Dr. Mintz brings a wealth of experience to his role as Chief Medical Officer at Verax. He is former president of the AABB who served as a tenured professor of Pathology and Medicine at the University of Virginia as well as Vice Chair of Pathology.
He also served on the AABB’s board of directors for nine years, and chaired and was a member of numerous AABB committees. Most recently, Dr. Mintz served as Director, Division of Hematology Clinical Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration.
On December 02, 2021 FDA issued a report to blood collection centers and hospitals that documented four geographically diverse septic reactions, including two fatalities, caused by the transfusion of bacterially contaminated pathogen-reduced platelets. The Agency emphasized these cases demonstrate the need to recognize the residual risk of bacterial contamination of platelets, including pathogen-reduced platelet components.
Authors from Canadian Blood Services have published a review of their experience with a Large Volume Delayed Sampling protocol. They conclude that a longer surveillance period will be necessary to assess the value of anaerobic cultures and also proof of enhancement of safety resulting from implementation of the protocol.
The Cochrane Group summarized and analyzed results of clinical trials from Europe and the Unite States that studied patients who received transfusions of pathogen-reduced platelets and untreated platelets and found significant differences between the two groups.
Rebulla and colleagues found lower post-transfusion platelet count increments with pathogen-reduced (PR) platelets compared with untreated platelets as well as increased red cell transfusions in recipients of PR platelets. They state pathogen reduction in infectious risk should be balanced against increased component utilization and its economic impact.
Hess and colleagues assert that hemorrhagic risk from reduced blood product potency of pathogen-reduced (PR) platelets and PR plasma for patients with trauma and other indications for massive transfusion is an important consideration in risk-based decision making for implementing PR.
Internationally renowned investigator Dr. Michael Jacobs and his colleagues have published a detailed summary of their research spanning 18 years studying the bacterial contamination and septic reaction rates associated with platelet transfusion both before and after the introduction of primary culture. They compare in detail their rates to other published studies. These distinguished investigators offer cogent conclusions and recommendations for mitigation of this serious, potentially fatal risk.
Hospitals across the country are implementing the Platelet PGDprime test for both in-date testing as well as dating extension of platelets to 7 days. This comprehensive review of the topic addresses training, validation, testing frequency, quality control, proficiency testing, information technology, FDA registration, AABB Standards, operational issues, labeling and customer support resources. This report is a detailed and referenced how-to guide to assist in going live with the test.
A recent minor product modification has resulted in a significant improvement in Platelet PGD Test specificity. Validation testing of the minor modification to the PGD product demonstrated improved specificity performance and no loss in ability of the assay to detect bacteria. Overall observed specificity of the modified PGD Test was approximately 99.9% compared to overall specificity of 99.4% for the original PGD Test.
A recent presentation at the Annual Meeting of the Association of Clinical Scientists and the associated peer-reviewed published abstract document substantial cost savings and significant outdate reductions with the use of the PGD test to extend platelet dating to seven days. Data from 66 hospitals and 16 blood collection centers are presented. Implementing testing to extend storage saved more money than the testing cost.
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Three proposed culture methodologies intended to improve the performance of culture testing for bacterial contamination of platelets are reviewed in depth in this white paper. Available published and presented data are analyzed that call into question any improvement these approaches offer compared to the current US early culture protocol.
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A summary of the results of a recently performed user satisfaction survey of 50 users of the Platelet PGD Test. Besides providing an overview of all users experiences it focuses on the findings of 14 sites who have used the test to implement 7-day platelet dating. Those sites reported annual combined savings of $1.25 million due to outdate reduction with the PGD Test.
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A review of a case of sepsis due to platelet contamination reported by Canadian observers in an article recently published in the journal Transfusion. Interestingly, the authors observe that although very high levels of the Gram-positive species Staphylococcus aureus were present in the transfused unit, onset of sepsis was delayed by 2.5 hours after the platelet transfusion was started.
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The Verax Platelet PGD Test has a broad range of FDA clearances to address whatever platelet types you may transfuse and now includes a new clearance for single units of whole blood derived platelets. In this report, we will review the specifics of each cleared indication for use and what this can mean for blood bank and transfusion service policies and procedures in your institution.
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In this commentary on the list of “priority pathogens” recently published by the WHO, the very real risk that they could play an increasing role as platelet contaminants is explored.
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The first in a series of key poster and presentation reviews from the 2016 AABB Annual meeting. In this poster, Bracey and colleagues address implementing PGD in a large transfusion service and report their multiyear experience with the test’s low false positive rate.
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In this AABB Annual Meeting poster, Vauthrin and colleagues present the results of their experience performing the PGD test daily over a 2 year period observing a repeat rate of just 1.17 tests per platelet dose.
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Septic transfusion reactions resulting from the transfusion of bacterially contaminated platelet components are a potentially fatal hazard of platelet transfusion. A review of the recent literature reveals just how ineffective passive surveillance is at recognizing when they occur and points the way towards active surveillance through testing as a better approach.
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Recent FDA product approvals and a pathway outlined in draft FDA guidance have allowed the reintroduction of seven day platelet dating in the United States. But just how safe and effective are seven day platelets? A review of published in vitro and in vivo studies reveals the current consensus.
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"I'm excited to work at Verax because the company shares my passion for patient safety and best transfusion practices. I'll use this blog to express my thoughts and views about current topics in transfusion medicine and how they may impact your transfusion service or blood bank."
- Paul D. Mintz, MD