Human Immunodeficiency Virus HIV-1 antigen and HIV-1 & HIV-2 Antibodies
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| Updated | 3/15/2021 (reviewed 5/23/2023)
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Search Terms
| HIV Antigen and Antibody Combo Test |
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| How to Order |
On the
Virology/Immunology Test Request Form (OHA0042), in the “HIV” section, check the “HIV: HIV-1/HIV-2 Antibody/Antigen Screen” box. Include the time of specimen collection on the Test Request Form.
CTS submitters: Also include "HIV-CTS" in the "Study ID" box.
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| Availability | All clients |
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| Performed | Daily on regular business days
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| Time to Reporting | Within 3 working days after receipt of specimen |
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| CPT Code | 87389 |
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Specimen Collection Details |
| Collection | One 7 ml red top tube or serum separator tube (SST).
If SST tubes are used, follow instructions provided by the manufacturer.
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| Optimal Volume | Blood: 10 mL; Serum 2.5 mL |
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| Minimum Volume | Blood: 1-2 mL Serum: 1 mL
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| Handling | After blood clots, store specimens at refrigerated temperatures (2-8°C) pending transport.
If specimen will not arrive to the OSPHL within 69 hours of collection, separate serum from the clot if possible. The separated serum should be poured off into a sterile, leak proof blood tube. A separated serum-only specimen may be frozen and must remain frozen until receipt at the laboratory (see transport).
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| Transport |
Package specimens with fully frozen ice packs to maintain refrigerated temperatures during transport.
If serum has not been removed from the clot, transport specimens for receipt at the OSPHL within 69 hours of specimen collection, but no later than 7 days after specimen collection (see comments).
If serum is frozen, ship with dry ice to maintain frozen temperatures during transport. Specimen must be tested within 30 days.
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| Rejection Criteria | Refrigerated specimens not tested within 7 days of specimen collection. SST tubes for which the gel separating the serum is disturbed during transit. Frozen specimens not tested within 30 days.
Specimens contaminated with visible contamination, hemolysis, gross lipemia, cadaver specimens, specimens collected using citrate anticoagulants, specimens received at room temperature.
Specimens are subject to the requirements of the OSPHL Specimen Submission Policy and Criteria, available at
http://bitly.com/SpecimenCriteria. |
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| Comments |
Original material submitted for testing is retained for 7 calendar days after receipt at the laboratory. The test used will detect HIV-1 p24 antigen, HIV-1 & HIV-2 antibodies. Specimens reactive by
Chemiluminescent microparticle immunoassay (CMIA) will automatically be reflexed to an HIV differentiation test. When results from these two assays are discordant, specimens are forwarded to a reference lab for HIV-1 NAT viral load testing.
HIV screening test can only be performed using refrigerated specimens up to 7 days after specimen collection and frozen serum specimens up to 30 days.
Serum must be removed from the clot within 72 hours to ensure specimen can be tested for HIV differentiation if needed. If serum is not removed from the clot within 72 hours of collection, a second specimen will be required if HIV differentiation testing is indicated.
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Method Details |
Methodology
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Chemiluminescent microparticle immunoassay (CMIA) on the Abbott Diagnostics Alinity i platform
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Performance
Specifications
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Detailed information about assay performance can be obtained by contacting the manufacturer of the testing platform,
Abbott Diagnostics, or on the
US Food and Drug Administration website.
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