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Louisiana Department of Health & Hospitals | Kathy Kliebert, Secretary

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Antibody to Hepatitis C Virus EIA

Antibody to Hepatits C Virus EIA

  • Laboratory Location – Central Laboratory
  • CPT Code – 86803
  • Synonyms – HCV, Anti-HCV
  • Test Description - The ORTHO HCV ELISA Test System is used for the detection of antibody to hepatitis C virus (Anti-HCV) in human serum. The hepatitis C virus (HCV) is now known to be a causative agent for most, if not all, blood-bornes non-A, non-B hepatitis.

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 - 210 μL (does not allow for repeat 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 ambient within 7 days of collection. 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
  • Gross hemolysis or heat-treated specimens
  • 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

Specimens with absorbance values greater than or equal to the cutoff value are considered initially reactive and should be retested in duplicate before final interpretation. Upon retesting an initially reactive specimen, the specimen is considered repeatedly reactive for antibody to HCV if either or both duplicate determination(s) is/are reactive, i.e. greater than or equal to the cutoff value. The presence of anti-HCV does not constitute a diagnosis of hepatitis C, but may be indicative of recent and/or past infection by hepatitis C virus. A non-reactive test does not exclude the possibility of exposure to hepatitis C virus. Levels of anti-HCV may be undetectable in early infection.

Interfering Substances

  • Clear, non hemolyzed specimens are preferred. However, no effect on reactivity was observed when specimens were treated with 50-200 mg/dL of hemoglobin and 194-1285 mg/dL of triglyceride.
  • Do not use any heat-treated specimens.

References

  • ORTHO® HCV ELISA Test System package insert
  • EVOLISTM Operator Manual

 

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