We currently run the Bayer TNI Ultra assay on our Centaur analysers, but are aware of an apparent shift in QC results when changing reagent lot. From Lot 1 to lot 2 we saw a drop of approx 10% in QC values and between lot 2 and lot 3 we have an increase of the same order ie a 20% upward shift from when we originally commenced the assay on Lot 1. This variation is most evident at our low and mid QC range (0.1ng/mL and 2.5ng/mL). I assume patient results are simmilarly affected although we have yet to look at this in detail. Have any other users seen this and if so what have you done in terms of adjusting patient results/cut-off levels?
Thanks
Derek
Dr Derek Pledger
Dept Clinical Biochemistry
Ipswich Hospital NHS Trust
Heath Road
Ipswich
IP1 4NS
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