Study-based evaluation of the Abbott RealTime High Risk HPV test in comparison to the HC2 HR HPV test in women aged ≥30 years using residual LBC ThinPrep specimens.
BACKGROUND
High-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.


METHODS
The 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.


RESULTS
HR 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 + .


CONCLUSIONS
The RT hrHPV assay is as sensitive and specific in detecting severe cervical lesions in women with abnormal cytology as the HC2 HR HPV test.
Division of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Elfriede-Aulhorn-Str. 6, Tübingen, 72076, Germany. Thomas.iftner@med.uni-tuebingen.de.
Thomas
T
Iftner
Clinical Epidemiology and Applied Biometry, University Hospital Tübingen, Tübingen, Germany.
Lisa
L
Wang
Division of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Elfriede-Aulhorn-Str. 6, Tübingen, 72076, Germany.
Angelika
A
Iftner
Division of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Elfriede-Aulhorn-Str. 6, Tübingen, 72076, Germany.
Barbara
B
Holz
Division of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Elfriede-Aulhorn-Str. 6, Tübingen, 72076, Germany.
Juliane
J
Haedicke-Jarboui
Division of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Elfriede-Aulhorn-Str. 6, Tübingen, 72076, Germany.
Nathalie
N
Iftner
Amedes Laboratory Bad Münder, Bad Münder, Germany.
Reinhard
R
von Wasielewski
Clinical Epidemiology and Applied Biometry, University Hospital Tübingen, Tübingen, Germany.
Peter
P
Martus
Amedes Laboratory Bad Münder, Bad Münder, Germany.
Gerd
G
Boehmer
D000328:Adult; D003581:Cytodiagnosis; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D012680:Sensitivity and Specificity
Abbott RealTime High Risk HPV; Cervical cancer screening; HPV; Hybrid Capture