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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI -- Ignore unavailable to you. Want to Upgrade?


To: JanyBlueEyes who wrote (1451)3/18/1998 5:33:00 PM
From: Dan Packer  Read Replies (2) | Respond to of 5736
 
Jane, in the FDA filing 78% of the babies were not considered candidates for any bilirubin determination. Another 10% were excluded from the study, so only ~13% of the starting population of newborns were considered candidates for examination.

The competing modalities were eyeball comparisons with a color chart. And a plasma colorimeter. First just looks at baby. Second shoves light through baby's blood - and requires a stick.

The CCSI gizmo did better. But how much better? Since you are really looking for thresholds, the issue was there a baby who had a toxic, or near toxic level without being captured by the color wheel or the plasma colorimeter? Can you answer that question? ie, What would it cost to prevent one case of kericterus?

Color me,

Dan