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Test Code HIVDX HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, 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 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.


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.

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:

-HIV Testing Algorithm (Fourth-Generation Screening Assay), Including Follow-up of Reactive Rapid Serologic Test Results.

-Meningitis/Encephalitis Panel Algorithm

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Reporting Name

HIV-1/-2 Ag and Ab Diagnostic, P

Specimen Type

Plasma EDTA

Specimen 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

Day(s) Performed

Monday through Saturday

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

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.