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Louisiana Department of Health & Hospitals | Kathy Kliebert, Secretary

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Statewide Initiatives



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Hepatitis B Surface Antigen EIA

Hepatitis B Surface Antigen EIA

  • Laboratory Location – Central Laboratory
  • CPT Code – 87340
  • Synonyms – HBsAg
  • Test Description - The HBsAg EIA is used to detect for circulating Hepatitis B Surface Antigen (HBsAg) in human serum. It is used as a detection method for early acute or chronic hepatitis B infection. 

Possible Results

  • Non-Reactive
  • Reactive

Reference Range

  • Non-Reactive

Specimen Requirements

  • Specimen Type - Serum
  • Specimen Container(s) - red top tubes, Marble top tubes, polypropylene vials
  • Minumum accepted volume - 300 μL (does not allow for repeat testing or confirmatory testing)

Specimen Collection Instructions

Blood should be collected in a plastic, sterile STD Program approved collection tube. Please follow the manufacturer's instructions on clot time and centrifuge speed/time requirements.

The Virology Lab 96 form must be filled out completely. The following information must be included on the form:

  • Patient's Name
  • Patient's Date of Birth
  • Patient's Gender
  • Date and time of specimen collection
  • Test requested
  • Type of specimen collected
  • Submitter's name and address

Storage and Transport Instructions

Specimens should be shipped refrigerated (2-8ºC) or at ambient temperatures for up to 7 days. For longer storage, specimens must be frozen at -20ºC or colder. Frozen specimens must be shipped on dry ice and received at a temperature of -20ºC or colder.

Causes for Rejection

  • expired collection tubes
  • incorrect specimen type
  • unspun samples
  • tubes that contain less than 90% of the total drawing capacity (QNS)
  • Improper storage or improper transport temperature requirements are also reasons for rejection

Limitations for the Procedure

A designation of reactive for HBsAg must not be based on a single reactive test result. Additional testing, such as confirmatory testing, is required to establish the specificity of any specimen reactive by the screening procedure. Initially reactive specimens must be retested in duplicate to validate the initial test results. If, after repeat testing, the absorbance values of both duplicate specimens are less than the cutoff value, the original specimen may be considered non-repeatedly reactive and negative for HBsAg. If, after repeat testing, the absorbance value of either of the duplicates is greater than or equal to the cutoff value, the specimen must be considered repeatedly reactive. A HBsAg Confirmatory Assay is performed on repeatedly reactive specimens. The specimen can be considered positive for HBsAg only if the HBsAg can be neutralized by the confirmatory procedure.

Interfering Substances

  • No clinically significant effect has been detected in assay results with increased levels of protien, lipids, bilirubin, or hemolysis, or after heat inactivation of patient samples.

References

  • BioRad Genetic Systems HBsAg EIA 3.0 package insert
  • EVOLISTM Operator Manual

 

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