JC Virus by PCR Quantitative

The detection and quantitation of JC Virus (JCV) by real-time PCR amplification. The primers used in this PCR reaction amplify the Large T antigen gene. The JC Virus probes are labeled with reporter dye FAM and quencher TAMRA. Quantitation of JC Virus DNA (IU/mL) is achieved by amplifying standard curves consisting of serial dilutions of a known number of DNA containing the JC Virus amplicons. The limit of detection (LoD), defined as the minimum viral level detectable in 95% of replicates, and the lower limit of quantification (LLoQ) are both 3000 IU/mL (3.48 log IU/mL).

This test was developed and its performance characteristics determined by the University of Washington Department of Laboratory Medicine and Pathology. It has not been cleared or approved by the US Food and Drug Administration.

For tissue biopsy, bone marrow, or cellular/viscous fluids (e.g., BAL or washings), refer to JC Virus Qualitative PCR, Tissue [JCVQLT].

Urine, refer to JC Virus by PCR Quantitative, Urine [UJCVQN].

Blood: 3 mL blood in EDTA (LAVENDER TOP) tube.

CSF: 1 mL in sterile container.

Clear non-cellular fluid (e.g. BAL or Washing): 1 mL in sterile container.

Also Acceptable: 3 mL blood in GOLD SST, RED, or PPT (PEARL TOP) tube.

Unacceptable samples: Plasma collected in sodium or lithium heparin.

Note: Separate specimens MUST be submitted when both Viral Culture/Serology and PCR testing are ordered.

Minimum sample requirement: 0.5 mL

Blood: Separate plasma/serum from whole blood within 24 hours of collection. Freeze at -10°C or colder and ship on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.

CSF: If CSF has cellular material, centrifuge & aliquot clear CSF. Freeze at -10°C or colder and ship on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw..

Clear non-cellular fluid: Freeze at -10°C or colder and ship on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.

Outside Laboratory: Ship samples on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Shipment time must not exceed 48 hours from collection. Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.