Hepatitis B Virus Surface Antigen (HBsAg) EIA

Test Code: 30815

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 and Procedure

Clinical Utility

The GS HBsAg EIA 3.0 is a qualitative enzyme immunoassay for detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma. It is indicated as a screening test for specimens from individual human donors, including donors of whole blood, blood components, and source plasma, and from other living donors. It is also intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating. The assay is not intended for use on cord blood specimens.

About Hepatitis B Surface Antigen

Hepatitis B virus (HBV) is a major public health problem worldwide, with significant transmission of the virus occurring through the use of contaminated donor blood and plasma. Also of concern is the transmission of HBV and other infectious diseases through tissue transplantation.¹ Because the presence of circulating Hepatitis B Surface Antigen (HBsAg) is used to detect potentially infectious blood and plasma.² Enzyme immunoassays to detect HBsAg have replaced relatively insensitive gel diffusion methods and have been reported to have equivalent sensitivity to radioimmunoassay methods.³ The application of monoclonal antibodies for the detection of HBsAg has been previously reported.^4.5 The GS HBsAg EIA 3.0 is a third generation enzyme immunoassay, which uses mouse monoclonal antibodies to detect HBsAg in human serum or plasma specimens.

Specimens that are non-reactive when tested with the GS HBsAg EIA 3.0 are considered negative for HBsAg and need not be tested further. Reactive specimens should be retested, in duplicate, using the GS HBsAg EIA 3.0 to determine whether they are repeatedly reactive. A repeatedly reactive specimen should be confirmed by a licensed neutralization procedure utilizing human anti-HBs (GS HBsAg Confirmatory Assay 3.0). If the HBsAg in the specimen can be neutralized by the confirmatory procedure, the specimen is considered positive for HBsAg and need not be tested further.

Procedure

Wells of the microwell strip plates are coated with mouse monoclonal antibody to HBsAg (anti-HBs). Serum or plasma and appropriate controls are added to the wells, and incubated with the bound antibody. If HBsAg is present, it will bind to the antibody and not be removed by washing. The strips are washed to remove any unbound material. Washing is followed by the addition of Conjugate Solution (peroxidase-conjugated mouse monoclonal antibodies directed against HBsAg). The Conjugate Solution will bind to the antibody-HBsAg complex, if present. Unbound conjugate is removed by a wash step. Next, Working TMB Solution is added to the plate and allowed to incubate. A blue or blue-green color develops in proportion to the amount of HBsAg present in the sample. The enzyme reaction is stopped by the addition of acid, which changes the blue-green color to yellow. The optical absorbance of specimens and controls is determined with a spectrophotometer set at 450 nm wavelength. 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.

Turnaround Time

Within 24 hours from receipt of specimen.

Specimen Information

Specimen Type	Order Code	CPT Code	NY Approved	Volume	Assay Range	Special Instructions
Plasma	30815	87340	Yes	300 µL (min 150 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 7 days. If not shipping original container, centrifuge and transfer 300 µL (min 150 µL) plasma to screw top tube. Plasma shipped at ambient or refrigerated temperature must be received within 7 days of collection or frozen.
Serum	30815	87340	Yes	300 µL (min 150 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 7 days. If not shipping original container, centrifuge and transfer 300 µL (min 150 µL) plasma to screw top tube. Plasma 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.

Disclaimer

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.