JC Virus Antibody with Reflex to Inhibition Assay (Sendout)

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General Information

Lab Name
JCV Stratify Antibody w/Reflex (Sendout)
Lab Code
RJCVST
Epic Name
JCV Stratify Antibody w/Reflex (Sendout)
External Test Id
91665
Description

Clinical Significance: 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. [1]

The PML risk-estimate algorithm for TYSABRI was developed based on data collected from patients taking TYSABRI. [2]

PML is a severe demyelinating disease of the central nervous system. It is an opportunistic infection caused by reactivation of JCV. Asymptomatic primary infection with JCV typically occurs prior to adolescence. In most individuals, JCV remains latent and causes no symptoms. In rare instances, however, it can reactivate and progress to PML. Individuals with immunosuppression are most at risk, and use of immunosuppressive therapies increases the risk. To date, the known risk factors for natalizumab-associated PML are: 1) presence of anti-JCV antibodies; 2) prior use of immunosuppressants; 3) duration of natalizumab use. [2]

Test Algorithm: If the Index Value is between 0.20-0.40 (inclusive), then STRATIFY JCV® DxSelect™ Antibody Inhibition Assay will be performed.

References
  1. Lee P, Plavina T, Castro A, Berman M, Jaiswal D, Rivas S, Schlain B, Subramanyam M. 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. J Clin Virol. 2013 Jun;57(2):141-6. doi: 10.1016/j.jcv.2013.02.002. Epub 2013 Mar 5. PMID: 23465394.
  2. Us package insert, STRATIFY JCV® DxSelect™ EL1950-5 Rev. 03 dated 16 Dec 2022
Synonyms
91665, JCV, John Cunningham virus, PML, Progressive Multifocal Leukoencephalopathy virus, rituximab
Components
Code Name
RJCVAR JCV Stratify Antibody
RJCVIV JCV Index Value
RJCVSI JCV Stratify Ab Interp.

Interpretation

Method

Immunoassay (IA)

Reference Range
See individual components
Ref. Range Notes
Reference Range: Negative
Interferences and Limitations

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.

References
  1. Lee P, Plavina T, Castro A, Berman M, Jaiswal D, Rivas S, Schlain B, Subramanyam M. 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. J Clin Virol. 2013 Jun;57(2):141-6. doi: 10.1016/j.jcv.2013.02.002. Epub 2013 Mar 5. PMID: 23465394.
  2. Us package insert, STRATIFY JCV® DxSelect™ EL1950-5 Rev. 03 dated 16 Dec 2022

Ordering & Collection

Specimen Type
Peripheral Blood
Collection

2 mL blood in a RED TOP tube or GOLD SST

  • Alternative Specimen: LAVENDER TOP (EDTA) tube
Handling Instructions

Outside Laboratories: Centrifuge sample and transfer serum or plasma to a separate plastic vial. Refrigerate sample while awaiting shipment. Transport with a cold pack.

Stability: Refrigerated (preferred): 14 days; Frozen: 90 days; Ambient: 7 days.

Reject Criteria: Gross hemolysis, grossly lipemic, or grossly icteric.

Quantity
Requested: 1 mL serum or plasma
Minimum: 0.5 mL serum or plasma

Processing

Receiving Instructions

Centrifuge sample and transfer serum or plasma to a separate plastic vial. Refrigerate sample.

Sendouts:

  • Order Quest SJC Test: 91665
  • QuestQuanum Ask at Order Entry Question: Natalizumab Therapy?
    • Select "Not Applicable" from the drop-down menu.

Stability: Refrigerated (preferred): 14 days; Frozen: 90 days; Ambient: 7 days.

Reject Criteria: Gross hemolysis, grossly lipemic, or grossly icteric.

Misc Sendout

Performance

Lab Department
Sendouts(SO)
Frequency
Test set up Mon-Sat. Results available in 1-4 days.
Available STAT?
No
Performing Location(s)
Sendout Quest Diagnostics Nichols Institute
800-642-4657

33608 Ortega Highway
San Juan Capistrano, CA 92675

Billing & Coding

LOINC
70173-0
Interfaced Order Code
UOW5407