Introducing Cervista HPV

Cervista HPV HR

Cervical Cancer Screening Just Got Smarter

When used together, the ThinPrep® Pap Test and Cervista® HPV HR test offer highly accurate and reliable cervical cancer screening results. The combined tests provide both the high sensitivity characteristic of HPV testing, as well as the high specificity offered by the ThinPrep Pap Test. The result of this advanced combination of tests is improved disease detection – plus peace of mind for you and your patients.

Sensitivity

With a greater than 99% negative predictive value (NPV) for CIN 2/3+, the combined tests can pinpoint existing cervical cancer and related precursor conditions, while assessing future risk due to high-risk HPV infections. The combined tests also provide both 100% sensitivity for CIN3+, an immediate precursor to cervical cancer. 4,5

Reliable Results

Cervista HPV HR also detects all 14 high-risk HPV types as designated by the International Agency for Research on Cancer. Current HPV tests can cross-react with low-risk strains of the HPV virus. Cervista HPV HR, by contrast, does not cross-react with common low-risk HPV types, substantially reducing false positives and the resulting potential for over treating patients. Likewise, patients with high-risk HPV types can be managed accordingly.

Convenient Sample Collection

Cervista HPV HR can be performed directly from the same specimen collected for a ThinPrep Pap Test. Cervista HPV HR requires a smaller sample size than other HPV tests, substantially reducing the number of Quantity Not Sufficient (QNS) results and the need to call patients back for retesting.

FDA Approved as an In Vitro Diagnostic Device

The FDA has approved Cervista HPV HR as a Class III In Vitro Diagnostic Device (IVD) indicated

  • To screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.
  • In women 30 years and older the Cervista HPV HR test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

Warnings:

  • The Cervista HPV HR test is not intended for use as a screening device for women under age 30 with normal cervical cytology.
  • The Cervista HPV HR test is not intended to substitute for regular cervical cytology screening.
  • Detection of HPV using the Cervista HPV HR test does not differentiate HPV types and cannot evaluate persistence of any one type.
  • The use of this test has not been evaluated for the management of women with prior cytological or histological abnormalities, hysterectomy, who are pregnant, postmenopausal, or who have other risk factors (e.g. HIV+, immunocompromised, history of STI).

The Cervista HPV HR test is designed to enhance existing methods for the detection of cervical disease and should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical examinations, and full medical history in accordance with appropriate patient management procedures.

Cervista HPV HR test results should not be used as the sole basis for clinical assessment and treatment of patients.

Cervista HPV HR is approved for use with the ThinPrep Pap Test, the most widely used Pap test in the United States. Now, with the convenience of a single sample, you can offer your patients highly reliable and comprehensive cervical cancer screening.

1. Conventional Pap - AHCPR Evaluation of Cervical Cytology Evidence Report/Technology Assessment, No. 99-E010 1999.

2. ThinPrep Pap Test and Imaging System Operations Summary and Clinical Information (c)2006 Cytyc Corporation.

3. Cervista HPV HR -- package insert #15-3053, 2009.

4. 100% CIN3 Detection in ASC-US: 95% CI (85.1% - 100%)

5. Consult package insert for full clinical details: Cervista®

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

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