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For hours, walk-ins and appointments.PrEP Use Only: HIV p24 Antigen/Antibody With Reflex to Confirmation
CPT:
87389
|
87389 |
| 8738987389 |
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 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).
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.
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
Usual blood collection technique. Do not freeze serum gel tubes; send to the lab refrigerated.
Storage Instructions
Refrigerate.
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Refrigerate. |
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Refrigerate.. |
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) |
Note: Stability provided by manufacturer or literature reference. |
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Test Details
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).
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 (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 |
| 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 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 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 2 | 083912 | PrEP: HIV-1/HIV-2 Qual RNA | 139826 | HIV-1 RNA | 25835-0 | |
| 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 2 | 083912 | PrEP: HIV-1/HIV-2 Qual RNA | 139827 | HIV-2 RNA | 69353-1 | |
| 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 | 083954 | Interpretation: | 80203-3 | |
| Reflex 2 | 083912 | PrEP: HIV-1/HIV-2 Qual RNA | 083965 | Final Interpretation | 85380-4 | |
| 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 2 | 083912 | PrEP: HIV-1/HIV-2 Qual RNA | 083944 | HIV 1/2 Supplemental Ab Test | N/A | |
| 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 2 | 083911 | PrEP: HIV-1/HIV-2 Qual RNA | 139826 | HIV-1 RNA | 25835-0 | |
| 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 2 | 083911 | PrEP: HIV-1/HIV-2 Qual RNA | 139827 | HIV-2 RNA | 69353-1 | |
| 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 | 083954 | Interpretation: | 80203-3 | |
| Reflex 2 | 083911 | PrEP: HIV-1/HIV-2 Qual RNA | 083963 | Final Interpretation | 85380-4 | |
| 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 2 | 083911 | PrEP: HIV-1/HIV-2 Qual RNA | 083944 | HIV 1/2 Supplemental Ab Test | N/A | |
| 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 2 | 083913 | PrEP: HIV-1/HIV-2 Qual RNA | 139826 | HIV-1 RNA | 25835-0 | |
| 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 2 | 083913 | PrEP: HIV-1/HIV-2 Qual RNA | 139827 | HIV-2 RNA | 69353-1 | |
| 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 | 083954 | Interpretation: | 80203-3 | |
| Reflex 2 | 083913 | PrEP: HIV-1/HIV-2 Qual RNA | 083967 | Final Interpretation | 85380-4 | |
| 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 2 | 083913 | PrEP: HIV-1/HIV-2 Qual RNA | 083944 | HIV 1/2 Supplemental Ab Test | N/A | |
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