The new medical opportunities that arise through modern therapies using monoclonal antibodies and other biologics pose new challenges to diagnostic procedures. It can be observed that classic antibody-based measurement methods such as Immunoassays are badly effected in presence of therapeutic antibodies when the free target molecule (antigen) of therapeutic antibody has to be determined using the measurements.
The newly developed recoveryELISA provides a diagnostic solution to the problem and provides more information and advantages. It is a patented development of BioTeZ which is based on a sandwich enzyme immunoassay. Using this test, it is possible to measure serum levels of patients despite the presence of therapeutic antibodies.

The recoveryELISA^® ready to use test kits provide three results in one test:

• Level of the free antigen
• Level of the therapeutic antibody
• Neutralisation rate of the target antigen (recovery value)

Only for drug development and research recoveryELISA provides further advantages.

recoveryELISA opens up the possibility of the treatment with therapeutic antibodies to assist specific diagnostic procedures. Simultaneously, the concentration of free antigens, therapeutic antibodies and their interaction levels (rank of neutralization) can be determined. The results could provide information concerning the antibody therapy, depending on the type of the recoveryELISA test kit used. Another advantage of recoveryELISA is that it provides the attending physicians a hint of whether the specific effect of the active reagent against the antigens is reduced due to the formation of autoantibodies against the TAB or not. The recoveryELISA cannot measure autoantibodies directly, but it can provide some information about it through calculation of the scale of interaction between the antigen and antibody.

Following recovery ELISA test kits /assays are now available:

recovery ELISA free IgE / omalizumab Kit (RIO), In-vitro Diagnostics (IVD, CE certified)
Order Number: R111 (for the determination of 7 serum samples)

recovery ELISA free TNF-α/ Adalimumab elisa kit (only for research purposes)
Order Number: R112 (for the determination of 7 serum samples)

recovery ELISA free TNF-α/ Infliximab elisa kit (only for research purposes)
Order Number: R113 (for the determination of 7 serum samples)

recovery ELISA free TNF-α/ Etanercept elisa kit (only for research purposes)
Order Number: R114 (for the determination of 7 serum samples)

Alternative: BioTeZ takes on the measurement of serum samples for you. Please send us an email.

recoveryELISA is not intended at providing treatment recommendations, i.e., whether a patient should receive a drug and if yes, in what kind of dose. The test must be carried out in a laboratory by skilled personnel. The measurement results are handed over to the physician. recoveryELISA was developed in collaboration with the pharmaceutical industry only there where it has been explicitly mentioned. Otherwise, the test is independent of all drugs and their conditions of authorisation.

Further information and publications can be found under the downloads section.

More information on recoveryELISA :

• Measurements are useful in patients both before start of a therapy as well as during treatments. Serum withdrawal should take place each time before drug injection. 
• The test kit can be purchased directly from BioTeZ, Berlin.
• BioTeZ can also measure individual serum samples.  
• For the analysis of serum samples, 0.5 ml and 0.15 ml would be perfectly adequate.
• When ordering measurements of the free antigen, the lab should be informed about presence of therapeutic antibodies in the sample in order to assure that they use the right assay.

Clinical trials

BioTeZ is very interested in implementation and monitoring of scientific studies regarding the treatment of patients with therapeutic antibodies and emphasizes on information exchange with attending physicians.

Please get in contact with BioTeZ if you are interested in studies or if you are a physician who wants to know more details about therapy monitoring with recoveryELISA.