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Test Code HVPRS HIV Antigen and Antibody Prenatal Routine Screen, Serum


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.

 

This test should not be used to test symptomatic individuals (ie, diagnostic purposes). For testing such patients, order HIVDS / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Serum.

 

This test should not be used to screen or test asymptomatic, nonpregnant individuals. For testing such patients, order HIVSS / HIV-1 and HIV-2 Antigen and Antibody Routine Screen, 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.



Specimen Required


Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection Container/Tube: Serum gel

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 serum into a plastic vial.


Forms

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

Secondary ID

617827

Useful For

Screening for HIV-1 and HIV-2 infection in nonsymptomatic pregnant patients

 

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
HVPPS HIV Ab Differentiation Prenatal, S Yes No
HPS12 HIV-1/HIV-2 RNA Detect Prenatal, S Yes No

Testing Algorithm

This test begins with HIV-1/-2 antigen and antibody (Ab) 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

 

For more information see HIV Prenatal Testing Algorithm, Including Follow-up of Reactive Rapid Serologic Test Results

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Specimen Type

Serum SST

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST 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 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 (HPS12 / HIV-1/HIV-2 RNA Detection, Prenatal, Serum) 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 Prenatal Testing Algorithm, Including Follow-up of Reactive Rapid Serologic Test Results

Method Description

The Elecsys HIV DUO assay is based on the sandwich principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HIV-1 p24 antigen (Ag) present in patient’s sample first reacts with biotinylated monoclonal anti-p24 antibodies and ruthenylated monoclonal anti-p24 antibodies, to form a sandwich complex. In a separate reaction vessel, HIV-1 and HIV-2 antibodies (Ab) present in the same sample react with biotinylated HIV-specific recombinant antigens/peptides and ruthenylated HIV-specific recombinant antigens/peptides, to form a sandwich complex. After addition of streptavidin-coated microparticles (solid phase) to each reaction vessel, the complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixtures are then each aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode which induces chemiluminescent emissions that are measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the reactions to the cutoff index values set from reagent lot-specific assay calibration for the corresponding HIV-1 p24 Ag and HIV Ab.(Package insert: Elecsys HIV DUO. Roche Diagnostics; v1.0, 12/2020)

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87389

G0475 (if appropriate)

86701 (if appropriate)

86702 (if appropriate)

87535 (if appropriate)

87538 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HVPRS HIV-1/-2 Ag and Ab Prenatal Scrn, S 56888-1

 

Result ID Test Result Name Result LOINC Value
HIVS5 HIV-1/-2 Ag and Ab Prenatal, S 56888-1