Hepatitis C Virus (HCV) by Quantitative NAAT

3000572
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Example Reports
Detected
Not Detected

Ordering Recommendation

Preferred single test to confirm hepatitis C virus (HCV) infection following a positive HCV antibody screen. May also be useful to diagnose suspected acute HCV infection or infection in seronegative immunocompromised individuals.

Mnemonic

HEPC QNT

Methodology

Quantitative Transcription-Mediated Amplification (TMA)

Performed

Sun-Sat

Reported

1-3 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation
Collect

Lavender (EDTA), pink (K2EDTA), yellow (ACD), plasma preparation tube (PPT), or serum separator tube (SST).

Specimen Preparation

Separate from cells within 6 hours of collection. Transfer 2 mL serum or plasma to an ARUP standard transport tube. (Min: 1.2 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Heparinized specimens.

Remarks
Stability

After separation from cells: Ambient: 24 hours (Critical: Ship FROZEN); Refrigerated: 5 days; Frozen: 2 months

Reference Interval

Not Detected

Interpretive Data

Normal range for this assay is "Not Detected."
The quantitative range of this assay is 10 -100,000,000 IU/mL (1.0 -8.0 log IU/mL).
Lower limit of quantitation (LLoQ):
10 IU/mL (1.0 log IU/mL)
LLoQ values do not apply to diluted specimens.
A result of "Not Detected" does not rule out the presence of inhibitors in the patient specimen or hepatitis C virus RNA concentrations below the level of detection of the test. Care should be taken when interpreting any single viral load determination.

This test should not be used for blood donor screening, associated reentry protocols, or for screening human cell, tissues and cellular tissue-based products (HCT/P). 

Compliance Category

FDA

Note

The limit of quantification for this RNA assay is 10 IU/mL (1.0 log IU/mL). If the assay DID NOT DETECT the virus, the test result will be reported as "Not Detected." If the assay DETECTED the presence of the virus but was not able to accurately quantify the number of copies, the test result will be reported as "< ;10 Detected."

Specimens received with less than minimum volume for testing will automatically be run with a dilution according to the guidelines below:
Specimens with 240-700 uL will be diluted 1:3 resulting in a quantitative range of 30 -300,000,000 IU/mL (1.48-8.48 log IU/mL).

This test is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy in conjunction with clinical and laboratory markers of infection. This test is also used in assessing HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow-up of treatment to determine sustained or nonsustained viral response.

Hotline History

N/A

CPT Codes

87522

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Components

Component Test Code* Component Chart Name LOINC
3000573 HCV Qnt by NAAT (IU/mL) 11011-4
3000574 HCV Qnt by NAAT (log IU/mL) 38180-6
3000966 HCV Qnt by NAAT Interp 11259-9
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • HCV monitoring
  • HCV quantitative
  • HCV Quantitative PCR
  • HCV Quantitative TMA
  • HCV Screen confirmation
  • HCV Viral Load
  • Nucleic Acid Amplification Test (NAAT)
  • Viral load monitoring
Hepatitis C Virus (HCV) by Quantitative NAAT