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HelpTest Code HIVDX HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Plasma
Reporting Name
HIV-1/-2 Ag and Ab Diagnostic, PPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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.
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
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 infants up to 2 years of age. Diagnosis of HIV infection in newborns and infants 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/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.
Specimen 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 |
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 (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 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
Day(s) Performed
Monday through Saturday
Report Available
1 to 3 daysTest 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)
87536 (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HIVDX | HIV-1/-2 Ag and Ab Diagnostic, P | 56888-1 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| HIVC4 | HIV-1/-2 Ag and Ab Diagnostic, P | 56888-1 |
Forms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.
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 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
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
The following algorithms are available: