POC Lead testing

Unfortunately choices are extremely limited when it comes to waived POC Lead analysis.

If a waived method is needed, then the ESA LeadCare-II or another version of the ESA by Magellan Diagnostics may be your only choice.  Unfortunately this testing methodology recently underwent a Class I recall earlier this year due to an identified issue with venous blood samples collected in rubber stoppered collection devices that resulted in an under estimate of the blood lead level.  The issue identified did not affect the accuracy of capillary samples.

We currently use the LeadCare II, but have found that Magellan was difficult to work with and unwilling to provide any assistance (when requested) with free kits when we performed a look back process and began retesting of patients identified as meeting the criteria established by the FDA.  We chose to perform all Look-Back testing at no charge, while Magellan indicated we could bill insurance and therefore did not warrant support with free test kits.

The ESA systems are easy to train/use.  Reproducibility is very good, but you will be limited to capillary samples only.  Cost per reportable may be on the higher end compared to other non-waived systems.

Best wishes.

The views expressed are those of the author and may not represent those of its employer.