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Test 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 Aliquot Tube 5 mL (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

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Reporting Name

Chronic Viral Hepatitis Profile, S

Specimen Type

Serum SST

Specimen 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

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

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. World Health Organization. Guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed October 8, 2024. 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 (AASLD) and Infectious Diseases Society of America (IDSA): HCV guidance: Recommendations for testing, managing, and treating hepatitis C. AASLD, IDSA; Updated December 19, 2023. Accessed October 8, 2024. Available at www.hcvguidelines.org/contents

Day(s) Performed

Monday through Saturday

Report Available

Same day/1 to 2 days

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

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:

-Gastroenterology and Hepatology Test Request (T728)

-Infectious Disease Serology Test Request (T916)

Mayo Clinic Laboratories | Microbiology and Infectious Disease Catalog Additional Information:

mml-hepatitis