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Test Code LAB1232034 JC Virus, Molecular Detection, PCR, Spinal Fluid

Important Note

Mayo code is JCPCR


Specimen Required


Collection Container/Tube:

Preferred: Vial number 2

Acceptable: Any vial number

Submission Container/Tube: Sterile screw cap vial

Specimen Volume: 0.5 mL

Collection Instructions: Do not centrifuge.


Useful For

Aiding in diagnosing progressive multifocal leukoencephalopathy due to JC virus

 

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

 

This test is not recommended for screening asymptomatic patients

Testing Algorithm

For more information see Meningitis/Encephalitis Panel Algorithm.

Reporting Name

JC Virus, PCR, CSF

Specimen Type

CSF

Specimen Minimum Volume

0.3 mL

Specimen Stability Information

Specimen Type Temperature Time
CSF Refrigerated (preferred) 7 days
  Frozen  7 days

Reject Due To

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

Reference Values

Negative

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 (non-spiked) specimens. One hundred percent of the spiked specimens were positive, and 100% of the non-spiked specimens were negative.

 

Analytical Sensitivity/Limit of Detection:

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

 

Analytical Specificity:

No polymerase chain reaction signal was obtained from the extracts of 15 viral isolates that may cause similar symptoms or be found in the CSF, including herpes simplex virus types 1 and 2, Epstein-Barr virus, cytomegalovirus, 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.

Method Description

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 polymerase chain reaction (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)

Day(s) Performed

Monday through Sunday

Report Available

Same day/ 1 to 4 days

Specimen Retention Time

7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87798

LOINC Code Information

Test ID Test Order Name Order LOINC Value
JCPCR JC Virus, PCR, CSF 33295-7

 

Result ID Test Result Name Result LOINC Value
618305 JC Virus, PCR, CSF 33295-7

Forms

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