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Test Code FSJCV STRATIFY JCV Antibody (with Index) with Reflex to Inhibition Assay


Specimen Required


Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel, lavender top (EDTA)

Submission Container/tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Draw blood in a plain, red-top tube; serum gel tube is acceptable.

2. Centrifuge and aliquot 1 mL of serum into a plastic vial.

3. Send refrigerate.


Secondary ID

75918

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
FSJIN STRATIFY JCV Ab INH No No

Testing Algorithm

If the Index Value is between 0.20-0.40 (Inconclusive), STRATIFY JCV DxSelect Antibody Inhibition Assay will be performed at an additional charge.

Method Name

ELISA

Reporting Name

STRATIFY JCV DxSelect RFL

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  90 days
  Ambient  7 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Clinical Information

The STRATIFY JCV(R) DxSelect(TM) Antibody Test is an enzyme-linked immunosorbent assay (ELISA) designed to detect JCV antibodies to help identify individuals who have been exposed to the virus. Samples with low level reactivity in the detection assay are retested in a confirmation (inhibition) assay to confirm presence or absence of JCV-specific antibodies.

 

Retrospective analyses of post marketing data from various sources, including observational studies and spontaneous reports obtained worldwide, suggest that the risk of developing PML may be associated with relative levels of serum anti-JCV antibody as measured by anti-JCV antibody index.(1)

Reference Values

Index interpretive criteria:

<0.20 Negative

0.20-0.40 Indeterminate

>0.40 Positive

Interpretation

Negative: Antibodies to JCV not detected.

 

Indeterminate: Low level reactivity detected, see Inhibition Assay result for the final antibody result.

 

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

CPT Code Information

86711

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FSJCV STRATIFY JCV DxSelect RFL Not Provided

 

Result ID Test Result Name Result LOINC Value
Z6367 Natalizumab Therapy? Not Provided
Z6368 Index Value 100977-8
Z6369 JCV Antibody 70173-0