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Hepatitis C Virus (HCV) Confirmatory LIA

Test Code: 30831

A special account is required to order pre-transplant testing. Contact Client Services or your account executive to set up a pre-transplant account to order this assay. Specimens should not be collected until after account has been created.

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Clinical Utility

The INNO-LIA™ HCV Score is a Line Immuno Assay (LIA) for the detection of antibodies to human hepatitis C virus (HCV) in human serum or plasma. It is intended for use as a supplementary test on human serum or plasma specimens found to be reactive using an anti-HCV screening procedure.

Procedure

The INNO-LIA™ HCV Score is a 3rd generation line immunoassay which incorporates HCV antigens derived from the core region, the E2 hypervariable region (HVR), the NS3 helicase region, the NS4A, NS4B, and NS5A regions.

The antigens were coated as 6 discrete lines on a nylon strip with plastic backing. In addition, four control lines are coated on each strip: background control line, 3+ positive control (anti-human Ig) which is also used as sample addition control line, 1+ positive control (human IgG), and the ± cut-off line (human IgG).

The INNO-LIA HCV Score is based on the principle of an enzyme immunoassay. A test sample is incubated in a trough together with the test strip. If present in the sample, HCV antibodies will bind to the HCV antigen lines on the strip. Subsequently, an affinity-purified alkaline phosphatase-labelled goat anti-human IgG (H+L) conjugate is added and reacts with specific HCV antigen/antibody complexes, if previously formed. Incubation with the enzyme substrate produces a chestnut-like color, the intensity of which is proportionate to the amount of HCV-specific antibody captured from the sample on any given line. Color development is stopped with sulfuric acid. Test performed by Gamma DynaCare Laboratories 1100 Bennett Rd., Bowmanville, ON. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. See package insert for more information.

14 business days from receipt of specimen.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
Serum 30831 86804 Yes

1.5 mL (min 1 mL)

Qualitative

  • Collect whole blood in an gold, red, or red/gray tiger top tube. Do not freeze whole blood.
  • Sample sent in original vacutainer tube can be shipped at ambient or refrigerated temperature, must be received within 7 days.
  • If not shipping in original container, centrifuge and transfer 1.5 mL (min 1 mL) serum to screw top tube. Serum shipped at ambient or refrigerated temperature must be received within 7 days of collection or frozen.
Shipping

All specimens must be labeled with patient's name and collection date. A Viracor/VRL Eurofins Pre-Transplant test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: VRL Eurofins, 6933 S. Revere Parkway, Centennial, CO 80112.

Causes for Rejection

Whole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

 

 

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on VRL Eurofins' interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. VRL Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

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