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


Ordering Guidance


For detection and quantification of hepatitis C RNA in serum for the diagnosis and monitoring progress of acute or chronic hepatitis C in women who are pregnant.



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 Aliquot Tube, 5 mL (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.


Useful For

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

 

Detection and confirmation of chronic HCV infection in women who are pregnant

 

Quantification of HCV RNA in serum of women who are pregnant for monitoring disease progression of chronic HCV infection (HCV antibody-positive)

Method Name

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

Reporting Name

HCV RNA Detect/Quant Prenatal, S

Specimen Type

Serum SST

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

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

Reference Values

Undetected

Interpretation

This assay has a result range of 15 to 100,000,000 IU/mL (1.18 log to 8.00 log IU/mL) for quantification of hepatitis C virus (HCV) RNA in serum.

 

An "Undetected" result indicates that the HCV is absent in the patient's serum specimen.

 

A result of "<15 IU/mL (<1.18 log IU/mL)" indicates that HCV RNA is detected, but the HCV RNA level present cannot be quantified accurately below this lower limit of quantification of this assay. When clinically indicated, follow-up testing with this assay is recommended in 1 to 2 months. To assess response-guided therapy eligibility, an "Undetected" result is required, and a result of "<15 IU/mL mL (<1.18 log IU/mL)" should not be considered equivalent to an "Undetected" result.

 

A quantitative result expressed in IU/mL and log IU/mL indicates the degree of active HCV viral replication in the patient. Monitoring HCV RNA levels over time is important to assess disease progression and/or monitoring a patient's response to anti-HCV therapy.

 

A result of ">100,000,000 IU/mL (>8.00 log IU/mL)" indicates the presence of active HCV viral replication, and the HCV RNA level present cannot be quantified accurately above this upper limit of quantification of this assay.

 

An "Inconclusive" result reported with a comment indicates that testing failed, likely due to presence of inhibitory substances in the submitted serum specimen. A new specimen should be collected for retesting.

Clinical Reference

1. Centers for Disease Control and Prevention (CDC). Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 2013;62(18):362-365

2. American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America (IDSA): HCV guidance: Recommendations for testing, managing, and treating hepatitis C. AASLD, IDSA; Accessed May 9, 2024. Available at www.hcvguidelines.org/contents

3. Society for Maternal-Fetal Medicine (SMFM), Hughes BL, Page CM, Kuller JA. Hepatitis C in pregnancy: screening, treatment, and management. Am J Obstet Gynecol. 2017;217(5):B2-B12

4. National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention: Pregnancy and HIV, viral hepatitis STD and TB prevention: HCV challenges. CDC; Reviewed October 31, 2023. Accessed May 9, 2024. Available at www.cdc.gov/nchhstp/pregnancy/challenges/hcv.html

5. Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC recommendations for hepatitis C screening among adults-United States, 2020. MMWR Recomm Rep. 2020;69(2):1-17

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
HCVRP HCV RNA Detect/Quant Prenatal, S 11011-4

 

Result ID Test Result Name Result LOINC Value
609749 HCV RNA Detect/Quant Prenatal, S 11011-4

Forms

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

-Microbiology Test Request (T244)

-Gastroenterology and Hepatology Test Request (T728)