Dimech Wayne, Panagiotopoulos Lena, Francis Barbara, Laven Nicholas, Marler Joan, Dickeson David, Panayotou Tony, Wilson Kim, Wootten Robyn, Dax Elizabeth M
National Serology Reference Laboratory, Australia, 4th Floor Healy Building, 41 Victoria Parade, Fitzroy 3065, Victoria, Australia.
J Clin Microbiol. 2008 Jun;46(6):1955-60. doi: 10.1128/JCM.00231-08. Epub 2008 Apr 23.
An evaluation of anti-rubella virus immunoglobulin G (IgG) immunoassays that report in international units per milliliter (IU/ml) was performed to determine their analytical performance and the degree of correlation of the test results. A total of 321 samples were characterized based on results from a hemagglutination inhibition assay. The 48 negative and 273 positive samples were used to determine the sensitivity and specificity of the assays. When equivocal results were interpreted as reactive, the sensitivity of the immunoassays ranged from 98.9 to 99.9% and the specificity ranged from 77.1 to 95.8%. All assays had positive and negative delta values of less than 2. A significant difference between the mean results of all assays was demonstrated by analysis of variance. However, post hoc analysis showed there was good correlation in the mean results expressed in IU/ml between some of the assays. Our results show the level of standardization between anti-rubella virus IgG immunoassays reporting results expressed as IU/ml has improved since a previous study in 1992, but further improvement is required.
对以每毫升国际单位(IU/ml)报告结果的抗风疹病毒免疫球蛋白G(IgG)免疫测定法进行了评估,以确定其分析性能和检测结果的相关程度。根据血凝抑制试验的结果对总共321份样本进行了特征描述。48份阴性样本和273份阳性样本用于确定这些测定法的灵敏度和特异性。当将可疑结果解释为阳性时,免疫测定法的灵敏度范围为98.9%至99.9%,特异性范围为77.1%至95.8%。所有测定法的阳性和阴性差值均小于2。方差分析表明所有测定法的平均结果之间存在显著差异。然而,事后分析表明,某些测定法之间以IU/ml表示的平均结果具有良好的相关性。我们的结果表明,自1992年的一项先前研究以来,报告结果以IU/ml表示的抗风疹病毒IgG免疫测定法之间的标准化水平有所提高,但仍需进一步改进。