CEO SUMMARY: Need proof that the issues surrounding today’s Vitamin 25(OH) D are of keen interest to laboratory professionals? Not only did the EXECUTIVE WAR COLLEGE’S in depth sessions on Vitamin D draw a large audience and enthusiastic participation by attendees, but within weeks, two of the lab industry’s most-watched magazines published headline stories about Vitamin D issues, built in-part around interviews with the All-Star Vitamin D panelists, as well as several other lab experts.
VITAMIN D IS THE LABORATORY TEST OF THE HOUR in our society. Media stories regularly trumpet new clinical studies which implicate Vitamin D insufficiency as a factor in a growing number of diseases and medical conditions.
Patients and physicians have responded by ordering more Vitamin D tests. In each of the last three years, the volume of Vitamin D tests performed in the United States has skyrocketed upward. In many labs, Vitamin D now ranks as one of the most-frequently ordered tests.
But all has not been well in the world of Vitamin D testing. Laboratory experts have been reticent to speak openly and in detail about a host of issues and problems—some with the potential to affect clinical care and expose patients to less-than ideal care.
Thus, it was no surprise that, at this year’s EXECUTIVE WAR COLLEGE ON LAB AND PATHOLOGY MANAGEMENT, two sessions on Vitamin D testing generated the most enthusiastic audience interest and participation. First was a presentation by Bruce Hollis, Ph.D., Professor of Pediatrics and Neonatology at the Medical University of South Carolina in Charleston, South Carolina.
Hollis developed the proprietary technology that is part of the most widely-used Vitamin 25(OH) D immunoassays. He reviewed the history of past and recent clinical studies involving Vitamin D. An ardent believer in the value of Vitamin D for maintaining optimal health, he provided evidence and made persuasive arguments that convinced many in the audience. This editor was told by several Executive War College attendees that they left the hotel at the end of the session and went to a pharmacy across the street to purchase Vitamin D3 supplements (which Hollis recommends over D2 supplements)!
All-Star Vitamin D Panel
Immediately after Hollis’ presentation was the All-Star Vitamin D Panel, populated by a group of international luminaries in Vitamin D testing. Along with Bruce Hollis, M.D., the other panelists were:
- Julian Barth, Ph.D. Consultant in Chemical Pathology & Metabolic Medicine, The General Infirmar y at Leeds, Leeds, West Yorkshire, United Kingdom
- Russell Grant, Ph.D. Strategic Director, National Office of Quality & Science, Esoterix, Inc., Burlington, North Carolina
- L.V. Rao, Ph.D. Director of Core Laboratories, UMass Memorial Medical Center, Worcester, Masssachusetts
- Andre Valcour, Ph.D. Vice President, Director of Laboratories, Laboratory Corporation of America, Burlington, North Carolina
During a lively one-hour session, this panel discussed, in polite, but candid detail, contemporary issues and problems with Vitamin D test methodologies, including immunoassay and mass spectrometry. The panel commented on how and why some current practices in laboratory testing for Vitamin D can be—at a minimum—unhelpful to clinicians, and at a maximum, have the potential to negatively affect appropriate diagnoses and treatments for individual patients.
This public discussion was a first in the laboratory industry because it directly addressed problems and challenges that confront any laboratory offering Vitamin D testing and competing for outreach lab testing business. The relevance and new ground covered by this EXECUTIVE WAR COLLEGE All-Star Vitamin D Panel is confirmed by a subsequent development.
Within weeks of the EXECUTIVE WAR COLLEGE, both CAP Today (published by the College of American Pathologists–CAP) and Clinical Laboratory News (published by the American Association of Clinical Chemistry–AACC) interviewed these panelists (and other lab experts) and headlined their respective editions with their coverage, based in part, from this All-Star Vitamin D Panel.
Readers of THE DARK REPORT who want to access this material should look for “Vitamin D Intrigues, But Not a Done Deal” in the June 2009 issue of CAP Today (Vol. 23, No. 6) and “Vitamin D Testing— What’s the Right Answer? Labs Grapple with Confusing Analytics, Evidence” in the July 2009 issue of Clinical Laboratory News (Vol. 35, No. 7).
Vitamin D Lab Test Practices
In anticipation of the publication of these stories, THE DARK REPORT has withheld its intelligence briefings and analysis of the Hollis session and the All-Star Panel. On the following pages, we provide the insights and experience of L.V. Rao, Ph.D., at UMass Laboratories, as he and his team worked through the challenges of offering clinicians both the FDA-cleared immunoassay methodology and their home brew tandem mass spectrometry (LC-MS) assay for Vitamin 25(OH) D.
During the All-Star Panel, Rao shared the data generated by the UMass Lab studies done as the LC-MS assay was developed and evaluated against the lab’s existing chemiluminescence assay and the LC-MS Vitamin D assay offered by Mayo Medical Laboratories. That data is presented on pages 5-10.
Rao offers pathologists and lab directors invaluable insights into the issues associated with Vitamin D methodologies. Of equal importance, he shares his lab’s experience working with physicians, along with the practical solutions his laboratory developed in response to the feedback it got from its physician-clients.