We are writing to clarify what we believe is an inaccuracy, perhaps due to some misunderstanding, found in Peter Gilligan's April 2004 minireview (2). To be specific, we reference statements made by the author on page 1394 under the subheading “Platelet contamination.” Paragraph two under that subheading contains sentences in which the author refers to TREK Diagnostic Systems, Inc., of Westlake (Cleveland), Ohio, as facing the imposition by BioMerieux of restrictions to the marketing of its technology for bacterial contamination testing of platelets similar to those Becton Dickinson faces.
We wish to inform the readers of your journal that TREK Diagnostic Systems, Inc., has no “similar” agreement restriction as stated in Gilligan's review. Users of TREK's ESP and VersaTREK technology are able to use these technologies in accordance with the American Association of Blood Banks (AABB) Standards for Blood Banks and Transfusion Services guidelines (edition 22) (1) for validation and routine use of bacterial contamination testing of platelet products via an automated culture system. TREK Diagnostic Systems, Inc., has an agreement that expressly protects “TREK, its Distributors, and End Users” from suit for TREK to market the ESP (and VersaTREK) technology worldwide for human diagnostic testing and related testing of sterile body fluids.
The March 2004 AABB Standards for Blood Banks and Transfusion Services, edition 22 (1), reminds facilities that “QC monitoring of bacteria detection may not be used for product labeling even if an FDA-cleared method is used.” Additionally, under the heading “Validation Techniques” (1), the standard states that “any technique—whether it is an FDA-approved technique used according to the manufacturer's directions or a technique that uses equipment and reagents outside intended or approved applications—requires validation to ensure that the performance of the technique is as expected. The validation plan for the procedure should be developed by each facility or laboratory, but some suggestions are offered here.” The document then proceeds to provide examples of acceptable validation protocols for various techniques, including staining, dipstick detection, spiking studies, etc.
- Copyright © 2004 American Society for Microbiology
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Author's Reply
It is my understanding that there is a legal understanding between TREK Diagnostics Systems and BioMerieux concerning the use of the VersaTREK automated blood culture system. BioMerieux's position is that this agreement precludes TREK from seeking Food and Drug Administration (FDA) clearance for use of the VersaTREK blood culture system for the detection of bacterial contamination of platelets; TREK, on the other hand, believes this agreement allows for such an indication. Although I am not privy to this agreement, it is my understanding, as indicated in the letter from TREK Diagnostics Systems, that the agreement allows for “human diagnostic testing and related testing of sterile body fluids.” BioMerieux's general position has been that blood processed to prepare platelet product is not a “sterile body fluid.” In any case, I do not have the legal expertise to make a judgment as to which side has the stronger legal position. Having said this, I fully agree with Mr. Stutzman and Dr. Sullivan that those laboratories that choose to use the VersaTREK system for the detection of bacterial contamination of platelets must validate this system for that purpose. Because this system does not have FDA approval for use in the detection of bacterial contamination of platelets, it is likely that any laboratory considering this use should do a fairly extensive and costly validation. Because the BioMerieux system has been cleared by the FDA for quality control of platelets and because there is a body of supporting literature in refereed journals, validation required for theBioMerieux system in a particular laboratory would likely be less extensive and expensive.
I thank Mr. Stutzman and Dr. Sullivan for their comments and interest. For the purposes of full disclosure, I state that I have received and am presently receiving research funding from BioMerieux. The FDA approval studies for the use of the BacTAlert automated blood culture system (BioMerieux, Durham, N.C.) for detection of bacterial contamination of platelets were done by Dr. Mark Brecher, a colleague of mine in the Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine. Dr. Charles Jere and Dr. David Heath, who were postdoctoral trainees under my supervision, participated in these studies and were coauthors on some of the publications in refereed journals cited elsewhere.
