Introducing Cervista HPV

Cervista HPV HR

Proprietary Invader® Chemistry

How Invader Works

Cervista® HPV advances the accuracy and reliability of HPV testing by using proprietary Invader chemistry to determine the presence of HPV types known to be highly oncogenic. Specifically, Invader chemistry works at the molecular level to detect individual base pair changes associated with high-risk HPV strains. Invader chemistry utilizes signal amplification and fluorescence detection, generating millions of accurate signals for detection through a series of simultaneous, dual reactions that:

  • Confirm that adequate DNA is present in the specimen for testing; and
  • Screen for the 14 HPV types designated as high-risk by the IARC (International Agency for Research on Cancer)..

Invader chemistry features two simultaneous reactions, described as primary and secondary. In the primary reaction, an Invader probe binds with the target area of the viral DNA and generates an overlapping structure. The flap of this structure is then cleaved with a proprietary Cleavase® enzyme. Multiple flaps are created through this process, generating fluorescent signals that can be detected by a fluorometer after the secondary reaction.

In the secondary reaction, the cleaved flaps created in the primary reaction function as a probe, binding with complementary sequences of the FRET (Fluorescence Resonance Energy Transfer) cassette. The secondary reaction utilizes the combination of cleaved flaps and FRET cassettes to create fluorescence-based signal amplification. The fluorescent signal is then measured by a fluorometer to confirm the presence (or absence) of a high-risk HPV strain.

Why Cervista HPV HR Is Different

In the primary reaction, the Cervista HPV HR test’s unique internal control creates red fluorophores when adequate DNA is present in the sample for testing. Similarly, in the secondary reaction, green fluorophores indicate the presence of high-risk HPV types.

Signal No Signal
Internal Control
Reaction Red
Adequate DNA present for valid test result Specimen not adequate for testing
Reaction Green
Presence of high-risk HPV types No high-risk HPV types present

Without an internal control, it is not possible to know if a negative result accurately reflects the absence of high-risk HPV or simply an overall lack of adequate DNA for testing. Cervista HPV HR is the only FDA-approved HPV test that ensures adequate DNA is present for testing. This substantially reduces the risk of producing false negatives, giving you and your patients greater confidence in the results.

Cervista HPV HR: The Only FDA-approved HPV Test with an Internal Control

Other HPV tests have been shown to cross-react with common low-risk types of HPV. This cross-reactivity can produce false-positive test outcomes, with the potential for over-treating patients at lower risk of developing cervical cancer.

Cervista HPV HR does not cross-react with common low-risk HPV types. This increases accuracy and ensures that patients most at risk can be managed appropriately, while safeguarding those with common low-risk HPV types from the stress of unnecessary treatments.

Learn more about the advanced clinical performance and improved workflow offered by Cervista HPV HR in the laboratory.

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