Instrumentation Laboratory (IL) has received clearance from the US Food and Drug Administration (FDA) to market a rapid point-of-care blood test for measuring total bilirubin (tBili) in newborns.
The tBili 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 analyser.
It allows clinicians to receive laboratory-quality test results in 90 seconds from whole blood in the Neonatal Intensive Care Unit (NICU), rather than waiting for up to an hour for results from the laboratory using traditional chemistry methods.
During the first few days of life, the body breaks down foetal red blood cells, producing tBili.
More tBili 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.
However, in eight to 10 per cent of newborns, jaundice progresses to severe hyperbilirubinemia.
Left untreated, hyperbilirubinemia can quickly evolve into kernicterus, an irreversible neonatal brain injury.
Anthony Napolitano, neonatologist and medical director of the Neonatal/Pediatric Transport Program at All Children's Hospital in St Petersburg, Florida, and medical director at Sarasota Memorial Hospital in Sarasota, Florida, said: 'Over the past decade, kernicterus has re-emerged, due to a variety of factors.
'The ability to assess tBili in the NICU with accuracy and precision is a tremendous advantage and has the potential to prevent this absolutely devastating outcome and reduce hospital readmissions,' he added.
The American Academy of Pediatrics recommends that a risk assessment for tBili be performed on every newborn to reduce the incidence of adverse events.
'Now, with the addition of the tBili assay to the Gem Premier 4000 analyser, screening can be performed immediately, with the highest-quality results assured,' said Ramon Benet, vice-president of US sales and worldwide service and marketing at IL.
According to the company, tBili assays performed on the Gem Premier 4000 are not affected by moderate turbidity or haemolysis, ensuring accuracy.
In addition, from a single whole blood sample, a full range of analytes can be measured, including blood gas, electrolytes, glucose, lactate and full CO-Oximetry, for an efficient and comprehensive assessment of patient status.
IL announced the FDA clearance of the tBili assay at the Annual Meeting of the American Association for Clinical Chemistry in Anaheim, California.
At the meeting, the company also introduced Gemweb Plus Custom Connectivity, a software solution for automated information management.
Gemweb Plus provides system-wide, bidirectional capabilities from any networked PC of the Gem Premier 4000 analyser.
The software provides complete control of all networked analysers, regardless of location, to enhance quality assurance and regulatory compliance.
