Geenius HIV 1-2 Supplemental Assay
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.
The Bio-Rad Geenius™ HIV 1/2 assay is an in vitro qualitative assay for the
detection and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2). A negative or indeterminate assay interpretation does not preclude the possibility of exposure to HIV or infection with HIV. False negative results may occur with individuals receiving the following therapies: ART, PEP, PrEP.
About HIV
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 (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.9-15
This second immunodeficiency virus is similar to, but distinct from, HIV-1. Both viruses have similar morphology and lymphotropism,16 and the modes of transmission appear to be identical.8,17 The HIV-1 and HIV-2 genomes exhibit about 60% homology in conserved genes such as gag and pol, and 39-45% homology in the envelope genes.18 Serologic studies have also shown that the core proteins of HIV-1 and HIV-2 display frequent cross reactivity whereas the envelope proteins are more type-specific.19
Within the two major HIV types, there is significant variation, as well. By analyzing sequences of representative strains, HIV-1 has been divided into four groups: group M (for major), including at least 9 subtypes, 3 sub-subtypes of A, and 2 sub-subtypes of F (A1, A2, A3, B, C, D, F1, F2, G, H, J, and K); group O (for outlier); group N (for non-M, non-O), and group P.20-24 Similarly, the HIV-2 strains have been classified into at least five subtypes (A through E).25 Some HIV-1 variants share ≤50% homology in their envelope genes with the sequences of more common prototype strains.
Despite some degree of immunological cross-reactivity between types and subtypes of HIV, reliable detection of the more divergent strains may only be achieved by incorporating specific sequences into the assay design. In one study, detection of HIV-2 positive samples by licensed HIV-1 antibody kits ranged from 60% to 91%, depending on the test used.26 Detection of HIV-1 Group O samples by HIV-1 and HIV-1/HIV-2 assays varied from 0% to 100% in studies with U.S.-licensed and European test kits.27-28
The Geenius™ HIV 1/2 Supplemental Assay is an immunochromatographic test that incorporates highly conserved recombinant proteins and synthetic peptides representing HIV-1 and HIV-2 proteins. The Geenius™ HIV 1/2 Supplemental Assay is simple and easy to use for the detection and differentiation of individual antibodies to HIV-1 and HIV-2 in serum or plasma.29
ProcedureThe Geenius™ HIV 1/2 Supplemental Assay cassette contains antibody-binding protein A, which is conjugated to colloidal gold dye particles, and HIV-1 and HIV-2 antigens, which are bound to the membrane solid phase. The sample is applied to the Sample + Buffer well. After the sample and buffer have migrated onto the test strip, additional buffer is added to the Buffer well. The buffer causes the specimens and reagents to flow laterally and facilitates the binding of antibodies to the antigens. In a reactive sample, the antibodies are captured by the antigens immobilized in the Test area.
The protein A-colloidal gold binds to the captured antibodies, causing development of pink/purple bands. When there are no HIV antibodies, there are no pink/purple bands in the Test area. The sample continues to migrate through the membrane and a pink/purple band develops in the Control (C) area, which contains Protein A. This built-in procedural control provides evidence that the test was performed properly and that the sample and reagents have migrated through the cassette.
Test performed by Eurofins DPT, 6933 South Revere Parkway Centennial, Colorado 80112. This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.
2-5 Business days from receipt of specimen.
| Specimen Type | Test Code | CPT Code | NY Approved | Volume | Assay Range | Special Instructions |
|---|---|---|---|---|---|---|
| Plasma (1) | 33260 | 86689 | Yes | 200 µL (min 100 µL) |
Qualitative |
|
| Serum (1) | 33260 | 86689 | Yes | 200 µL (min 100 µL) |
Qualitative |
|
All specimens must be labeled with patient's name and collection date. Please contact Client Services or your Account Executive for detailed shipping instructions.
Causes for RejectionWhole 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.