Differential diagnosis of recent acute viral hepatitis
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HAIGM | Hepatitis A IgM Ab, S | Yes | Yes |
| HBAG | HBs Antigen, S | Yes | Yes |
| HBIM | HBc IgM Ab, 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 | Yes | No |
If the hepatitis C virus (HCV) antibody result is reactive, then HCV RNA detection and quantification by real-time reverse transcription-polymerase chain reaction will be performed at an additional charge.
If the hepatitis B surface antigen result 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
HAIGM, HBAG, HBIM, HCVDX, HBGNT: Electrochemiluminescence Immunoassay (ECLIA)
HCVQN: Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
AHEP
If the hepatitis C virus (HCV) antibody result is reactive, then HCV RNA detection and quantification by real-time reverse transcription-polymerase chain reaction will be performed at an additional charge.
If the hepatitis B surface antigen result 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
Serum SST
Date of collection is 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).
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 2.7 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 2 mL serum into a plastic vial labeled as SST Serum, and ship frozen (preferred).
If not ordering electronically, complete, print, and send 1 of the following:
1.9 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 |
Differential diagnosis of recent acute viral hepatitis
If the hepatitis C virus (HCV) antibody result is reactive, then HCV RNA detection and quantification by real-time reverse transcription-polymerase chain reaction will be performed at an additional charge.
If the hepatitis B surface antigen result 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
Hepatitis A:
Hepatitis A virus (HAV) is an RNA virus that accounts for 20% to 25% of acute viral hepatitis in adults in the United States. Hepatitis A 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 among injection drug users). 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. The infection 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. Hepatitis C shows a high rate of progression (~75%) to chronic infection and disease and accounts for the majority of chronic viral hepatitis In the United States. Cirrhosis and hepatocellular carcinoma are sequelae of chronic infection with this virus.
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 Virus (HAV):
HAV-specific antibodies are is usually detectable by the onset of symptoms (usually 15 to 45 days after exposure). The initial antibody consists almost entirely of IgM subclass antibody. Anti-HAV IgM usually falls to undetectable levels 3 to 6 months after infection.
Hepatitis B Virus (HBV):
HBsAg is the first serologic marker appearing in the serum 6 to 8 weeks following 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.
During acute hepatitis B in symptomatic individuals, detectable anti-HBc consists almost entirely of the IgM subclass. Anti-HBc IgM can be detected shortly after the onset of symptoms and usually remains detectable for 6 months. Anti-HBc IgM and Anti-HBc total may be the only serologic markers of a recent HBV infection detectable in the “window period”, during which HBsAg has declined to become undetectable and anti-HBs has not yet become detectable.
Hepatitis C Virus (HCV):
In immunocompetent individuals, HCV-specific IgG and IgM antibodies are usually not detectable in the first 2 months after exposure to HCV, and this “window period” may be as long as 6 months in immunocompromised individuals. HCV antibodies are not neutralizing and does not provide immunity against subsequent HCV infection.
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
Consider administration of human 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 (HBsAg) or positive anti-hepatitis A virus (HAV) IgM test results should be reported by the attending physician to the State Department of Health, as required by law in some states.
Serum specimens from individuals taking biotin supplements at 20 mg or more per day may have false-negative results for anti-HAV IgM, anti-HBc IgM, and anti-HCV Ab, due to interference of biotin with the assay. Such individuals should stop taking these biotin-containing dietary supplements for minimum 12 hours before blood collection for this test.
Performance characteristics have not been established for the following specimen characteristics:
-Grossly icteric (total bilirubin level of >25 mg/dL)
-Grossly lipemic (intralipid level of >1000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >1000 mg/dL)
-Containing particulate matter
-Cadaveric specimens
1. LeFevre ML, et al. Screening for hepatitis B virus infection in nonpregnant adolescents and adults: U.S. 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 (Hoboken). 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. 2017. Accessed October 7, 2023. Available at www.who.int/hepatitis/publications/HEP17001_WEB11.pdf?ua=1
5. Centers for Disease Control and Prevention. Screening and testing for hepatitis B virus infection: CDC Recommendations - United States, 2023. MMWR Recomm Rep; 2023:72(No. RR-1):1-25. Available at https://www.cdc.gov/mmwr/volumes/72/rr/rr7201a1.htm?s_cid=rr7201a1_w
Hepatitis B Surface Antigen Screen:
The Elecsys HBsAg (hepatitis B surface antigen) II assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HBsAg present in the patient’s sample reacts with two biotinylated monoclonal anti-HBs, and a mixture of monoclonal anti-HBs and polyclonal anti-HBs labeled with a ruthenium complex react to form a sandwich complex. After addition of streptavidin-coated microparticles (solid phase), the complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the reaction product in the patient’s sample to the cutoff index (COI) value set from reagent lot-specific assay calibration.(Package insert: Elecsys HBsAG II. Roche Diagnostics; v3.0, 02/2022)
Hepatitis B Surface Antigen Confirmation:
The Elecsys HBsAg II Auto Confirm assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. This test is based on 2 parallel measurements. For the first measurement, the sample is treated with the control pretreatment reagent (PT2) prior to immunoreaction. This measurement serves as a reference. For the second measurement the sample is treated with the confirmatory pretreatment reagent (PT1) prior to immunoreaction. During incubation with confirmatory pretreatment, unlabeled polyclonal anti-HBs are bound to the sample HBsAg and thereby block the binding sites for the labeled antibodies used in the following immunoreaction. The confirmation result (%) is automatically assessed by determining the ratio of both measurements.
During testing, the auto-diluted sample is incubated with control pretreatment and confirmatory pretreatment, followed by formation of sandwich complexes of biotinylated monoclonal anti-HBs and a mixture of monoclonal anti-HBs and polyclonal anti-HBs labeled with a ruthenium complex. After addition of streptavidin-coated microparticles (solid phase), the complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixture is then aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. Results are determined by comparing the electrochemiluminescence signal generated from the reaction product to the cutoff index value set from reagent lot-specific assay calibration. The confirmation result (%) is calculated from the ratio of the COI obtained for the measurement with confirmatory pretreatment to the COI obtained for the measurement with control pretreatment.(Package Insert: Elecsys HBsAg II Auto Confirm. Roche Diagnostics; v1.0, 12/2020)
Hepatitis A IgM Antibody:
The Elecsys Anti-HAV (hepatitis A virus) IgM assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HAV-specific IgM antibody (anti-HAV IgM) in the patient’s serum sample is pretreated with anti-Fdy reagent to block specific IgG in the presence of monoclonal anti-HAV antibodies labeled with ruthenium complex. After addition of biotinylated monoclonal human-IgM-specific antibodies, HAV antigen, and streptavidin-coated microparticles, patient’s anti-HAV IgM form a sandwich complex with the HAV antigen and the ruthenium-labeled anti-HAV antibody which becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is then aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, and unbound substances are washed away. Voltage is applied to the electrode and induces chemiluminescent emissions that are measured by a photomultiplier. Test result is determined automatically by the assay-specific software program by comparing the electrochemiluminescence signal generated from the patient’s sample to the COI value set from reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HAV IgM. Roche Diagnostics; v5.0, 11/2022)
Hepatitis B Core IgM Antibody:
The Elecsys Anti-HBc (hepatitis B core) IgM assay is based on the sandwich immunoassay principle and performed with an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. Anti-HBc IgM present in patient’s sample is pretreated with anti-Fdy reagent to block specific IgG. After addition of biotinylated monoclonal human-IgM-specific antibodies, the complexes formed from reaction of ruthenium-labeled HBc antigen, streptavidin-coated microparticles (solid phase), anti-HBc IgM present in the sample, and the biotinylated anti-human IgM bind to the solid phase via interaction of biotin and streptavidin. The reaction mixture is then aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, and unbound substances are washed away. Voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the sample to the COI value set from reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HBc IgM. Roche Diagnostics; v1.0, 09/2020)
Hepatitis C Virus Antibody:
The Elecsys Anti-HCV (hepatitis C virus) II assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the fully automated cobas e 801 immunochemistry analyzer. HCV antibodies present in the patient’s sample react with biotinylated HCV-specific antigens and a reagent containing HCV-specific antigens labeled with a ruthenium complex to form a sandwich complex. After addition of streptavidin-coated microparticles (solid phase), these complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the patient’s sample to the COI value set from reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HCV II. Roche Diagnostics v1.0, 03/2023)
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.
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)
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| AHEP | Acute Hepatitis Profile | 24363-4 |
| 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.
|
|---|---|---|
| HBIM | HBc IgM Ab, S | 24113-3 |
| H_BAG | HBs Antigen, S | 5196-1 |
| HAIGM | Hepatitis A IgM Ab, S | 13950-1 |
| HCVA4 | HCV Ab, S | 40726-2 |