What are the recommended testing kits for Human Papillomavirus (HPV)?

HPV Testing Kits: FDA-Cleared Options for Clinical Use

Several FDA-cleared HPV DNA and RNA tests are available for cervical cancer screening, with the Cobas 4800 HPV test and Onclarity HPV test approved for primary screening, while Hybrid Capture 2, Cervista, and APTIMA tests are cleared for adjunctive use with cytology or triage of abnormal results. 1

FDA-Cleared HPV Tests for Primary Screening

The following tests detect 14 oncogenic HPV types and provide individual genotyping for HPV 16 and 18, making them suitable for primary cervical cancer screening 1:

• Cobas 4800 HPV test (Roche Molecular Diagnostics): Detects types 16,18,31,33,35,39,45,51,52,56,58,59,66, and 68 with individual identification of types 16 and 18 1
• Onclarity HPV test (Becton Dickinson): Same detection profile as Cobas 4800 1

FDA-Cleared HPV Tests for Adjunctive Use Only

These tests should not be used for primary HPV screening as they are only cleared for use alongside cytology or for triaging abnormal Pap results 1:

• Hybrid Capture 2 High-Risk HPV DNA test (Qiagen): Detects 13 high-risk HPV types 1
• Cervista HPV High-Risk test (Hologics): Detects 13-14 high-risk HPV types 1
• Cervista HPV 16/18 test (Hologics): Type-specific detection of HPV 16 and 18 1
• APTIMA HR HPV test (Gen Probe): RNA-based detection of high-risk HPV types 1
• Digene HC2 HPV DNA test (Qiagen): Detects 13 high-risk or 5 low-risk types, though low-risk detection is not indicated for clinical use 1

Critical Usage Guidelines

Appropriate Clinical Indications

HPV testing is only appropriate for 1:

• Primary cervical cancer screening in women ≥30 years (using tests cleared for this purpose) 1
• Adjunctive testing with cytology in women ≥30 years 1
• Triage of ASC-US cytology in women ≥21 years 1
• Follow-up after abnormal screening or treatment of cervical precancers 1

Situations Where HPV Testing Should NOT Be Used

HPV testing is contraindicated in the following scenarios 1:

• Women aged <25 years for routine screening 1
• Adolescents aged <21 years for any indication 1
• Deciding whether to vaccinate against HPV 1
• Testing for low-risk HPV types (e.g., types 6 and 11) 1
• STD screening or evaluation of genital warts 1
• Testing oral or anal specimens (tests only FDA-cleared for cervical specimens) 1

Historical Context and Evolution

The Hybrid Capture test was the first FDA-approved HPV DNA test available in 2000, though it only detected the presence of HPV without identifying specific subtypes 1. Polymerase chain reaction (PCR) could identify specific HPV subtypes but lacked commercial approval at that time 1. The landscape has since evolved significantly, with multiple FDA-cleared options now available that provide both pooled high-risk detection and individual genotyping for the highest-risk types (16 and 18) 1.

Common Pitfalls to Avoid

• Do not use adjunctive-only tests for primary screening: Tests like Hybrid Capture 2, Cervista, and APTIMA are not cleared for primary screening and should only be used with cytology or for triage 1
• Ensure CLIA certification: All HPV testing must be performed in CLIA-certified laboratories 1
• Avoid self-collection: While self-collection for HPV testing has potential to increase screening rates, it is not FDA-cleared or recommended by U.S. medical organizations 1
• Do not test for low-risk types: Testing for non-oncogenic HPV types (6,11) has no clinical utility and should not be performed 1