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HelpTest ID: CRHEP Chronic Viral Hepatitis (Unknown Type), Serum
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 5 mL Aliquot Tube (T914)
Collection Container/Tube: Serum gel (red-top tubes are not acceptable)
Submission Container/Tube: Plastic vial
Specimen Volume: 2.5 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.
Useful For
Diagnosis and evaluation of patients with symptoms of hepatitis lasting more than 6 months
Distinguishing between chronic hepatitis B and C
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBC | HBc Total Ab, S | Yes | Yes |
| HBAB | HBs Antibody, S | Yes | Yes |
| HBAG | HBs Antigen, S | Yes | Yes |
| HCVDX | HCV Ab w/Reflex to HCV PCR, S | Yes | Yes |
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBGNT | HBs Antigen Confirmation, S | No | No |
| HCVQN | HCV RNA Detect/Quant, S | Yes | No |
Testing Algorithm
If hepatitis C virus (HCV) antibody is reactive, then HCV RNA detection and quantification by real-time reverse transcription polymerase chain reaction will be performed at an additional charge.
If hepatitis B virus surface antigen (HBsAg) is reactive, then confirmation will be performed at an additional charge.
The following algorithms are available:
-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Special Instructions
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
Reporting Name
Chronic Viral Hepatitis Profile, SSpecimen Type
Serum SSTSpecimen Minimum Volume
1.8 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | 84 days | |
| Refrigerated | 6 days |
Clinical Information
Hepatitis B:
Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. The infection is spread primarily through percutaneous contact with infected blood products (eg, blood transfusion, sharing of needles among injection drug users). The virus is found in virtually every type of human body fluid and is known to be spread through oral and genital contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions; it is not commonly transmitted transplacentally.
After a course of acute illness, HBV persists in approximately 10% of patients. Some of these carriers are asymptomatic while others develop chronic liver disease, including cirrhosis and hepatocellular carcinoma.
Individuals who have recovered from acute hepatitis B (defined as being negative for hepatitis B virus surface [HBs] antigen positive for hepatitis B virus core [HBc] total antibodies, negative or positive for HBs antibody) are lower risk (up to 20%) of HBV reactivation than those with inactive chronic hepatitis B during immunosuppressive therapy or organ transplantation.
For individuals born in regions of the world where HBV prevalence is moderate to high, universal HBV serologic screening before initiation of immunosuppressive therapy is recommended. In the absence of systematic, risk-based testing, universal HBV serologic screening is an option to reduce the risk of missing persons with HBV infection prior to initiation of immunosuppressive treatment.
Hepatitis C:
Hepatitis C virus (HCV) is an RNA virus recognized as the cause of most cases of posttransfusion hepatitis and is a significant cause of morbidity and mortality worldwide. HCV is transmitted through contaminated blood or blood products or close, personal contact. HCV shows a high rate of progression (~75%) to chronic disease. In the United States, HCV infection is quite common, with an estimated 3.5 to 4 million chronic HCV carriers. Cirrhosis and hepatocellular carcinoma are sequelae of chronic HCV.
Laboratory testing for HCV infection usually begins by screening for the presence of HCV-specific antibodies in serum, using an US Food and Drug Administration-approved screening test. Specimens that are repeatedly reactive by screening tests should be confirmed with HCV tests with higher specificity, such as direct detection of HCV RNA by reverse transcription polymerase chain reaction or HCV-specific antibody confirmatory tests.
HCV antibodies are usually not detectable during the first 2 months following infection, but they are usually detectable by the late convalescent stage (>6 months after onset) of infection. These antibodies do not neutralize the virus and they do not provide immunity against this viral infection.
The following algorithms are available:
-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Reference Values
HEPATITIS B SURFACE ANTIGEN:
Negative
HEPATITIS B SURFACE ANTIBODY, QUALITATIVE/QUANTITATIVE
Hepatitis B Surface Antibody
Unvaccinated: Negative
Vaccinated: Positive
HEPATITIS B SURFACE ANTIBODY, QUANTITATIVE
Unvaccinated: <8.5 mIU/mL
Vaccinated: ≥11.5 mIU/mL
HEPATITIS B CORE TOTAL ANTIBODIES:
Negative
HEPATITIS C ANTIBODY:
Negative
Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles.
Interpretation
Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles
Chronic hepatitis B:
Hepatitis B surface antigen (HBsAg is the first serologic marker appearing in the serum 6 to 8 weeks following hepatitis B viral (HBV) infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms. Persistence of HBsAg for more than 6 months indicates development of either a chronic carrier state or chronic HBV infection.
Hepatitis B virus core IgM and total antibodies (anti-HBc IgM and total) appear shortly after the onset of symptoms of HBV infection and soon after the appearance of HBsAg. The anti-HBc IgM usually falls to undetectable levels within 6 months and anti-HBc total remains detectable for many years.
Anti-HBs usually appears with the resolution of hepatitis B after the disappearance of HBsAg.
If HBsAg and anti-HBc total antibody are positive, testing for HBeAg, anti-HBe, HBV-DNA, and anti-HDV total is recommended.
Chronic hepatitis C:
HCV antibodies (anti-HCV) are almost always detectable by the late convalescent and chronic stage of infection.
Reactive anti-HCV 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.
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.
Clinical Reference
1. LeFevre MLL. Screening for hepatitis B virus infection in nonpregnant adolescents and adults: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161(1):58-66. doi:10.7326/M14-1018
2. Jackson K, Locarnini S, Gish R. Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis. 2018;12(1):5-11. doi:10.1002/cld.729
3. Coffin CS, Zhou K, Terrault NA. New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019;156(2):355-368.e3. doi:10.1053/j.gastro.2018.11.037
4. WHO guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed September 9, 2023. Available at www.who.int/publications/i/item/9789241549981
5 Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and Testing for Hepatitis B Virus Infection: CDC Recommendations - United States, 2023. MMWR Recomm Rep. 2023;72(1):1-25. Published 2023 Mar 10. doi:10.15585/mmwr.rr7201a1
6. American Association for the Study of Liver Diseases and Infectious Diseases Society of America: HCV guidance: Recommendations for testing, managing, and treating hepatitis C. Updated August 27, 2020. Accessed October 19, 2022. Available at www.hcvguidelines.org
Day(s) Performed
Monday through Saturday
Report Available
Same day/1 to 2 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
86704
86706
86803
87340
87341 (if appropriate)
87522 (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CRHEP | Chronic Viral Hepatitis Profile, S | 92889-5 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| HCVA4 | HCV Ab, S | 40726-2 |
| H_BAG | HBs Antigen, S | 5196-1 |
| HBC | HBc Total Ab, S | 13952-7 |
| HB_AB | HBs Antibody, S | 10900-9 |
| HBSQN | HBs Antibody, Quantitative, S | 5193-8 |
Forms
If not ordering electronically, complete, print, and send 1 of the following:
mml-hepatitis