lot release and parallel QA testing

[mlongval]

Currently at our facility we are using a Rosys Plato for donor testing. When we receive new kit reagents we do a thorough visual inspection and a parallel QC test. Now the manufacturer is shipping componets instead of kits.

1. Should each lot of capture tray be tested?

2. Should each lot of indicatior cell be tested?

3. Should each lot of positive and negative control be tested?

Feedback would be apprecitated as to how you ensure QA of reagents received at your facility. email mlongval@partners.org or respond to this thread.

Thank you,

-Matt

[adiescast]

If the Rosys is anything like the ABS2000, you have to do QC with a new lot before you can use it anyway, so you will essentially be performing the parallel QC when you place the new lot on the instrument. If that is not the case, then you may want to have a policy to perform new QC when a new lot is placed on the instrument to cover your lot change.

[Kochman]

If you haven't done so already, you should first check the instructions provided by the manufacturer with the reagents and with the instruments. If these are not clear, you should consult the manufacturer.