The laboratory for analysis of neutralizing antibodies
Since 2003 we have offered possibilities to analyze for neutralizing antibodies (NAbs or nADA) against interferon beta (IFNbeta) and from 2006 also antibodies against Tysabri (Natalizumab).
During the start-up period of the NAb-lab the analyses were done free of charge, which was made possible by a generous unrestricted grant from BiogenIdec.
Now that the methods have been established, the users pay the cost of the analyses. Due to decrease number of patients being treated with these drugs and therefore less need to test for ADA, we need to increase the price of the tests to be able to still provide it. Currently new prices from May 2016 are the following:
- Screening for NAbs against IFNbeta: 3125 SEK.
- Screening + titration for NAbs against IFNbeta: 5000 SEK.
- Screening for NAbs against Tysabri: 2500 SEK.
- Value-added tax (VAT) 25% is added to the price.
When the samples are analyzed for IFNbeta NAbs, they are first tested for only presence or absence of NAbs in a screening assay. If they are found to be positive the samples are titrated in an additional test to determine the levels of antibodies (expressed as ten-fold reduction units per ml - TRU/ml). That is why the screening plus titration is more expensive than screening only. It should be noted that the cut-off for positivity in the screening is set to be rather low, so samples that are screened as positive might turn out to be negative in titration.
The method used for IFNbeta NAb analysis is a bioassay where growth arrested cells are stimulated with IFNbeta and blocked by patients’ serum if it contains NAb. We are since 2013 using the iLite method (provided by Euro Diagnostica and distributed by Thermo Fisher in Sweden).
Analysis of antibodies against Tysabri is done with an ELISA method provided by BiogenIdec.
From November 2007 the results from the analyses can be found in the Swedish MS-register for clinicians in Sweden. The answers are also sent by ordinary mail or can be e-mailed electronically on request.
The referral forms can be downloaded below. Please ensure the patient is informed that their sample will be stored in biobanks and may be used for research in ethically approved research projects.
Analysis of antibodies against rituximab (Mabthera) is now available with a CE-marked ‘Bridging’ ELISA method provided by Promonitor. A new method based on electrochemiluminescence (ECL) for analysis of ADA against rituximab (Mabthera) using the Meso Scale Discovery (MSD) platform is also in development.
We also have the iLite method available for analysis of ADA and drug levels for: adalimumab (Humira), etanercept (Enbrel) and infliximab (Remicade). Please contact us if you are interested in this.
The following prices for TNF and Mabthera as of January 2016:
- Drug levels (high/low): 3000 SEK
- Titration of drug levels (µg/mL): 3000 SEK (6000 SEK total, including screening)
- Screening for neutralizing antibodies (nADA, pos/neg): 3000 SEK
- Titration of nADA positive samples (titer): 3000 SEK (6000 SEK total, including screening)
- Value-added tax (VAT) 25% is added to the price
Welcome to send in your samples,
Anna Fogdell-Hahn and Jan Hillert