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HelpOrder Code HVDIP HIV-1 and HIV-2 Antibody Confirmation and Differentiation, Plasma
Additional Codes
RMC Reflex Order Code: LABHVDIP
Mayo Code: HVDIP
Ordering Guidance
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 infants up to 2 years should be made by virologic tests, such as detection of HIV-RNA (HIP12 / HIV-1/HIV-2 RNA Detection, Plasma).
This test is not suitable for follow-up testing of patients with reactive results from any rapid HIV tests, regardless of specimen type tested, with the exception of patients who were reactive by the Determine HIV-1/-2 Antigen/Antibody Combo rapid point-of-care test on serum or plasma (but not whole blood). Per the latest Centers for Disease Control and Prevention recommended HIV testing algorithm, the patients with reactive results from any rapid HIV tests 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.
If specimens are autopsy or cadaver blood sources, the proper US Food and Drug Administration-licensed assay is HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, 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.
Necessary Information
Date of collection is required.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Lavender top (EDTA)
Submission Container/Tube: Plastic vial
Specimen Volume: 1 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 plastic vial
Useful For
Confirmation and differentiation of HIV-1 and HIV-2 antibodies in plasma specimens that show reactive results with third-(HIV-1/-2 antibody only) and 4th-generation (HIV antigen and antibody) HIV serologic assays
This test is not useful as a screening test for HIV infection in symptomatic or asymptomatic individuals.
This test is not to be used as a screening or confirmatory test for blood donor specimens.
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HIP12 | HIV-1/HIV-2 RNA Detect, P | Yes | No |
| HIVQN | HIV-1 RNA Detect/Quant, P | Yes | No |
Testing Algorithm
This test is for confirmation and differentiation of HIV-1/2 antibodies (Ab). If the following result types are obtained, 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, 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 Neonatal Testing and Follow-up of Reactive Rapid Serologic Test Results.
Special Instructions
Method Name
Rapid Immunochromatographic Assay
Reporting Name
HIV Ab Confirm / Differentiation, PSpecimen Type
PlasmaSpecimen Minimum Volume
0.8 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Plasma | Frozen (preferred) | 30 days | |
| Refrigerated | 6 days |
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
Reference Values
Negative
Method Description
The Geenius HIV 1/2 Supplemental Assay cassette contains antibody-binding protein A, which is conjugated to colloidal gold dye particles, and HIV-1 and HIV-2 antigens, which are bound to the membrane solid phase. The sample is applied to the sample and buffer well. After the sample and buffer have migrated onto the test strip, additional buffer is added to the buffer well. The buffer causes the specimens and reagents to flow laterally and facilitates the binding of antibodies to the antigens. In a reactive sample, the antibodies are captured by the antigens immobilized in the test area.
The protein A-colloidal gold binds to the captured antibodies, causing development of pink or purple lines. When there are no HIV antibodies, there are no pink or purple lines in the test area. The sample continues to migrate through the membrane and a pink or purple line develops in the control (C) area, which contains Protein A. This built-in procedural control provides evidence that the test was performed properly and that the sample and reagents have migrated through the cassette.(Package insert: Geenius HIV 1/2 Supplemental Assay. Bio-Rad Laboratories; 07/2019)
Day(s) Performed
Monday through Friday
Performing Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
86701
86702
87535 (if appropriate)
87538 (if appropriate)
87536 (if appropriate)
Forms
If not ordering electronically, complete, print, and send an Infectious Disease Serology Test Request (T916) with the specimen.