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Comparison of Murex Single-Use Diagnostic System with Traditional Enzyme Immunoassay for Detection of Exposure to Human Immunodeficiency Virus

Department of Pathology, The University of Michigan Medical School,¹ Warde Medical Laboratory, Ann Arbor, Michigan²

Received 29 March 2001/ Returned for modification 11 June 2001/ Accepted 26 September 2001

Because a retrospective study detected 13 negative Western blots out of 38 single-use diagnostic system (SUDS)-positive cases over a 1-year period, we performed a prospective study to compare the performance of the SUDS test with that of enzyme immunoassay (EIA). Of 888 SUDS-tested sera, 875 (98.4%) were both SUDS and EIA negative and 5 (0.6%) were SUDS, EIA, and Western blot positive. The rate of SUDS-positive samples decreased from 3.16/month in the retrospective study to 1.33/month in the prospective study. The immunoassays had sensitivities and specificities of 100 and 99.7 (SUDS) and 100 and 99.4% (traditional EIA), respectively. In laboratories with experienced personnel, the SUDS test performs as well as the EIA as a screen for infection with the human immunodeficiency virus.