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PrEP Use Only: HIV p24 Antigen/Antibody With Reflex to Confirmation

Test Number 083909
Test number copied
CPT 87389
Synonyms
  • HIV antigen/antibody
  • HIV antigen/antibody with Reflex
  • HIV PrEP
  • HIV-1
  • HIV-2
  • Human immunodeficiency virus
  • p24
  • pre-exposure prophylaxis screening for HIV

Test Details

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)

Result Turnaround Time

1 - 2 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.

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).

Use

This test is used for baseline testing and monitoring for HIV in patients administered HIV PrEP (CDC-recommended algorithm for laboratory diagnosis of HIV infection, including acute and primary infection).

Special Instructions

PrEP use only. Contains CPT code modifier for CARES Act.

This test requires a dedicated, unopened, specimen tube sent directly to the testing facility.

If reflex test is performed, additional charges/CPT code(s) may apply.

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.

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.

Specimen Requirements

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

Collection Instructions

Usual blood collection technique. Do not freeze serum gel tubes; send to the lab refrigerated.

Stability Requirements

Temperature

Period

Refrigerated

7 days (stability provided by manufacturer or literature reference)

Frozen

14 days (stability provided by manufacturer or literature reference) *This stability information is intended for laboratory storage. Do not freeze serum gel tubes - send to the lab refrigerated.)

Freeze/thaw cycles

Stable x5 (stability provided by manufacturer or literature reference)

Storage Instructions

Refrigerate.

References

Association of Public Health Laboratories (APHL). Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm. APHL website: https://www.aphl.org/aboutAPHL/publications/Documents/ID-2019Jan-HIV-Lab-Test-Suggested-Reporting-Language.pdf. Published January 2019. Accessed November 2019.
Branson BM, Owen MS, Wesolowski LG, et al. Laboratory testing for the diagnosis of HIV infection: updated recommendations. Published June 27, 2014. Accessed November 2019 at https://stacks.cdc.gov/view/cdc/23447.
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.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
083909 PrEP: HIV Ag/Ab with Reflex 75622-1 083936 HIV Ab/p24 Ag Screen 56888-1
Order Code083909
Order Code NamePrEP: HIV Ag/Ab with Reflex
Order Loinc75622-1
Result Code083936
Result Code NameHIV Ab/p24 Ag Screen
UofM
Result LOINC56888-1
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083941 HIV 1 Ab 68961-2
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083941
Result NameHIV 1 Ab
UofM
Result LOINC68961-2
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083942 HIV 2 Ab 81641-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083942
Result NameHIV 2 Ab
UofM
Result LOINC81641-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3
Reflex Table for HIV Ab/p24 Ag Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083910 PrEP: HIV 1/2 Ab 083954 Interpretation: 80203-3
Reflex 1
Order Code083910
Order NamePrEP: HIV 1/2 Ab
Result Code083954
Result NameInterpretation:
UofM
Result LOINC80203-3