Test Id : AHEP

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 surface antigen is reactive, then confirmation will be performed at an additional charge.

The following algorithms are available:

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

-Viral Hepatitis Serologic Profiles

Date of collection is required.

Two aliquots of serum are required for testing: 0.5-mL of refrigerated serum and 2.5-mL of frozen serum

Patient Preparation: For 24 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 3 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot 0.5 mL serum into a plastic vial labeled as HAIGM, and ship refrigerate (required).

3. Aliquot remaining 2.5 mL serum into a second plastic vial labeled as SST Serum, and ship frozen (preferred).

• Viral Hepatitis Serologic Profiles
• Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
• Hepatitis C: Testing Algorithm for Screening and Diagnosis

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

-Gastroenterology and Hepatology Client Test Request (T728)

-Infectious Disease Serology Test Request (T916)

2 mL (send 0.5 mL refrigerate and the remaining 1.5 mL frozen)

Differential diagnosis of recent acute viral hepatitis

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 surface antigen is reactive, then confirmation will be performed at an additional charge.

The following algorithms are available:

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

-Viral Hepatitis Serologic Profiles

Hepatitis A:

Hepatitis A virus (HAV) is an RNA virus that accounts for 20% to 25% of viral hepatitis in adults in the United States. HAV infection is spread by the oral/fecal route and produces acute hepatitis, which follows a benign, self-limited course. Spread of the disease is usually associated with contaminated food or water caused by poor sanitary conditions. Outbreaks frequently occur in overcrowded situations and institutions or high-density centers such as prisons and healthcare centers. Epidemics may occur following floods or other disaster situations. Chronic carriers of HAV have never been observed.

Hepatitis B:

Hepatitis B virus (HBV) is an endemic DNA virus throughout the world. The infection is spread primarily through percutaneous contact with infected blood products (eg, blood transfusion, sharing of needles by drug addicts). The virus is also found in virtually every 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 chronic carriers are asymptomatic; others develop chronic liver disease, including cirrhosis and hepatocellular carcinoma.

Hepatitis C:

Hepatitis C virus (HCV) is an RNA virus that is a significant cause of morbidity and mortality worldwide. HCV is transmitted through contaminated blood or blood products or other close, personal contacts. It is recognized as the cause of most cases of posttransfusion hepatitis. HCV shows a high rate of progression (>50%) 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.

HEPATITIS B SURFACE ANTIGEN

Negative

HEPATITIS B SURFACE ANTIGEN CONFIRMATION

Negative

HEPATITIS B CORE IgM ANTIBODY

Negative

HEPATITIS A IgM ANTIBODY

Negative

HEPATITIS C ANTIBODY

Negative

HEPATITIS C VIRUS RNA DETECTION AND QUANTIFICATION BY REAL-TIME RT-PCR

Undetected

Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles

Hepatitis A:

Antibody against hepatitis A antigen is usually detectable by the onset of symptoms (usually 15-45 days after exposure). The initial antibody consists almost entirely of IgM subclass antibody. Antibody to hepatitis A virus (anti-HAV) IgM usually falls to undetectable levels 3 to 6 months after infection.

Hepatitis B:

Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum 6 to 16 weeks following hepatitis B virus (HBV) infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms. Anti-HBs appears with the resolution of HBV infection after the disappearance of HBsAg. Anti-HBs also appear as the immune response following a course of inoculation with the hepatitis B vaccine.

Initially, hepatitis B core antibody (anti-HBc) consists almost entirely of the IgM subclass. Anti-HBc, IgM can be detected shortly after the onset of symptoms and is usually present for 6 months. Anti-HBc may be the only marker of a recent HBV infection detectable following the disappearance of HBsAg and prior to the appearance of anti-HBs, ie, window period.

Hepatitis C:

Hepatitis C antibody is usually not detectable during the early months following infection and is almost always detectable by the late convalescent stage of infection. Hepatitis C antibody is not neutralizing and does not provide immunity.

If HBsAg, anti-HAV IgM, and anti-HCV are negative and patient's condition warrants, consider testing for Epstein-Barr virus or cytomegalovirus.

The following algorithms are available:

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

Consider administration of immune globulin to individuals exposed to patients with hepatitis A.

Consider administration of hepatitis B immune globulin and/or hepatitis B vaccine to individuals exposed to hepatitis B patient's blood or body fluids.

Positive hepatitis B surface antigen or positive antibody to hepatitis A virus IgM test results should be reported by the attending physician to the State Department of Health, as required by law in some states.

Performance characteristics have not been established for the following specimen characteristics:

-Grossly icteric (total bilirubin level of >20 mg/dL)

-Grossly lipemic (triolein level of >3000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >500 mg/dL)

-Containing particulate matter

-Cadaveric specimens

1. Roque-Afonso AM, Desbois D, Dussaix E: Hepatitis A virus: serology and molecular diagnostics. Future Virology. 2010 Mar;5(2):233-242

2. de Paula VS: Laboratory diagnosis of hepatitis A. Future Virology. 2012 May;7(5):461-472

3. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF Diagnostic markers of chronic hepatitis B infection and disease. Antivir Ther. 2010;15(Suppl 3):35-44

4. Wasley A, Fiore A, Bell BP: Hepatitis A in the era of vaccination. Epidemiol Rev. 2006;28:101-111

5. American Association for the Study of Liver Diseases and Infectious Diseases Society of America: HCV guidance: Recommendations for testing, managing, and treating hepatitis C. Accessed October 7, 2022. Available at www.hcvguidelines.org/contents

6. LeFebre ML, U.S. Preventive Services Task Force: Screening for hepatitis B virus infection in nonpregnant adolescents and adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Jul;161(1):58-66. doi:10.7326/M14-1018

7. Jackson K, Locarnini S, Gish R: Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis (Hoboken). 2018 Aug;12(1):5-11. doi: 10.1002/cld.729

8. Coffin CS, Zhou K, Terrault NA: New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019 Jan;156(2):355-368.e3. doi: 10.1053/j.gastro.2018.11.037

9. World Health Organization: WHO guidelines on hepatitis B and C testing. 2017. Accessed October 7, 2022. Available at www.who.int/hepatitis/publications/HEP17001_WEB11.pdf?ua=1

10. Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention: Testing and public health management of persons with chronic hepatitis B virus infection. Centers for Disease Control and Prevention. Updated March 28, 2022. Accessed October 7, 2022. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm

• Viral Hepatitis Serologic Profiles
• Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
• Hepatitis C: Testing Algorithm for Screening and Diagnosis

Hepatitis B Surface Antigen:

Specimens are first tested by the VITROS hepatitis B surface antigen (HBsAg) assay. With modification to the assay manufacturer's instructions for use, specimens yielding signal-to-cutoff ratio (S/Co) of 1.00 to 100.0 will be confirmed by the VITROS HBsAg Confirmatory assay. Specimens that are strongly positive (ie, S/Co >100.0) do not require this confirmation.

This immunometric technique involves the simultaneous reaction of HBsAg in the sample with mouse monoclonal hepatitis B surface antibody (anti-HBs) coated onto the wells and horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HBs antibody in the conjugate. Unbound conjugate is removed by washing. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent are added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample.(Package insert: VITROS HBsAg assay, no. GEM1201_US_EN. Ortho-Clinical Diagnostics, Inc; Version 13.1, 09/06/2019)

HBs Antigen Confirmation:

The VITROS HBsAg Confirmatory Kit uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The sample is tested twice: the first aliquot is incubated with a neutralizing reagent containing high titer anti-HBs (the confirmatory antibody); the second aliquot is incubated with a non-neutralizing control reagent (the sample diluent). The confirmatory antibody binds to HBsAg in the sample inhibiting its reaction in the VITROS HBsAg assay. This leads to a reduced result compared to that for the non-neutralized control sample.(Package insert: VITROS HBsAg Confirmation assay, no. GEM4201_US_EN. Ortho-Clinical Diagnostics, Inc; Version 13.1, 09/06/2019)

Hepatitis A IgM Antibody:

The ARCHITECT HAVAB-M assay is a 2-step automated immunoassay designed for the qualitative detection of hepatitis A virus (HAV)-specific IgM antibody in human serum and plasma using chemiluminescent microparticle immunoassay method. Prediluted patient sample, assay diluent, and HAV-coated paramagnetic microparticles are combined first in a reaction well. Anti-HAV IgM present in the patient sample binds to the HAV-coated microparticles. After washing, acridinium-labeled antihuman IgM conjugate is added to bind to anti-HAV IgM. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLU). A direct relationship exists between the amount of anti-HAV IgM present in the patient sample and the RLU detected by the ARCHITECT System optics. The presence or absence of anti-HAV IgM in the patient sample is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined from an active ARCHITECT HAVAB-M calibration. Specimens with S/Co values at or above 1.21 are considered positive for anti-HAV IgM. Specimens with S/Co values of 0.80 to below 1.21 are considered equivocal. Specimens with S/Co values below 0.80 are considered negative.(Package insert: Architect HAVAB-M. Abbott Laboratories; 05/2020)

Hepatitis B Core IgM Antibody:

An antibody class capture technique is used. This involves the dilution of the sample and the simultaneous reaction of IgM in the diluted sample with biotinylated mouse monoclonal antihuman-IgM antibody. The immune complex is captured by streptavidin on the wells. Unbound materials are removed by washing. HRP-labeled mouse monoclonal anti-hepatitis B core (anti-HBc) IgM antibody, which has been complexed with recombinant HBc antigen (conjugate), is then captured by anti-HBc specific IgM bound to the wells. Unbound material is removed by washing.

The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminal derivative and a peracid salt) and an electron transfer agent are added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminal derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The amount of HRP conjugate bound is indicative of the concentration of anti-HBc IgM present in the sample.(Package insert: VITROS Anti-HBc IgM assay, GEM0216_US_EN. Ortho-Clinical Diagnostics, Inc; Version 14.1, 09/06/2019)

Hepatitis C Virus Antibody:

The VITROS anti-hepatitis C virus (HCV) assay is an immunometric technique involving a 2-stage reaction. In the first stage, HCV antibody present in the sample binds to HCV recombinant antigens coated on the reaction wells, and unbound sample is removed by washing. In the second stage, HRP-labeled antibody conjugate (mouse monoclonal antihuman IgG) binds to human IgG captured on the well in the first stage. Unbound conjugate is removed by washing. A reagent containing luminogenic substrates (a luminal derivative and a peracid salt) and an electron transfer agent are added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminal derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The emitted light signals are detected and measured. The amount of HRP conjugate bound is directly proportional to the level of anti-HCV antibodies present in a given sample.(Ismail N, Fish GE, Smith MB: Laboratory evaluation of a fully automated chemiluminescence immunoassay for rapid detection of HBsAg, antibodies to HBsAg, and antibodies to hepatitis C virus. J Clin Microbiol. 2004;42:610-617; package insert: VITROS Anti-HCV Assay, no. GEM 1243. Ortho-Clinical Diagnostics, Inc; Version 14.1, 09/06/2019)

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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.

80074 (if all 4 initial tests are performed)

86709 (if all 4 are not performed)

86705 (if all 4 are not performed)

87340 (if all 4 are not performed)

86803 (if all 4 are not performed)

87522 (if appropriate)

87341 (if appropriate)

Sample Reports

Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports

International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports