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Test Code JCVCSF JC Virus (JCV) Quantitative Real-time PCR, CSF

Performing Laboratory

Viracor Eurofins Clinical Diagnostics

Methodology

Real-Time Polymerase Chain Reaction (PCR)

Reference Values

None detected

 

Assay Range: 72 copies/mL to 1.00E+08 copies/mL

The limit of quantitation (LOQ) is 72 copies/mL. JC virus DNA

detected below the LOQ will be reported as Detected:<72 copies/mL.

This test was developed and its performance characteristics

determined by Viracor Eurofins. It has not been cleared or approved

by the U.S. Food and Drug Administration. Results should be used in

conjunction with clinical findings, and should not form the sole

basis for a diagnosis or treatment decision.

Test Classification and CPT Coding

87799

Day(s) and Time(s) Performed

Monday through Saturday

 

TAT 1 - 3 Days

Specimen Required

Container/Tube: Sterile screw cap vial
Specimen Volume: 2 mL CSF ( 0.5 mL min)

Transport Temperature:  Frozen

 

Used For

JCV is the etiologic agent of progressive multifocal leukoencephalopathy (PML) which is mainly seen in HIV patients, organ transplant patients, and other immunodeficient syndromes. In addition to PML, JCV also causes nephropathy in the renal transplant setting, although with considerably less frequency than BKV. JCV should always be considered in an immunocompromised patient with progressively deteriorating CNS function. Quantitative JCV DNA PCR can be used to detect JCV in CSF in the setting of CNS disease, and blood and urine in the setting of renal dysfunction. Quantitative DNA PCR can be used to track the course of infection as well as monitor response to treatment.

 

Specificity

The primers and probes used in this assay are specific for all known JCV strains based on similarity search algorithms. Additionally, no cross reactivity was detected when tested against adenoviruses, BKV, CMV, EBV, HSV-1, HSV-2, HHV-6 variant A, HHV-6 variant B, HHV-7, HHV-8, parvo B19, SV-40, and VZV.

Computer Interface Code

PDM #  5905860