Karem Kevin L, Poon Alysia C, Bierl Cynthia, Nisenbaum Rosane, Unger Elizabeth
Viral Exanthems and Herpesvirus Branch, Division of Viral and Rickettsial Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.
Clin Diagn Lab Immunol. 2002 May;9(3):577-82. doi: 10.1128/cdli.9.3.577-582.2002.
A strategy was developed for the control, standardization, and critical evaluation of an enzyme-linked immunosorbent assay (ELISA) for the detection of human papillomavirus-specific immunoglobulin G in human sera. Control human sera, polyclonal animal sera, and monoclonal antibodies were used to establish optimal assay parameters, including antigen coating, serum dilutions, and criteria for daily reproducibility, monitoring, and rejection of assays. Three evaluation techniques were used in parallel to define an optimal cutoff absorbance value that yields greater than 93% sensitivity and 98.5% specificity in the assay's ability to discriminate positive and negative control sera. This strategy provides an optimal method by which to determine cutoff absorbance values for ELISA.
开发了一种策略,用于对检测人血清中人乳头瘤病毒特异性免疫球蛋白G的酶联免疫吸附测定(ELISA)进行控制、标准化和严格评估。使用对照人血清、多克隆动物血清和单克隆抗体来确定最佳测定参数,包括抗原包被、血清稀释以及每日重复性、监测和测定拒收的标准。同时使用三种评估技术来确定最佳临界吸光度值,该值在测定区分阳性和阴性对照血清的能力方面具有大于93%的灵敏度和98.5%的特异性。该策略提供了一种确定ELISA临界吸光度值的最佳方法。