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D-dimer QC issues - IL


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We have been having problems for the last month or so with D-dimer QC on our TOPS analyzers.  We are using the regular HemosiL reagents and controls, and no matter what we do, the QC runs with a Mean close to the upper insert range limit on both controls.  Does anyone else have this problem?  

We have been using these analyzers and IL products for over a year and now this happens. We are wondering if the formulation of the QC has changed.  Once reconstituted, they are supposed to be good for a month in the fridge -- it appears to us that they may be only reliable for about a day. 

Thanks, Scott

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When I started with the DDHS500 line a few years back I had a horrible time with controls. That 30 day claim is junk - and I thought they were going to work on changing that wording in the package insert. I could only get 3 days out of mine. They did seem to work out the issue I was having, though.  I believe it was a combination reagent stability AND qc stability.  (We ended up switching to BioRad controls simply because in NYS I have to have a "negative" control, and IL doesn't make one that low yet.)  But in all the years of using IL, that is the ONLY problem I've had. The TOP analyzers are rock stars! (and I just got my new 550's in!)

The best thing to do is document EVERYTHING. I had a log at the instrument where I had the techs write down every time they changed reagent or made up new qc and why (empty vs. qc trouble). And then I would print the Levy-Jennings and send them in.

Do you submit monthly to the AccuTrak? If everyone else is running high, that is in your favor.

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