Diagnosis and evaluation of patients with symptoms of hepatitis with a duration more than 6 months
Distinguishing between chronic hepatitis B and chronic hepatitis C
| 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 |
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HCVQN | HCV RNA Detect/Quant, S | Yes | No |
| HBGNT | HBs Antigen Confirmation, S | No | No |
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:
-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Chemiluminescence Immunoassay (CIA)
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:
-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Serum SST
Date of collection is required.
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 serum into plastic vial.
If not ordering electronically, complete, print, and send 1 of the following:
2.75 mL
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
| Heat-inactivated specimen | Reject |
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | 84 days | |
| Refrigerated | 6 days |
Diagnosis and evaluation of patients with symptoms of hepatitis with a duration more than 6 months
Distinguishing between chronic hepatitis B and chronic hepatitis C
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:
-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
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 by 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.
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 close, personal contact. It is recognized as the cause of most cases of post-transfusion 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.
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 B SURFACE ANTIGEN:
Negative
HEPATITIS B SURFACE ANTIBODY, QUALITATIVE/QUANTITATIVE
Hepatitis B Surface Antibody
Unvaccinated: Negative
Vaccinated: Positive
Hepatitis B Surface Antibody, Quantitative
Unvaccinated: <5.0 mIU/mL
Vaccinated: > or =12.0 mIU/mL
HEPATITIS B CORE TOTAL ANTIBODIES:
Negative
HEPATITIS C ANTIBODY:
Negative
Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles.
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 16 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 core antibodies (anti-HBc Ab) appear shortly after the onset of symptoms of HBV infection and soon after the appearance of HBsAg. The IgM subclass usually falls to undetectable levels within 6 months, and the IgG subclass may remain for many years.
Anti-HBs usually appears with the resolution of hepatitis B virus infection after the disappearance of HBsAg.
If HBsAg and anti-HBc (total antibody) are positive and patient's condition warrants, consider testing for hepatitis Be antigen (HBeAg, anti-HBe, HBV-DNA or anti-HDV.
Chronic Hepatitis C:
Anti-HCV is almost always detectable by the late convalescent and chronic stage of infection.
The serologic tests currently available do not differentiate between acute and chronic hepatitis C infections.
Positive hepatitis B surface antigen (HBsAg) test results should be reported by the attending physician to the State Department of Health as required by law in some states.
Consider administration of hepatitis B immune globulin (HBIG) and hepatitis B vaccine to HBsAg antibody negative individuals exposed to the HBsAg-positive patient's blood or body fluids.
Neonates (<1 month old) with positive hepatitis B core (anti-HBc) total antibody results from this assay method should be tested for anti-HBc IgM antibody to rule out possible maternal anti-HBc total antibody causing false-positive results. Repeat testing for anti-HBc total antibody within 1 month is also recommended in these anti-HBc total antibody-positive neonates.
Assay performance characteristics have not been established for:
-Individuals under 10 years of age for HCVDX / Hepatitis C Virus (HCV) Antibody with Reflex to HCV RNA, PCR, Symptomatic, Serum
-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)
-Cadaveric specimens
-Those that contain particulate matter
1. Wietzke P, Schott P, Braun F, Mihm S, Ramadori G: Clearance of HCV RNA in a chronic hepatitis C virus-infected patient during acute hepatitis B virus superinfection. Liver. 1999 Aug;19(4):348-353
2. Villari D, Pernice M, Spinella S, et al: Chronic hepatitis in patients with active hepatitis B virus and hepatitis C virus combined infections: a histological study. Am J Gastroenterol. 1995 Jun;90(6):955-958
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. 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 19, 2022. Available at www.hcvguidelines.org
5. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol. 2001 Jun;21(3):229-237
6. LeFebre ML, US Preventive Services Task Force: Screening for hepatitis B virus infection in nonpregnant adolescents and adults: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Jul 1;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 22;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. WHO Guidelines Development Group: World Health Organization Guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed October 19, 2022. Available at www.who.int/publications/i/item/9789241549981
10. Centers for Disease Control and Prevention. Testing and public health management of persons with chronic hepatitis B virus infection. Updated March 28, 2022. Accessed October 19, 2022. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm
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 (S/Co) of 1.00 or greater but 100.0 or less 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 light signals are read by the instrument. 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; V 13.1, 09/06/2019)
HBsAg Confirmation:
The VITROS HBsAg Confirmatory Kit uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The sample is tested twice: 1 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; V 13.1, 09/06/2019)
HBs Antibody:
This chemiluminescent immunoassay is based on an immunometric technique in which the anti-HBs present in the clinical serum sample reacts with HBsAg (ad and ay subtypes) coated onto the assay reaction wells. A HRP-labeled HBsAg conjugate (ad and ay subtypes) then complexes with the bound anti-HBs forming an "antigen sandwich." Unbound materials are 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. HRP in the bound conjugate catalyzes the oxidation of the luminol derivative to produce light. The electron transfer agent increases the level and duration of the light produced. The light signals are detected by the system. The amount of HRP conjugate bound is directly proportional to the concentration of anti-HBs antibody present.(Package insert: VITROS Anti-HBs Quantitative Assay, no. GEM1208_US_EN. Ortho-Clinical Diagnostics, Inc; V 13.1,04/08/2020)
Hepatitis B Core Total Antibody:
The VITROS anti-hepatitis B core (anti-HBc) assay is a competitive immunoassay method based on the reaction of anti-HBc in the sample with hepatitis B core antigen (HBcAg)-coated wells. Unbound sample is removed by washing. HRP-labeled antibody conjugate (mouse monoclonal anti-HBc) is then allowed to react with the remaining exposed HBcAg on the well surface. Unbound conjugate is removed by washing. The bound HRP conjugate is measured by a luminescent reaction. 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 light signals are read by the system. The amount of HRP conjugate bound is indicative of the concentration of anti-HBc present in the sample.(Package insert: VITROS Anti-HBc Assay, no. GEM1211_US_EN. Ortho-Clinical Diagnostics, Inc; V 14.1, 09/06/2019)
Hepatitis C Virus Antibody:
The VITROS anti-hepatitis C virus (anti-HCV) assay is performed using 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 by the system. The amount of HRP conjugate bound is directly proportional to the level of anti-HCV antibodies present in a given sample.(Package insert: VITROS Anti-HCV Assay, no. GEM1243_US_EN. Ortho-Clinical Diagnostics, Inc; V 14.1, 09/06/2019)
Monday through Saturday
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.
86704
86706
86803
87340
87341 (if appropriate)
87522 (if appropriate)
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| CRHEP | Chronic Viral Hepatitis Profile, S | 92889-5 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| HBC | HBc Total Ab, S | 13952-7 |
| HB_AB | HBs Antibody, S | 10900-9 |
| HBSQN | HBs Antibody, Quantitative, S | 5193-8 |
| H_BAG | HBs Antigen, S | 5196-1 |
| HCVA4 | HCV Ab, S | 40726-2 |