PrEP HIV Baseline, Female Panel with Reflexes

Test Code
37133


CPT Codes
87389, 84702, 82565, 86803, 87340, 86706, 86704, 86592, 87491, 87591

Includes
hCG, Total, Quantitative
Creatinine
HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes
Hepatitis C Antibody with Reflex to HCV RNA,PCR w/Reflex to Genotype, LiPA
Hepatitis B Surface Antigen with Reflex Confirmation
Hepatitis B Surface Antibody, Qualitative
Hepatitis B Core Antibody, Total, with Reflex to IgM
RPR (Diagnosis) with Reflex to Titer and Confirmatory Testing
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital

If HIV Antigen and Antibody, 4th Generation Screen is Repeatedly Reactive, then HIV-1/2 Antibody Differentiation will be performed at an additional charge (CPT code(s): 86701, 86702).
If HIV-1/2 Antibody Differentiation is Indeterminate or Negative, then HIV-1 RNA, Qualitative, TMA will be performed at an additional charge (CPT code(s): 87535).

If Hepatitis C Antibody is reactive or borderline, then Hepatitis C Viral RNA, Quantitative, Real-Time PCR will be performed at an additional charge (CPT code(s): 87522).
If Hepatitis C Viral RNA, Quantitative, Real-Time PCR is ≥300 IU/mL, then Hepatitis C Viral RNA Genotype, LiPA will be performed at an additional charge (CPT code(s): 87902).

Hepatitis B Surface Antigen: Positive samples will be confirmed based on the manufacturer's FDA approved recommendations at an additional charge (CPT code(s): 87341).

If Hepatitis B Core Antibody Total is reactive, then Hepatitis B Core IgM Antibody will be performed at an additional charge (CPT code(s): 86705).

If RPR screen is reactive, then RPR Titer and Fluorescent Treponemal Antibody (FTA) Confirmatory testing will be performed at an additional charge (CPT code(s): 86593, 86780).


Preferred Specimen
5 mL serum collected in each of four separate serum separator tubes (SST) and urine collected in an Aptima® Urine Collection Tube


Patient Preparation
Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen.

Minimum Volume
3 mL serum (x4)


Other Acceptable Specimens
5 mL serum collected in each of four separate serum separator tubes (SST) and
Endocervical swab collected in Aptima® Combo 2 Assay Unisex Swab Specimen Collection Kit, or Vaginal swabs in the Aptima® Combo 2 Assay Vaginal Swab Collection Kit or Multitest Collection, or Urethral swabs in Aptima® Combo 2 Assay Unisex Swab Specimen Collection Kit


Instructions
HIV serum: Spun serum separator tubes may be submitted at room temperature or refrigerated unopened without transfer to a plastic, screw-cap vial.
⁠⁠⁠⁠⁠⁠⁠
Submitted tubes must be labeled with patient identifier and submitted only for HIV testing.


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Serum separator tubes (SST)
Room temperature: 72 hours
Refrigerated: 5 days
Frozen: 21 days

Urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year

Swabs
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Grossly lipemic • Grossly icteric • Plasma • Red-top tube (no gel)⁠⁠⁠⁠⁠⁠⁠ • Frozen serum separator tube (SST)


Methodology
See individual tests

Setup Schedule
Set up: Mon-Sat; Report available: 2-5 days


Clinical Significance
Pre-exposure prophylaxis (PrEP) is a protocol that decreases the risk of acquiring HIV infection in people who do not have HIV, but are at high risk of becoming infected. PrEP involves taking a medication to prevent new HIV infection. All persons who are under consideration for PrEP should undergo baseline and monitoring laboratory testing, in order to identify those who are at risk for harm from the therapy and require close monitoring.

Laboratory testing for PrEP includes a baseline panel to rule out HIV, HBV and HCV infections; sexually transmitted infections (syphilis, chlamydia and gonorrhea); and renal dysfunction that would make the PrEP medication unsafe. In female patients, a test is also performed to rule out pregnancy. After PrEP is initiated, quarterly laboratory monitoring is indicated to rule out HIV infection, sexually transmitted infections, renal dysfunction and pregnancy (in females).




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.