Clinical performance of the APTIMA® HPV Assay for the detection of high-risk HPV and high-grade cervical lesions

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ABSTRACT

Background

Human papillomavirus (HPV) DNA testing is widely used in conjunction with Papanicolaou (Pap) testing in cervical cancer screening programs to improve the detection of high-grade lesions. While HPV DNA test sensitivity is good, an improvement in specificity is desired. Detection of HPV mRNA may improve specificity. The APTIMA® HPV Assay detects the mRNA of 14 high-risk HPV types in liquid-based cytology specimens.

Objective

To evaluate APTIMA HPV Assay performance for detection of high-risk HPV and high-grade cervical intraepithelial neoplasia (CIN) compared to Qiagen's Hybrid Capture 2 HPV DNA (HC2) test.

Study design

Liquid Pap specimens were collected from 800 women referred to colposcopy and tested with the APTIMA HPV Assay and the HC2 test. Complete results were available for 753 subjects. A subset of samples (n = 393) were typed using Roche's Linear Array HPV Genotyping Test.

Results

Sensitivity and specificity for detection of high-risk HPV were >92% and 99% for the APTIMA HPV Assay and 93% and 82% for the HC2 test. Clinical sensitivity and specificity were 91% and >55% for detection of CIN 2+, and 98% and 53% for detection of CIN 3+ for the APTIMA HPV Assay; values for the HC2 test were 95% and 47% for CIN 2+, and 99% and 44% for CIN 3+. Conclusions: The APTIMA HPV Assay is sensitive and very specific for detection of high-risk HPV. The APTIMA HPV Assay had similar clinical sensitivity for disease detection but higher clinical specificity than the HC2 test, which may improve patient management and reduce the cost of care.

References (43)

  • SK Kjaer et al.

    Type specific persistence of high risk human papillomavirus (HPV) as indicator of high grade cervical squamous intraepithelial lesions in young women: population based prospective follow up study

    BMJ

    (2002)
  • GM Clifford et al.

    Human papillomavirus genotype distribution in low-grade cervical lesions: comparison by geographic region and with cervical cancer

    Cancer Epidemiol Biomarkers Prev

    (2005)
  • J Cuzick et al.

    Overview of the European and North American studies on HPV testing in primary cervical cancer screening

    Int J Cancer

    (2006)
  • TC Wright et al.

    Interim guidance for the use of human papillomavirus DNA testing as an adjunct to cervical cytology for screening

    Obstet Gynecol

    (2004)
  • P Naucler et al.

    Human papillomavirus and Papanicolaou tests to screen for cervical cancer

    N Engl J Med

    (2007)
  • KU Petry et al.

    Inclusion of HPV testing in routine cercical cancer screening for women above 29 years in Germany: results for 8466 patients

    Br J Cancer

    (2003)
  • PE Castle et al.

    Human papillomavirus genotype specificity of Hybrid Capture 2

    J Clin Microbiol

    (2008)
  • Digene hc2 Hybrid Capture® 2 High-Risk HPV DNA Test® [package insert]. Digene Corp., Gaithersburg, MD, USA;...
  • F Carozzi et al.

    Agreement between the AMPLICOR Human Papillomavirus Test and the Hybrid Capture 2 assay in detection of high-risk human papillomavirus and diagnosis of biopsy-confirmed high-grade cervical disease

    J Clin Microbiol

    (2007)
  • P Halfon et al.

    Prospective evaluation of the Hybrid Capture 2 and AMPLICOR human papillomavirus (HPV) tests for detection of 13 high-risk HPV genotypes in atypical squamous cells of uncertain significance

    J Clin Microbiol

    (2007)
  • MP Stevens et al.

    Comparison of the Digene Hybrid Capture 2 assay and Roche AMPLICOR and LINEAR ARRAY human papillomavirus (HPV) tests in detecting high-risk HPV genotypes in specimens from women with previous abnormal Pap smear results

    J Clin Microbiol

    (2007)

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