Hello,

My facility has recently initiated a purchase order for Ortho's Panel B cells and I'm wondering if it is common-place to perform a validation for a new reagent before being put into use?  We won't be using them past their expiration date and we currently use Panel A cells.  I have no idea if we performed any validation when we started using Panel A but if we did then we didn't save any record of it.

Thanks for any insight

Within NHSBT in the UK, and despite the fact that the commercial antibody panels were tested centrally, we ALWAYS performed validation of these panels (and, indeed those produced by NHSBT itself) before they were put into use, to ensure that they had not been "damaged" in transit.  We then QC'ed them twice a day when in use with weak anti-D, weak anti-c, weak anti-K and weak anti-Fya.

We took no risks.  There was little or no risk involved with patients' samples.  There was a HUGE risk with the accreditation people who inspected us (usually, with little or no knowledge of blood group serology), as they had the power to shut us down (see my previous phrase in brackets).

I believe the topic -- QC for panel cells -- has been discussed a few times here on Pathlabtalk.  As far as "validation", not sure you need anything beyond what the manufacturer suggests.  And I think Ortho only mentions QC.

Scott

I've  QC'd new panels for years (at least since 1989.

Only test them for pos rxs.  Never been cited for this (AABB & CAP).

If I remember correctly, we QC'd new panels on the day we received them and then each day of use (daily for us).  I started doing that 9 years before David and never had an issue with any inspecting/accrediting agency.  

Since it's the same vendor I don't think you need a validation.  When I changed from Immucor to BioRad for our tube panels I did performance validation covering avidity (strength of reaction), accuracy and precision (predictability). The FDA liked it and that's my plan now that I'm changing over to BioRad's gel reagents as well.

On 12/27/2019 at 8:20 AM, Sonya Martinez said:

  When I changed from Immucor to BioRad for our tube panels I did performance validation covering avidity (strength of reaction), accuracy and precision (predictability). The FDA liked it and that's my plan now that I'm changing over to BioRad's gel reagents as well.

I have to ask, did you do this for every antigen listed on the panel? 

On ‎12‎/‎28‎/‎2019 at 11:10 AM, John C. Staley said:

I have to ask, did you do this for every antigen listed on the panel? 

You are a cruel man John. 

We don't but I assume that as we use panels for antisera QC it by default QCs the panel.

1 hour ago, Ensis01 said:

We don't but I assume that as we use panels for antisera QC it by default QCs the panel.

If you mean you use the panel cells as positive and negative controls for your grouping antisera, no it doesn't, as these reagents are MUCH more avid than most human antibodies.

2 hours ago, Malcolm Needs said:

If you mean you use the panel cells as positive and negative controls for your grouping antisera, no it doesn't, as these reagents are MUCH more avid than most human antibodies.

Then we do not QC new panels aside from visual inspection and any insert changes. 
Apart from damage in transit it seems any in-house validation is FAR less than the manufacturer must do. 

We cross-check our panels on receipt with the panel currently in use.  This gives us the cross-check of the new panel and the "intermediate" check of the current panel.

We do not do any QC testing on a panel on other days of use.

On ‎1‎/‎1‎/‎2020 at 9:50 AM, Ensis01 said:

Then we do not QC new panels aside from visual inspection and any insert changes. 
Apart from damage in transit it seems any in-house validation is FAR less than the manufacturer must do. 

We only QC the antibody panels, both for pos and neg reactions, when they are being put into use--specifically to make sure they were not "damaged in transit".

Scott

20 hours ago, TreeMoss said:

We cross-check our panels on receipt with the panel currently in use.  This gives us the cross-check of the new panel and the "intermediate" check of the current panel.

We do not do any QC testing on a panel on other days of use.

What do you mean by "cross-check"? 

On 12/28/2019 at 8:10 AM, John C. Staley said:

I have to ask, did you do this for every antigen listed on the panel? 

Hi John, No we did not do every antigen.  Hemo Bioscience makes a validation kit that contains 8 positives and 2 negative specimens plus they make MedTEK kits that contain vials with a single antibody in them including D, C, c, E, K, Fya and S.  I'm using both to validated our new Bio Rad IH manual gel this quarter

21 hours ago, Sonya Martinez said:

Hi John, No we did not do every antigen.  Hemo Bioscience makes a validation kit that contains 8 positives and 2 negative specimens plus they make MedTEK kits that contain vials with a single antibody in them including D, C, c, E, K, Fya and S.  I'm using both to validated our new Bio Rad IH manual gel this quarter

Personally, I would consider this extensive QC and not validation.  There really is a difference.  There truly are things that can not be reasonably or realistically validated in the clinical setting, antibody panels and antibody screens are just 2 of them and for the same reasons.  

 I think I'll stop there.   

Edited January 11, 20205 yr by John C. Staley
I wanted to.

We will test any antibody panel on receipt with a diluted version of a commercial anti-sera (Such as anti-K).

On ‎1‎/‎3‎/‎2020 at 7:47 AM, John C. Staley said:

What do you mean by "cross-check"? 

We test both panels with the same diluted antibody and make sure the results are the same.

Thank you all for the feedback.  As always this is very helpful.