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Test Code PHSP Prenatal Hepatitis Evaluation, Serum

Reporting Name

Prenatal Hepatitis Evaluation

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

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

 

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).

 

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.

Method Name

Electrochemiluminescence Immunoassay (ECLIA)


Necessary Information


Date of collection is required.



Specimen 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).

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel (red-top tubes are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 2.2 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 serum into a plastic vial and ship frozen (preferred).


Specimen Type

Serum SST

Specimen Minimum Volume

1.6 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 84 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Reference Values

HEPATITIS B VIRUS SURFACE ANTIGEN

Negative

 

HEPATITIS C VIRUS ANTIBODY

Negative

 

See Viral Hepatitis Serologic Profiles

Interpretation

Hepatitis B virus surface antigen (HBsAg) is the first serologic marker appearing in the serum 6 to 8 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. HBs antibody (anti-HBs) appears with the resolution of HBV infection after the disappearance of HBsAg.

 

Hepatitis B e antigen (HBeAg) appears at approximately the same time as HBsAg and indicates that the virus is replicating and the individual is infectious. Appearance of 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 cutoff index (COI) at or below 20.0 are not predictive of the true HCV antibody status; additional testing is recommended to confirm HCV antibody status.

 

Reactive results with COI greater than 20.0 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.

Day(s) Performed

Monday through Saturday

Report Available

Same day/1 to 4 days

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 101653-4

 

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

Forms

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

-Gastroenterology and Hepatology Test Request (T728)

-Infectious Disease Serology Test Request (T916)

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

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

Testing Algorithm

If the hepatitis B virus surface antigen (HBsAg) result is reactive, then HBsAg confirmation testing will be performed at an additional charge. If the HBsAg confirmation result is positive, then HBe Ag 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 will be performed at an additional charge.

 

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