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Test ID HVDIP HIV-1 and HIV-2 Antibody Confirmation and Differentiation, Plasma


Advisory Information


1. 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 should be made by virologic tests, such as detection of HIVQN / HIV-1 RNA Detection and Quantification, Plasma.

2. Except for patients who were reactive by the Determine HIV-1/-2 Ag/Ab Combo rapid point-of-care test on serum or plasma (but not whole blood), this test is not suitable for follow-up testing of patients with reactive results from any rapid HIV tests, regardless of the specimen type tested. 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, per the latest CDC recommended HIV testing algorithm.

3. If specimens are autopsy or cadaver blood sources, the proper FDA-licensed assay is HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum.

4. 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: Aliquot Tube, 5 mL (T465)

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube 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 fourth-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. It 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
HIVQN HIV-1 RNA Detect/Quant, P Yes No

Testing Algorithm

This test is for confirmation and differentiation of HIV-1/2 antibodies. If the following result types are obtained then HIV-1 RNA detection and quantification will be performed at an additional charge:

-HIV-1 and HIV-2 both negative

-Indeterminate for HIV-1 and negative for HIV-2

-Negative for HIV-1 and indeterminate for HIV-2

-HIV-1 and HIV-2 both indeterminate

 

See HIV Testing Algorithm (Fourth Generation Screening Assay), Including Neonatal Testing and Follow-up of Reactive Rapid Serologic Test Results in Special Instructions.

Method Name

Rapid Immunochromatographic Assay

Reporting Name

HIV Ab Confirm / Differentiation, P

Specimen Type

Plasma

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

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

Reference Values

Negative

Day(s) and Time(s) Performed

Monday through Friday; Varies

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved or is exempt by the U.S. 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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HVDIP HIV Ab Confirm / Differentiation, P 89365-1

 

Result ID Test Result Name Result LOINC Value
91947 HIV-1 Ab Differentiation, P 68961-2
91951 HIV-2 Ab Differentiation, P 81641-3

NY State Approved

Yes