Improved serologic detection of hepatitis C virus with a paramagnetic microparticle assay using multiple antigenic sequences.
A paramagnetic microparticle (MP) assay for antibody to hepatitis C virus (anti-HCV) was developed, in which the probe for antibody consisted of synthetic peptides corresponding to HCV capsid and nonstructural c-100 regions, as well as a recombinant protein corresponding to the nonstructural c33c region. Assay performance was evaluated by testing serum from 108 geographically diverse patients with non-A, non-B hepatitis (NANBH). The frequency of anti-HCV reactivity detected with the MP assay and with an enzyme-linked immunosorbent assay (ELISA) for c-100 was 91 and 70 percent, respectively. All c-100 HCV ELISA-reactive specimens also reacted on the MP assay. In addition, anti-HCV seroconversion in three plasma donors was detected one to two blood collection dates earlier by the MP assay than by the c-100 HCV ELISA and at similar blood collection dates by the MP assay and a second-generation anti-HCV ELISA. Serologic responses to the three distinct antigenic regions of HCV in NANBH patients varied: reactivity to all three antigens was most common (49%), reactivity to both capsid and c33c (40%) was next most common, and single-antigen reactivity was rare (4%). MP assay reactivity of 825 volunteer donors was 0.1 percent. These results demonstrate both the utility of additional HCV antigens for an effective anti-HCV screening assay and the application of paramagnetic MP technology to serologic testing for HCV infection.
Leahy
D
D
Baxter Diagnostics, Inc., Pandex, Mundelein, Illinois.
Kink
J
J
Byrne
R
R
Shah
D
D
Preisel-Simmons
B
B
Laska
S
S
Dienstag
J
J
Thomas
H
H
Karayiannis
P
P
Brown
J
J
D000918:Antibody Specificity; D000956:Antigens, Viral / Q000378:metabolism; D004578:Electron Spin Resonance Spectroscopy / Q000379:methods; D004797:Enzyme-Linked Immunosorbent Assay; D016174:Hepacivirus / Q000276:immunology / Q000302:isolation & purification*; D006508:Hepatitis Antibodies / Q000097:blood; D006801:Humans; D007164:Immunosorbents
D000956:Antigens, Viral; D006508:Hepatitis Antibodies; D007164:Immunosorbents