BACKGROUND: Rubella virus generally causes a mild fever, rash illness similar in clinical presentation to infections by other viruses including measles and parvovirus B19. Rubella infections in pregnant women in the first trimester carry a high risk of congenital rubella syndrome (CRS) which can result in severe congenital defects in the infants. The goal of rubella immunization programs is therefore to eliminate CRS. The primary test for the laboratory confirmation of rubella is IgM serology. It is therefore important to evaluate currently available commercial rubella IgM immunoassays to ensure high quality rubella diagnostic testing. STUDY DESIGN: In this study, we compared the performance of seven commercial rubella IgM enzyme immunoassays (EIA) (Meddens, Denka Seiken, Behring, Wampole, Captia, Sigma and Abbott Axsym) using well-defined panels of sera from rubella and non-rubella/rash-illness cases. RESULTS: The Meddens, Denka Seiken, Behring and Wampole rubella IgM EIAs all performed similarly for sensitivity (range of 74.1-76.8%) and specificity (range of 93.9-96.1%). Relative to the other assays, the Axsym had a higher sensitivity (78.9%) but lower specificity (86.5%). The Captia assay had the lowest overall sensitivity (66.4%), while the Sigma assay had a lower specificity (85.6%) in relation to the other assays. CONCLUSIONS: In conclusion, the Meddens, Denka Seiken, Behring and Wampole rubella IgM EIAs are comparable in their overall performance with respect to sensitivity and specificity.
BACKGROUND:Rubella virus generally causes a mild fever, rash illness similar in clinical presentation to infections by other viruses including measles and parvovirus B19. Rubella infections in pregnant women in the first trimester carry a high risk of congenital rubella syndrome (CRS) which can result in severe congenital defects in the infants. The goal of rubella immunization programs is therefore to eliminate CRS. The primary test for the laboratory confirmation of rubella is IgM serology. It is therefore important to evaluate currently available commercial rubella IgM immunoassays to ensure high quality rubella diagnostic testing. STUDY DESIGN: In this study, we compared the performance of seven commercial rubella IgM enzyme immunoassays (EIA) (Meddens, Denka Seiken, Behring, Wampole, Captia, Sigma and Abbott Axsym) using well-defined panels of sera from rubella and non-rubella/rash-illness cases. RESULTS: The Meddens, Denka Seiken, Behring and Wampole rubella IgM EIAs all performed similarly for sensitivity (range of 74.1-76.8%) and specificity (range of 93.9-96.1%). Relative to the other assays, the Axsym had a higher sensitivity (78.9%) but lower specificity (86.5%). The Captia assay had the lowest overall sensitivity (66.4%), while the Sigma assay had a lower specificity (85.6%) in relation to the other assays. CONCLUSIONS: In conclusion, the Meddens, Denka Seiken, Behring and Wampole rubella IgM EIAs are comparable in their overall performance with respect to sensitivity and specificity.
Authors: Rita F Helfand; Cesar Cabezas; Emily Abernathy; Carlos Castillo-Solorzano; Ana Cecilia Ortiz; Hong Sun; Fernando Osores; Lucia Oliveira; Alvaro Whittembury; Myrna Charles; Jon Andrus; Joe Icenogle Journal: Clin Vaccine Immunol Date: 2007-09-19
Authors: Beth M Isaac; Jane R Zucker; Francesca R Giancotti; Emily Abernathy; Joseph Icenogle; Jennifer L Rakeman; Jennifer B Rosen Journal: Clin Vaccine Immunol Date: 2017-09-05
Authors: Joanne Hiebert; Vanessa Zubach; Carmen L Charlton; Jayne Fenton; Graham A Tipples; Kevin Fonseca; Alberto Severini Journal: J Clin Microbiol Date: 2021-10-27 Impact factor: 5.948
Authors: Emily Abernathy; Cesar Cabezas; Hong Sun; Qi Zheng; Min-hsin Chen; Carlos Castillo-Solorzano; Ana Cecilia Ortiz; Fernando Osores; Lucia Oliveira; Alvaro Whittembury; Jon K Andrus; Rita F Helfand; Joseph Icenogle Journal: J Clin Microbiol Date: 2008-11-12 Impact factor: 5.948