Test Catalog

Test Id : FSJCV

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STRATIFY JCV Antibody (with Index) with Reflex to Inhibition Assay

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Overview

Test Catalog

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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
A short description of the method used to perform the test

ELISA

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

STRATIFY JCV DxSelect RFL

Aliases
Lists additional common names for a test, as an aid in searching

JC Virus

JC Polyoma Virus

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Specimen Type
Describes the specimen type validated for testing

Serum

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
Z6367 Natalizumab Therapy? PT CONSIDERING
NOT APPLICABLE
YES PRESCRIBED

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Index interpretive criteria:

<0.20 Negative

0.20-0.40 Indeterminate

>0.40 Positive

Interpretation
Provides information to assist in interpretation of the test results

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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. TYSABRI(natalizumab) US Prescribing Information

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

4 to 8 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Quest Diagnostics

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86711

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
FSJCV STRATIFY JCV DxSelect RFL Not Provided
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
Z6367 Natalizumab Therapy? Not Provided
Z6368 Index Value 100977-8
Z6369 JCV Antibody 70173-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2024-12-16