POC Lead testing

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Hello,
I'm being asked to look into POC lead testing for mostly pediatric patients. Does anyone have a platform they recommend? If so, do you have any validation data or package inserts you'd be willing to share?
Thanks,
Jake

Jacob.Fray@dhha.org

4 Replies

Mark Slaughter

Wed Mar 27, 2024 at 1:58PM

The LeadCare II by Magellan is, I believe, the only CLIA-waived lead test on the market. It is available through most major distributors (Medline, Schein, etc.).

Mark Slaughter
Territory Representative – IN, KY, OH | HemoCue America
M: (812) 325-2385
mark.a.slaughter@hemocue.com
hemocue.us
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Katherine Johnston

Wed Mar 27, 2024 at 2:15PM

Hi Jake. I just wanted to share out experience with LeadCare II (Magellan Diagnostics). We went through multiple FDA recalls with results being falsely low. The providers weren't happy and after giving the manufacturer six months to prove themselves, we looked into beginning to reimplement. We had a rep come out, and while we went out to each family medicine site the QC failed (running too low). The root cause had not actually been addressed. Again, this past December, our providers reached out asking to reimplement, but we got a recall notice almost immediately (December 20th, 2023) that about 75 lots of test kits were under investigation due to issues with the treatment reagent tubes in them.

We won't go back to it at this point even though both the smaller sample volume and three minute turn-around-time appeal to providers.

Jake Fray

Wed Mar 27, 2024 at 2:17PM

Wow, thank you so much for telling me this! It sounds like these issues were recent, within the past year or so?
Thanks,
Jake

Katherine Johnston

Wed Mar 27, 2024 at 2:20PM

We had issues in 2021, 2022, and did not return to using the product due the FDA recalls. When asked to reimplement, another recall notice came out at the end of 2023.

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POC Lead testing