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Hepatitis C Virus Antibody (HCV Ab) EIA

Test Code: 30823

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

ORTHO® HCV Version 3.0 ELISA Test System is an enzyme-linked, immunosorbent assay for the qualitative detection of antibody to hepatitis C virus (anti-HCV) in human serum or plasma specimens. This product is intended for use as a donor screening test to detect antibodies to hepatitis C virus in plasma and serum samples from individual human donors, including volunteer donors of Whole Blood, blood components, source plasma, and other living donors. This test is not intended for use on samples of cord blood.

The ORTHO® HCV Version 3.0 ELISA Test System is intended for use in a fully manual mode, in semi-automated mode using the ORTHO VERSEIA® Pipetter, or in automated mode with the ORTHO® Summit System (OSS).The Hepatitis C Virus Encoded Antigen (Recombinant c22-3, c200 and NS5) used in the manufacture of ORTHO® HCV Version 3.0 ELISA Test System is prepared under U.S. License by Novartis Vaccines and Diagnostics, Inc. under a shared manufacturing arrangement.

About Hepatitis C

Three recombinant hepatitis C virus encoded antigens are used in ORTHO® HCV Version 3.0 ELISA Test System. The three recombinant antigens, developed by Novartis Vaccines and Diagnostics, Inc., are c22-3, c200 and NS5. The use of HCV recombinant proteins derived from the core, NS3, NS4 and NS5 regions of the HCV genome has shown to be effective in identifying a greater number of diagnosed acute and chronic non-A, non-B hepatitis patients than single antigen (c100-3) assays.5,6 In addition, the use of these additional proteins allows for earlier detection of seroconversion following HCV infection. Although antibody responses to NS5 region-encoded antigens are not as prevalent in response to HCV infection as those to core and NS3 region-encoded antigens, the addition of NS5 to c22-3 and c200 recombinant proteins in ORTHO® HCV Version 3.0 ELISA Test System affords antibody detection to a greater number of HCV-encoded epitopes. 

Procedure

ORTHO® HCV Version 3.0 ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) which utilizes microwells coated with recombinant hepatitis C virus encoded antigens as the solid phase. ELISA technology utilizes the principle that antigens or antibodies which become bound to the solid phase can be detected by complementary antibody or antigen which is labeled with an enzyme capable of acting on a chromogenic substrate. When enzyme substrate is applied, the presence of antigen or antibody can be detected by the development of a colored end product. Test performed by VRL Eurofins,  6933 S. Revere Parkway, Centennial, CO 80112. This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. See package insert for more information. 

Within 24 hours from receipt of specimen.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
Plasma 30823 86803 Yes

100 µL (min 50 µL)

Qualitative

  • Collect whole blood in an EDTA, lavender top tube. Whole blood in ACD, Lithium Heparin, Sodium Citrate, or Sodium Heparin tubes are also accepted. Do not freeze whole blood.
  • Sample sent in original vacutainer tube can be shipped ambient or refrigerated temperature, must be received within 10 days.
  • If not shipping original container, centrifuge whole blood and transfer 100 µL (min 50 µL) plasma to screw top tube. Plasma shipped at ambient or refrigerated temperature must be received within 10 days of collection or frozen received within 28 days.
Serum 30823 86803 Yes

100 µL (min 50 µL)

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 10 days.
  • If not shipping in original container, centrifuge and transfer 100 µL (min 50 µL) serum to screw top tube. Serum shipped at ambient or refrigerated temperature must be received within 10 days of collection or frozen received within 28 days.
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 8011

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. This test is not intended for use on samples of cord blood.

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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