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CDC-Compliant

PrEP Testing Panels

To confirm patients are negative for acute HIV prior to and while taking PrEP, the CDC now recommends PrEP testing using an HIV antigen/antibody test with an added qualitative or quantitative HIV-1 RNA test.¹
Scientist checking a sample in a lab

CDC PrEP Guidelines

Among patients who have taken oral PrEP or have received injectable PrEP, the addition of qualitative or quantitative HIV-1 RNA to HIV antibody/antigen testing is recommended to optimize the determination of HIV status. In recent clinical trials of injectable PrEP, it was found that PrEP drugs may delay the timing of antibody development, and thus additional testing is required to confirm HIV status.2 Therefore, updated CDC guidance incorporates HIV-1 RNA testing at specified time points to increase the likelihood of detecting acute infection and facilitate the timely transition from PrEP to antiretroviral therapy where necessary.3

 

Labcorp’s CDC-compliant PrEP panels

 Sex Assigned at BirthPrEP TypeTest No.Test NameHIV RNA*HIV Ag/AbSyphilisCT/NG
(Urine)		HCVHBVeGFRβ-hCG
Initiate PrEP (Baseline)MaleOral254842PrEP, Male, Oral Baseline + HIV RNAXXXXXXX 
Injectable254972PrEP, Male, Injectable Baseline + HIV RNAXXXXXX  
FemaleOral254855PrEP, Female, Oral Baseline + HIV RNAXXXXXXXX
Injectable254988PrEP, Female, Injectable Baseline + HIV RNAXXXXXX X
Manage PrEP (Monitor)MaleOral254868PrEP, Male, Oral Monitor + HIV RNAXXXX    
Injectable254736PrEP, Male, Injectable Monitor + HIV RNAXXXX    
FemaleOral254880PrEP, Female, Oral Monitor + HIV RNAXXXX   X
Injectable254801PrEP, Female, Injectable Monitor + HIV RNAXXXX   X

 

Legacy Panels without the recommended HIV RNA

 Sex Assigned at BirthPrEP TypeTest No.Test NameHIV RNA*HIV Ag/AbSyphilisCT/NG
(Urine)		HCVHBVeGFRβ-hCG

Manage PrEP (Monitor) without HIV RNA

(Optional)

MaleOral254892PrEP, Male, Oral Monitor (No HIV RNA)XXXX    
Injectable254937PrEP, Male, Injectable Monitor (No HIV RNA)XXXX    
FemaleOral254905PrEP, Female, Oral Monitor (No HIV RNA)XXXX   X
Injectable254951PrEP, Male, Injectable Monitor (No HIV RNA)XXXX   X

 

 

 

Additional PrEP-Related Testing

NumberName
188710PrEP Use Only: Chlamydia/Gonococcus, Pharyngeal Swab, NAA
188725PrEP Use Only: Chlamydia/Gonococcus, Rectal Swab, NAA
401423PrEP Use Only: Lipid Panel
550420Human Immunodeficiency Virus 1 (HIV-1), Quantitative, Real-time PCR (Graphical)
550430Human Immunodeficiency Virus 1 (HIV-1), Quantitative, Real-time PCR (Nongraphical)

Individual labs for PrEP

NumberName
083935HIV p24 Antigen/Antibody With Reflex to Confirmation
082345Syphilis: Treponemal Antibodies With Reflex to RPR and RPR Titer, Reverse Screening and Diagnosis Algorithm
183194Chlamydia/Gonococcus, NAA
144050Hepatitis C Virus (HCV) Antibody With Reflex to Quantitative Real-time PCR
144547HBV Baseline Evaluation, HCV Direct-acting Antivirals
100768Glomerular Filtration Rate, Estimated (eGFR)
004416Human Chorionic Gonadotropin (hCG), β-Subunit, Quantitative
139825Human Immunodeficiency Virus 1 & 2 (HIV-1/HIV-2), Qualitative, RNA

For questions regarding our PrEP portfolio, please contact your Labcorp representative

PrEP Guidelines by the CDC
 

For Oral PrEP Testing

  • Prior to initiation (Baseline Panel)
  • Every 3 months (Monitor Panel)
  • Renal function testing at baseline and every 6 months for patients taking oral TDF/FTC, >50 years of age or eCrCL <90
  • Lipid evaluation in persons taking FTC/TAF

For Injectable PrEP Testing

  • Prior to initiation (Baseline Panel)
  • 1 month follow up (Monitor Panel)
  • Every 2 months (Monitor Panel)

PrEP Insurance Coverage

Out of pocket costs can be a burden to preventive care. PrEP services received a Grade A recommendation from the United States Preventive Services Task Force (USPSTF). This means for commercial health insurances and Medicaid expansion programs, the Affordable Care Act requires PrEP services to be covered with no cost sharing before any deductible and without coinsurance or copayment*.4

When you order Labcorp's CDC-compliant PrEP panels, we will bill the tests in accordance with the no cost-sharing policy set forth by the Affordable Care Act, which can help minimize your patients' out-of-pocket costs.

 

*Please note: Not all health plans have adopted this policy. Therefore, complete coverage is still subject to the patient’s individual health insurance.

References

  1. US Public Health Service; Preexposure prophylaxis for the prevention of HIV infection in the United States – 2021 A clinical practice guideline. Available at https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed December 22, 2022.
  2. Marzinke MA, Grinsztejn B, Fogel JM, et al. Characterization of human immunodeficiency virus (HIV) infection in cisgender men and transgender women who have sex with men receiving injectable cabotegravir for HIV prevention: HPTN 083. Infect Ds. 2021;
  3. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States-2021 Update Clinical Practice Guideline, US Public Health Service and the Centers for Disease Control
  4. National Alliance of State & Territorial AIDS Directors (NASTAD). NASTAD PrEP Coverage Brief: PrEP Services Covered with No Cost-Sharing. https://nastad.org/sites/default/files/2021-11/PDF-NASTAD-PrEP-Coverage-Brief.pdf. Accessed December 22, 2022.