Antibody Panel Validation

[sarara26]

I am switching from an Immucor antibody panel to a Quotient antibody panel and need to do a validation.  Does anyone have any suggestions regarding this? How many samples (both pos and neg) I should use or know of any references I can look at?

[Clarest]

I would like to know, as well. We're planning to change one regular panel to an enzyme panel and wondering how should the validation be done.

Clarest

[R1R2]

A validation is not necessary in my opinion.   Would run a few patient samples with current and new panel and results should be comparable or better than the current to be acceptable.  

[exlimey]

16 hours ago, sarara26 said:

I am switching from an Immucor antibody panel to a Quotient antibody panel and need to do a validation.

My personal opinion - no validation required.

You are switching from one FDA-licensed product to an equivalent. Unless you plan to use it in a fashion contrary to the manufacturer's instructions it's a business decision rather than one of quality or performance.

If you have an internal policy that directs you to "validate" in these situations, you should change that policy. Anything that an end user does to "validate" a commercial, FDA-licensed red cell panel is dwarfed by the process involved to get these products to the market. 

Perhaps more important is that the replacement product suit your facility's specific needs. The typical antigenic make-up of the panel you select should reflect your particular testing requirements. For example....if you have lots of patients with anti- D, a panel with lots of D+ cells my not be very useful.

 

[exlimey]

14 hours ago, Clarest said:

I would like to know, as well. We're planning to change one regular panel to an enzyme panel and wondering how should the validation be done.

Clarest

Enzyme-treated cells can be very useful in the hands of expert serologists who know the pros and cons of their use. Routine use by front-line techs is probably ill-advised.

In this case, some level of feasibility testing might be useful before switching to an enzyme-treated panel, but I would hesitate to call it "validation". Each facility should determine if such a panel is useful to them, or if it would cause more problems that it would solve.

As I mentioned in earlier in this thread - I believe these are FDA-license reagents and they do not require validation.

[goodchild]

1 hour ago, exlimey said:

My personal opinion - no validation required.

You are switching from one FDA-licensed product to an equivalent. Unless you plan to use it in a fashion contrary to the manufacturer's instructions it's a business decision rather than one of quality or performance.

If you have an internal policy that directs you to "validate" in these situations, you should change that policy. Anything that an end user does to "validate" a commercial, FDA-licensed red cell panel is dwarfed by the process involved to get these products to the market. 

Perhaps more important is that the replacement product suit your facility's specific needs. The typical antigenic make-up of the panel you select should reflect your particular testing requirements. For example....if you have lots of patients with anti- D, a panel with lots of D+ cells my not be very useful.

 

I can't agree more, with both of your posts.

[Clarest]

23 hours ago, exlimey said:

Enzyme-treated cells can be very useful in the hands of expert serologists who know the pros and cons of their use. Routine use by front-line techs is probably ill-advised.

In this case, some level of feasibility testing might be useful before switching to an enzyme-treated panel, but I would hesitate to call it "validation". Each facility should determine if such a panel is useful to them, or if it would cause more problems that it would solve.

As I mentioned in earlier in this thread - I believe these are FDA-license reagents and they do not require validation.

Thank you very much exlimey. Really appreciate your input.

[sarara26]

Thanks for the input everyone.  I guess from a blood banker's mindset everything needs a validation, but in the case of FDA licensed antisera probably not a requirement.