Test Catalog

Test Id : LCJC

JC Virus, Molecular Detection, PCR, Spinal Fluid

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aids in diagnosing progressive multifocal leukoencephalopathy due to JC virus (JCV)

 

This test is not to be used as a diagnostic tool for Creutzfeldt-Jakob disease (CJD).

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

See Meningitis/Encephalitis Panel Algorithm in Special Instructions.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization

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

JC Virus PCR, CSF

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

JCV DNA

JCV Qualitative DNA

John Cunningham Virus (JCV)

Polyomavirus

Progressive Multifocal Leukoencephalopathy (PML)

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

See Meningitis/Encephalitis Panel Algorithm in Special Instructions.

Specimen Type
Describes the specimen type validated for testing

CSF

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

Supplies: Aliquot Tube, 5 mL (T465)

Preferred: 12 x 75-mm screw cap vial (T465)

Acceptable: Sterile screw cap vial

Container/Tube: Sterile vial

Specimen Volume: 0.5 mL

Collection Instructions: Do not centrifuge.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.3 mL

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

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

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
CSF Refrigerated (preferred) 7 days
Frozen 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aids in diagnosing progressive multifocal leukoencephalopathy due to JC virus (JCV)

 

This test is not to be used as a diagnostic tool for Creutzfeldt-Jakob disease (CJD).

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

See Meningitis/Encephalitis Panel Algorithm in Special Instructions.

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

JC virus (JCV), a member of the genus Polyomavirus, is a small nonenveloped DNA-containing virus. Primary infection occurs in early childhood, with a prevalence of greater than 80%.(1) The virus is latent but can reactivate in immunosuppressed patients, especially those with AIDS.

 

JCV is recognized as the etiologic agent of progressive multifocal leukoencephalopathy (PML), a fatal demyelinating disease of the central nervous system.(2,3) Histologic examination of brain biopsy tissue may reveal characteristic pathologic changes localized mainly in oligodendrocytes and astrocytes. Detection of JCV DNA by PCR (target gene, large T antigen) in the cerebrospinal fluid specimens of patients with suspected PML infection has replaced the need for biopsy tissue for laboratory diagnosis.(4) Importantly, the PCR test is specific with no cross-reaction with BK virus, a closely related polyomavirus.

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.

Negative

Interpretation
Provides information to assist in interpretation of the test results

Detection of JC virus (JCV) DNA supports the clinical diagnosis of progressive multifocal leukoencephalopathy due to JCV.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

A negative result does not rule out the possibility of JC virus (JCV) infection.

 

The reference range in cerebrospinal fluid is "negative" for this assay, although JCV DNA may be detectable in the absence of clinical symptoms in certain patient populations.(5,6) However, this assay is only to be used for patients with appropriate neurological and neuroradiological features of progressive multifocal leukoencephalopathy, and is not indicated for screening asymptomatic patients.

Supportive Data

The following data supports the use of this assay for clinical testing.

 

Accuracy:

Twenty-six negative cerebrospinal fluid (CSF) specimens were spiked with JC virus (JCV)-positive control plasmid at the limit of detection (approximately 10 targets/mcL). The 26 spiked specimens were run in a blinded manner with 14 negative (nonspiked) specimens. 100% of the spiked specimens were positive and 100% of the nonspiked specimens were negative.

 

Analytical Sensitivity/Limit of Detection (LoD:

The lower limit of detection (LoD) of this assay is 10 DNA target copies per mcL in CSF.

 

Analytical Specificity:

No PCR signal was obtained from the extracts of 15 viral isolates that may cause similar symptoms or be found in the CSF, including herpes simples virus (HSV) types 1 and 2, Epstein-Barr virus (EBV), cytomegalovirus (CMV), human herpesvirus (HHV)-6, HHV-7, HHV-8, enterovirus, mumps, adenovirus, BK virus, and Simian virus 40 (SV40).

 

Precision:

Interassay precision was 100% and intraassay precision was 100%.

 

Reference Range:

The reference range in CSF is "negative" for this assay.

 

Reportable Range:

This is a qualitative assay and the results are reported as either negative or positive for targeted JCV DNA.

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

1. Safak M, Khalili K: An overview: human polyomavirus JC virus and its associated disorders. J Neurovirol 2006;9 Suppl 1:3-9

2. Khalili K, White MK: Human demyelinating disease and the polyomavirus JCV. Mult Scler 2006 Apr;12(2):133-142

3. Ahsan N, Shah KV: Polyomaviruses and human diseases. Adv Exp Med Biol 2006;577:1-18

4. Romero JR, Kimberlin DW: Molecular diagnosis of viral infections of the central nervous system. Clin Lab Med 2003 Dec;23(4):843-865

5. Chen Y, Bord E, Tompkins T, et al: Asymptomatic reactivation of JC virus in patients treated with natalizumab. N Engl J Med 2009 Sep 10;361(11):1067-1074

6. Egli A, Infanti L, Dumoulin A, et al: Prevalence of polyomavirus BK and JC infection and replication in 400 healthy donors. J Infect Dis 2009 Mar 15;199(6):837-846

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

Viral nucleic acid is extracted from the specimen using the MagNA Pure automated instrument (Roche Applied Science). Primers are directed to the large T antigen gene, which is a conserved sequence specific for JC virus (JCV). This assay detects only JCV; it does not detect BK virus or Simian virus 40 (SV40) (other polyomaviruses). The LightCycler instrument (Roche Applied Science) amplifies and monitors the development of target nucleic acid sequences after the annealing step during PCR cycling. This automated PCR system can rapidly detect amplicon development through stringent air-controlled temperature cycling in capillary cuvettes. The detection of amplified products is based on the fluorescence resonance energy transfer (FRET) principle. For FRET product detection, a hybridization probe with a donor fluorophore, fluorescein, on the 3'-end is excited by an external light source and emits light that is absorbed by a second hybridization probe with an acceptor fluorophore, LC-Red 640, at the 5'-end. The acceptor fluorophore then emits a light of a different wavelength that can be measured with a signal that is proportional to the amount of specific PCR product.(Unpublished Mayo method)

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 Friday

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.

2 to 5 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

1 week

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

Rochester

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 Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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.

87798

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