Evaluation of a multiplex bead-based screening assay for detection of binding antibodies to interferon-beta.
Multiple sclerosis patients treated with interferon-beta (IFNbeta) can develop neutralizing binding antibodies (BAbs) that reduce the agent's effectiveness. Screening for these antibodies can be performed by ELISA. We investigated a multianalyte immune detection (MAID) assay as an alternative to ELISA to detect anti-IFNbeta-1a and -1b. For 146 sera representing both 1a and 1b treated groups, MAID concordance with ELISA was 94% and 92%, respectively. For all discordant results, the corresponding ELISA and MAID values were within 4 units of each other, and all discordant values but one fell within 2 units of the BAbs cutoff value for reflexing to neutralization testing (4 units). Our data indicate that the MAID assay is an accurate and cost-effective alternative to ELISA for detecting BAbs to IFNbeta.
Lapé Nixon
Mary
M
Focus Diagnostics, Cypress, CA 90630, USA. mlape-nixon@focusdx.com
Matud
Jose
J
Yeh
Cindy
C
Prince
Harry E
HE
D000906:Antibodies / Q000032:analysis* / Q000097:blood*; D001667:Binding, Competitive / Q000276:immunology; D003362:Cost-Benefit Analysis; D004351:Drug Resistance / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards; D005188:False Negative Reactions; D005189:False Positive Reactions; D015200:Fluoroimmunoassay / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D016899:Interferon-beta / Q000276:immunology* / Q000378:metabolism* / Q000627:therapeutic use; D009103:Multiple Sclerosis / Q000188:drug therapy / Q000276:immunology; D011237:Predictive Value of Tests; D011485:Protein Binding / Q000276:immunology; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors
D000906:Antibodies; D016899:Interferon-beta