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NC Department of Health and Human Services
State Laboratory of Public Health
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Virology / Serology: Hepatitis

General Information

Hepatitis B serologies are available on a limited basis for diagnosis of acute and chronic disease, for monitoring the course of disease and the effectiveness of therapy, and for screening select patient populations. Hepatitis A IgM testing is available on a limited basis for the diagnosis of acute disease.

Three types of testing panels are available: diagnostic, screening, and monitoring.

Specimen Acceptance Policy

Serologic testing for hepatitis infection is available only to patients who are seen in local health departments and state-operated health care facilities.

Hepatitis B virus testing is available to the following patient populations:

  • Symptomatic patients
  • Prenatal patients
  • Refugees
  • Sexual or needle sharing contacts of known infected persons
  • Patients who are household contacts of hepatitis B carriers and are candidates for vaccine
  • Infants born to infected mothers
  • Known previous HBsAg positives
  • Previously vaccinated health department employees with percutaneous exposure to hepatitis B virus
  • Source patient of percutaneous exposure

Hepatitis A virus serology is available to patients who are:

  • Symptomatic without an epidemiological link to another case of known hepatitis A infection
  • Suspected cases, whether or not epidemiologically-linked, who are:
    • food handlers
    • health care workers
    • day care attendees
    • day care workers
    • at risk of liver disease through IV drug abuse, alcohol abuse, etc.
  • Associated with an outbreak situation (prior approval required)

Routine testing for either hepatitis A or B is limited to those groups listed above; however, if you have special needs that are not addressed in the acceptance criteria, please call (919) 733-7544. Special arrangements for testing can be made on an individual basis.

NOTE: Hepatitis B immune status testing will not be performed to determine immune status of health care workers, dental workers, etc. who are candidates for routine vaccination or to establish routine post-vaccination immunity.

Specimen Collection and Identification

A full 3 mL of serum should be submitted for hepatitis testing in a well-constructed plastic screw capped vial with threads on the outside. Serum transport tubes should not be overfilled past the 3.0 mL line in the tubes. Excessively hemolyzed, grossly contaminated, or extremely lipemic sera are unacceptable for hepatitis assays. Specimens that are not acceptable for testing will be reported as UNSATISFACTORY.

Clearly label each vial of serum with the patient's full first and last name and either SSN, date of birth, or other unique identifier. Complete a submission form DHHS Hepatitis Serology Form #3722 (PDF, 103 KB). All items on this form must be completed before the specimen can be processed. Failure to supply the requested patient information may result in significantly delayed specimen testing.

Specimens submitted for testing that are not labeled with the correct patient identification information will not be tested. Specimens which, for any reason, are deemed unsuitable or inappropriate for serologic testing will not be tested. Rejected specimens will be properly stored for ten days pending verbal and/or written notification of the submitter. Unless alternate arrangements are initiated by the submitter upon notification of specimen rejection, the specimen will be discarded at the end of the holding period.

Shipment

Properly identified vials of patient sera along with the completed submission forms should be sent in buff colored specimen mailers labeled HEP SEROLOGY. For detailed shipping instructions using the double mailers, see Packing Instructions Using Outer Baggie (PDF, 4.6 MB). Ship at ambient temperature by the State Courier or U.S. Mail. Specimens should be shipped immediately and should arrive in the laboratory within 48 hours of collection. If transport to the laboratory is to be delayed, specimens can be refrigerated up to seven days or frozen.

Serum transport tubes and buff colored specimen mailers are available through the NCSLPH online supply ordering system at this website. DHHS Hepatitis Serology Form #3722 (PDF, 103 KB) may be downloaded and printed from this website.

Reporting Procedure and Interpretation

The following chart provides information regarding turn-around-times, test methods, and negative reference ranges:

Interpretations and Turn-Around-Times
Test Test Method Negative Reference Range Turn-Around-Time
Hepatitis B virus surface antigen IA-Qualitative Screen Antigen not detected 2 working days
Hepatitis B virus surface antigen IA-Confirmatory Interpreted by report 3 working days
Hepatitis B virus core-IgM antibody IA-Qualitative No antibody detected 3 working days
Hepatitis B virus core-total antibody IA-Qualitative No antibody detected 3 working days
Hepatitis B virus surface antibody IA-Qualitative No antibody detected 3 working days
Hepatitis A virus IgM antibody IA-Qualitative No antibody detected 1 working day

Abbreviations

  • IA: Immunoassay
  • IgM: Immunoglobulin M

Virology/Serology Information