Waived Bilirubin Options
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Hello,
Is anyone aware of any CLIA waived bilirubin options?
Thanks!!
Raychel
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Hi Raychel,
I always check the FDA site for any tests I'm looking for. You can search by test and complexity.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm
Hello Raychel,
At my previous job with Cincinnati Children's Hospital, the outpatient sites switched to the Piccolo Express for bilirubin testing. It is CLIA waived. You would just use the Hepatic panel cartridge wheel, it includes both total and direct bili. We did correlation studies with BR2 (what the outpatient sites used prior, not waived), and with the main lab's vitro analyzers. Correlated very well.
My only complaint is the Piccolo sometimes (not all the time) had issues with giving direct bili results with severely icteric specimens, which as you know, jaundiced babies' specimens will be icteric.
I lied.... it is CLIA waived for total bili only, not for Direct bili. Sorry. When I looked it up to check myself, the hepatic panel is not waived. Not sure why yet but I will research.