The goal of this study was to evaluate the BioPlex 2200 Toxoplasma, rubella, and cytomegalovirus (CMV) Congenital infections caused by Toxoplasma gondii, rubella, and cytomegalovirus (CMV) are a significant cause of neonatal mortality and childhood morbidity worldwide (6,18,21). Due to their nonspecific clinical manifestations and the importance of early recognition of in utero infection, serologic screening for these pathogens has been considered a routine practice in many parts of the world (11). Conventional methods for the detection of antibodies to Toxoplasma, rubella, and CMV (ToRC) include immunofluorescence (IFA), enzyme immunoassay (EIA), and enzyme-linked fluorescent assay (ELFA). These techniques have been used for years in both diagnostic and screening protocols for ToRC infection and have demonstrated reliable performance (5,10,14,22). However, these methods have certain limitations, including low throughput, significant hands-on time, and in the case of IFA, a subjective interpretation of results.(Recently, multiplex flow immunoassay (MFI) technology emerged as a novel approach to assess the serologic response to various infectious diseases (3, 4, 13). This technology is similar to traditional EIA but allows for the simultaneous detection and identification of multiple analytes in a single reaction. MFI technology uses a liquid suspension array of up to 100 unique microspheres (5-to 6-m beads), each conjugated with a different capture molecule (e.g., antibody, antigen, nucleic acid). Each capture analyte is detected and quantitated following the addition of a fluorescently labeled reporter molecule (e.g., phycoerythrin) whose emission is measured by a flow-based detector. In 2009, Bio-Rad Laboratories (Hercules, CA) received FDA clearance for a ToRC IgG immunoassay based on MFI technology. In addition, Bio-Rad has developed a prototype ToRC IgM assay for use in cases of suspected acute infection. These assays are fully automated on the BioPlex 2200 automated analyzer (Bio-Rad Laboratories), allowing for a high-throughput analysis of the ToRC IgG and IgM class antibody response.Due to increasing test volumes (ϳ20% in the past 5 years) and the limitations of conventional methods (e.g., low throughput, increased hands-on time, and the requirement to aliquot samples prior to testing), we undertook a study to evaluate the BioPlex ToRC IgG and IgM immunoassays using clinical serum samples. The goal of this study was to compare the results of the BioPlex to routine testing by EIA/ELFA, using a third assay to arbitrate discordant results.
MATERIALS AND METHODSStudy design. Prospective serum specimens (n ϭ 600) submitted to our reference laboratory for routine ToRC IgG and IgM testing by EIA (SeraQuest, Doral, FL; Diamedix, Miami, FL) or ELFA (Vidas; bioMérieux, Durham, NC) were also tested by the BioPlex ToRC IgM and IgG immunoassays using the BioPlex 2200 automated analyzer (Bio-Rad). Other specimen types, including cord blood samples, were not included in this evaluation. Specimens showing discordant res...