LAMP and RT-PCR accelerated stability tests
I am successfully producing RT-qPCR and LAMP enzymes in Brazil. The following steps consist of registering these products as IVD in our “FDA,” but we need to perform first the stability tests.
My question is:
Does anyone know any Norm or official method to do stability tests in molecular biology proteins? I have seen some protocols using 50C-60C temperatures to perform the accelerated tests. I am afraid that this general protocol would not be suitable for these proteins. If those enzymes and their mixes do not stand for longer than a week, these kits will have a very short expiry date.
Let me know if you have a hind to do that.
Robson – ECRA Biotec