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For hours, walk-ins and appointments.PrEP, Male, Injectable Monitor + HIV RNA
CPT:
86780; 87389; 87491; 87535; 87538; 87591
Synonyms
- HIV
- PrEP
- Prophylaxis
Test Includes
HIV p24 antigen/antibody with reflex to antibody differentiation; HIV-1/2 qualitative RNA; T. pallidum antibody w/reflex to RPR (with titer); Chlamydia/Gonococcus, NAA
Special Instructions
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
2 - 3 days (testing performed daily)
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.
Related Documents
Specimen Requirements
Specimen
Serum and urine
Volume
5 mL serum and 2 mL of a 20 mL to 30 mL urine collection
Minimum Volume
3.75 mL serum (this volume does not allow for repeat testing) and 2 mL of a 15 mL urine collection
Container
Gel-barrier tube and APTIMA® urine specimen transport
Collection
Serum specimen: Usual blood collection technique.
Urine specimen: The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Add urine to the APTIMA® Combo 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL). PCR test: Centrifuge sample within 24 hours of collection. Transfer serum to a screw-cap polypropylene transport tube. Ship frozen (preferred) or refrigerated.
Storage Instructions
Serum: Gel-barrier tubes refrigerated up to 7 days
PCR test: Frozen up to 6 weeks
APTIMA® Urine: Maintain at room temperature or refrigerate (2°C to 30°C)
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | Urine: 30 days (stability provided by manufacturer or literature reference) |
Refrigerated | Serum: 7 days (stability provided by manufacturer or literature reference) |
Frozen | Serum: 6 weeks (stability provided by manufacturer or literature reference) |
Freeze/thaw cycles | Serum: Stable x4 (stability provided by manufacturer or literature reference) |
Patient Preparation
Patient should not have urinated for one hour prior to specimen collection.
Causes for Rejection
Hemolysis; lipemia; received outside of specimen and/or storage and/or labeling requirements; aliquot received for HIV testing; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; APTIMA® urine transport >30 days from collection; APTIMA® urine transport with incorrect specimen volume
Test Details
Use
This profile aligns with current guidelines for monitoring male patients on injectable HIV PrEP.
The profile includes HIV Antibody/p24 Antigen and HIV-1/2 RNA for the detection of HIV infection; Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid amplification; serologic testing for syphilis.
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
See individual test components.
References
Centers for Disease Control and Prevention (CDC). Pre-Exposure Prophylaxis (PrEP). CDC website: https://www.cdc.gov/hiv/clinicians/prevention/prep.html. Accessed January 2023.
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 254736 | PrEP Monitor Inj+HIV RNA (M) | 083903 | HIV Antibody/p24 Antigen | 56888-1 | ||
| 254736 | PrEP Monitor Inj+HIV RNA (M) | 139826 | HIV-1 RNA | 25835-0 | ||
| 254736 | PrEP Monitor Inj+HIV RNA (M) | 139827 | HIV-2 RNA | 69353-1 | ||
| 254736 | PrEP Monitor Inj+HIV RNA (M) | 083969 | Test Information | 55752-0 | ||
| 254736 | PrEP Monitor Inj+HIV RNA (M) | 082356 | T pallidum Antibodies | 47236-5 | ||
| 254736 | PrEP Monitor Inj+HIV RNA (M) | 188078 | Chlamydia trachomatis, NAA | 43304-5 | ||
| 254736 | PrEP Monitor Inj+HIV RNA (M) | 188086 | Neisseria gonorrhoeae, NAA | 43305-2 | ||
| 254736 | PrEP Monitor Inj+HIV RNA (M) | 019054 | N/A |
| Reflex Table for HIV Antibody/p24 Antigen | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 083938 | HIV 1/2 Ab Differentiation | 083907 | HIV 1 Ab | 68961-2 | |
| Reflex Table for HIV Antibody/p24 Antigen | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 083938 | HIV 1/2 Ab Differentiation | 083908 | HIV 2 Ab | 81641-3 | |
| Reflex Table for T pallidum Antibodies | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 082361 | PrEP: RPR | 006097 | RPR | 20507-0 | |
| Reflex 2 | 006476 | RPR, Quant | 006476 | RPR, Quant | titer | 31147-2 |
| Reflex Table for T pallidum Antibodies | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 082361 | PrEP: RPR | 006097 | RPR | 20507-0 | |
| Reflex 2 | 163038 | T pallidum Antibody, EIA | 163038 | T pallidum Antibody, EIA | 34147-9 | |
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