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Test ID HIVDI HIV-1 and HIV-2 Antibody Confirmation and Differentiation, Serum

Useful For

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

Testing Algorithm

This HIV-1 and HIV-2 antibody confirmation and differentiation test begins with Geenius HIV-1/2 Supplemental Assay (Bio-Rad Laboratories).

 

For explanation of testing algorithm involving this assay, see HIV Testing Algorithm (Fourth Generation Screening Assay) including Follow-up of Reactive HIV Rapid Serologic Test Results in Special Instructions.

Method Name

Rapid Immunochromatographic Assay

Reporting Name

HIV Ab Confirm / Differentiation, S

Specimen Type

Serum

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Spin down and remove serum from clot within 24 hours.

Additional Information: 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.

Specimen Minimum Volume

0.1 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen (preferred) 30 days
  Refrigerated  14 days
  Ambient  48 hours

Clinical Information

AIDS is caused by 2 known types of HIV. HIV type 1 (HIV-1) is found in patients with AIDS, AIDS-related complex, and asymptomatic infected individuals at high risk for AIDS. The virus is transmitted by sexual contact, by exposure to infected blood or blood products, or from an infected mother to her fetus or infant. HIV type 2 (HIV-2) infection is endemic only in West Africa, and it has been identified in individuals who had sexual relations with individuals from that geographic region. HIV-2 is similar to HIV-1 in viral morphology, overall genomic structure, and its ability to cause AIDS.

 

Antibodies against HIV-1 and HIV-2 are usually not detectable until 6 to 12 weeks following exposure and are almost always detectable by 12 months. They may fall to undetectable levels (ie, seroreversion) in the terminal stage of AIDS when the patient's immune system is severely depressed.

 

Routine serologic screening of patients at risk for HIV-1 or HIV-2 infection usually begins with a HIV-1/-2 antigen and/or antibody screening test, which may be performed by various FDA-approved assay methods, including rapid HIV antibody tests, enzyme immunoassays, chemiluminescent immunoassays. In testing algorithms that begin with these methods, supplemental or confirmatory testing should be requested only for specimens that are repeatedly reactive by these methods according to assay manufacturers' instructions for use.

Reference Values

Negative

 

See HIV Serologic Interpretive Guide in Special Instructions for further interpretive information.

Cautions

This test is not offered as a screening test for HIV infection in symptomatic or asymptomatic individuals. It is not to be used as a screening or confirmatory test for blood donor specimens.

 

This test is not offered for maternal or newborn HIV screening for specimens originating in New York State.

 

This test is not suitable for follow-up testing of patients with reactive results from any rapid HIV tests. These patients should be tested subsequently with laboratory-based HIV antigen and antibody combination immunoassays, such as HIVCO / HIV-1 and HIV-2 Antigen and Antibody Evaluation, Serum at Mayo Medical Laboratories, per the latest CDC recommended HIV testing algorithm.

 

A negative result for both HIV-1 and HIV-2 antibodies does not rule-out acute HIV infection. If acute HIV-1 infection is suspected, detection of HIV-1 RNA (HIVDQ / HIV-1 RNA Detection and Quantification, Plasma) is recommended. For patients at risk for HIV-2 infection (eg, having lived in West Africa or have sexual partners from West Africa), testing for HIV-2 DNA/RNA (FHV2Q / HIV-2 DNA/RNA Qualitative Real-Time PCR) is recommended.

 

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.

 

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 18 months). Diagnosis of HIV infection in newborns and infants up to 18 months should be made by virologic tests, such as detection of HIV RNA (HIVDQ / HIV-1 RNA Detection and Quantification, Plasma).

 

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

Day(s) Performed

Monday through Friday; Varies

Report Available

1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86701-HIV-1 Antibody

86702-HIV-2 Antibody

NY State Approved

Yes