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Test Code LAB1834 Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR, Serum


Ordering Guidance


For detection and quantification of hepatitis C viral RNA in serum before, during, and after antiviral therapy for chronic hepatitis C.



Shipping Instructions


1. Freeze serum immediately, and ship specimen frozen on dry ice only.

2. If shipment will be delayed for more than 24 hours, freeze serum at -20 to -80° C (up to 84 days) until shipment on dry ice.



Specimen Required


Supplies: Sarstedt 5 mL Aliquot Tube (T914)

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial within 2 hours of collection.


Secondary ID

97291

Useful For

Detection of acute hepatitis C virus (HCV) infection before the appearance of HCV antibodies in serum (ie, <2 months from exposure)

 

Detection and confirmation of chronic HCV infection

 

Quantification of HCV RNA in serum of patients with chronic HCV infection (HCV antibody-positive)

 

Monitoring disease progression in chronic HCV infection and response to antiviral therapy

 

Determining cure and detection of relapse after completion of antiviral therapy

Method Name

Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)

Reporting Name

HCV RNA Detect/Quant, S

Specimen Type

Serum SST

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum SST Frozen (preferred) 84 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Reference Values

Undetected

Cautions

Except for immunocompromised patients or patients with suspected acute hepatitis, laboratory evaluation of hepatitis C virus (HCV) infection status should begin with HCV serologic testing, including testing for the presence of HCV antibodies (see Hepatitis C: Testing Algorithm for Screening and Diagnosis). A diagnosis of chronic HCV infection should not be based solely on the presence of detectable or quantifiable HCV RNA in a single serum specimen.

 

An "Undetected" HCV RNA test result with a "Reactive" HCV antibody screen result may be due to:

1. A false-reactive HCV antibody screen result

2. Resolved or past HCV infection

3. Transient low viremia (ie, episodic viral replication) of active HCV infection

To distinguish between the first 2 conditions, another HCV antibody test (eg, HCCAD / Hepatitis C Virus Antibody Screen for Cadaveric or Hemolyzed Specimens, Serum) can be requested. To distinguish between the latter 2 conditions, patients should be retested for HCV RNA in 1 to 2 months, as clinically indicated.

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87522

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HCVQN HCV RNA Detect/Quant, S 11011-4

 

Result ID Test Result Name Result LOINC Value
97291 HCV RNA Detect/Quant, S 11011-4

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Gastroenterology and Hepatology Test Request (T728)

-Microbiology Test Request (T244)

-General Test Request (T239)