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HIV-1/HIV-2 Plus O EIA

Test Code: 30816

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 GS HIV-1/HIV-2 PLUS O EIA is an enzyme immunoassay utilizing recombinant proteins and synthetic peptides for the detection of antibodies to HIV-1 (Groups M and O) and/or HIV-2 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. In addition, it is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. The assay is not intended for use on cord blood specimens.

About HIV

The acquired immunodeficiency syndrome (AIDS) is caused by viruses transmitted by sexual contact, exposure to blood (including sharing contaminated needles and syringes) or certain blood products, or transmitted from an infected mother to her fetus or child during the perinatal period.1 Additionally, transmission of these viruses can occur through tissue transplantation.2 Human Immunodeficiency Virus Type 1 (HIV-1) has been isolated from patients with AIDS and AIDS-related complex (ARC).3-5 HIV-1 was thought to be the sole causative agent of these syndromes until 1986, when a second type of Human Immunodeficiency Virus (Human Immunodeficiency Virus Type 2 or HIV-2) was isolated and also reported to cause AIDS.6-7 Since the initial discovery, hundreds of cases of HIV-2 infection have been documented worldwide, including cases of AIDS related to HIV-2.8 In the United States, there have been more than 80 cases of infection with HIV-2 reported, including three potential blood donors.

Any specimen that reacts in an initial test (is initially reactive) with the GS HIV-1/HIV-2 PLUS O EIA must be retested in duplicate with the GS HIV-1/HIV-2 PLUS O EIA. Initially reactive specimens that are reactive in either one or both duplicates from the repeat testing are referred to as repeatedly reactive. Repeatedly reactive specimens may contain antibodies to either HIV-1 or HIV-2. Therefore, additional, more specific or supplemental tests for antibodies to both HIV-1 and HIV-2, such as Western blot or immunofluorescence, must be performed to verify the presence of antibodies to HIV-1 or HIV-2. Recommendations for appropriate use of additional tests may be issued periodically by the United States Public Health Service.

Procedure

The GS HIV-1/HIV-2 PLUS O EIA is an enzyme immunoassay based on the principle of the direct antibody sandwich technique. Microwell strip plates (the solid phase) are coated with purified antigens; gp160 and p24 recombinant proteins derived from HIV-1; a peptide representing the immunodominant region of the HIV-2 transmembrane glycoprotein, gp36; and a synthetic polypeptide mimicking as artificial (i.e., encoded by no existing virus) HIV-1 Group O specific epitope.

Samples and controls are added to the wells along with Specimen Diluent. The Specimen Diluent contains a dye that changes color from purple to blue when combined with a sample or control. The wells are incubated and then washed. The next step is the addition of a color Conjugate Solution (green), which contains peroxidase-conjugated antigens (peptides mimicking various immunodominant epitopes of the HIV-1 and HIV-2 transmembrane glycoproteins, and a P24 recombinant protein). The wells are then incubated. If HIV-1 and/or HIV-2 antibody is present, it will bind to the antigen coated on the well and to the peroxidase-conjugated antigens in the conjugate. The antigen-antibody-antigen complexes remain bound to the well during the subsequent wash step, which will remove any unbound materials. 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 HIV antibody present in the sample. Color development is stopped by the addition of an acid, which changes the blue-green color to yellow. The optical absorbance of specimens and controls is determined spectrophotometrically at a wavelength of 450 nm. 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 30816 86703 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 and 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 30816 86703 Yes

300 µL (min 150 µL)

Qualitative

  • Collect whole blood in an gold, red, or red/gray tiger top tube.
  • Sample sent in original vacutainer tube can be shipped at ambient or refrigerated temperature and must be received within 7 days of collection. Do not freeze whole blood.
  • If not shipping original container, centrifuge and transfer 300 µL (min 150 µL) serum to a screw top tube. Can be shipped ambient or refrigerated and must be received within 7 days 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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