Test Directory

This assay is a qualitative assay for the detection of antibodies to JC virus (JCV) in human serum or plasma. This assay was designed and evaluated for use, in conjunction with other clinical data, as an aid in the stratification of risk for the development of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients receiving or considering TYSABRI® (natalizumab) therapy

Specimen Type: Serum

Alternate Specimen Type: Plasma

Collection Container: Gold Top, Serum Separator or Red Top, Plain 

Alternate Collection Container: Lavender Top (EDTA)    

Desired Specimen Volume: 1 mL

1. Collect a gold top serum separator tube via venipuncture.

1. Separate serum from cells.
2. Transfer 1 mL of serum to a clear aliquot tube (screw cap).
3. Natalizumab Therapy Status is required for testing. Answer options are: PTCON, NAPP, YESPR

Transport to the laboratory refrigerated. 

• Gross hemolysis
• Grossly lipemic
• Grossly icteric

See patient report.

A positive result with this assay does not necessarily mean that the patient has or will develop PML.

This assay should not be used to diagnose PML and is not intended for donor screening. The performance of this assay has not been established for use in other immunocompromised patient populations or in neonates and pediatric patient populations.

The performance of this assay has not been established for use with patients with different disease conditions or undergoing other treatments, for example: Other MS treatments, non-Hodgkin lymphoma treatments, chronic lymphocytic leukemia treatments, Hodgkin lymphoma treatments, systemic anaplastic large cell lymphoma treatments, rheumatoid arthritis treatments, renal transplant treatments.

JC Polyoma Virus Ab