I’ve been working with Instrumentation Laboratory, a Bedford, MA company, to spread the word about its new diagnostic test that helps prevent brain injury in newborns.  Newly cleared by the FDA, it’s first-ever, rapid point-of-care, lab-quality blood test for measuring  total bilirubin (tBili) in neonates.

Bilirubin, a toxin, can, in high amounts, lead to irreversible brain injury in neonates.  The new tBili assay is performed on IL’s GEM Premier 4000 critical care analyzer.    It allows clinicians to receive lab-quality test results in 90 seconds fromwhole blood in the Neonatal Intensive Care Unit (NICU), rather than wait up to an hour for results from the lab, using traditional chemistry methods.    

 During the first few days of life, the body breaks down fetal red blood cells, producing bilirubin.  More bilirubin is produced than the liver can remove, and it remains circulating in the blood. 

This results in jaundice, the most common condition requiring medical attention in newborns, present in approximately 70%.  However, in 8-10% of newborns, jaundice progresses to severe hyperbilirubinemia.  Left untreated, hyperbilirubinemia can quickly evolve into kernicterus, a devastating, irreversible neonatal brain injury. 

IL announced that it had received the FDA clearance for the test on Tuesday, at the annual meeting of the American Association for Clinical Chemistry. For more information,  check out the Instrumentation Laboratory (US) Web site-http://www.instrumentationlaboratory.com/ilus.aspx .

—Anita Harris

HarrisCom Blog is a publication of the Harris Communications Group of Cambridge, MA. We also publish New Cambridge Observer and Ithaca Diaries Blogs.

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