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