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Development and Validation of an Ultrasensitive Single Molecule Array Digital Enzyme-linked Immunosorbent Assay for Human Interferon-α
Published on: June 14, 2018
Identification of interferon-beta antibodies in a reference laboratory setting: findings for 1144 consecutive sera
Harry E Prince1, Mary Lapé-Nixon, Carol Audette
1Focus Diagnostics, 5785 Corporate Avenue, Cypress, CA 90630, USA. hprince@focusdx.com
Insights
Antibody detection frequencies differ between multiple sclerosis patients using different interferon-beta (IFNbeta) products. Reference laboratory testing confirmed lower antibody levels in Avonex users compared to Rebif and Betaseron users.
Area of Science:
- Immunology
- Neuroscience
- Pharmacology
Background:
- Interferon-beta (IFNbeta) is a critical treatment for multiple sclerosis (MS).
- Clinical studies report varying frequencies of anti-IFNbeta antibodies among MS patients on different IFNbeta formulations.
- The impact of these formulation differences on antibody detection in a controlled laboratory setting requires investigation.
Purpose of the Study:
- To determine if differences in interferon-beta (IFNbeta) antibody detection persist in a reference laboratory setting.
- To compare the frequencies of binding antibodies (BAbs) and neutralizing antibodies (NAbs) across different IFNbeta products.
- To explore the relationship between BAbs and NAbs in patients treated with various IFNbeta therapies.
Main Methods:
- Serum samples from multiple sclerosis patients were analyzed for IFNbeta binding antibodies (BAbs) using ELISA.
- BAbs-positive samples were further assessed for neutralizing antibody (NAbs) activity via bioassay.
- Data were analyzed to compare antibody frequencies between treatment groups (Avonex, Rebif, Betaseron).
Main Results:
- Frequencies of BAbs-positive and NAbs-positive sera were lower in patients treated with Avonex (IFNbeta-1a) compared to Rebif (IFNbeta-1a) and Betaseron (IFNbeta-1b).
- A predictive relationship between BAbs levels and NAbs activity was identified in patients receiving IFNbeta-1a products.
- This predictive relationship was not observed in patients treated with IFNbeta-1b.
Conclusions:
- Reference laboratory testing confirms that antibody detection frequencies vary among different interferon-beta (IFNbeta) products used for multiple sclerosis.
- IFNbeta-1a products (Avonex, Rebif) showed different antibody detection profiles compared to IFNbeta-1b (Betaseron).
- The predictive value of binding antibodies for neutralizing activity differs between IFNbeta-1a and IFNbeta-1b therapies.
Abstract:
Clinical studies demonstrate differences in interferon-beta (IFNbeta) antibody detection frequencies among multiple sclerosis patients receiving different IFNbeta products. We sought to determine if these differences are also found when IFNbeta antibodies are measured in a reference laboratory, where factors normally controlled in clinical studies are unknown. Serum IFNbeta binding antibodies (BAbs) were quantitated by ELISA; BAbs-positive samples were then tested in a bioassay for neutralizing antibodies (NAbs). Consistent with clinical studies, frequencies of BAbs-positive sera and NAbs-positive sera were lower in the Avonex (IFNbeta-1a) treatment group than Rebif (IFNbeta-1a) and Betaseron (IFNbeta-1b) groups. We further identified a predictive relationship between positive BAbs levels and NAbs activity in patients treated with IFNbeta-1a products, but not those treated with IFNbeta-1b.
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