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Development of human anti-rubella IgG and IgM assays for the Abbott ARCHITECT Instrument

Abstract number: p628

Maine  G.T., Vickstrom  R., Krishnan  K., Prostko  J., Kogan  Z., Morey  J., Lagedrost  J., Jacob  J., Stricker  Rn., Stricker  Rt., Pustowoit  B.

Objectives: 

Develop a panel of human anti-rubella immunoassays on a high throughput automated platform. The ARCHITECT Rubella IgG assay is intended to be used for the quantitative measurement of IgG antibodies to rubella virus in human sera or plasma to aid in the determination of immune status to rubella virus. The ARCHITECT Rubella IgM assay is intended to be used for the qualitative measurement of IgM antibodies to rubella virus in human serum or plasma to aid in the diagnosis of primary or acute infection.

Methods: 

The prototype rubella assays for the ARCHITECT instrument are two-step immunoassays utilizing rubella whole virus coated paramagnetic microparticles for the capture of anti-rubella antibodies. An acridinium labelled monoclonal antibody conjugate directed against human IgG or IgM is utilized for detection. Samples from pregnant women, blood donors, hospital patients, IgG/IgM screened negative samples, known rubella IgM positive samples, vaccine serial bleeds and seroconversion panels have been tested on the new ARCHITECT Rubella assays in comparison to the Abbott AxSYM Rubella IgG and IgM assays. Discrepant samples were tested on 1 additional Rubella IgG or IgM on-market assay and resolved with the consensus.

Results: 

The ARCHITECT Rubella IgG shows a resolved relative sensitivity of 99.89% and a resolved relative specificity of 100% compared to AxSYM on the population described above (N = 1198). The ARCHITECT Rubella IgM assay shows a resolved relative sensitivity of 98.08% and a resolved relative specificity of 100% compared to AxSYM on the population described above (N = 1059). The seroconversion sensitivity of the ARCHITECT Rubella IgG and IgM assays were equivalent and better than the AxSYM Rubella IgG and IgM assays, respectively. The ARCHITECT Rubella IgG and IgM assays exhibited equivalent or greater sensitivity than the AxSYM Rubella IgG and IgM assays on serial bleeds as well as before and after vaccination.

Conclusion: 

The performance of the 2 new ARCHITECT Rubella IgG and IgM assays is better than or equivalent to the AxSYM Rubella IgG and IgM assays.

Session Details

Date: 01/08/2007
Time: 00:00-00:00
Session name: XXIst ISTH Congress
Subject:
Location: Oxford, UK
Presentation type:
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