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Clinical and Diagnostic Laboratory Immunology, September 2005, p. 1104-1108, Vol. 12, No. 9
1071-412X/05/$08.00+0     doi:10.1128/CDLI.12.9.1104-1108.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Evaluation of Three Immunoassays Used for Detection of Anti-Rubella Virus Immunoglobulin M Antibodies

Wayne Dimech,1* Lena Panagiotopoulos,1 Joan Marler,2 Nicolas Laven,2 Susan Leeson,3 and Elizabeth M. Dax1

National Serology Reference Laboratory, Australia, 4th Floor, Healy Building, 41 Victoria Parade, Fitzroy 3065,1 Department of Serology, Mayne Health, Dorevitch Pathology, 18 Banksia Street, Heidelberg 3084,2 Department of Serology, Mayne Health, Laverty Pathology, 60 Waterloo Road, North Ryde 2113, Australia3

Received 1 April 2005/ Returned for modification 4 May 2005/ Accepted 13 June 2005

Three automated assays (Abbott AxSYM, Bayer ADVIA Centaur, and bioMerieux VIDAS) used for the detection of rubella virus-specific immunoglobulin M were evaluated. A total of 57 samples from individuals with evidence of infection with rubella virus were used to estimate sensitivity, and 220 samples from blood donors and individuals attending an antenatal clinic who had no evidence of recent infection were used to estimate specificity. Seroconversion panels comprising an additional 31 samples from four individuals were used to determine clinical sensitivity. Samples containing potentially cross-reacting substances were also tested. The sensitivities of the three assays ranged from 84.2 to 96.5%, and the specificities ranged from 96.8 to 99.9%. The Abbott AxSYM assay detected more reactive samples than the other two assays when a panel of 57 positive samples was tested. Bayer ADVIA Centaur detected more reactive samples in the seroconversion panels than the other two assays. All three assays evaluated reported a reactive result in 1 or more of the 48 samples containing potentially cross-reacting analytes. The assays demonstrated comparable performance in testing of a well-characterized panel of samples.

* Corresponding author. Mailing address: 4th Floor, Healy Building, 41 Victoria Parade, Fitzroy, Victoria, 3065, Australia. Phone: 61 3 9418 1132. Fax: 61 3 9418 1155. E-mail: wayne{at}nrl.gov.au.

Clinical and Diagnostic Laboratory Immunology, September 2005, p. 1104-1108, Vol. 12, No. 9
1071-412X/05/$08.00+0     doi:10.1128/CDLI.12.9.1104-1108.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.





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