Yes. The Bordier kits are CE-marked for Medical Professional Use only in accordance with EU IVD regulations (IVDD 98/79/EC).
Yes. Bordier hold a valid ISO 13485:2016 certificate which can be found HERE.
Components 02, 03, 04, 05 and 10 can be used with any lot and any Bordier ELISA kit.
Components 01, 06, 07, 08 and 09 should be used only together with the same lot number.
Yes, on any open ELISA machine with an appropriate program. Bordier can help with designing your program upon request.
Extra washing solutions and conjugates can be provided for free. Other components cannot be provided on their own.
The use of plasma is validated with heparined plasma for products ref 9310, 9300 and 9350. We consider that there is no technical contraindication to use plasma with other ELISA kits.
The protein A of the conjugate has the capacity to bind antibodies from many species (cow, horse, mouse, pig, rabbit, dog and monkey). Bordier ELISA kits can be used with serum samples from these species but the cut-off of the kit should not be used, as it was designed for human serum only. Users have to design their own cut-off according to their experience.
The use of other samples than serum is not validated with Bordier ELISA kits. However, it can be designed by the user and used for research only. However, users can design their own protocol and use it for research only.
No. However, we can supply a slide coated with spores on request. It can be revealed with the kit in order to train the user to identify the spores.
