Abstract
BackgroundHigh-risk human papillomavirus (HR HPV) testing is already part of cervical cancer screening programs in a number of countries. New tests need to be validated not only in clinical studies but also in routine screening settings with regard to their clinical performance.MethodsThe Abbott RealTime High Risk HPV Test (RT hrHPV test) was evaluated in a random sample of 1,456 patients from a German routine screening population of 13,372 women ≥30 years of age screened primarily by liquid-based cytology (LBC) that was complemented by 48 CIN3+ cases. Clinical sensitivities, relative specificities and positive predictive values (PPV) for both HPV tests were determined based on histologically confirmed high-grade cervical disease (CIN3+) as clinical outcome.ResultsHR HPV prevalence in residual LBC samples was found to be 5.4 % by the RT hrHPV test and 5.6 % by the HR HC2 test, respectively. The Kappa-value for overall agreement between the RT hrHPV test and the HC2 assay for detection of HR HPV was 0.87. Relative sensitivities for detection of CIN3+ in patients with abnormal cytology was 93.8 % for the RT hrHPV assay and 97.9 % for HC2 (p-value = 0.5). Relative specificities and PPVs were comparable for both tests. The highest PPV was calculated for the specific detection of HPV16 by the RT hrHPV test (84.2 %). The RT hrHPV test showed a reduced sensitivity for detection of HVP31-positive CIN3 + .ConclusionThe RT hrHPV assay is as sensitive and specific in detecting severe cervical lesions in women with abnormal cytology as the HC2 HR HPV test.
Highlights
High-risk human papillomavirus (HR Human Papillomavirus (HPV)) testing is already part of cervical cancer screening programs in a number of countries
Of 2,303 overall specimens a total of 847 samples had to be excluded from the analysis either because they returned unsatisfactory cytology results (n = 196), because they could not be analyzed by all three tests due to insufficient material (n = 547) or because study participants were younger than 30 years of age (n = 104)
The 1,456 remaining specimens were tested by both RT hrHPV and HC2 (Fig. 1). 358 of these samples had an abnormal cytology result (Pap ≥ III; ≥ Atypical squamous cells – cannot exclude High grade squamous intraepithelial lesion (HSIL) (ASC-H)) 56 were classified as Atypical squamous cells of undetermined significance (ASC-US) (Pap IIw) and 1,042 women had normal cytology results (Pap I/II) (Table 1 and 2)
Summary
High-risk human papillomavirus (HR HPV) testing is already part of cervical cancer screening programs in a number of countries. 4,600 new cases and approximately 1,500 deaths due to cervical cancer are diagnosed in Germany each year [2]. The HC2 has been developed for the collective detection of 13 carcinogenic HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) [7]. It is one of the best validated HPV tests whose methodology is based on nucleic acid hybridization with signal amplification for qualitative detection of HPV-DNA within cervical samples
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