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Cervista® HPV HR

Cervista HPV HR from Hologic, a 14-type High Risk Screening Test, represents the next generation in HPV DNA testing and provides your lab new levels of efficiency, clinical accuracy and responsiveness.

 Cervista® HPV HR

Be Certain

Clinical Integrity and Reliability of Results

There’s nothing more important in clinical testing than accuracy. That’s why Cervista HPV HR delivers consistently reliable results that give confidence to laboratories as well as physicians and their patients.

Demonstrating highly accurate disease detection

  • 100% detection of CIN3+1,2
  • 99.1% negative predictive value (NPV) for CIN2+

Cervista HPV’s clinical trial results met all objectives and proved to be comparable to those from the landmark ALTS trial, underscoring the test’s accuracy. Specifically, Cervista HPV’s NPV and sensitivity for CIN2+ as well as CIN3+, an immediate precursor to cervical cancer, closely matched ALTS levels, providing confidence in test results.

Delivering enhanced clinical reliability

The Cervista HPV HR test has consistently demonstrated superior assay reliability and robustness for high-risk screening assays, including:

  • <1.0% indeterminate rate (best-in-class)
  • No equivocal (gray) zone for interpretation

Cervista HPV HR test results are consistently reliable. Other tests may have indeterminate rates of 4% or more and problematic “equivocal” zones that confound interpretation.

Cervista HPV: No cross-reactivity with these common low-risk HPV types

Cross-reactivity to low-risk HPV types causes false-positive results, which can lead to patient over-treatment.

Provides the confidence of an internal control

  • Confirms that physician sample collection is adequate
  • Indicates that no inhibitory substances are present
  • Minimizes false-negatives due to insufficient sample cellularity

Cervista’s internal control serves both quality and processing control roles.

“Finally, the Invader method contains an internal control to determine the presence of sufficient DNA for reliable results and for the presence of potentially interfering substances. The hc2 method does not contain this control; therefore, laboratory professionals will never know if a negative hc2 result is due to the absence of HPV DNA or a simple lack of cellularity on the liquid cytology sample.” 6

Johnson et al., AJCP 2008

Accurate detection by design

  • Detects all 14 HPV types designated as high-risk by the IARC7
  • High-risk types detected: 16,18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68.

1100% CIN3 Detection in ASC-US: 95% CI (85.1% - 100%)

2Consult Package Insert for full clinical details. Cervista HPV HR PI 2009. Cervista HPV 16-18 PI 2009.

3Hybrid Capture® 2 High-Risk HPV DNA Test® Package Insert #L00665, Rev. 2, 2007.

4Cervista HPV HR Package Insert #15-3053, 2009.

5Castle, PE, Solomon, D., et al. Human Papillomavirus Genotype Specificity of Hybrid Capture 2. J Clin
  Microbiol. 2008:46:2595-2604.

6Johnson LR, Starkey CR, et al. A Comparison of Two Methods to Determine the Presence of High-Risk HPV
  Cervical Infections. Am J Clin Pathol. 2008;130:401-408.

7International Agency for Research on Cancer

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Be In Control

Superior Laboratory Efficiency and Workflow

  • Fewer technologist hours devoted to running HPV tests
  • Perform fewer repeat tests
  • Deliver clear, specific results with a minimal indeterminate rate

Maximizing lab productivity

Many competitive tests require numerous process checks. Cervista HPV HR, however, features a full four-hour walk-away period. Enhanced productivity makes Cervista HPV HR the clear choice for labs to optimize efficiency.


Cervista HPV HR results can be read at your convenience within 24 hours, maximizing flexibility.

 

Substantially reduces patient
call-backs1

Cervista HPV HR optimizes laboratory performance by:

  • Limiting QNS results: requires only half the sample volume of other HPV tests (2 ml vs. 4 ml)
  • Increasing the likelihood of useful sample volume remaining for additional testing
  • Providing clear results without an equivocal (gray) zone
  • Reducing the indeterminate rate to under <1.0%, compared with 4% or more for other HPV tests2
 HPV HR 16/18

 

Cervista HPV HR: The only FDA-approved HPV test with an internal control

  • Internal control assures accuracy of negative test results
  • Competitive HPV tests without an internal control cannot assess whether a negative result is truly negative—or simply due to insufficient cellularity.


1Cervista HPV multicenter clinical trial, 2006-2008. Clinical and analytical data on file, Hologic, Inc.

2Solomon et al, JNCI, 2001