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Re: [IP] home hba1c test approved by FDA



Hi,
If the meter reads +/-20% then if my true H1ac = 7.0 +8.4 - 5.6. The range is 5.6 to 8.4. On the low side all is better than expected but on the high side what kind of complations should I expect, I better work very very hard to get this down but no matter what I do it will not come down.
I really don't understand how the whole world is using such a large erroe measurement.

From: "James Handsfield" <email @ redacted>
Date: Fri, 20 Dec 2002 21:21:12 -0500
To: <email @ redacted>
Subject: Re: [IP] home hba1c test approved by FDA

> William Eddie Hollyfield <email @ redacted> wrote:
> 
> > Several things we must be concerned about: how much error is introduced in
> the measurement, lab test +- 5% lab, then +-2%, after all this, is the
> measure meaningfull? What is the real cost? How many measurements do you get
> at what +/-. If your H1ac does not change that much over a given period. You
> d'nt need a precrip as of last Thur.
> > BE Good.
> 
> I haven't seen the data on this test but I strongly suspect that it is a
> waived test under CLIA regulations.  If so, then the precision is the same
> as for home test meters - IOW approximately +/- 20%.
> 
> Jim Handsfield
> email @ redacted
> 
> The opinions expressed are mine and do not necessarily represent those of my
> wife who runs our house and makes more important decisions than I do.
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