HIV p24 Antigen/Antibody With Reflex to Confirmation

CPT 87389. If reflex testing is performed, concomitant CPT codes/charges will apply.
Synonyms
  • HIV Antigen/Antibody
  • HIV-1
  • HIV-2
  • Human Immunodeficiency Virus
  • p24

Test Details

Use

CDC-recommended algorithm for laboratory diagnosis of HIV infection, including acute and primary infection

CDC-recommended algorithm for laboratory diagnosis of HIV infection, including acute and primary infection.

CDC-recommended algorithm for laboratory diagnosis of HIV infection, including acute and primary infection

Special Instructions

This test requires a dedicated, unopened, gel-barrier tube or red-top tube sent directly to the testing facility.

This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.

Test Includes

HIV p24 antigen/antibody screen for HIV-1 antibody, HIV-2 antibody, and HIV-1 p24 antigen by EIA; reflex of EIA positive specimens to a HIV-1/HIV-2 antibody differentiation assay; specimens positive by the screening assay but negative by the antibody differentiation assay reflex to HIV-1/HIV-2 RNA testing by qualitative nucleic acid amplification (NAA).

Limitations

Reactive (repeatedly) specimens must be investigated by additional supplemental tests. A negative test for an individual does not preclude exposure to or infection with HIV-1 and/or HIV-2. Negative results can occur if the quantity of the marker present in the sample is too low for detection by the assay or if the marker is not present during the stage of disease in which a sample is collected.

Methodology

(1) HIV antigen/antibody enzyme immunoassay (EIA) screen for antibodies to HIV-1 and HIV-2 and HIV-1 p24 antigen: Reflex to supplementary differentiation assay; (2) Screen positive with negative antibody typing: Reflex to qualitative nucleic acid amplification (NAA)

References

Association of Public Health Laboratories. Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm. APHL 2019. APHL Web site. https://www.aphl.org/aboutAPHL/publications/Documents/ID-2019Jan-HIV-Lab-Test-Suggested-Reporting-Language.pdf. Accessed November 2019.
Centers for Disease Control and Prevention. Laboratory testing for the diagnosis of HIV infection : updated recommendations. CDC Stacks Web site. https://stacks.cdc.gov/view/cdc/23447. Accessed November 2019.
Clinical and Laboratory Standards Institute. Criteria for Laboratory Testing and Diagnosis of the Human Immunodeficiency Virus Infection, Approved Guideline. M53-A. Wayne, Pa: CLSI; 2011.

Specimen Requirements

Information on collection, storage, and volume

Specimen

Serum

Volume

2 mL

Minimum Volume

1 mL (Note: This volume does not allow for repeat testing.)

Container

Gel-barrier tube or red-top tube

Storage Instructions

Refrigerate.

Refrigerate. Sample may be stored for two days at room temperature. For shipping, it is recommended that serum be refrigerated.

Refrigerate..

Causes for Rejection

Specimen aliquot; specimen grossly hemolyzed; specimen in container other than those listed; received outside of specimen and/or storage and/or labeling requirements

Collection

Usual blood collection technique (do not freeze serum gel tubes; send to the lab refrigerated)