When used with a Pap, the digene HPV Test* is a more effective way to determine a woman's risk of developing cervical disease and cancer than cytology alone. The signal-amplified, nucleic acid, detection-based test has been shown to be clinically effective in studies reported in more than 300 peer-reviewed publications. Below is just a sampling of the wealth of clinical information that has been derived from these studies:
 
  • When incorporated into a well established organised screening programme, primary HPV screening with cytology triage was more sensitive than conventional cytology in detecting CIN III+ lesions. The number of cases of cervical cancer was small, but considering the high probability of progression of CIN III the findings are of importance regarding cancer prevention.
    Ahti Anttila et al. Rate of cervical cancer, severe intraepithelial neoplasia, and adenocarcinoma in situ in primary HPV DNA screening with cytology triage: randomised study within organised screening programme, BMJ 2010;340:c1804 online

  • HPV-based screening is more effective than cytology in preventing invasive cervical cancer, by detecting persistent high-grade lesions earlier and providing a longer low-risk period.
    “For women aged 35 years or more, our results support the use of HPV-DNA testing for primary screening at prolonged intervals, with cytology reserved for triage of HPV-positive women.” concluded the study authors.
    Ronco, G. et al. Efficacy of human papillomavirus testing for the detection of invasive cervical cancers and cervical intraepithelial neoplasia: a randomised controlled trial. The Lancet Oncology 2010, Vol. 11 No. 3 pp 249-257. online

  • Compared with cytology, HPV testing has greater sensitivity for the detection of cervical intraepithelial neoplasia. The sensitivity of HPV testing for CIN grade 2 or 3 was 94.6%, whereas the sensitivity of cytology alone was 55.4%. The sensitivity of both tests used together was 100%, and the specificity was 92.5%.
    Franco, E. et al. Human Papillomavirus DNA versus Papanicolaou Screening Tests for Cervical Cancer. New England Journal of Medicine 2007; 357: 1579-1588.

  • Implementation of HPV DNA testing in cervical screening led to a substantial increase in the number of CIN 2/3+ lesions detected at the baseline screening round. At the subsequent round, combined HPV DNA and cytological testing was used in both study groups and significantly fewer CIN 2/3+ lesions were seen in the women who received both tests at the baseline round than in the control group. Therefore, the results show that implementation of HPV DNA testing in cervical screening leads to earlier detection of clinically relevant cervical lesions.
    Meijer, C. et al. Human papillomavirus DNA testing for the detection of cervical intraepithelial neoplasia grade 3 and cancer: 5-year follow-up of a randomized controlled implementation trial. The Lancet 2007; DOI:10.1016/S0140-6736(07)61450-0.

  • HPV testing in primary screening and HPV vaccination against the most common types have the potential to reduce the incidence of invasive adenocarcinoma.
    Castellsague, X. et al. Worldwide Human Papillomavirus Etiology of Cervical Adenocarcinoma and Its Cofactors: Implications for Screening and Prevention. Journal of the National Cancer Institute 2006; 98: 303-315.

  • HPV testing is substantially more sensitive in detecting CIN 2+ than cytology (96.1% vs. 53%) but is less specific (90.7% vs.96.3%). In this analysis, the sensitivity of HPV testing was similar in all studies carried out in different areas of Europe and North America, whereas the sensitivity of cytology was highly variable. These results support the use of HPV testing as the sole primary screening test, with cytology reserved for women who test HPV-positive.
    Cuzick, J. et al. Overview of the European and North American studies on HPV testing in primary cervical cancer screening. International Journal of Cancer 2006; 119: 000-000.

  • HPV testing alone was more sensitive than conventional cytology among women 35- 60 years old. Adding liquid-based cytology improved sensitivity only marginally, while increasing false-positives. HPV testing using QIAGEN's Hybrid Capture® 2 technology with a 2 pg/mL cutoff may be more appropriate than a 1 pg/mL cutoff for primary cervical cancer screening.
    Ronco, G. et al. Human Papillomavirus Testing and Liquid-Based Cytology: Results at Recruitment From the New Technologies for Cervical Cancer Randomized Controlled Trial. Journal of the National Cancer Institute 2006; 98: 765 – 74.

  • Because HPV DNA testing is more sensitive than cervical cytology in detecting CIN 2 and CIN 3, women with negative concurrent test results can be reassured that their risk of unidentified CIN 2 and CIN 3 or cervical cancer is approximately 1 in 1,000.
    ACOG Practice Bulletin No. 61, "Human Papillomavirus. Clinical Management Guidelines for Obstetrician-Gynecologists." April 2005.

  • The negative predictive value of combined HPV/Pap testing is 99.21% for CIN 3.
    Sherman M.E., et al. Human Papillomavirus Testing, and Risk for Cervical Neoplasia: A 10-Year Cohort Analysis. Journal of the National Cancer Institute, 2003;95:46-52.

  • In another study of more than 11,000 women, the digene HPV Test was shown to be 97% sensitive for CIN 2+, compared to 77% for conventional Paps resulting in ASC-US or abnormal results. The study also documented that women infected with high-risk HPV and who have normal or borderline cytology can be managed as effectively with repeat testing after 12 months with immediate colposcopy.
    Cuzick, J. et al. Management of women who test positive for high-risk types of human papillomavirus: the HART study. The Lancet 2003;362:1871-76.

  • Still another study demonstrated that HPV testing is a more sensitive indicator of high-grade CIN than either conventional or liquid cytology alone. Screening with both an HPV and Pap test offered a sensitivity and negative predictive value of almost 100%. Twenty-one percent of women who were persistently positive for high-risk HPV DNA types when tested with the digene HPV Test were diagnosed with CIN 2/3 within 36 months, compared to only 0.08% of women who were initially HPV-negative.
    Lorincz, A., Richart, R. Human Papillomavirus DNA Testing As An Adjunct To Cytology In Cervical Screening Programs. APLM 2003;127:959-968.

  • A study of 8,466 women undergoing routine cervical cancer screening showed that when used in conjunction with a Pap, the sensitivity of the the digene HPV Test test was 100% for detection of CIN 2+, while that of the Pap alone was 43.5%.
    Petry K., et al. Inclusion of HPV testing in routine cervical cancer screening for women above 29 years in Germany: results for 8,466 patients, British Journal of Cancer,2003;88:1570-1577.

  • Women with persistent HPV infection are more than 300 times more likely than HPV-negative women to develop high-grade cervical disease.
    Bory J., et al. Recurrent Human Papillomavirus Infection Detected with the Hybrid Capture 2 Assay Selects Women with Normal Cervical Smears at Risk for Developing High Grade Cervical Lesions: A Longitudinal Study of 3,091 Women. Int. J. Cancer, 2002;102:519-525.

  • In an ASC-US population, the sensitivity of the digene HPV Test for detecting high-grade precursors and cervical cancer is 96%, compared to 85% for a repeat liquid-based Pap test.
    Solomon D., et al. Comparison of Three Management Strategies for Patients with Atypical Squamous Cells of Undetermined Significance: Baseline Results from a Randomized Trial, J. Nat Cancer Inst, 2001; 93:293-299.

  • A cohort analysis of 5,671 women older than 30 (conducted within a larger study of 7,932 women) showed that conventional cytology was 57% sensitive for HSIL; liquid cytology was 84% sensitive, and the digene HPV Test was 100% sensitive.
    Clavel C., et al. Human Papillomavirus Testing in Primary Screening for the Detection of High-Grade Cervical Lesions: A Study of 7,932 Women. Brit J Cancer, 2001; 89 (12):1616-1623.

  • High-risk HPV types have been detected in 99.7% of cases of cervical cancer, confirming that the virus must be present for cervical cancer to develop.
    Walboomers J.M.M., et al. Human Papillomavirus is a Necessary Cause of Invasive Cervical Cancer Worldwide. Journal of Pathology 1999;189:12-19.



The FDA-approved and CE-marked "digene HPV Test" is also known to laboratories and physicians as the "digene HC2 HPV DNA Test®". This does not refer to the QIAGEN product that tests for several types of the virus commonly referred to as "low-risk HPV", which are not associated with cervical cancer.