CMV Quantitative by PCR

Cytomegalovirus by PCR, PCR-CMV, Viral load-CMV, Viral load-Cytomegalovirus, UOW264

Blood

The Abbott RealTime FDA approved CMV assay uses real-time PCR fluorescent detection for the quantitation of CMV DNA in plasma. The PCR assay amplifies two select targets of conserved regions of the CMV genome, UL34 and UL80.5 genes. The limit of quantitation (the minimum virus level that gives a positive result in 95% of replicates) is 50 IU/mL (1.70 log IU/mL). The assay is standardized against the 1st World Health Organization (WHO) International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162). Results are reported in International Units per milliliter (IU/mL).

CSF or Clear non-cellular fluid (e.g. Swab, BAL, or Washing)

The detection and quantification of CMV by real-time PCR amplification. PCR detects amplicons of the immediate-early (IE) viral protein 1 (IE1, UL123) and Glycoprotein B (gB, UL55) coding regions. Quantitation of CMV DNA (IU/mL) is achieved by amplifying a standard curve at the same efficiency, consisting of serial dilutions of a known amount of DNA containing the CMV amplicons. Results are reported in International Units per milliliter (IU/mL). The minimum virus level that gives a positive result in 95% of replicates is 300 IU/mL (2.48 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.

Blood: 5 mL blood in EDTA (LAVENDER TOP) tube.

CSF: 1 mL in sterile container.

Swab: In sterile tube/universal transport media (UTM).

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.

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

Serum/Plasma, CSF, or Clear non-cellular fluid (e.g. Swab, BAL, or Washing)

2 mL serum/plasma. 1 mL for CSF or Clear non-cellular fluid (e.g. Swab, BAL, or Washing)

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.

Swabs: 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: 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. Shipment time must not exceed 48 hours from collection if stored at 2-8°C. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.

1 mL serum/plasma. 0.5 mL for CSF or Clear non-cellular fluid (e.g. Swab, BAL, or Washing)

Unacceptable samples: Plasma collected in sodium or lithium heparin. No urine samples.

Virology

Real-time Polymerase Chain Reaction.

Serum/Plasma: Monday-Saturday. CSF or Clear non-cellular fluid (e.g. Swab, BAL, or Washing): Tuesday and Friday.

CMVQNS          CMV Quant Specimen Description
CMQNR            CMV Quant Result
CMLOG             CMV DNA IU/mL (Log10)
CMVQNI          CMV Quant Interpretation

87497

No

UW

24041-6