Antibody Panel QC

[BANKTECH]

Wondering if everyone does QC on their antibody panels, prior to being placed into use. What is being used for QC? We currently use patients with known antibodies. This has never been questioned by inspectors. I started thinking though, if I perform QC with Anti-K there are other antibodies that will be identified with this panel. Should I continue as is? Should I use a serum that is positive on all cells? Do I not need to do QC on antibody panels? Sorry if this is a repeat topic, I didn't see when I did a search.  

[Malcolm Needs ☆]

We always used to do a QC before use (i.e. before the previous panel had reached expiry date), otherwise, if the new panel was not up to scratch, we were left without any panels.

We used a weak anti-D, a weak anti-c, a weak anti-K and a weak anti-Fy^a, all obtained from NHSBT.  Obviously, there were still antigens untested (M, N, S, s, P1, Lu^a, Lu^b, Le^a, Le^b, Jk^a and Jk^b), but you have to stop somewhere!  These four weak antibodies gave us a positive and a negative with all ten cells.

[John C. Staley]

Nope, never did any QC on panels.  Could not see the sense in it.  How could you possibly test for all the antigens!!  As Malcolm says above, "You have to stop somewhere!"  I chose not to start. 

[Laurie Underwood]

Had a Joint Commission inspector ask for this documentation in 2012. I had the paperwork to show him! The package insert for the panels we use state that the panel should be tested periodically with weak antibodies. We use a weak Anti-D and Anti-c for the positive control so all cells will react. We have a TANGO so we use the Solidscreen II Negative Control reagent for the negative control on the panel. We QC the panels once a month, when we receive them.

[SMILLER]

Obviously, running testing for ALL antigens on the panels is impractical (we don't do that for screening cells either).  Also, I do not think anyone runs QC every time a panel is run. 

Here in our hospital, we had done nothing for QC for panels for years, until a few years ago, when I believe there was some guidance out there from FDA or JCAHO or whatever, regarding QC practices.  After all is said and done, one must at least follow manufacturers instructions for ANY test system used in the Lab. 

For example, Ortho wants the panel to be "tested periodically with weak antibodies".  Immucor says to "check periodically by testing antigens likely to deteriorate".  We test each panel with our regular QC sera when first received, (along with a diluent negative) and then let it go at that.  Neither FDA or JCAHO has had a problem with this, (although they could argue that we do not have evidence that the panel is still reactive at the END of the expiration period).  Our thinking is that if it is reactive when we receive it, nothing has happened during shipment, so it should be good to the manufacturers stated expiration.  This is not dissimilar to what we do when we receive new shipments of POC materials.

Scott

[Alana]

Hi all,

Thank you for the conversion on this topic. I have found it very interesting.

I'd like to mention that the package insert for OCD panel A/B says 'should be tested periodically' and Panocell from Immucor says, 'may be checked periodically'. Neither say must or shall. With that being said, the manufacturer is recommending but does not say it MUST be done.

Therefore at this time, we QC the test system (solid phase, tube and gel) with a known positive and negative but not each panel.

Alana

[BANKTECH]

Thank you all for your replies

[SMILLER]

On 9/21/2017 at 9:23 AM, Alana said:

Hi all,

Thank you for the conversion on this topic. I have found it very interesting.

I'd like to mention that the package insert for OCD panel A/B says 'should be tested periodically' and Panocell from Immucor says, 'may be checked periodically'. Neither say must or shall. With that being said, the manufacturer is recommending but does not say it MUST be done.

Therefore at this time, we QC the test system (solid phase, tube and gel) with a known positive and negative but not each panel.

Alana

Just be careful when interpreting any manufacturer's verbiage as: we don't have to do this -- as it's only "should" or "may be".  Remember you have other regulators like CLIA/CAP or CLIA/JCAHO (in the US) that require, for ANY Lab test system, that appropriate QC be run.  (Even POC systems require running QC when a new lot number is put into in use!)

This particular thread on panel QC occurs on this site over and over.  Those  interested  in previous discussions can search for them.  The general sense we have gotten here over the last few inspections is that regulators will look for some sort of QC being run on each panel lot.  So if you choose NOT to do anything you better have a good argument ready.

Scott

[Jennifer Castle]

We run the panel with diluted anti-sera (Currently Anti-Fya at 1:500 dilution). I am assuming that you are testing the cell viability, and that the panel will perform as expected. We test before the old lot expires. 

 

[exlimey]

On 9/22/2017 at 2:26 PM, Jennifer Castle said:

We run the panel with diluted anti-sera (Currently Anti-Fya at 1:500 dilution). I am assuming that you are testing the cell viability, and that the panel will perform as expected. We test before the old lot expires. 

 

Please explain how a negative result with (diluted) anti-Fy^a determines "cell viability".

"We test before the old lot expires" - this means you qualify the new panel before putting it into use ?

 

[BB1956]

For years we have been using our QC antisera and rotating one cell from the panel each day and testing it with our routine daily tube QC.  It was not so overly burdensome( one additional cell)  and even though we are testing only one cell each day we make it through the entire panel at least once during the month.  This way we are testing the "panel" if not every cell each day of use and  we have some quality control.  Everyone is correct there is no way to check every antigen so we felt this was a good compromise.

[DPruden]

Couldn't the argument be made, that performing panels and comparing to patients' history with the same antibody being identified, that the panel is being tested "periodically"? 

[Carrie Easley]

The Grifols panel cells use even stronger language   "A known negative control and a known positive control with weak reacting antibodies should be run in parallel each day of use".  We test a random heterozygous cell & known negative w/ dilute antisera daily.  I don't really feel like it adds much value, but I didn't think I could argue it.

[Carrie Easley]

A representative f/ Grifols saw my post and provided documentation that "lightens" the language a bit.