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This article is part of the supplement: 15th International Conference on Human Retroviruses: HTLV and Related Viruses

Open Access Meeting abstract

Multi-laboratory evaluations of XMRV nucleic acid detection assays

Graham Simmons12*, John M Coffin34, Indira K Hewlett5, Shyh-Ching Lo6, Judy A Mikovits78, William M Switzer9, Jeffrey M Linnen10, Francis Ruscetti11, Simone A Glynn12 and Michael P Busch12

Author Affiliations

1 Blood Systems Research Institute, San Francisco, CA 94118, USA

2 Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, 94118, USA

3 National Cancer Institute-Frederick, MD, USA

4 Department of Molecular Biology and Microbiology, Tufts University, Boston, MA, 02111, USA

5 Office of Blood Research and Review, FDA, Bethesda, MD, 20892, USA

6 Division of Cellular and Gene Therapies and Division of Human Tissues, FDA, Bethesda, MD, 20892, USA

7 Whittemore Peterson Institute, Reno, Nevada, 89557, USA

8 University of Nevada, Reno, NV, 89557, USA

9 Laboratory Branch, Division of HIV/AIDS Prevention, CDC, Atlanta, GA, 30333, USA

10 Gen-Probe Incorporated, San Diego, CA, 92121, USA

11 Laboratory of Experimental Immunology, National Cancer Institute- Frederick, Frederick, MD, 21701, USA

12 Transfusion Medicine and Cellular Therapeutics Branch, NHLBI, Bethesda, MD, 20892, USA

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Retrovirology 2011, 8(Suppl 1):A231  doi:10.1186/1742-4690-8-S1-A231

The electronic version of this article is the complete one and can be found online at: http://www.retrovirology.com/content/8/S1/A231


Published:6 June 2011

© 2011 Simmons et al; licensee BioMed Central Ltd.

This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Meeting abstract

The Blood XMRV Scientific Research Working Group was formed to facilitate collaborative studies into the impact of XMRV in blood donors. Studies will evaluate XMRV detection assays in terms of sensitivity, specificity and reproducibility; assess performance on specimens represented in existing blood donor repositories, and determine the prevalence of XMRV in donors. Phase I utilized analytical performance panels spiked with XMRV infected cells or virus. These panels were tested in a blinded fashion using XMRV nucleic acid testing (NAT) assays developed by six participating laboratories, with all laboratories determined to have sensitive NAT assays. Phase II represented pilot studies to compare XMRV detection using PBMCs, WB and plasma derived from individuals identified as XMRV viremic and antibody positive in previous studies. An unblinded pilot study resulted in two laboratories detecting MLV-like sequences in the plasma, but not PBMCs or WB, from all four subjects. A third laboratory detected no viral sequences. A blinded pilot study using the same four subjects and two validated negatives was less conclusive, with 3/4 laboratories detecting no viral sequences with any of the samples. A FACS-based serological assay detected antibodies in 3/4 XMRV-positive individuals, but also in 1/2 negatives. Seroreactivity to XMRV was not observed in plasma samples by Western blot. Phase III involves further evaluation of the clinical sensitivity and specificity of candidate assays by using a blinded panel of 35 pedigreed positives, together with negatives and controls. Results are expected soon. Phase IV will test a blinded panel of 300 blood donor samples.