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

Reporting Name

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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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.

Method Name

Electrochemiluminescence Immunoassay (ECLIA)


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.

 

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. Transfer plasma into a plastic vial.


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

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 (HPP12 / HIV-1/HIV-2 RNA Detection Prenatal, Plasma) 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.

 

The following algorithms are available:

-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

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

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

G0475 (if appropriate)

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

Forms

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

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HVDSP HIV Ab Differentiation Prenatal, P Yes No
HPP12 HIV-1/HIV-2 RNA Detect 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 (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

 

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