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For hours, walk-ins and appointments.Test Includes
Hepatitis A Antibody, IgM [006734]; Hepatitis B Surface Antigen (HBsAg) Screen, Qualitative [006510]; Hepatitis B Core Antibody, IgM [016881]; Hepatitis C Virus (HCV) Antibody with reflex to Quantitative Real-time PCR [144050]
Special Instructions
If reflex testing is performed, additional charges/CPT code(s) may apply.
This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Related Documents
Specimen Requirements
Specimen
Serum or EDTA plasma
Volume
5 mL
Minimum Volume
2.5 mL
Container
Gel-barrier tube, plasma preparation tube (PPT), serum transfer tube, EDTA-plasma transfer tube
Collection
Centrifuge sample within 24 hours of collection. If tube other than a gel-barrier tube is used, or if sample will be shipped frozen, transfer separated serum/plasma to a screw-cap polypropylene transport tube.
Storage Instructions
Refrigerated (preferred)
HAV and HBV: stable 14 days at room temperature, refrigerated (preferred) and frozen
HCV: stable 24 hours at room temperature, 6 days refrigerated or 6 weeks frozen
Causes for Rejection
Heat-inactivated specimens; cord blood; cadaveric specimens; or body fluids other than serum or EDTA plasma; gross hemolysis; excessive lipemia; improper labeling; frozen gel-barrier tube
Test Details
Use
Aid in the diagnosis of acute viral hepatitis due to infection with HAV, HBV, and/or HCV.
Limitations
The assays in this panel have not been FDA cleared or approved for the screening of blood or plasma donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.
Methodology
Immunochemiluminometric assay (ICMA)
Additional Information
Hepatitis A virus (HAV) is a picovirus primarily transmitted via the fecal-oral route. HAV replicates in the liver and is shed in high concentrations in feces from 2-3 weeks before to 1 week after the onset of clinical illness. IgM antibody develops within a week of symptom onset, peaks around three months, and is usually no longer detectable after six months. The presence of IgM antibody to HAV is diagnostic of acute HAV infection.
Hepatitis B surface antigen (HBsAg) is a distinctive serological marker of acute or chronic hepatitis B infection. HBsAg is the first antigen to appear following infection with HBV and is generally detected 1-10 weeks after the onset of clinical symptoms. HBsAg assays are routinely used to diagnose suspected HBV infection and monitor the status of infected individuals to determine whether the infection has resolved or the patient has become a chronic carrier of the virus. In patients that recover from HBV infection, HBsAg is undetectable 3-5 months after the onset of infection. In patients with chronic infection, HBsAg remains detectable for life.
Anti-HBc IgM increases rapidly, peaks during the acute infection stage of HBV infection, and then falls to a relatively low level as the patient recovers or becomes a chronic carrier. Anti-HBc IgM is useful in the diagnosis of acute HBV infection even when HBsAg concentrations are below the sensitivity of the diagnostic assay.
Detection of both HCV antibody and HCV RNA indicates current HCV infection. Detection of HCV antibody in the absence of HCV RNA is consistent with the absence of current HCV infection. Repeat HCV RNA testing is recommended if the person tested is suspected to have had HCV exposure within the past 6 months or has clinical evidence of HCV disease.
References
Abara WE, Oaseem A, Schillie S. McMahon BJ, Harris AM, High Value Care Task Force of the American College of Physicians and the Centers for Disease Control and Prevention. Hepatitis B Vaccination, Screening, and Linkage to Care: Best Practice Advice from the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med. 2017 Dec 5;167(11):794-804.29159414
American Association for the Study of Liver Diseases, Infectious Diseases Society of America. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C: HCV Testing and Linkage to Care. HCVGuidelines.org web site: https://www.hcvguidelines.org/evaluate/testing-and-linkage. Accessed June 2021.
Centers for Disease Control and Prevention. Hepatitis B. CDC web site: www.cdc.gov/hepatitis/hbv/index.htm. Accessed May 2021.
Terrault NA, Lok ASF, McMahon BJ, et al. Update on Prevention, Diagnosis, and Treatment of Chronic Hepatitis B: AASLD 2018 Hepatitis B Guidance. Hepatology. 2018 Apr;67(4):1560-1599.29405329
Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015 Jun 5;64(RR-03):1-137.26042815
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 144000 | Acute Hepatitis | 24363-4 | 006734 | Hep A Ab, IgM | 13950-1 | |
| 144000 | Acute Hepatitis | 24363-4 | 006510 | HBsAg Screen | 5196-1 | |
| 144000 | Acute Hepatitis | 24363-4 | 016881 | Hep B Core Ab, IgM | 24113-3 | |
| 144000 | Acute Hepatitis | 24363-4 | 144035 | HCV Ab | 40726-2 |
| Reflex Table for HBsAg Screen | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 016105 | HBsAg Confirmation | 016105 | HBsAg Confirmation | 7905-3 | |
| Reflex Table for HCV Ab | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 144030 | Interpretation: | 144030 | Interpretation: | 13955-0 | |
| Reflex Table for HCV Ab | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 550362 | HCV RT-PCR, Quant (Non-Graph) | 550338 | Hepatitis C Quantitation | IU/mL | 11011-4 |
| Reflex 2 | 550352 | HCV RNA (International Units) | 550353 | HCV RNA (International Units) | IU/mL | 11011-4 |
| Reflex Table for HCV Ab | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 550362 | HCV RT-PCR, Quant (Non-Graph) | 550338 | Hepatitis C Quantitation | IU/mL | 11011-4 |
| Reflex 2 | 550352 | HCV RNA (International Units) | 550354 | HCV log10 | log10 IU/mL | 38180-6 |
| Reflex Table for HCV Ab | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 550362 | HCV RT-PCR, Quant (Non-Graph) | 550339 | HCV log10 | log10 IU/mL | 38180-6 |
| Reflex Table for HCV Ab | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 550362 | HCV RT-PCR, Quant (Non-Graph) | 550314 | Test Information: | 19147-8 | |
| Reflex Table for HCV Ab | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 550362 | HCV RT-PCR, Quant (Non-Graph) | 550396 | Interpretation: | 62365-2 | |
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The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf