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


Ordering Guidance


If testing is needed for autopsy or cadaver blood sourced specimens, order the US Food and Drug Administration-licensed assay: HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum.

 

This test should not be used to test or screen pregnant individuals. For testing such patients, order HVPPS / HIV-1 and HIV-2 Antibody Confirmation and Differentiation Prenatal, Serum.

 

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 old should be made by virologic tests, such as detection of HIV RNA (HIP12 / HIV-1/HIV-2 RNA Detection, Plasma or HIS12 / HIV-1/HIV-2 RNA Detection, Serum).

 

This test is not useful for follow-up testing of patients with reactive results from any rapid HIV tests. Per the latest Centers for Disease Control and Prevention recommended HIV testing algorithm, these patients should be tested subsequently with laboratory-based HIV antigen and antibody combination immunoassays, such as HIVDX / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Plasma or HIVDS / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Serum.



Necessary Information


Date of collection is required.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Centrifuge blood collection tube per manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into a plastic vial.


Forms

If not ordering electronically, complete, print, and send an Infectious Disease Serology Test Request (T916) with the specimen.

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 4th-generation (HIV antigen and antibody) HIV serologic assays

 

Confirmation and differentiation of HIV-1 and HIV-2 antibodies in cadaveric blood or hemolyzed serum specimens that show reactive results with initial HIV serologic screening assays

 

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

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HIS12 HIV-1/HIV-2 RNA Detect, S Yes No

Testing Algorithm

This HIV-1 and HIV-2 antibody (Ab) confirmation and differentiation test begins with Geenius HIV-1/2 supplemental assay.

 

This test is for confirmation and differentiation of HIV-1/2 antibodies. If the following result types are obtained, HIV-1/HIV-1 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

 

For more information see HIV Testing Algorithm (Fourth Generation Screening Assay), Including Follow-up of Reactive Rapid Serologic Test Results.

Method Name

Rapid Immunochromatographic Assay

Reporting Name

HIV Ab Confirm / Differentiation, S

Specimen Type

Serum

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 30 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Clinical Information

AIDS is caused by 2 known types of HIV. HIV type 1 (HIV-1) is found in patients with AIDS or AIDS-related complex and in 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 US Food and Drug Administration-approved assay methods, including rapid HIV antibody tests, enzyme immunoassays, and 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

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US 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

86702

87535 (if appropriate)

87538 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HIVDI HIV Ab Confirm / Differentiation, S 89365-1

 

Result ID Test Result Name Result LOINC Value
36112 HIV-1 Ab Differentiation, S 68961-2
36113 HIV-2 Ab Differentiation, S 81641-3