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PrEP Use Only: HIV Antigen/Antibody and HIV RNA, Qualitative
CPT:
87389; 87535; 87538
Synonyms
- HIV PrEP
- pre-exposure prophylaxis screening for HIV
Test Includes
HIV p24 antigen/antibody screen for HIV-1 antibody; HIV-2 antibody and HIV-1 p24 antigen by EIA; HIV-1/HIV-2 RNA testing by qualitative nucleic acid amplification (NAA). EIA positive specimens reflex to an HIV-1/HIV-2 antibody differentiation assay.
Special Instructions
PrEP use only. Contains CPT code modifier.
This profile requires a dedicated, unopened, gel-barrier tube and a frozen (preferred) or refrigerated serum pour-off tube.
Tests included within this profile 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 testing about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Expected Turnaround Time
3 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Specimen Requirements
Specimen
Serum
Volume
2.5 mL
Minimum Volume
1.5 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube or red-top tube
Collection
Collect using the usual blood collection technique. Do not freeze serum gel tubes; send to the lab refrigerated. Send frozen or refrigerated serum for RNA test in serum pour-off tube.
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Collect using the usual blood collection technique. Do not freeze serum gel tubes; send to the lab refrigerated. Send frozen or refrigerated serum for RNA test in serum pour-off tube. |
Storage Instructions
HIV Ag/Ab: gel barrier-tubes refrigerated up to 7 days
HIV RNA: frozen up to 6 weeks or refrigerated up to 7 days
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HIV RNA: frozen up to 6 weeks |
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HIV Ag/Ab: gel barrier-tubes refrigerated up to 7 days HIV RNA: frozen up to 6 weeks or refrigerated up to 7 days |
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 7 days |
| Frozen | 6 weeks |
Note: Stability provided by manufacturer or literature reference.
Causes for Rejection
Hemolysis; lipemia; received outside of specimen and/or storage and/or labeling requirements; aliquot received for HIV Ag/Ab testing; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested
Test Details
Use
PrEP use only: This profile includes HIV p24 antigen/antibody with reflex to antibody differentiation and HIV-1/2 qualitative RNA to support baseline assessment and monitoring of patients on PrEP for HIV infection.
Limitations
HIV p24 antigen/antibody specimens with reactive results 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) Qualitative nucleic acid amplification (NAA) for HIV-1 and HIV-2 RNA
References
Centers for Disease Control and Prevention (CDC). Pre-Exposure Prophylaxis (PrEP). CDC website: https://www.cdc.gov/hiv/risk/prep/. Accessed January 2024.
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