Jump to content

Validation studies


KRIS

Recommended Posts

Hello everyone , Our supplier (Immucor)will discontinue the polyclonal  Anti-Fyb reagent and  will supply a new monoclonal Anti-Fyb, is it necessary  to do a validation studies?

Thanks and God bless..

Link to comment
Share on other sites

9 hours ago, John C. Staley said:

Yes, but the validation does not have to be exhaustive and unreasonable.  All you need to do is prove that it works as advertised in your lab.  :coffeecup:

Sir John , in my case I am working in  a small hospital and its my first time to work in Blood bank, most of my antibody screening are all negative. I rarely or never got an antibody positive patient in a month. In this case what will be my sample for validation studies? 

Link to comment
Share on other sites

15 hours ago, KRIS said:

Sir John , in my case I am working in  a small hospital and its my first time to work in Blood bank, most of my antibody screening are all negative. I rarely or never got an antibody positive patient in a month. In this case what will be my sample for validation studies? 

David answered your question exactly they way I would have.  Validation does not require patient samples, only positive and negative samples in your testing procedures.  Follow David's suggestions and you will be fine.  The manufacturer has done all the heavy lifting to get it to market.  You just need to show it works for you.  

Link to comment
Share on other sites

  • 2 months later...
On 3/29/2020 at 8:15 AM, Kathyang said:

  Yes. We just had to validate the Gamma N-Hance since we had been using ImmuAdd.

Hi Kathyang,

When you use either ImmuAdd or Gamma N-Hance, do you do the microscopic check for the negative reaction at AHG phase?

Link to comment
Share on other sites

  • 2 weeks later...

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
  • Recently Browsing   0 members

    • No registered users viewing this page.
  • Advertisement

×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.