Test Code HVCOP HIV-1 and HIV-2 Antigen and Antibody Routine Screen, Plasma
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.
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 children up to 2 years of age. Diagnosis of HIV infection in newborns and children up to 2 years of age should be made by virologic tests, such as detection of HIV RNA (HIP12 / HIV-1/HIV-2 RNA Detection, Plasma).
New York State clients: This test should not be requested for maternal or 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: Lavender top (EDTA)
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 plasma into a plastic vial.
Secondary ID
48341Useful For
Screening for HIV-1 and HIV-2 infection in nonsymptomatic, nonpregnant individuals older than 2 years
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 |
---|---|---|---|
HVDIP | HIV Ab Confirm / Differentiation, P | Yes | No |
HIP12 | HIV-1/HIV-2 RNA Detect, P | Yes | No |
HIVQN | HIV-1 RNA Detect/Quant, P | 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.
-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 from the HIV-1/-2 confirmation/differentiation, 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
For more information see HIV Testing Algorithm (Fourth Generation Screening Assay), Including Follow-up of Reactive Rapid Serologic Test Results.
Special Instructions
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
Reporting Name
HIV-1/-2 Ag and Ab Screen, PSpecimen Type
Plasma EDTASpecimen Minimum Volume
1 mL
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Plasma EDTA | 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 an 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 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 (HIP12 / HIV-1/HIV-2 RNA Detection, Plasma) 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 the 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 second 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 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 RochesterTest 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
G0475
86701 (if appropriate)
86702 (if appropriate)
87536 (if appropriate)
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
HVCOP | HIV-1/-2 Ag and Ab Screen, P | 56888-1 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
HIVC3 | HIV-1/-2 Ag and Ab Screen, P | 56888-1 |
Forms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916)