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HelpTest Code HCSRN Hepatitis C Virus (HCV) Antibody Screen with Reflex to HCV RNA, PCR, Asymptomatic, Serum
Reporting Name
HCV Ab Scrn w/Reflex to HCV PCR, SPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Useful For
Screening for hepatitis C virus (HCV) infection in primary care settings in high-risk persons with a current or previous history of illicit injection drug use or a history of receiving a blood transfusion prior to 1992
Screening for hepatitis C in primary care settings in non-high-risk persons born from 1945 through 1965
Screening at least once in a lifetime for all adults greater or equal to 18 years, except in settings where the prevalence of HCV infection is less than 0.1%
This test is not offered as a screening or confirmatory test for hepatitis C in blood or human cells/tissue donors.
This test profile is not useful for detection or diagnosis of acute hepatitis C, since HCV antibodies may not be detectable until after 2 months following exposure and HCV RNA testing is not performed on specimens with negative HCV antibody screening test results.
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
Ordering Guidance
This test is not intended for testing symptomatic individuals (ie, diagnostic purposes). For testing such patients with or without risk factors for hepatitis C virus (HCV) infection, order HCVDX / Hepatitis C Virus (HCV) Antibody with Reflex to HCV RNA, PCR, Symptomatic, Serum.
For testing autopsy/cadaver or hemolyzed specimens, order HCCAD / Hepatitis C Virus Antibody Screen for Cadaveric or Hemolyzed Specimens, Asymptomatic, Serum for asymptomatic individuals or HCCDD / Hepatitis C Virus Antibody in Cadaveric or Hemolyzed Specimens, Symptomatic, Serum for symptomatic individuals.
For patients with acute or recent HCV infections (<3 months from time of exposure) or are repeatedly reactive by screening tests and should be confirmed by a more HCV-specific test, order HCVQN / Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR, Serum.
If testing is desired to distinguish between true positivity and biologic false positivity for HCV antibody, then testing may be done with a second HCV antibody assay approved by the US Food and Drug Administration for diagnosis of HCV infection that is different from the assay used for initial antibody testing (HCCAD / Hepatitis C Virus Antibody Screen for Cadaveric or Hemolyzed Specimens, Asymptomatic, Serum).
Shipping Instructions
If shipment will be delayed for more than 24 hours, freeze serum at -70° C until shipment on and transport on dry ice.
Necessary Information
Date of collection is required.
Specimen Required
Patient Preparation: For 24 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Serum gel (red-top tubes are not acceptable)
Submission Container/Tube: Plastic vial
Specimen Volume: 1.3 mL
Collection Instructions:
1. Centrifuge blood collection tube per manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
Specimen Type
Serum SSTSpecimen Minimum Volume
0.9 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | 84 days | |
| Refrigerated | 6 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Interpretation
Reactive HCV antibody screening results with cutoff index (COI) values less than or equal to 20.0 with this assay are not predictive of the true HCV antibody status. Additional testing is available to confirm HCV antibody status.
Reactive results with COI values of greater than 20.0 with this assay are highly predictive (95% or greater probability) of the true HCV antibody status, but additional testing is needed to differentiate between past (resolved) and chronic hepatitis C. Based on CDC recommendations, reactive HCV antibody screen results should be followed by HCV RNA testing (HCVQN / Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR, Serum). Detection of HCV RNA indicates current HCV infection. If HCV RNA is not detected, that indicates either past, resolved HCV infection, or false HCV antibody positivity.
A negative screening test result does not exclude the possibility of exposure to or infection with HCV. Negative screening test results in individuals with prior exposure to HCV may be due to low antibody levels that are below the limit of detection of this assay or lack of reactivity to the HCV antigens used in this assay. Patients with acute or recent HCV infections (<2 months from time of exposure) may have false-negative HCV antibody results due to the time needed for seroconversion (average of 8 to 9 weeks). Testing for HCV RNA using HCVQN / Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR, Serum is necessary for detection of HCV infection in such patients.
Day(s) Performed
Monday through Saturday
Report Available
Same day/1 to 3 daysTest 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
86803
G0472 (if appropriate for government payers)
87522 Hepatitis C, quantification (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HCSRN | HCV Ab Scrn w/Reflex to HCV PCR, S | 40726-2 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| HCVA5 | HCV Ab Screen, S | 40726-2 |
Forms
If not ordering electronically, complete, print, and send 1 of the following:
Testing Algorithm
If the hepatitis C virus (HCV) antibody screen is reactive, then HCV RNA by reverse transcription polymerase chain reaction) will be performed at an additional charge.
For more information, see Hepatitis C: Testing Algorithm for Screening and Diagnosis
Special Instructions
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HCVQN | HCV RNA Detect/Quant, S | Yes | No |