PrEP, Male, Injectable Baseline + HIV RNA

TEST: 254972
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CPT: 86704; 86706; 86780; 86803; 87340; 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; HBV Baseline Evaluation - Hepatitis B Surface Antigen (HBsAg) screen with reflex to HBV quant DNA; Hepatitis B Surface antibody (anti-HBS); Hepatitis B Core antibody, Total (anti-HBc); Hepatitis C Virus (HCV) antibody with reflex to quantitative real-time PCR

Special Instructions

This profile requires a dedicated, unopened, gel-barrier tube and 2 frozen (preferred) or refrigerated serum pour-off tubes.

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

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

Minimum Volume

7 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 6 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: 6 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 assessment of male patients prior to the initiation of 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; serological assessment of HBV infection status; and reflexive testing for the detection of HCV infection.

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
254972 PrEP, BL Inj + HIV RNA (M) 083903 HIV Antibody/p24 Antigen 56888-1
254972 PrEP, BL Inj + HIV RNA (M) 139826 HIV-1 RNA 25835-0
254972 PrEP, BL Inj + HIV RNA (M) 139827 HIV-2 RNA 69353-1
254972 PrEP, BL Inj + HIV RNA (M) 083969 Test Information 55752-0
254972 PrEP, BL Inj + HIV RNA (M) 082356 T pallidum Antibodies 47236-5
254972 PrEP, BL Inj + HIV RNA (M) 188078 Chlamydia trachomatis, NAA 43304-5
254972 PrEP, BL Inj + HIV RNA (M) 188086 Neisseria gonorrhoeae, NAA 43305-2
254972 PrEP, BL Inj + HIV RNA (M) 019054 PDF N/A
254972 PrEP, BL Inj + HIV RNA (M) 006510 HBsAg Screen 5196-1
254972 PrEP, BL Inj + HIV RNA (M) 006408 Hep B Surface Ab, Qual 22322-2
254972 PrEP, BL Inj + HIV RNA (M) 006718 Hep B Core Ab, Tot 13952-7
254972 PrEP, BL Inj + HIV RNA (M) 144721 Rfx to HBcIgM 77202-0
254972 PrEP, BL Inj + HIV RNA (M) 006720 Interpretation 56850-1
254972 PrEP, BL Inj + HIV RNA (M) 144035 HCV Ab 40726-2
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 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
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 016105 HBsAg Confirmation 016105 HBsAg Confirmation 7905-3
Reflex Table for Rfx to HBcIgM
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 144722 PrEP: Hep B Core Ab, IgM 016881 Hep B Core Ab, IgM 24113-3
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 144030 Interpretation: 144030 Interpretation: 13955-0
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550644 HCV RT-PCR, Quant (Non-Graph) 550338 Hepatitis C Quantitation IU/mL 11011-4
Reflex 2 550352 HCV RNA (International Units) 550353 HCV RNA (International Units) IU/mL 11011-4
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550644 HCV RT-PCR, Quant (Non-Graph) 550338 Hepatitis C Quantitation IU/mL 11011-4
Reflex 2 550352 HCV RNA (International Units) 550354 HCV log10 log10 IU/mL 38180-6
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550644 HCV RT-PCR, Quant (Non-Graph) 550339 HCV log10 log10 IU/mL 38180-6
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550644 HCV RT-PCR, Quant (Non-Graph) 550314 Test Information: 19147-8
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550644 HCV RT-PCR, Quant (Non-Graph) 550396 Interpretation: 62365-2

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