Busch, Michael P

Coffin, John M

Glynn, Simone A

Hewlett, Indira K

Linnen, Jeffrey M

Lo, Shyh-Ching

Mikovits, Judy A

Ruscetti, Francis

Simmons, Graham

Switzer, William M

English

PubMed

Graham Simmons

John M Coffin

Indira K Hewlett

Shyh-Ching Lo

Judy A Mikovits

William M Switzer

Jeffrey M Linnen

Francis Ruscetti

Simone A Glynn

Michael P Busch

Springer - Publisher Connector

Multi-laboratory evaluations of XMRV nucleic acid detection assays

Crossref

Retrovirology

Switzer William M

Mikovits Judy A

Lo Shyh-Ching

Hewlett Indira K

Coffin John M

Simmons Graham

Linnen Jeffrey M

Ruscetti Francis

Glynn Simone A

Busch Michael P

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MEETING ABSTRACT Open Access
Multi-laboratory evaluations of XMRV nucleic acid
detection assays
Graham Simmons1,2*, John M Coffin3,4, Indira K Hewlett5, Shyh-Ching Lo6, Judy A Mikovits7,8, William M Switzer9,
Jeffrey M Linnen10, Francis Ruscetti11, Simone A Glynn12, Michael P Busch1,2
From 15th International Conference on Human Retroviruses: HTLV and Related Viruses
Leuven and Gembloux, Belgium. 5-8 June 2011
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, specifi-
city and reproducibility; assess performance on speci-
mens 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 labora-
tory detected no viral sequences. A blinded pilot study
using the same four subjects and two validated nega-
tives 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 eva-
luation of the clinical sensitivity and specificity of candi-
date 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.
Author details
1Blood Systems Research Institute, San Francisco, CA 94118, USA.
2Department of Laboratory Medicine, University of California, San Francisco,
San Francisco, CA, 94118, USA. 3National Cancer Institute-Frederick, MD, USA.
4Department of Molecular Biology and Microbiology, Tufts University, Boston,
MA, 02111, USA. 5Office of Blood Research and Review, FDA, Bethesda, MD,
20892, USA. 6Division of Cellular and Gene Therapies and Division of Human
Tissues, FDA, Bethesda, MD, 20892, USA. 7Whittemore Peterson Institute,
Reno, Nevada, 89557, USA. 8University of Nevada, Reno, NV, 89557, USA.
9Laboratory Branch, Division of HIV/AIDS Prevention, CDC, Atlanta, GA,
30333, USA. 10Gen-Probe Incorporated, San Diego, CA, 92121, USA.
11Laboratory of Experimental Immunology, National Cancer Institute-
Frederick, Frederick, MD, 21701, USA. 12Transfusion Medicine and Cellular
Therapeutics Branch, NHLBI, Bethesda, MD, 20892, USA.
Published: 6 June 2011
doi:10.1186/1742-4690-8-S1-A231
Cite this article as: Simmons et al.: Multi-laboratory evaluations of XMRV
nucleic acid detection assays. Retrovirology 2011 8(Suppl 1):A231.
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* Correspondence: gsimmons@bloodsystems.org
1Blood Systems Research Institute, San Francisco, CA 94118, USA
Full list of author information is available at the end of the article
Simmons et al. Retrovirology 2011, 8(Suppl 1):A231
http://www.retrovirology.com/content/8/S1/A231
© 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.


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Multi-laboratory evaluations of XMRV nucleic acid detection assays

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