HIV-1 and HIV-2 Antibody Confirmation and Differentiation, Plasma (not for screening purposes)
Synonym(s)
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)
Test ID
HVDIP
General Information
Useful for:
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 fourth-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, oras a screening or confirmatory test for blood donor specimens
Testing Algorithm:
This test is for confirmation and differentiation of HIV-1/2 antibodies
If the following result types are obtained, HIV-1 RNA detection and quantification will be performed at an additional charge:
Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes)
Aliquot plasma into plastic vial.
Required Information
Date of collection is required
Stability
Frozen (preferred): 30 days
Refrigerated: 6 days
Limitations
Screening, supplemental, or confirmatory serologic tests for HIV-1 or HIV-2 antibodies cannot distinguish between active neonatal HIV infection and passive transfer of maternal HIV antibodies in infants during the postnatal period (up to 2 years). Diagnosis of HIV infection in newborns and infants up to 2 years should be made by virologic tests, such as detection of HIVQN / HIV-1 RNA Detection and Quantification, Plasma
This test is not suitable for follow-up testing of patients with reactive results from any rapid HIV tests, regardless of specimen type tested, with the exception of patients who were reactive by the Determine HIV-1/-2 Ag/Ab Combo rapid point-of-care test on serum or plasma (but not whole blood). Per the latest CDC recommended HIV testing algorithm, the patients with reactive results from any rapid HIV tests should be tested subsequently with laboratorybased HIV antigen and antibody combination immunoassays, such as HIVDX / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Plasma
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 vaccinespecific 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
Presence of particulate matter
Cadaveric specimens
If specimens are autopsy or cadaver blood sources, the proper FDA-licensed assay is HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum
