和BI ELISA结果之间显示出良好的相关性（萨宾1型、2型、3型的r值分别为0.7、0.77、0.65）。这些结果表明，在疫苗接种者和大规模血清流行病学研究中，BI ELISA可作为NT的可靠替代方法，用于测定脊髓灰质炎病毒的中和相关抗体。