Clinical and analytical performance of the PapilloCheck HPV-Screening assay using the VALGENT framework.
The benefit of HPV testing for cervical cancer screening and disease management has been shown in many recent studies and is part of several new evidence-based guidelines. Assessment of emerging HPV tests in this context is essential, using well-annotated samples, such as those generated via the Validation of Genotyping Tests-HPV (VALGENT) framework.



Our aim was to assess the PapilloCheck HPV assay in terms of absolute and relative accuracy for primary cervical cancer screening, using a standard comparator test (GP5+/6+EIA)already validated in randomised trials.



Type-specific HPV prevalence was stratified by age and cytology grade and compared with the luminex typing assay incorporating a GP5+6+ PCR (GP5+/6+ LMNX Assay). Clinical outcomes were compared with GP5+/6+EIA.



Prevalence of hrHPV types (high-risk HPV) increased with severity of cytology. The concordance between PapilloCheck and the GP5+/6+ LMNX Assay was excellent when assessed at the qualitative hrHPV presence/absence level also at the type-specific level in the whole population and in women over 30 years of age. Absolute clinical sensitivity and specificity of the PapilloCheck was high and ranged between 95.5% and 98.2% for sensitivity and between 82.7% and 91.6% for specificity, depending on the outcome and population.



The sensitivity and specificity of this assay for the outcomes of CIN2+ were similar to those of the standard comparator assay, GP5+/6+ EIA.
French Human papilomavirus Reference Laboratory, Institut Pasteur, France; Department of Endocrinology and Reproductive Medicine, IE3M, Groupe Hospitalier Pitié-Salpêtrière, Assistance Publique, Hôpitaux de Paris (AP-HP), Paris, France. Electronic address: isabelle.heard@pasteur.fr.
I
I
Heard
Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, 51 Little France Crescent, EH16 4SA, United Kingdom.
K
K
Cuschieri
DDL Diagnostic Laboratory, Rijswijk, The Netherlands.
D T
DT
Geraets
DDL Diagnostic Laboratory, Rijswijk, The Netherlands.
W
W
Quint
Unit of Cancer Epidemiology and Belgian Cancer Centre, Scientific Institute of Public Health, Brussels, Belgium.
M
M
Arbyn
D000293:Adolescent; D000328:Adult; D000368:Aged; D003430:Cross-Sectional Studies; D055088:Early Detection of Cancer; D005260:Female; D060005:Genotyping Techniques / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000821:virology; D055815:Young Adult
Cervical cancer screening; Diagnostic test accuracy; Human papillomavirus; Validation of tests