As part of our commitment to enabling our customers’ safe and timely decisions by delivering the highest quality, most accurate laboratory services, LABS, Inc., is pleased to announce that we have added two new Zika Virus (ZIKV) test offerings to our extensive test menu: Nucleic Acid Testing (NAT) for ZIKV; and Enzyme Immunoassays (EIAs) specific for IgM and IgG ZIKV antibodies.
NAT Testing for ZIKV
In August of this year, the U.S. Food and Drug Administration (FDA) issued their revised recommendations for reducing the risk of ZIKV transmission by blood and blood components. The recommendations require immediate implementation of ZIKV testing for blood banks in the areas of the United States where local transmission of the virus by mosquitos has been reported. For blood banks in proximal areas, testing should be implemented no later than November 18, 2016. While currently there is no FDA-licensed blood donor screening test for ZIKV, under its Investigational New Drug (IND) study protocol, the agency has approved a ZIKV screening test co-developed by Grifols and Hologic, leaders in the lab assay and instrumentation market.
“The investment of time, personnel and funds needed to offer this test is well worth it,” responded Dr. Gregory D. Clark, President and CEO of LABS when commenting on the purchase of the assay and equipment for the new test offering, “especially when we consider how this will help our blood bank customers provide the safest blood possible while combating the threat to public health the Zika virus represents.”
At this time, LABS can only offer ZIKV NAT to blood banks; however, when and if the IND is expanded to include testing to screen other types of living and cadaveric donors, LABS will be able to fulfill testing needs in this area as well.
Serological diagnosis of ZIKV
LABS provides laboratory testing specialized for donation and transplantation. In addition to our blood bank clients, we serve a variety of other customers including: eye banks, organ procurement organizations, reproductive health organizations, stem cell organizations, tissue processors and transplant programs. We strive to be our clients’ trusted advisor in testing and always seek to understand the worldwide environment impacting them. As such, while we recognize that the detection of ZIKV using NAT Testing or RT-PCR methods is most effective during the on-set phase of the infection, we realize that the need for a ZIKV testing option which will allow detection of infection long after the initial infection is over. Therefore, we are now offering Enzyme Immunoassays (EIAs) specific for IgM and/or IgG ZIKV antibodies via the Euroimmun assays which are currently labeled for Research Use Only. Euroimmun has applied for Emergency Use Authorization for their IgG/IgM EIA assays, but approval is currently pending.
When announcing this second ZIKV test option, Dr. Clark stated “By offering ZIKV testing via both NAT and IgG/IgM testing, we are ready and standing by when the FDA issues final guidelines on the necessary testing for both living as well as cadaveric donation.” Dr. Clark further explains that, “The implementation of these new testing options is intended to provide our customers with the most up-to-date products and services supported by the exceptional customer service experience our clients have come to expect from LABS.”
If your organization is interested in ZIKV testing, please contact us at sales(at)labs-inc(dot)org.
For additional information about ZIKV, please visit the U.S. Food and Drug Administration or Centers for Disease Control and Prevention.
About LABS, Inc.
Founded in 1978, LABS provides laboratory services specialized for transplantation and biomedical applications. Our mission is to enable customers’ safe and timely decisions by delivering the highest quality, most accurate laboratory services. We hold an extensive list of registrations, accreditations and licensures including the American Association of Blood Banks (AABB), Clinical Laboratory Improvement Amendments (CLIA), and the U.S. Food and Drug Administration (FDA). We combine our industry-leading credentials with a customer consultative approach to deliver precisely what’s needed, when and how it’s needed. As a result, our customers are able to make safe, informed and prompt decisions that impact their business, and the lives of those they serve. At LABS, we look beyond the testing to what is possible as the result of it. Lives are at stake, innovation is impacted and potential is effected. What we do matters, but what our customers do with it matters even more. LABS. Realize the potential. For more information, please visit us on LinkedIn.