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Test ID HIVSP HIV Antigen and Antibody Prenatal Routine Screen, Plasma


Advisory Information


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

 

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 old). Diagnosis of HIV infection in newborns and infants up to 2 years old should be made by virologic tests, such as detection of HIV-1 DNA and RNA (HIVP / HIV-1 DNA and RNA Qualitative Detection by PCR, Plasma) or HIV-1 RNA (HIVQN / HIV-1 RNA Detection and Quantification, 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


Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 4 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. Transfer plasma into aliquot tube.


Useful For

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

 

This test is not offered as a screening or confirmatory test for blood donor specimens.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HVDSP HIV Ab Differentiation Prenatal, P Yes No
HIQNP HIV-1 RNA Detect/Quant Prenatal, P Yes No

Testing Algorithm

This test begins with HIV-1/-2 antigen and antibody screen by the chemiluminescence immunoassay method. If the screen result is reactive, then HIV-1/-2 antibody differentiation test by immunochromatographic method is performed at an additional charge.

 

If HIV-1/-2 antibody differentiation is negative for both HIV-1 antibody and HIV-2 antibody, or indeterminate/negative for HIV-1/HIV-2 antibody, or indeterminate/indeterminate for HIV-1/ HIV-2 antibody, then HIV-1 RNA prenatal will be performed at an additional charge.

 

The following algorithms are available in Special Instructions:

-HIV Prenatal Testing Algorithm, Including Follow-up of Reactive Rapid Serologic Test Results

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

Method Name

Chemiluminescent Microparticle Immunoassay

Reporting Name

HIV-1/-2 Ag and Ab Prenatal Scrn, P

Specimen Type

Plasma

Specimen Minimum Volume

1.2 mL

Specimen Stability Information

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

Reference Values

Negative

Day(s) and Time(s) Performed

Monday through Saturday; Varies

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared or approved 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

87389

G0475

LOINC Code Information

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

 

Result ID Test Result Name Result LOINC Value
HIVC5 HIV-1/-2 Ag and Ab Prenatal Scrn, P 56888-1

NY State Approved

Yes