Retrovirology

, 8:A231 | Cite as

Multi-laboratory evaluations of XMRV nucleic acid detection assays

  • 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
Open Access
Meeting abstract
  • 2.2k Downloads

Keywords

Blood Donor Collaborative Study Blinded Fashion Viral Sequence Detection Assay 

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.

Copyright information

© Simmons et al; licensee BioMed Central Ltd. 2011

This article is published under license to 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.

Authors and Affiliations

  • Graham Simmons
    • 1
    • 2
  • John M Coffin
    • 3
    • 4
  • Indira K Hewlett
    • 5
  • Shyh-Ching Lo
    • 6
  • Judy A Mikovits
    • 7
    • 8
  • William M Switzer
    • 9
  • Jeffrey M Linnen
    • 10
  • Francis Ruscetti
    • 11
  • Simone A Glynn
    • 12
  • Michael P Busch
    • 1
    • 2
  1. 1.Blood Systems Research InstituteSan FranciscoUSA
  2. 2.Department of Laboratory MedicineUniversity of California, San FranciscoSan FranciscoUSA
  3. 3.National Cancer Institute-FrederickUSA
  4. 4.Department of Molecular Biology and MicrobiologyTufts UniversityBostonUSA
  5. 5.Office of Blood Research and ReviewFDABethesdaUSA
  6. 6.Division of Cellular and Gene Therapies and Division of Human TissuesFDABethesdaUSA
  7. 7.Whittemore Peterson InstituteRenoUSA
  8. 8.University of NevadaRenoUSA
  9. 9.Laboratory Branch, Division of HIV/AIDS PreventionCDCAtlantaUSA
  10. 10.Gen-Probe IncorporatedSan DiegoUSA
  11. 11.Laboratory of Experimental ImmunologyNational Cancer Institute- FrederickFrederickUSA
  12. 12.Transfusion Medicine and Cellular Therapeutics BranchNHLBIBethesdaUSA

Personalised recommendations