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Test ID: PHSP Prenatal Hepatitis Evaluation, Serum

Reporting Name

Prenatal Hepatitis Evaluation

Useful For

Screening pregnant women for chronic hepatitis B

 

Determining the level of infectivity of chronic hepatitis B in pregnant women

 

This test is not useful for diagnosis of hepatitis B during the "window period" of acute hepatitis B virus infection (ie, after disappearance of hepatitis B surface antigen and prior to appearance of hepatitis B surface antibody).

 

Screening of pregnant women for hepatitis C in primary care settings, with or without risk factors for hepatitis C 

This test should not be used as a screening test for hepatitis C in blood or human cells/tissue donors.

 

This test profile is not useful for detection or diagnosis of acute hepatitis C virus (HCV) in pregnancy, since HCV antibodies may not be detectable until after 2 months following exposure and HCV RNA testing is not performed on specimens with negative HCV antibody screening test results.

Clinical Information

Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. After a course of acute illness, HBV persists in about 10% of patients who were infected during adulthood. Some carriers are asymptomatic; others may develop chronic liver disease including cirrhosis and hepatocellular carcinoma.

 

HBV is spread primarily through percutaneous contact with infected blood products (ie, blood transfusion, sharing of needles by drug addicts). The virus is found in virtually every type of human body fluid and is spread through oral and genital contact.

 

HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted transplacentally. Infection of the infant can occur if the mother is a chronic hepatitis B surface antigen carrier or has an acute HBV infection at the time of delivery. Transmission is rare if an acute infection occurs in either the first or second trimester of pregnancy.

 

Hepatitis C virus (HCV) is recognized as the cause of most cases of posttransfusion hepatitis and is a significant cause of morbidity and mortality worldwide. In the United States, HCV infection is quite common, with an estimated 2.4 million chronic HCV carriers.

 

Laboratory testing for HCV infection usually begins by screening for the presence of HCV-specific antibodies in serum, using an FDA-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 transcriptase-polymerase chain reaction (RT-PCR) 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. Decrease in the HCV antibody level in serum may occur following resolution of infection.

 

Current screening serologic tests to detect antibodies to HCV include enzyme and chemiluminescence immunoassays. Despite the value of serologic tests to screen for HCV infection, several limitations of serologic testing exist:

-There may be a long delay (up to 6 months) between exposure to the virus and the development of detectable HCV-specific antibodies

-False-reactive screening test result can occur

-A reactive screening test result does not distinguish between past (resolved) and present HCV infection

-Serologic tests cannot provide information on clinical response to anti-HCV therapy

 

Reactive screening test results should be followed by a supplemental or confirmatory test, such as a nucleic acid test for HCV RNA or HCV antibody confirmatory test. Nucleic acid tests provide a very sensitive and specific approach for the direct detection of HCV RNA.

 

For more information, see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management.

Interpretation

Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum 6 to 16 weeks following hepatitis B virus (HBV) infection. A confirmed positive result for HBsAg is indicative of acute or chronic hepatitis B. 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 liver disease. Hepatitis B surface antibody (anti-HBs) appears with the resolution of HBV infection after the disappearance of HBsAg.

 

Hepatitis Be-antigen (HBeAg) appears at approximately the same time as HBsAg and indicates that the virus is replicating, and the individual is infectious. Appearance of hepatitis Be antibody (anti-HBe) after the disappearance of HBsAg and HBeAg usually indicates recovery and loss of infectivity.

 

Reactive hepatitis C virus (HCV) antibody screening results with signal-to-cutoff (S/CO) ratios of below 8.0 are not predictive of the true HCV antibody status and additional testing is recommended to confirm HCV antibody status.

 

Reactive results with S/CO ratios of 8.0 or greater 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 (<3 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 HCVRP / Hepatitis C Virus (HCV) RNA Detection and Quantification, Real-Time Reverse Transcription-PCR Prenatal, Serum is recommended for detection of HCV infection in such patients.

Report Available

Same day/1 to 4 days

Day(s) Performed

Monday through Saturday

Clinical Reference

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

2. Jackson K, Locarnini S, Gish R: Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis. 2018 Aug 22;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 Jan;156(2):355-368. doi: 10.1053/j.gastro.2018.11.037

4. WHO Guidelines Development Group: World Health Organization guidelines on hepatitis B and C testing. Geneva: World Health Organization; 2017. Accessed September 29, 2020. Available at www.who.int/hepatitis/publications/guidelines-hepatitis-c-b-testing/en/

5. Centers for Disease Control and Prevention. Testing and public health management of persons with chronic hepatitis B virus infection. Accessed April 8, 2020. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm

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; Accessed January 28, 2021. Available at www.hcvguidelines.org/contents

7. US Preventive Services Task Force, Owens DK, Davidson KW, et al: Screening for hepatitis C virus infection in adolescents and adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2020 Mar 10;323(10):970-975. doi: 10.1001/jama.2020.1123

8. Society for Maternal-Fetal Medicine (SMFM), Hughes BL, Page CM, Kuller JA: Hepatitis C in pregnancy: screening, treatment, and management. Am J Obstet Gynecol. 2017 Nov;217(5):B2-B12

9. National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention: Pregnancy and HIV, viral hepatitis STD and TB prevention: HCV challenges. CDC; Reviewed May 22, 2019. Accessed January 28, 2021. Available at www.cdc.gov/nchhstp/pregnancy/challenges/hcv.html

10. Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB: CDC recommendations for hepatitis C screening among adults-United States, 2020. MMWR Morb Mortal Wkly Rep 2020 Apr 10;69(2):1-17

Method Name

Chemiluminescence Immunoassay (CIA)

Specimen Type

Serum SST


Necessary Information


Date of collection is required.



Specimen Required


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: 2.5 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial within 24 hours.


Specimen Minimum Volume

2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 28 days
  Refrigerated  7 days
  Ambient  24 hours

Reference Values

HEPATITIS B SURFACE ANTIGEN

Negative

 

HEPATITIS C ANTIBODY

Negative

 

See Viral Hepatitis Serologic Profiles

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

87340

86803

G0472 (if appropriate for government payers)

87522 (if appropriate)

86707 (if appropriate)

87341 (if appropriate)

87350 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PHSP Prenatal Hepatitis Evaluation In Process

 

Result ID Test Result Name Result LOINC Value
HBSAP HBs Antigen Prenatal, S 5196-1
HCVA6 HCV Ab Prenatal, S 40726-2

Testing Algorithm

If the result for hepatitis B surface antigen (HBsAg) prenatal is reactive, then HBsAg confirmation prenatal testing will be performed at an additional charge. If the HBsAg confirmation is positive, then hepatitis Be-antigen (HBe) and HBe-antibody testing will be performed at an additional charge.

 

If the hepatitis C virus (HCV) antibody screen is reactive, then HCV RNA testing by reverse transcriptase-polymerase chain reaction (RT-PCR) will be performed at an additional charge.

 

For more information, see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
EAG Hepatitis Be Ag, S Yes No
HEAB HBe Antibody, S Yes No
HBNTP HBs Ag Confirmation Prenatal, S No No
HCVRP HCV RNA Detect/Quant Prenatal, S Yes No

Profile Information

Test ID Reporting Name Available Separately Always Performed
HBAGP HBs Antigen Prenatal, S Yes Yes
HCVSP HCV Ab Scrn Prenatal, S Yes Yes

Forms

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)

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

mml-hepatitis