Diagnostic accuracy of high-risk HPV DNA genotyping for primary cervical cancer screening and triage of HPV-positive women, compared to cytology: preliminary results of the PIPAVIR study.
OBJECTIVE
The purpose of the presented PIPAVIR (persistent infections with human papillomaviruses; http://www.pipavir.com ) subanalysis is to assess the performance of high-risk (hr) HPV-DNA genotyping as a method of primary cervical cancer screening and triage of HPV positive women to colposcopy compared to liquid-based cytology (LBC) in an urban female population.


METHODS
Women, aged 30-60, provided cervicovaginal samples at the Family-Planning Centre, Hippokratio Hospital of Thessaloniki, Greece, and the Department of Gynecology and Obstetrics in Mare Klinikum, Kiel, Germany. Cytology and HPV genotyping was performed using LBC and HPV Multiplex Genotyping (MPG), respectively. Women positive for cytology [atypical squamous cells of undetermined significance (ASC-US) or worse] or hrHPV were referred for colposcopy.


RESULTS
Among 1723/1762 women included in the final analysis, hrHPV and HPV16/18 prevalence was 17.7 and 9.6%, respectively. Cytology was ASCUS or worse in 7.6%. Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) was detected in 28 women (1.6%). Sensitivity of cytology (ASCUS or worse) and HPV DNA testing for the detection of CIN2+ was 50.0 and 100%, and specificity was 94.49 and 85.49%, respectively. The screening approach according to which only women positive for HPV16/18 and for hrHPV(non16/18) with ASCUS or worse were referred to colposcopy presented 78.57% sensitivity and 13.17% positive predictive value (PPV).


CONCLUSIONS
HPV testing represents a more sensitive methodology for primary cervical cancer screening compared to cytology. For triage of HPV positive women to colposcopy, partial HPV genotyping offers better sensitivity than cytology, at the cost of higher number of colposcopies.
4th Department of Obstetrics and Gynecology, Hippokratio General Hospital, Aristotle University of Thessaloniki, 49 Konstantinoupoleos st, 54642, Thessaloniki, Greece. kimon.chatzistamatiou@gmail.com.
Kimon
http://orcid.org/0000-0002-5357-4708
K
Chatzistamatiou
Institute of Applied Biosciences, Centre for Research and Technology-Hellas, 57001, Thessaloniki, Greece.
Theodoros
T
Moysiadis
Faculty of Sciences, School of Informatics, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Eleftherios
E
Angelis
Department of Gynecology, Charité Campus Benjamin Franklin and Campus Mitte, Berlin, Germany.
Andreas
A
Kaufmann
Laboratory of Cytology, Hippokratio General Hospital, Thessaloniki, Greece.
Alkmini
A
Skenderi
Research Institute for Biomedical Aging Research, University of Innsbruck, Innsbruck, Austria.
Pidder
P
Jansen-Duerr
Laboratory of Bioinformatics, Department of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Irini
I
Lekka
Laboratory of Bioinformatics, Department of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Vasilis
V
Kilintzis
Department of Histopathology, Hippokratio General Hospital, Thessaloniki, Greece.
Stamatia
S
Angelidou
Department of Histopathology, Hippokratio General Hospital, Thessaloniki, Greece.
Evangelia
E
Katsiki
MVZ Im Mare, Kiel, Germany.
Ingke
I
Hagemann
4th Department of Obstetrics and Gynecology, Hippokratio General Hospital, Aristotle University of Thessaloniki, 49 Konstantinoupoleos st, 54642, Thessaloniki, Greece.
Athena
A
Tsertanidou
Mikrogen GmbH, Neuried, Germany.
Isabel
I
Koch
Mikrogen GmbH, Neuried, Germany.
Oliver
O
Boecher
Mikrogen GmbH, Neuried, Germany.
Erwin
E
Soutschek
Laboratory of Bioinformatics, Department of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Nikolaos
N
Maglaveras
4th Department of Obstetrics and Gynecology, Hippokratio General Hospital, Aristotle University of Thessaloniki, 49 Konstantinoupoleos st, 54642, Thessaloniki, Greece.
Theodoros
T
Agorastos
D000328:Adult; D003127:Colposcopy; D004279:DNA, Viral / Q000032:analysis*; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D005838:Genotype; D052162:Human papillomavirus 16 / Q000302:isolation & purification; D052161:Human papillomavirus 18 / Q000302:isolation & purification; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D014218:Triage; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology
D004279:DNA, Viral
Cervical cancer screening; HPV DNA testing; HPV genotyping; Human papillomavirus; Liquid-based cytology; Secondary cervical cancer prevention