Pre-Exposure Prophylaxis (PrEP) HIV Profile, Male, Baseline

CPT: 82565; 86704; 86706; 86780; 86803; 87340; 87389; 87491; 87591
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Test Includes

Chlamydia trachomatis; Neisseria gonorrhoeae; creatinine, serum; eGFR calculation; enzyme immunoassay (EIA) for antigen/antibody screen for HIV with reflex to supplementary differentiation assay for HIV-1 or HIV-2. The antigen/antibody assay detects antibodies to HIV-1 and HIV-2 as well as HIV-1 p24 antigen. Specimens positive by the screening assay but negative by the supplementary antibody typing assay will reflex to qualitative nucleic acid amplification (NAA). This test also includes hepatitis B core antibody, total; hepatitis B surface antibody, qualitative; hepatitis B surface antigen; hepatitis C virus (HCV) antibody with reflex to quantitative real-time PCR; Treponema pallidum (syphilis) with reflex to qualitative rapid plasma reagin (RPR) on positives. If reflex testing is performed, additional charges/CPT code(s) may apply.


Special Instructions

This profile requires a dedicated, unopened, gel-barrier tube and frozen 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.



Specimen Requirements


Specimen

Serum and urine


Volume

8 mL refrigerated serum, 2 mL frozen serum, and 2 mL of a 20 mL to 30 mL urine collection


Minimum Volume

6 mL refrigerated serum (Note: This volume does not allow for repeat testing), 1 mL frozen serum, 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.


Storage Instructions

Serum: Gel-barrier tubes refrigerated up to 14 days; PCR test: Frozen up to six 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: 14 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

Detect HIV infection using fourth-generation HIV antigen-antibody assay; detect Chlamydia trachomatis and Neisseria gonorrhoeae; serological test for screening for syphilis infection; determine HBV infection status; diagnosis of active hepatitis C virus (HCV) infection; the estimated glomerular filtration rate (eGFR) provides an assessment of the filtering capacity of the kidney


Limitations

Fourth-generation HIV antigen-antibody specimens with repeatedly 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. All estimates of GFR based on serum creatinine will be less accurate for patients at the extremes of muscle mass (including frail elderly, critically ill, or cancer patients), those with unusual diets, and those with conditions associated with reduced secretion or extrarenal elimination of creatinine.


Methodology

See individual test components.


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
245476 PrEP, Male, Baseline 001370 Creatinine mg/dL 2160-0
245476 PrEP, Male, Baseline 100791 eGFR If NonAfricn Am mL/min/1.73 88294-4
245476 PrEP, Male, Baseline 100797 eGFR If Africn Am mL/min/1.73 88293-6
245476 PrEP, Male, Baseline 006510 HBsAg Screen 5196-1
245476 PrEP, Male, Baseline 006718 Hep B Core Ab, Tot 13952-7
245476 PrEP, Male, Baseline 006408 Hep B Surface Ab, Qual 22322-2
245476 PrEP, Male, Baseline 144035 HCV Ab s/co ratio 48159-8
245476 PrEP, Male, Baseline 082356 T pallidum Antibodies 24110-9
245476 PrEP, Male, Baseline 083936 HIV Screen 4th Generation wRfx 56888-1
245476 PrEP, Male, Baseline 188078 Chlamydia trachomatis, NAA 43304-5
245476 PrEP, Male, Baseline 188086 Neisseria gonorrhoeae, NAA 43305-2
245476 PrEP, Male, Baseline 019054 PDF N/A
245476 PrEP, Male, Baseline 100791 eGFR If NonAfricn Am mL/min/1.73 88294-4
245476 PrEP, Male, Baseline 100797 eGFR If Africn Am mL/min/1.73 88293-6
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 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 550362 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 550362 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 550362 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 550362 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 550362 HCV RT-PCR, Quant (Non-Graph) 550396 Interpretation: 62365-2
Reflex Table for T pallidum Antibodies
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 006099 RPR 006097 RPR 20507-0
Reflex 2 006476 RPR, Quant 006476 RPR, Quant 31147-2
Reflex Table for T pallidum Antibodies
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 006099 RPR 006097 RPR 20507-0
Reflex 2 163025 T pallidum Immunoblot 163026 T pallidum Immunoblot 40679-3
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083941 HIV 1 Ab 68961-2
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083942 HIV 2 Ab 81641-3
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083952 RNA Qualitative 083951 HIV 1 RNA Qualitative 25835-0
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083952 RNA Qualitative 083960 Final Interpretation 62365-2
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083952 RNA Qualitative 083944 HIV 1/2 Supplemental Ab Test N/A
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083953 RNA Qualitative 083951 HIV 1 RNA Qualitative 25835-0
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083953 RNA Qualitative 083961 Final Interpretation 62365-2
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083953 RNA Qualitative 083944 HIV 1/2 Supplemental Ab Test N/A
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083950 RNA Qualitative 083951 HIV 1 RNA Qualitative 25835-0
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083950 RNA Qualitative 083959 Final Interpretation 62365-2
Reflex Table for HIV Screen 4th Generation wRfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 083940 HIV 1/2 Ab Differentiation 083954 Interpretation: 80203-3
Reflex 2 083950 RNA Qualitative 083944 HIV 1/2 Supplemental Ab Test N/A

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