3000572
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Hepatitis C Virus (HCV) by Quantitative NAAT

HEPC QNT
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.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

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

Specimen Preparation

Separate from cells within 24 hours of collection.
Transfer 2 mL serum or plasma to an ARUP standard transport tube (ARUP supply #15824). Available online through eSupply using ARUP Connect™ or contact ARUP Client Services at 800-522-2787.
(Minimum volume: 1.3 mL)

Storage/Transport Temperature

Frozen

Unacceptable Conditions

Heparinized specimens

Remarks
Stability

After separation from cells:
Room temperature: 24 hours (Critical: ship FROZEN); Refrigerated: 6 days; Frozen: 3 months

Methodology

Quantitative Polymerase Chain Reaction (PCR)

Performed

Sun-Sat

Reported

1-3 days

Reference Interval

Not Detected

Interpretive Data

The quantitative range of this test is 15-100,000,000 IU/mL (1.18-8.0 log IU/mL).

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 is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.

This test is also intended for use as an aid in the management of patients with an HCV infection undergoing antiviral therapy. The assay can be used to measure 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. The results must be interpreted within the context of all relevant clinical and laboratory findings.

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

Compliance Category

FDA

Note

The limit of quantification for this RNA assay is 15 IU/mL (1.18 log IU/mL). If the assay DETECTED the presence of the virus but was not able to accurately quantify, the test will be reported as "Not Quantified, Detected."

Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
08/19/2024
X
X
X
X
X
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 Screen confirmation
  • HCV Viral Load
  • Nucleic Acid Amplification Test (NAAT)
  • Viral load monitoring
Hepatitis C Virus (HCV) by Quantitative NAAT