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ColoVantage®; (Methylated Septin 9)

Test Summary

Methylated Septin 9 is a DNA marker associated with colorectal cancer.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

10 mL frozen plasma collected in an EDTA (lavender-top) tube

Minimum Volume

5 mL

Instructions

This test requires 10 mL of plasma (minimum volume 5 mL). Specimens with less than 5 mL of plasma will be rejected. To obtain this volume of plasma, collect blood in two (2) 10 mL EDTA (lavender-top) tubes or five (5) standard EDTA (lavender-top) tubes. Centrifuge the blood samples, separate plasma and combine them. Send plasma in a single 10 mL pour-off tube. If a 10 mL pour-off tube is not available, two (2) 5 mL pour-off tubes can be used.

Patient Preparation

N/A

Storage

Plastic screw-cap vial

Transport Temperature

Frozen

Specimen Stability

  • Room temperature: Unacceptable
  • Refrigerated: Unacceptable
  • Frozen: 28 days

Limitations

N/A

Other Acceptable Specimens

N/A

Unacceptable Specimens

N/A

Order Code

COLVNT

EPIC (Premier) Code

LAB5316

Includes

N/A

CPT Code

  • 81327 - This test code is for non-New York patient testing. For New York patient testing
  • use test code 16984.

Billing Code

  • 671055
  • 671056
  • 671057
  • 671058
  • 671059

CPT Statement

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)

FDA Status

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153

Department

Reference Testing

Reference Range

Not detected

Setup Schedule / Expected Turnaround Time

Daily morning; Report available: 3 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

10 mL frozen plasma collected in an EDTA (lavender-top) tube

Minimum Volume

5 mL

Instructions

This test requires 10 mL of plasma (minimum volume 5 mL). Specimens with less than 5 mL of plasma will be rejected. To obtain this volume of plasma, collect blood in two (2) 10 mL EDTA (lavender-top) tubes or five (5) standard EDTA (lavender-top) tubes. Centrifuge the blood samples, separate plasma and combine them. Send plasma in a single 10 mL pour-off tube. If a 10 mL pour-off tube is not available, two (2) 5 mL pour-off tubes can be used.

Patient Preparation

N/A

Storage

Plastic screw-cap vial

Transport Temperature

Frozen

Specimen Stability

  • Room temperature: Unacceptable
  • Refrigerated: Unacceptable
  • Frozen: 28 days

Limitations

N/A

Other Acceptable Specimens

N/A

Unacceptable Specimens

N/A

Billing

CPT Code

  • 81327 - This test code is for non-New York patient testing. For New York patient testing
  • use test code 16984.

Billing Code

  • 671055
  • 671056
  • 671057
  • 671058
  • 671059

CPT Statement

Result Information

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)

Testing Laboratory

N/A

Reference Range

Not detected

Setup Schedule / Expected Turnaround Time

Daily morning; Report available: 3 days