XMRV-Related Abstracts from the 15th Conf. on Human Retrovirology: HTLV and Related Viruses

4 Responses to “XMRV-Related Abstracts from the 15th Conf. on Human Retrovirology: HTLV and Related Viruses”

1. 

   John

   08. Jun, 2011 at 8:45 pm #

   Great job, thanks for this. Would it be possible to ask the CAA if it would please post links to either all three XMRV Blood Working Group studies or at least relevant summaries when the third phase comes out? So far it looks like it’s been a coin toss as to whether any of the participating labs can detect XMRV with any concordance and/or repeatability and it would be nice to have information from all three parts collated. Thanks again.

   Reply
   • 

     Kim McCleary

     09. Jun, 2011 at 1:45 pm #

     John, here’s a summary of the XMRV Scientific Research Working Group study (so far) from our XMRV Overview (http://www.cfids.org/xmrv/default.asp), with some additional links to more detailed information. We’ll keep you posted!

     In Oct. 2009, the U.S. Department of Health and Human Services announced that it would conduct studies to assess the potential risks to the blood supply and that will also help standardize tests for XMRV. The studies are being supported by the National Heart, Lung and Blood Institute and coordinated by the Department of Health and Human Services Blood XMRV Scientific Research Working Group, of which Association scientific director Suzanne D. Vernon, PhD, is a member. The studies are organized into the following four phases:

     Phase I: Analytical Panels — evaluate performance of XMRV nucleic acid test assays
     Phase II: Pilot Clinical Studies — compare assays using whole blood versus peripheral blood mononuclear cells and evaluate timing of sample preparation
     Phase III: Clinical Sensitivity/Specificity Panel — assess assay performance on pedigreed clinical samples
     Phase IV: Blood Donor Clinical Panel — make initial estimate of XMRV nucleic acid prevalence in blood donors and initiate blood donor seroprevalence studies.

     At the July 26, 2010 meeting of the Food and Drug Administration’s (FDA) Blood Products Advisory Committee (BPAC), seven groups made informational presentations about XMRV, including researchers at the FDA, NIH and CDC. Results from Phase I were reported. Analytical panels of blinded samples of XMRV and negative controls were tested by six laboratories (including the Whittemore Peterson Institute) to assess results using different methods. All six laboratories were able to detect XMRV in whole blood using nucleic acid testing and four of five plasma RNA assays performed well. CDC’s whole blood assay was the most sensitive under these conditions, while WPI was the only lab reporting an unexplained false positive result on a negative sample. The Phase I study has its limitations and these results should not be extended to other published data.

     On Dec. 14, 2010, the BPAC heard nine presentations on XMRV research and testimony from several public witnesses. Results of the Phase II (parts a and b) were presented by Graham Simmons, PhD, on behalf of the HHS Blood XMRV Scientific Research Working Group. On Dec. 17, 2010, the CFIDS Association hosted a webinar featuring Dr. Simmons, Michael Busch, MD, PhD and Steven Kleinman, BSc, MD to provide an update on the activities of the HHS Blood XMRV Scientific Research Working Group, including results of the Phase II study that had been presented to BPAC on Dec. 14, 2010. (You can view the recording here: http://www.youtube.com/watch?v=0HynlkG0cVc) Collection of samples for Phase III began in spring 2011 and updates will be provided as new information becomes available. Results from Phase III are expected by fall 2011.

     In response to a request from the CFIDS Association about the impact of the publication of four studies about possible routes of contamination in XMRV/MLV research published on Dec. 20, 2010, the Blood XMRV Scientific Research Working Group issued this statement on Dec. 27, 2010:

     “The Blood XMRV Scientific Research Working Group has discussed the findings from the four studies published in Retrovirology on December 20, 2010. These studies confirmed the importance of carefully checking XMRV/MLV related-positive results for any evidence of contamination with mouse genetic materials. The Working Group is proceeding with phase III which will evaluate the clinical sensitivity and specificity of multiple laboratory assays that test for the RNA and/or DNA of XMRV/MLVs or antibodies to these viruses. All laboratories have and will continue to apply best practices and check to the best of their ability that no contamination with mouse DNA is present before reporting any positive results. These reports also substantiate the importance of employing tests that not only detect viral DNA and/or RNA but can also detect the virus itself (culture) and/or an immunological reaction to the virus. These tests are reflected in the Working Group planned phase III study.”

     The AABB updated its statement about XMRV on Feb. 10, 2011. The March 2011 issue of the journal, Transfusion, included updates from the AABB Interorganizational XMRV Task Force (http://www.aabb.org/pressroom/Documents/xmrvcommrpt011811.pdf) and the DHHS Blood XMRV Scientific Research Working Group (http://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2011.03063.x/abstract).

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