In 2003, Digene introduced the Hybrid Capture 2 High-Risk HPV DNA test. It was the first HPV test approved by the FDA for the detection of high-risk HPV (HR-HPV). Since then, other HPV tests have also received FDA approval. Table 1 is a partial list of the FDA-approved HPV tests. The Hybrid Capture 2 DNA, the Cervista HPV DNA, and the Cobas HPV tests are further explained on the following pages.
Table 1. FDA-Approved HPV Tests.Instrument (Manufacturer) | Summary of the Test | Test Principle | Intended Use |
Hybrid Capture® 2 High-Risk HPV DNA test (Digene) | Identifies genetic DNA from HPV in cervical cells. Detects the presence of 13 hrHPV types. | Uses a DNA-Probe-Hybrid immunoassay technique and is used combined when a woman's Pap test results are mildly abnormal | - Detection of high-risk HPV (HR-HPV)
- Follow-up test when a PAP smear is mildly abnormal
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Cervista™ HPV HR and Genfind™ DNA Extraction (Hologic-GEN-PROBE) | Identifies DNA from 14 high-risk genital HPV types commonly associated with cervical cancer | Uses DNA-probe technology | - Determine a patient's risk for developing cervical cancer
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Cervista™ HPV 16/18 (Hologic-GEN-PROBE) | Identifies HPV types 16 and 18 in cervical samples | Uses specific DNA-probe technology and may be used in combination or as a follow-up to the Cervista HPV HR test | - Determine a patient's risk for developing cervical cancer
- Used for women age 30 and over or any age with borderline cytology results to determine the need for additional follow-up procedures
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Cobas® HPV test (Roche Molecular Systems) | Used on the cobas® 4800 system and the 6800/8800 systems to identify DNA from 14 high-risk genital HPV types commonly associated with cervical cancers. Specific for HPV types 16 and 18 but also identifies other high-risk types. | Uses fluorescent-labeled DNA probes | - Provide information on a patient’s risk for developing cervical cancer
- For women age 30 or over or women age 21 and older with borderline cellular results to assess the need for additional follow-up and diagnostic procedures
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APTIMA® HPV Assay (Hologic-GEN-PROBE) | Used with the Tigris DTS system to identify RNA from 14 high-risk genital HPV types commonly associated with cervical cancer. Detects messenger RNA from two HPV viral oncogenes, E6 and E7 | Uses RNA capture and amplification of HPV RNA | - Determine a patient's risk for developing cervical cancer
- Use for women age 30 and over or any age with borderline cytology results to determine the need for additional follow-up procedures
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| Onclarity™ HPV Assay (BD) | Reports individual results for 6 of the 14 high-risk genotypes and grouped results for the remaining 8 high-risk genotypes | Uses primers and fluorescently-labeled probes to amplify target DNA sequences
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