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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI
CCSI 23.10-1.1%Dec 19 4:00 PM EST
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To: STLMD who wrote (2578)6/9/1998 10:54:00 PM
From: Robin  Read Replies (2) of 5736
 
Thanks, Stephen!

Looks like the Colormate is definitely more accurate than a physician's visual assessment, but not as accurate as the actual blood serum measurement (as would be expected). From the wording of the document, it appears that CCSI claims equivalence, but I am not an expert who could confirm or refute such.

Anyone out there qualified to assess whether the Colormate is accurate enough to replace the heel stick (at least to determine if one's bilirubin level warrants further management)?

Also, whether or not the Colormate is approved (by the FDA) to supercede the blood serum measurement? or is its approved use limited to initial assessment?

And, is the correlation good enough for the FDA and the practicing physician to allay their concerns for best provision of healthcare and for minimizing liability. Anyone qualified care to answer?

Also does anyone know if these variations between actual bilirubin levels and the Colormate's measurements vary from patient to patient (i.e., you calibrate to the patient to get accurate measurements from that point on with that patient)or from measurement to measurement (dependent on one or more unspecified variables)?

Good luck to all and thanks!

Rockin' Robin
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