I'm trying to move my MSC culture into a GMP lab, but first have to have them screened for a number of viral markers (HIV 1 and 2, HBV, HCV, CMV and syphilis). I'm not sure if I can get some form of ELISA based assay from a biotech company and do it myself, or if there is a way to send them to someone else (like the HPA, or a clinical immunology department n a hospital) to get it done.
(note - these are not MSC cultures that I have bought from a company, they are culters that I've grown from bone biopsies from hip replacments, but not all the patients have had the screening done before the bone biopsies).
heamagglutination assays is based on viruses having surface projections which aer detected via the blood cells and quantifies viral concentration .Do you have acces to this type of assay .
The ELISA assay i think you are best ti go with a bio tech company as they have standard protocols with thier products which validates he results if you do it yourself the results might not be valid.
hope this helps,good luck
It will probably too time-consuming to set up all the assays by yourself. I would contact a nearby clinical institute (transfusion medicine, immunogenetics) and ask them to test your cell culture (supernatants). These viral tests are a routine procedure for most of these clinical institutes, and their results will be reliable.
If you want to translate your MSC culture in GMP you need to screen your source of cells (as bone marrow) by using validated assays for viral screening as those used for blood donors. Such tests (ELISA or Cheluminescence) are high sensitive and are currently used for blood donors screening often in addition to NAT (Nuceleic Amplification Technology) screening. I suggest you to contact the Transfusion Service or Blood Donor Bank to manage the check of your MSC source.
Hi Sylvia,
All the assays that you need have to be validated according to standards. This is best done by a facility that have the assays already developed and validated.t will be faster and cheaper.
Good luck,
Nelli
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