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


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.

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) Performed

Monday through Friday

Report Available

1 to 3 days

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

86701

86702

87535 (if appropriate)

87538 (if appropriate)

87536 (if appropriate)

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

Forms

If not ordering electronically, complete, print, and send an Infectious Disease Serology Test Request (T916) with the specimen.