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

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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; human chorionic gonadotropin (hCG), β-subunit, quantitative, serum; 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


Serum and endocervical or vaginal swab or first-void urine (patient should not have urinated for one hour prior to specimen collection)


9 mL refrigerated serum, 2 mL frozen serum, and one swab (endocervical or vaginal) or 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 one swab (endocervical or vaginal) or 2 mL of a 15 mL urine collection


Gel-barrier tube and Gen-Probe® APTIMA® swab or APTIMA® urine specimen transport


Serum specimen: Usual blood collection technique.

Option 1: Gen-Probe® Aptima® Endocervical or Vaginal Swab

Endocervical swab: Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white-shaft swab in the package with red printing). Discard this swab. Insert the specimen collection swab (blue-shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents. Recap the swab specimen transport tube tightly.

Vaginal swab: Care provider specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® vaginal swab kit by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Patient self-collection: Partially open the package of the Gen-Probe® Aptima® vaginal swab kit. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima® swab specimen collection kit. Remove the swab. Carefully insert the swab into the vagina about two inches past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube, and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.

Option 2: 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. Female patients should not cleanse the labial area prior to providing 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® Swab or Urine: Maintain at room temperature or refrigerate at (2°C to 30°C)

Stability Requirements



Room temperature

Swab: 60 days, Urine: 30 days (stability provided by manufacturer or literature reference)


Serum: 14 days (stability provided by manufacturer or literature reference)


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; APTIMA® swab transport >60 days from collection; APTIMA® swab specimen without a swab; cleaning swab (white-shaft swab) in APTIMA® swab transport; APTIMA® transport device with multiple swabs

Test Details


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; early detection of pregnancy


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.


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