BiliDx

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Does anyone have or know anything about the BiliDx for neonates? I am being asked to look into this as a POC device.
Thank you

6 Replies

Kathleen David

Tue Aug 22, 2023 at 9:38AM

This device looks interesting. It appears to be something similar to a glucose meter. However, it also looks like it's not FDA approved. It is CE marked. I wonder if the company is trying for FDA approval. If it does get FDA approval, and is accurate, then this could change a lot of practices. As far as I know, there is no POCT device to test neonatal bilirubin in the US.

Jeremy MacDonald

Tue Aug 22, 2023 at 10:42AM

Humm... on face value this system appears to be missing a number of features that would say are required nowadays to be an acceptable POC system. If the system doesn't have the ability to restrict users which includes an access expiration date, have QC lockout, interface results to EMR to name a few I'm not interested.

There is no reference it being interfaceable.

Lanette Kroupa

Wed Aug 23, 2023 at 9:20AM

I had an office interested in it, so I contacted our state CLIA person and she said it is not considered a Lab test. It falls under nursing care standards or something similar to that.

Kathleen David

Wed Aug 23, 2023 at 9:34AM

This test is not similar to the transcutaneous neonatal bilirubin out there by Draeger and BiliChek. This BiliDx device does use blood from the baby, so will be considered a lab test if it ever gets approved by the FDA. And, not sure if the FDA would consider it waived or nonwaived.

Lanette Kroupa

Wed Aug 23, 2023 at 9:38AM

Oh, my mistake I thought it was the same as BiliChek. Thanks.

Jeremy MacDonald

Wed Aug 23, 2023 at 10:32AM

Completely agree with Kathleen, it would fall under the lab for reasons cited.

Non-waived vs waived. The website contradicts itself so I'm even more wary of it. It states that it transmits light through a *serum* sample but then cites the sample required is "75μl (Whole Capillary Blood)". If the sample required is truly a serum sample I would expect it to be approved as a non-waived system. The user would be required to manipulate the sample prior to testing: allow to clot and centrifuge to obtain the serum sample prior to testing.

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