EVALUATION OF A MULTIPLEX IMMUNOASSAY FOR THE SEROLOGIC DETECTION OF IGG CLASS ANTIBODY TO RUBEOLA, MUMPS, RUBELLA AND VARICELLA ZOSTER VIRUS

Background: Measles, Mumps, Rubella and Varicella (MMRV) are viral syndromes that have historically occurred in children and young adults.  A national vaccination program has significantly reduced the incidence of disease associated with these viruses.  However, cases of acute disease continue to occur worldwide as a result of vaccine failure, non-immunization, or waning immunity.  Serologic testing for IgG-class antibodies to MMRV is a useful tool for measuring the response to vaccination and determining immune status. Conventional testing has traditionally been performed by immunofluorescence assay (IFA) or enzyme immunoassay (EIA). These methods are sensitive and specific, yet require separate assays for each individual analyte.

Methods: This study evaluated the performance of the MMRV IgG Athena Multi-Lyte® multiplex assay (Zeus Scientific, Inc., Raritan, NJ) using 1,983 serum specimens submitted to our laboratory for routine testing. Samples submitted for Mumps (n=492) and Rubella (n=500) were initially tested by enzyme-linked fluorescent immunoassay (ELFA) (VIDAS, bioMerieux, Inc., Durham, NC), and specimens submitted for Rubeola (n=494) and VZV (n=497) were analyzed by EIA (Diamedix, Miami, FL).  Each sample was also tested by the Athena Multi-Lyte multiplex assay using the Automated Immunoassay Multiplexing System (AIMS) (Inverness Medical, Inc., Waltham, MA). Specimens showing discordant results following initial testing by ELFA/EIA and Athena Multi-Lyte were retested by both assays.  Further discrepancies were analyzed by a third method to arbitrate discordant results.

Results: Following the resolution of discordant results, the MMRV IgG Athena Multi-Lyte assays demonstrated a sensitivity and specificity of 98.5%/93.3% (Rubeola), 100%/84.6% (Mumps), 97.8%/100% (Rubella) and 100%/100% (VZV), respectively.

Conclusions: The MMRV IgG Athena Multi-Lyte assays demonstrated comparable performance to routine testing by ELFA and EIA.  Use of this multiplex system allows for the simultaneous detection of IgG-class antibody to MMRV, potentially decreasing sample volume requirements, aliquot errors, and hands-on time associated with testing.