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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI

CCSI 24.53

-1.9%

3:59 PM EST

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To: Steve who wrote (3329)	6/22/1998 8:47:00 PM
From: JanyBlueEyes	Read Replies (2) of 5736

Steve, from CCSI's response to Assensio's false allegations: Message 4821970 Part 1: EXPERT REPORT Dr. Jeffrey Maisels.........who is recognized as one of the world's leading authorities on bilirubin infant jaundice and has published extensively on this subject stated, 5. "The Colormate III's(TM) clinical test only compared its bilirubin measurement performance to those of a physician's visual assessment." Dr. Maisels' response is: "This is patently false. If the authors of this document had taken the trouble to read the published data or had spoken to Dr. Ian Holzman the principle investigator in the major clinical studies performed to date they would have seen that the Colormate(TM) measurements were compared to serum bilirubin measurements in newborn infants and found to correlate closely with those measurements. In their study, Dr. Holzman, et. al. showed that visual estimates of jaundice correlate extremely poorly with serum bilirubin measurements, hence the urgent need for an instrument like the Colormate III(TM) TLc-BiliTest(TM) that will non-invasively determine the serum bilirubin levels.(2)(3) The ability to estimate clinical jaundice is notoriously poor. This is the case even for trained observers."(5) ------------ From your most recent message: <<DIRECT is the same as CONJUGATED and INDIRECT is the same as UNCONJUGATED>> Again from Message 4821970 : 6. CCSI's Colormate like other colorimeters, can only be used to estimate the total amount of bilirubin in the blood. It does not estimate indirect or direct bilirubin levels which are necessary and are commonly provided by blood tests. Dr. Maisels' response is: "This statement is partly false and certainly misleading. It is true that this instrument provides an estimate of the total bilirubin. In the overwhelming majority of babies in the newborn nursery and those followed after discharge from the hospital, measurements of direct bilirubin levels are unnecessary. All of the current recommendations for management and treatment of jaundiced infants (including the use of phototherapy or exchange transfusion) are based on total bilirubin levels and not indirect bilirubin levels. Measurements of direct bilirubin levels are only needed when there is a suspicion of cholestatic (obstructive) jaundice and are of no relevance until the baby is at least 2-3 weeks old."(4) ------------- Message 4821987 - CCSI's response to Assensio's false allegations Part 2 Message 4822451 - More information on Dr. Maisels

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