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PrEP, Male, Oral Monitor (No HIV RNA)

CPT 86780; 87389; 87491; 87591
Synonyms
  • HIV
  • PrEP
  • Prophylaxis

Test Details

Methodology

See individual test components.

Result 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

Test Includes

HIV p24 antigen/antibody with reflex to antibody differentiation and HIV-1/2 qualitative RNA, if indicated; T. pallidum antibody w/reflex to RPR (with titer); Chlamydia/Gonococcus, NAA

Use

This profile aligns with current guidelines for monitoring male patients on oral HIV PrEP.

The profile includes HIV Antibody/p24 Antigen screen with reflex for the detection of HIV infection; Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid amplification; serologic testing for syphilis.

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.

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.

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.

Specimen Requirements

Specimen

Serum and urine

Volume

4 mL serum and 2 mL of a 20 mL to 30 mL urine collection

Minimum Volume

3 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 Instructions

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.

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)

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)

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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
254892 PrEP Monitor Oral (M) 083936 HIV Ab/p24 Ag Screen 56888-1
254892 PrEP Monitor Oral (M) 082356 T pallidum Antibodies 47236-5
254892 PrEP Monitor Oral (M) 188078 Chlamydia trachomatis, NAA 43304-5
254892 PrEP Monitor Oral (M) 188086 Neisseria gonorrhoeae, NAA 43305-2
254892 PrEP Monitor Oral (M) 019054 PDF 11502-2
Order Code254892
Order Code NamePrEP Monitor Oral (M)
Order Loinc
Result Code083936
Result Code NameHIV Ab/p24 Ag Screen
UofM
Result LOINC56888-1
Order Code254892
Order Code NamePrEP Monitor Oral (M)
Order Loinc
Result Code082356
Result Code NameT pallidum Antibodies
UofM
Result LOINC47236-5
Order Code254892
Order Code NamePrEP Monitor Oral (M)
Order Loinc
Result Code188078
Result Code NameChlamydia trachomatis, NAA
UofM
Result LOINC43304-5
Order Code254892
Order Code NamePrEP Monitor Oral (M)
Order Loinc
Result Code188086
Result Code NameNeisseria gonorrhoeae, NAA
UofM
Result LOINC43305-2
Order Code254892
Order Code NamePrEP Monitor Oral (M)
Order Loinc
Result Code019054
Result Code NamePDF
UofM
Result LOINC11502-2
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 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
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 1
Order Code082361
Order NamePrEP: RPR
Result Code006097
Result NameRPR
UofM
Result LOINC20507-0
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 1
Order Code082361
Order NamePrEP: RPR
Result Code006097
Result NameRPR
UofM
Result LOINC20507-0
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 1
Order Code082361
Order NamePrEP: RPR
Result Code006097
Result NameRPR
UofM
Result LOINC20507-0