Follow up on Magellan & Blood Lead Testing Instrumentation Concerns

Dear friends,

Below is my promised follow up on the current concern about Magellan blood lead analyzers (a concern that is again today being plastered all over the news as a result of this week’s press releases from and involving the CDC and FDA)…

What I have to say (and what needs to be emphasized) is really a very simple concept that is being virtually ignored (or buried deep down) in the public agencies’ collective public statements, especially as quoted (and distorted) by the news media.

Here’s what needs to be said front and center:

The concern for accuracy of Magellan’s blood lead testing instrumentation does not involve their most commonly used testing system with the most common application of that system: the LeadCare II used with capillary (finger-stick or heel-stick) testing for “instant” blood lead test results in approximately three minutes.

It has always been my understanding (in my 6 years of working side-by-side with this company as an advocate and knowing the people and science behind their testing fairly well) that the LeadCare II capillary blood lead testing comprises the majority of their business (and therefore the majority of the tests done with their company’s instrumentation.).

I reconfirmed this with Magellan’s President & CEO Amy Winslow today. She told me: “Overall more than 90% of our tests are LeadCare II.”

The misleading information in the public agency statements and subsequent/resultant press coverage of the issue centers around the fact that opening statements and headlines leave the casual (non-thorough and non-technically savvy) reader thinking that ALL of the Magellan testing is being reviewed by the FDA and ALL of their testing methodologies and equipment are being questioned.

Some of the articles in the press even go so far as to insinuate (primarily with their headlines) that all blood lead testing by all companies may be faulty(!)

Most regular consumers (and especially parents of young children being tested) don’t generally know or understand the distinctions between the different instrumentation and testing methodologies (used by Magellan and other companies who do blood lead testing.)

With only press releases and news stories to go on, parents are left questioning their own child’s capillary (finger-prick) blood lead test, which more likely than not was analyzed with a LeadCare II and therefore would not be included in the testing that is a concern (being address by the FDA.)

Click here to read Magellan’s public statement from May 26, 2017

Across the board, the implied scope of the concern (as it is being presented to the public) is therefore very misleading.

To reiterate: Magellan’s most popular, most widely used instrument, the LeadCare II (that accounts for 90% of their blood lead testing and “magically” gives relatively instant blood lead test results in the field and in doctor’s offices – using a blood taken from a finger or heel stick) is not being questioned at all when used (as designed and intended) with capillary testing.

Parents — if your child had a capillary blood lead test and you were given same-day instant results your test was done on a LeadCare II and those results are not in question. [If you had a venous draw for your child’s test, you can contact your doctor to ask about the testing instrumentation used to analyze that sample to determine if it may need to be redone.]

Clinicians — If you are a using the LeadCare II with capillary testing for while-you-wait results, the LeadCare II is still the best (and actually the only) tool for the job [performing a screening blood test for the presence of lead at 3.3 micrograms of lead per deciliter (or higher) with results in 3 minutes.]

The LeadCare II is (and has always been marketed as) a screening tool*, and, accordingly, it is (and has always been) advised that if your capillary-draw test result is positive with a BLL of 3.3 or higher using a LeadCare II, that a follow up test using a venous draw (at the doctor’s office or a lab or hospital) is advised.

There are many companies making instrumentation for venous draw analysis and there are multiple ways to analyze blood taken with a venous draw, and it is my understanding that only a small portion of blood lead tests done with a venous draw are analyzed using Magellan’s instruments [instruments that include others that are distinctly different from the LeadCare II which, again, is not under review by the FDA at this time for results produced when used with capillary samples.]

*Screening tools are an invaluable important first line of defense for identifying a child’s risk of exposure. Unfortunately in the United States, our children are still “canaries in the coal mine” and if they aren’t tested we have no way of knowing if there is exposure, let alone of knowing the extent of the exposure. The LeadCare II makes it possible to quickly identify children who may be at risk for incidental or chronic exposure, by bringing testing instrumentation directly to those in need of testing – at WIC offices, at doctor’s offices, and at health fairs and public festivals.

Thank you for reading.

In the immortal words of Douglas Adams: “DON’T PANIC“!

Please be patient with the FDA review (and internal corporate review) of Magellan’s testing instrumentation being used for the analysis of venous draw samples (a very small percentage of what the company does), and know that this concern is not as likely to have impacted your personal test results as the headlines are making it seem.

We all know that news in this country tends to lean towards the sensationalized and overly-dramatic  headline, and this case is no different.

Disclosure: I have not been paid or compensated in any way to endorse this product – although the company is one of the many sponsors of my film – and generously donated resources (manpower, instrumentation and testing vials) that have made it possible for me to work with them and their portable instrumentation at events around the country – including offering free blood lead testing which has identified both children and adults who tested positive  (or “low”/ less than 3.3 micrograms per deciliter) for lead in New Orleans, New Hampshire and Flint, Michigan.

Sincerely,

Tamara Rubin
Mother of Lead Poisoned Children
“Unexpected Lead Expert”