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Hello

We are currently developing a strategy to confirm to the UKAS acceptance testing standard. 

‘5.3.2.3
Reagents and consumables - Acceptance testing: New lots/batches of reagents shall be verified as performing satisfactorily before being used in conjunction with patient samples. If the formulation changes then the performance should again be verified’

Would anyone, particularly those who have gone through the UKAS inspection, like to share how they went about this? 

My understanding is that every batch, i.e. delivery will require testing before being ‘accepted’ and hence usable.  This must be done on arrival, and not as the reagents are loaded as essentially the process ensures the reagents have been stored correctly etc. by the manufacturer/ during shipment.

We plan to quarantine all reagents on arrival, test a selection of assays with pre-prepared pooled serum, before moving the reagents to the ‘usable’ cold room.  We are hoping testing a selection e.g 4 or 5 assays would be sufficient.  To test all reagents from each delivery would be difficult to manage in practice.

Any advice would be appreciated

Thanks

Stephen

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