title: Evaluation of eight anti-rubella virus immunoglobulin g immunoassays that report results in international units per milliliter.
abstract: 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.
authors.affiliation: National Serology Reference Laboratory, Australia, 4th Floor Healy Building, 41 Victoria Parade, Fitzroy 3065, Victoria, Australia. wayne@nrl.gov.au
authors.forename: Wayne
authors.initials: W
authors.lastname: Dimech
authors.forename: Lena
authors.initials: L
authors.lastname: Panagiotopoulos
authors.forename: Barbara
authors.initials: B
authors.lastname: Francis
authors.forename: Nicholas
authors.initials: N
authors.lastname: Laven
authors.forename: Joan
authors.initials: J
authors.lastname: Marler
authors.forename: David
authors.initials: D
authors.lastname: Dickeson
authors.forename: Tony
authors.initials: T
authors.lastname: Panayotou
authors.forename: Kim
authors.initials: K
authors.lastname: Wilson
authors.forename: Robyn
authors.initials: R
authors.lastname: Wootten
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Dax
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D006385:Hemagglutination Inhibition Tests / Q000592:standards; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards*; D007074:Immunoglobulin G / Q000097:blood*; D012015:Reference Standards; D012409:Rubella / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D012412:Rubella virus / Q000276:immunology*; D012680:Sensitivity and Specificity; D014944:World Health Organization
chemical_list: D000914:Antibodies, Viral; D007074:Immunoglobulin G