Study Supports Use of Bilirubin Analyzer

The study was published in Pediatrics (2001;107[6]).

The study involved 210 newborns at leading medical centers in Europe. Researchers found that the results of local hospital laboratory blood tests and the BiliChek bilirubin analyzer were within 3% sensitivity and 4% specificity of each other when compared with blood tested by a high-performance laboratory analyzer. The researchers also reported that a majority of invasive blood tests could be avoided by using the BiliChek device, which analyzes light reflected from a baby's forehead to predict the level of bilirubin.

This method of using light noninvasively to detect and monitor medical conditions is called biophotonics and was developed by Spectrx, Inc. (Norcross, GA, USA). The BiliChek has been cleared for use as a monitoring device before, during, and after phototherapy by the U.S. Food and Drug Administration (FDA). "This study is a further validation of our biophotonic technology in general and an important scientific indicator that the BiliChek is capable of becoming the standard of care for infant jaundice screening and monitoring worldwide,” said Mark A. Samuels, chairman and CEO of Spectrx.




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