In clinical trials, the accuracy of the cobas HPV test was assessed on prospectively collected cervical/endocervical samples in ThinPrep media and tested using both the Digene Hybrid Capture 2 High-Risk HPV DNA test and the Roche cobas HPV test. The overall average agreement between the two tests was 91%. In addition, the test was compared to the results of colposcopy and demonstrated a sensitivity of 91% and specificity of 31%. When compared to the results of a tissue biopsy diagnosis, the Cobas HPV test was found to have a sensitivity of 52% and specificity of 87%.
Two independent studies have been conducted in recent years that evaluated cytology, co-testing, and primary HPV screening. The Kaiser Permanente Northern California (KPNC) study was published in 2011 and the Addressing THE Need for Advanced HPV Diagnostics (ATHENA) trial, which evaluated the performance of the cobas HPV test, was conducted several years later. If you would like further details regarding the KPNC study and the ATHENA trial, please review the PDF documents included on this page.
While the ATHENA and Kaiser Studies, as well as the FDA approval for the cobas HPV test, lend support to the use of the HPV test as the primary screening test for cervical cancer, other scientific experts are not yet convinced that the HPV test should be used for that purpose. The thought by some is that co-testing with the PAP test may be better since a clinician may discover more disease than if the HPV test is employed as the sole test. In the June, 2014 CAP TODAY lead article entitled “Data spark new directions in cervical cancer," Dr. William Check presents an extensive review of the clinical data supporting the use of the HPV test as a primary screen for cervical cancers. In addition, the article points out the reservations from other experts about the use of the HPV test as a primary algorithm for cervical cancer screening, citing still unanswered issues and questions about the test as well as a need for professional groups to evaluate the data.*
It is clear that the high sensitivity of the HPV test suggests that a woman with a negative test will have a significantly low risk of developing cervical cancer. This raises the possibility of extending the recommended screening interval for cervical cancer screening. Although the FDA approval of the cobas HPV test does extend the use of the test to include use as either a co-test or use as a primary cervical cancer screening test, it does not presently change current medical practice guidelines for cervical cancer screening.
*Reference: Check W. Data spark new directions in cervical cancer. CAP TODAY. June 2014.
