HIV 1 and 2 Antibody Differentiation

Message

Sendout, Mayo test code: HVDIP

Test Code

LAB5210025

Alias/See Also

Acquired Immune Deficiency Syndrome (AIDS)
Anti-HIV
Anti-HIV-1/-2
Anti-HIV-1/-2 Differentiation
HIV Antibody Differentiation
HIV Types 1 and 2 Antibodies
HIV-1/-2
HIV-1/-2 Ab
HIV-1/-2 Antibodies
HIV-1/-2 Antibody Differentiation
Human Immunodeficiency Virus (HIV)
HVDIP

CPT Codes
86701, 86702

Includes

This test is for confirmation and differentiation of HIV-1/2 antibodies (Ab). If the following result types are obtained, HIV-1/HIV-2 RNA detection will be performed at an additional charge:
-Negative for both HIV-1 Ab and HIV-2 Ab
-Indeterminate for HIV-1 Ab but negative for HIV-2 Ab
-Negative for HIV-1 Ab but indeterminate for HIV-2 Ab
-Indeterminate for both HIV-1 Ab and HIV-2 Ab
-Positive for both HIV-1 Ab and HIV-2 Ab

If the following result types are obtained, HIV-1 RNA detection and quantification will be performed at an additional charge:
-Positive for HIV-1 Ab and negative for HIV-2 Ab
-Positive for HIV-1 Ab and indeterminate for HIV-2 Ab

Preferred Specimen

1 mL plasma from a lavender EDTA tube.

Minimum Volume

0.8 mL

Instructions

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot plasma into plastic vial

Transport Temperature

Frozen

Specimen Stability

Frozen (preferred): 30 days
Refrigerated: 6 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Hemolysis: OK
Lipemia: OK
Icterus: OK

Methodology
The 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 and 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 or purple lines. When there are no HIV antibodies, there are no pink or purple lines in the test area. The sample continues to migrate through the membrane and a pink or purple line 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.(Package insert: Geenius HIV 1/2 Supplemental Assay. Bio-Rad Laboratories; 09/2017)

FDA Status
Approved

Setup Schedule

Monday - Friday

Report Available

2 days

Limitations

A negative result for both HIV-1 and HIV-2 antibodies does not rule-out acute HIV infection.

All initially positive supplemental or confirmatory HIV test results should be verified by submitting a second specimen for repeat testing. Such positive HIV test results are required under laws in many states in the United States to be reported to the departments of health of the respective states where the patients reside.

Participation in the recipients of HIV-1 vaccine (eg, participants in HIV-1 vaccine study trials) may develop vaccine-specific antibodies that may cross-react with this test and yield to the vaccine giving a positive, indeterminate, or unreadable HIV-1 antibody result, while they may or may not be infected with HIV-1.

Assay performance characteristics have not been established for the following specimen characteristics:
-Heat-inactivated specimens
-Cadaveric specimens
-Presence of particulate matter

Reference Range

Included with report

Clinical Significance

Confirmation and differentiation of HIV-1 and HIV-2 antibodies in plasma specimens that show reactive results with third-(HIV-1/-2 antibody only) and 4th-generation (HIV antigen and antibody) HIV serologic assays

This test is not useful as a screening test for HIV infection in symptomatic or asymptomatic individuals.

This test is not to be used as a screening or confirmatory test for blood donor specimens.

Performing Laboratory
Mayo Clinic Laboratories, Rochester, Minnesota

Additional Information
HIV-1 and HIV-2 Antibody Confirmation and Differentiation, Plasma

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.