StatSensor Creatinine vs Beckman AU discrepancy

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I'm well aware of the accuracy/precision issues with creatinine on the Nova Statsensor and our devices are set up with a y intercept offset of 0.2 to help address this issue. According to my correlation studies over the last two years, we should rarely see the Statsensor creatinine turn out lower (ie - GFR rarely higher) than the core lab creatinine, and then only by a tiny, non-clinically significant amount. 

The other week we had a near miss and a major discrepancy that I am trying to solve that has my faith in this test shaken. CT staff got a creat of 1.60 (gfr 47) and was ready to administer contrast and then the lab creat of 2.46 (gfr 27) came back, which was a shock. Thankfully the CT tech had not yet administered dye. The CT tech used the second drop of blood from the capillary stick, so tissue fluid dilution was not a likely contributing issue. Strips are good and qc was good.

Does anyone have any knowledge about possible issues contributing to this massive discrepancy? My CT and MRI techs need to know that this is a reliable screening test (or not) and I need to figure out if there are medical conditions that could contribute to this sort of inaccuracy. I plan to reach out to Nova as well.

Thanks for any insights!
Ken

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Hi Ken,
From my experience with the proficiency testing (PT) results, the problem is the strips.  The strips do not last 90 days as stated in the package insert.  When we used strips from a vial that had already been opened, but within 90 days, we had very wide SDI.  However, when we used freshly opened strips, the SDI were much tighter.  Also, the higher the results, the wider the SDI.   

We had an issue with a patient giving a Stat Sensor creatinine of 1.70 and a main lab plasma creatinine of 3.0. Everyone is going crazy about the discrepancy. This is whole blood vs plasma, POCT Stat Sensor vs Abbott's Architect. All our correlation has been whole blood vs whole blood. Prime Plus vs Stat Sensor.  How would you resolve this? The results are confusing people. Thanks!

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Ken C
almost 5 years ago
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