Evaluation of a new commercial enzyme immunoassay for the detection of IgM antibodies to West Nile virus using a ratio method to eliminate nonspecific reactivity

Abstract

As West Nile virus (WNV) has become endemic in the United States, following the first reported cases in New York during the summer of 1999, the demand for specific serology has increased. Several IgM capture ELISA assays for the detection of WNV‐specific IgM have been approved by the Food and Drug Administration for in vitro diagnostic testing, including kits from Focus Diagnostics and InBios International, Inc. The Focus Diagnostics IgM capture ELISA has a background subtraction protocol and the InBios IgM capture ELISA implements a ratio method to detect nonspecific reactivity due to rheumatoid factor, heterophile antibodies, and other interfering substances. We compared the InBios IgM capture ELISA with the Focus Diagnostics capture ELISA. Agreement, sensitivity, and specificity of the InBios IgM capture ELISA were 99, 98, and 100%, respectively. Samples that originally tested positive on the Focus Diagnostics IgM capture ELISA without the subtraction protocol and were then determined negative following the subtraction protocol agreed 100% with the InBios IgM capture ELISA. We conclude that a method to eliminate background reactivity is a necessary portion of any anti‐WNV IgM assay in order to eliminate false‐positive results. J. Clin. Lab. Anal. 22:362–366, 2008. © 2008 Wiley‐Liss, Inc.