Leadcare

Hi Kathleen,

We are in the process of bringing in LeadCare at our facility but are early in the process. I do not have any documents to share yet but I was wondering what LeadCare instrument you were bringing in- LeadCare II or LeadCare Plus?

Thanks!

LeadCare II is what they purchased. They did not involve POCT in the decision. I'm not sure what the difference is.

Kathleen, I can send you the resources we used previously. However, I did pull the plug in December 2023 and fully discontinued offering POCT Lead testing, due to recalls and Proficiency Testing failures, added on to shortcomings related specifically to the device.

Thanks Mickayla. I would be interested in hearing more about the reasons to pull the testing, and what shortcomings you found. The clinics will go ahead with the testing, but it could be helpful to know what issues we'll find. Since this is waived, and the clinics are under their own CLIA, we don't normally do Proficiency Testing. But we want to provide accurate results, so any information is welcome.

I had a clinic that wanted to bring this testing on but the multiple recalls and supply issues were a factor in it not be implemented so far. 
The collection of the specimen has to be done in such a way to make sure no contamination is introduced. Not impossible but it is a factor to doing this testing.

Mickayla- Would it be possible for me to get your LeadCare resources as well? We are looking to bring in the LeadCare Plus. While it is not waived like the LeadCare II we will be performing testing in our main laboratory and it can be interfaced. I am wondering how many similarities there would be between the two.

Thanks!

We used to have the LeadCare II also, but after the numerous recalls, we discontinued testing.  I'm now getting pushback to add it again due to Headstart requiring it on children.  Still hesitant as to all the issues in the past and still see pop up occasionally.  I don't know the difference between the LeadCare II and LeadCare Plus either (besides waived vs non-waived), but my understanding is they are made by the same company.  Any insight (pros and cons) of the two different types would be helpful.

I would love to know what the issues.  They were brought in by management and lab was not involved.

Hi Kathleen.  I was tasked with implementing lead & hct testing in our pediatric clinic.  I saw where you were gathering information.  Would you please share what you gathered with me and any insights you have had during your implementation process.  Much appreciated. Norma.           norma.j.corona.civ@health.mil