PrEP, Male, Injectable Monitor + HIV RNA

CPT: 86780; 87389; 87491; 87535; 87538; 87591
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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)


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 PDF 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 082348 Treponemal Antibodies, TPPA 082349 Treponemal Antibodies, TPPA 24312-1
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 082348 Treponemal Antibodies, TPPA 010003 Interpretation: N/A

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