I think what you refer to in regard to the pipettor/camera would be encapsulated by the clinical engineer who conducts the OQ (operational qualification) portion of the validation. My discussion was in reference to PQ (performance qualification). i.e. We know the analyzer is FDA approved and functional but specifically how does the equipment and results it churns out compare to the current results/procedures? Does it meet our expectations? Do we need to modify our expectations/procedures/etc?

From my own experience, despite the fact that they use the same reagents, manual gel and ProVue gel can often provide very different results. I think it's important to have context from validation to support the use of the analyzer in its future operation.

 

Edited January 11, 20178 yr by goodchild
Incomplete thought.

I'd be interested in knowing what kind of differences you saw between manual and Provue gel.  With what frequency?  Which turned out to be the false result?

I should add that most validation policies require that the span of reactions be tested (in this case negative, w+ to 4+) as well as testing reactions per well so you should pick your samples wisely.  Don't forget that this instrument has been through rigorous testing to pass FDA approval so no need to reinvent the wheel IMO.   

On ‎1‎/‎11‎/‎2017 at 4:00 PM, Mabel Adams said:

I'd be interested in knowing what kind of differences you saw between manual and Provue gel.  With what frequency?  Which turned out to be the false result?

I wasn't involved in the validation of our ProVue but from my recollection of the repercussions (and my own subsequent review) it wasn't a great study. When the analyzer 'went live' it was used to perform type and screens, antibody id panels, polyspecific DATs, cord blood evaluations, crossmatches (IS & IAT), donor unit processing - the works. Fast forward to today, where we perform only type and screens.

Just thought I would confirm from an earlier reply of mine that you can now load partial gel cards onto the Vision.  This is after their software upgrade that came out near the end of 2016.  You should not load partial cards that have had any columns run by manual testing, but you can load it back on if it was only used on the analyzer.  The partial cards are loaded in the manual review rack (dual purpose drawer) and they are held in the middle incubator (not in the main gel card drawer).  If the card is not used in 4 hours, it will get spit out again in the manual review rack.  You can re-load it again if you would like to; or if it is a less frequently used card, like the Poly cards for us, then you can wait and re-load it once you need that type of card again.

Hope this makes sense and is helpful.

Stephanie