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Test Code LABRFJCABS STRATIFY JCV® DxSelect™ Antibody (with Index) with Reflex to Inhibition

Important Note

Order LABRFJCABS in Epic

 

Specimen and Container/Tube

Preferred Specimen(s):   1 mL serum collected in Red Top Tube 

Alternative Specimen(s):  Plasma collected in: EDTA (lavender-top) tube

 

Collection Instructions

  1. Draw blood in a plain, red-top tube(s)
  2. Centrifuge between 1000-2000 x g for 10 minutes
  3. Aliquot 1.0 ml serum in plastic vial with screw cap


 

Specimen Handling and Transport Instructions

Transport Temperature:  Room temperature

Rejection Criteria

Gross hemolysis

Grossly lipemic

Grossly icteric

Reference Values

Index interpretive criteria:

<0.20 negative

0.20-0.40 indeterminate

Negative: Antibodies to JCV not detected.

Indeterminate: Low level reactivity detected 

Positive: Antibodies to JC virus (JCV) detected indicating the patient has been exposed to JCV at an undetermined time.

>0.40 positive

Clinical Indications

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. 

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.

LOINC Codes

70173-0

100977-8

Methodology

Immunoassay (IA)

Synonyms/Keyword Search

JC Virus

JCAB

Stratify JCV

CPT Code(s)

86711

Turnaround Time

Set up: Mon-Sat; Report available: 2-4 days

Specimen Stability

  • Room temperature: 7 days
  • Refrigerated: 14 days
  • Frozen: 90 days

Volume

Preferred Volume: 1.0 mL 

Minimum Volume: 0.5 mL 

Performing Laboratory

Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042