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A Novel Semi-Automated Paramagnetic Microparticle Based Enzyme Immunoassay for Hepatitis C Virus: Its Application to Serologic Testing

John Todd Department of Assay Development, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

John Kink Department of Assay Development, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

David Leahy Department of Assay Development, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Barbara Preisel-Simmons Department of Assay Development, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Sharon Laska Department of Assay Development, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Pam Wolff Department of Assay Development, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Pam Jacobson Department of Assay Development, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Robert Byrne Department of Protein Chemistry, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Scott Babler Department of Protein Chemistry, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Mary McCoy-Haman Department of Protein Chemistry, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Dinesh Shah Department of Bio-Organic Chemistry, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Andrew Schneider Department of Bio-Organic Chemistry, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Ming Huang Department of Bio-Organic Chemistry, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Michael Jolley Department of Computational Chemistry, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Delia Bethell Department of Cell Biology, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Mark Kieselburg Department of Molecular Virology, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Badr Saeed Department of Molecular Virology, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Terence Ryan Department of Molecular Virology, Baxter Diagnostics, Inc., Pandex Mundelein, IL, USA

Terukatsu Arima Second Department of Internal Medicine, Kagoshima University Medical School, Japan

Eiki Maeda Second Department of Internal Medicine, Kagoshima University Medical School, Japan

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Abstract

A new rapid serologic enzyme immunoassay for antibodies to hepatitis C virus (HCV) is described. The assay combines synthetic peptide and recombinant antigens representing putative structural and non structural HCV gene products with paramagnetic microparticle assay (MP assay) technology. Assay readout is based upon an enzymatically generated fluorescent product which is quantified with a novel semi-automated washer/reader instrument system. Assay sensitivity and specificity was determined to be greater than the first generation HCV C-100 EIA using a non-A, non-B hepatitis disease panel, an HCV performance panel, an HCV seroconversion panel, dilutions of HCV reactive sera, and random volunteer blood donor specimens.

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A Novel Semi-Automated Paramagnetic Microparticle Based Enzyme Immunoassay for Hepatitis C Virus: Its Application to Serologic Testing

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A Novel Semi-Automated Paramagnetic Microparticle Based Enzyme Immunoassay for Hepatitis C Virus: Its Application to Serologic Testing

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