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Test Code HIVDS HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Serum


Ordering Guidance


If the specimen is obtained from either autopsy or cadaver blood sources, order HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum which is the US Food and Drug Administration-approved assay for these specimen types.

 

This test should not be used to screen or test asymptomatic, nonpregnant individuals. For testing such patients, order HIVSS / HIV-1 and HIV-2 Antigen and Antibody Routine Screen, Serum.

 

This test should not be used to test pregnant individuals. For testing such patients, order HVPRS / HIV Antigen and Antibody Prenatal Routine Screen, 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 old). 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 (HIS12 / HIV-1/HIV-2 RNA Detection, Serum).

 

New York State clients: This test should not be requested for maternal/newborn HIV screening on specimens originating in New York State, due to state regulatory requirements for expedited result reporting.



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 and aliquot 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.

Secondary ID

617825

Useful For

Detecting HIV-1 and HIV-2 infection in symptomatic patients older than 2 years

 

Follow-up testing of symptomatic individuals with reactive rapid HIV test results

 

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

Disease States

  • HIV-2 infection
  • HIV infection

Reflex Tests

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

Testing Algorithm

This test begins with HIV-1/-2 antigen and antibody (Ab) screen by electrochemiluminescence immunoassay. If the screen result is reactive, then HIV-1/-2 antibody confirmation/differentiation test by immunochromatographic method is performed at an additional charge.

 

If the following result types are obtained from the HIV-1/-2 confirmation/differentiation test, 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

 

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

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Reporting Name

HIV-1/-2 Ag and Ab Diagnostic, S

Specimen Type

Serum SST

Specimen Minimum Volume

1 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Heat-inactivated specimen Reject

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, but HIV p24 antigen should be detectable and yield reactive results with the HIV antigen-antibody combination detection assays.

 

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.

Reference Values

Negative

Interpretation

Negative HIV-1/-2 antigen and antibody screening test results usually indicate the absence of HIV-1 and HIV-2 infection. However, such negative results do not rule-out acute HIV infection. If acute HIV-1 or HIV-2 infection is suspected, detection of HIV RNA (HIS12 / HIV-1/HIV-2 RNA Detection, Serum) is recommended.

 

Reactive HIV-1/-2 antigen and antibody screening test results suggest the presence of HIV-1 and/or HIV-2 infection, but it is not diagnostic for HIV infection and should be considered preliminary. A reactive result does not differentiate among reactivity with HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody. Diagnosis of HIV infection must be based on results of supplemental tests, such as HIV antibody confirmation/differentiation test (automatically added to all samples with reactive screen test results at an additional charge).

 

All initially positive supplemental or confirmatory HIV test results (by serologic or molecular test methods) should be verified by submitting a plasma 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.

 

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

Method Description

The Elecsys HIV DUO assay is based on the sandwich principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HIV-1 p24 antigen (Ag) present in patient’s sample first reacts with biotinylated monoclonal anti-p24 antibodies and ruthenylated monoclonal anti-p24 antibodies, to form a sandwich complex. In a separate reaction vessel, HIV-1 and HIV-2 antibodies (Ab) present in the same sample react with biotinylated HIV-specific recombinant antigens/peptides and ruthenylated HIV-specific recombinant antigens/peptides, to form a sandwich complex. After addition of streptavidin-coated microparticles (solid phase) to each reaction vessel, the complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixtures are then each aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode which induces chemiluminescent emission that is measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the reactions to the respective cutoff index values set from reagent lot-specific assay calibration for the corresponding HIV-1 p24 Ag and HIV Ab.(Package insert: Elecsys HIV DUO. Roche Diagnostics; v1.0, 12/2020)

Day(s) Performed

Monday through Saturday

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

87389

86701 (if appropriate)

86702 (if appropriate)

87535 (if appropriate)

87538 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HIVDS HIV-1/-2 Ag and Ab Diagnostic, S 56888-1

 

Result ID Test Result Name Result LOINC Value
HIVS4 HIV-1/-2 Ag and Ab Diagnostic, S 56888-1