A second-generation ELISA (STRATIFY JCV™ DxSelect™) for detection of JC virus antibodies in human serum and plasma to support progressive multifocal leukoencephalopathy risk stratification

Journal of Clinical Virology

Volumn 57, Issue 2, 2013, Pages 141-146

  Lee, Peter ^a   Plavina, Tatiana ^b   Castro, Albert ^a   Berman, Melissa ^b   Jaiswal, Dipeshkumar ^a   Rivas, Suzanne ^a   Schlain, Brian ^b   Subramanyam, Meena ^b  

^a Focus Diagnostics   (United States)

^b BIOGEN   (United States)

Author keywords

JCV antibody assay; Multiple sclerosis; PML risk stratification

Indexed keywords

JC VIRUS ANTIBODY; NATALIZUMAB; UNCLASSIFIED DRUG; VIRUS ANTIBODY;

ANTIBODY BLOOD LEVEL; ARTICLE; CLINICAL TRIAL (TOPIC); CONTROLLED STUDY; ELISA KIT; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; JC VIRUS; MAJOR CLINICAL STUDY; MICROTITER PLATE ASSAY; MULTIPLE SCLEROSIS; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; SEROPREVALENCE; VIRUS LIKE AGENT;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIBODIES, VIRAL; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; JC VIRUS; LEUKOENCEPHALOPATHY, PROGRESSIVE MULTIFOCAL; MALE; MULTIPLE SCLEROSIS; REPRODUCIBILITY OF RESULTS; RISK FACTORS;

EID: 84877006912     PISSN: 13866532     EISSN: 18735967     Source Type: Journal    
DOI: 10.1016/j.jcv.2013.02.002     Document Type: Article

References (9)

1. Major E. Progressive multifocal leukoencephalopathy in patients on immunomodulatory therapies. Annu Rev Med 2010, 61:35-47.
2. Berger J.R. Progressive multifocal leukoencephalopathy and newer biological agents. Drug Saf 2010, 33:969-983.
3. Gorelik L., Lerner M., Bixler S., Crossman M., Schlain B., Simon K., et al. Anti-JC virus antibodies: implications for PML risk stratification. Ann Neurol 2010, 68:295-303.
4. Plavina T., Berman M., Njenga M., Crossman M., Lerner M., Gorelik L., et al. Multi-site analytical validation of an assay to detect anti-JCV antibodies in human serum and plasma. J Clin Virol 2012, 53:65-71.
5. Bloomgren G., Richman S., Hotermans C., Subramanyam M., Goelz S., Natarajan A., et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy. N Engl J Med 2012, 366:1870-1880.
6. Clinical Laboratory Standards Institute. Method comparison and bias estimation using patient samples: approved guideline-second edition. CLSI document EP9-A2-IR, Clinical and Laboratory Standards Institute, Wayne, PA; 2010.
7. Stolt A., Sasnauskas K., Koskela P., Lehtinen M., Dillner J. Seroepidemiology of the human polyomaviruses. J Gen Virol 2003, 84(Pt 6):1499-1504.
8. Knowles W.A., Pipkin P., Andrews N., Vyse A., Minor P., Brown D.W., et al. Population-based study of antibody to the human polyomaviruses BKV and JCV and the simian polyomavirus SV40. J Med Virol 2003, 71(1):115-123.
9. Kean J.M., Rao S., Wang M., Garcea R.L. Seroepidemiology of human polyomaviruses. PLoS Pathog 2009, 5(3):e1000363. Epub 2009 Mar 27.