PrEP, Male, Injectable Monitor + HIV RNA

Test Number 254736

Test number copied

CPT 86780; 87389; 87491; 87535; 87538; 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.

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

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.

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

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 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	Result Code	Result Code Name	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	11502-2
Order Code	254736
Order Code Name	PrEP Monitor Inj+HIV RNA (M)
Order Loinc
Result Code	083903
Result Code Name	HIV Antibody/p24 Antigen
UofM
Result LOINC	56888-1
Order Code	254736
Order Code Name	PrEP Monitor Inj+HIV RNA (M)
Order Loinc
Result Code	139826
Result Code Name	HIV-1 RNA
UofM
Result LOINC	25835-0
Order Code	254736
Order Code Name	PrEP Monitor Inj+HIV RNA (M)
Order Loinc
Result Code	139827
Result Code Name	HIV-2 RNA
UofM
Result LOINC	69353-1
Order Code	254736
Order Code Name	PrEP Monitor Inj+HIV RNA (M)
Order Loinc
Result Code	083969
Result Code Name	Test Information
UofM
Result LOINC	55752-0
Order Code	254736
Order Code Name	PrEP Monitor Inj+HIV RNA (M)
Order Loinc
Result Code	082356
Result Code Name	T pallidum Antibodies
UofM
Result LOINC	47236-5
Order Code	254736
Order Code Name	PrEP Monitor Inj+HIV RNA (M)
Order Loinc
Result Code	188078
Result Code Name	Chlamydia trachomatis, NAA
UofM
Result LOINC	43304-5
Order Code	254736
Order Code Name	PrEP Monitor Inj+HIV RNA (M)
Order Loinc
Result Code	188086
Result Code Name	Neisseria gonorrhoeae, NAA
UofM
Result LOINC	43305-2
Order Code	254736
Order Code Name	PrEP Monitor Inj+HIV RNA (M)
Order Loinc
Result Code	019054
Result Code Name	PDF
UofM
Result LOINC	11502-2

Reflex Table for HIV Antibody/p24 Antigen
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	083938	HIV 1/2 Ab Differentiation	083907	HIV 1 Ab	68961-2
Reflex 1
Order Code	083938
Order Name	HIV 1/2 Ab Differentiation
Result Code	083907
Result Name	HIV 1 Ab
UofM
Result LOINC	68961-2

Reflex Table for HIV Antibody/p24 Antigen
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	083938	HIV 1/2 Ab Differentiation	083908	HIV 2 Ab	81641-3
Reflex 1
Order Code	083938
Order Name	HIV 1/2 Ab Differentiation
Result Code	083908
Result Name	HIV 2 Ab
UofM
Result LOINC	81641-3

Reflex Table for T pallidum Antibodies
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	082361	PrEP: RPR	006097	RPR	20507-0
Reflex 1
Order Code	082361
Order Name	PrEP: RPR
Result Code	006097
Result Name	RPR
UofM
Result LOINC	20507-0

Reflex Table for T pallidum Antibodies
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	082361	PrEP: RPR	006097	RPR	20507-0
Reflex 1
Order Code	082361
Order Name	PrEP: RPR
Result Code	006097
Result Name	RPR
UofM
Result LOINC	20507-0

Reflex Table for T pallidum Antibodies
	Order Code	Order Name	Result Code	Result Name	Result LOINC
Reflex 1	082361	PrEP: RPR	006097	RPR	20507-0
Reflex 1
Order Code	082361
Order Name	PrEP: RPR
Result Code	006097
Result Name	RPR
UofM
Result LOINC	20507-0

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