PrEP, Male, Injectable Monitor (No HIV RNA)

TEST: 254937
Test number copied
CPT: 86780; 87389; 87491; 87591
Print Share

Synonyms

  • HIV
  • PrEP
  • Prophylaxis

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

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

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

Minimum Volume

3 mL (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 screen with reflex 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
254937 PrEP Monitor Inj (M) 083936 HIV Ab/p24 Ag Screen 56888-1
254937 PrEP Monitor Inj (M) 082356 T pallidum Antibodies 47236-5
254937 PrEP Monitor Inj (M) 188078 Chlamydia trachomatis, NAA 43304-5
254937 PrEP Monitor Inj (M) 188086 Neisseria gonorrhoeae, NAA 43305-2
254937 PrEP Monitor Inj (M) 019054 PDF 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 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
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

For Providers

Please login to order a test

Order a Test

© 2021 Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.

CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf