Validation studies

[KRIS 0]

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..

[Malcolm Needs ★ 4,848]

Yes.  All changes have to be validated.

[Kathyang 47]

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

[John C. Staley 1,147]

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.  

[KRIS 0]

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.  

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 Saikin 1,408]

Run some panel cells;  negative, heterozygous and homozygous.

[John C. Staley 1,147]

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.  

[Clarest 20]

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?

[Kathyang 47]

No we don't use the microscope.

[AMcCord 1,274]

On 6/19/2020 at 3:49 PM, Clarest said:

Hi Kathyang,

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

A magnification aid is optional for N-Hance. It could be an agglutination viewer, rather than a microscope.