TY - JOUR
T1 - Papilloplex HR-HPV test has non-inferior clinical performance for detection of human papillomavirus infection
T2 - assessment using the VALGENT framework
AU - Bhatia, Ramya
AU - Alcaniz Boada, Elia
AU - Bonde, Jesper Hansen
AU - Quint, Wim G V
AU - Xu, Lan
AU - Ejegod, Ditte Moller
AU - Cuschieri, Kate
AU - Arbyn, Marc
N1 - © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/3
Y1 - 2023/3
N2 - AIM: The Papilloplex high-risk human papillomavirus (hrHPV) test (Genefirst, Oxford, UK) is a single tube real-time HPV test which provides multiplex detection and separate identification of 14 hrHPV types. Here, we present the clinical validation of the test in SurePath samples in comparison to a clinically validated reference test, the GP5+/6+Enzyme ImmunoAssay (GP5+/6+EIA) using the VALGENT (VALidation of HPV GENotyping Tests) framework.METHODS: Clinical performance was assessed using 998 unselected, cervical screening samples enriched with 297 cytologically abnormal specimens (100 atypical squamous cells of unspecified significance, 100 low-grade squamous intraepithelial lesions, 97 high-grade squamous intraepithelial lesions). Cases were defined as women diagnosed with histologically confirmed cervical intraepithelial neoplasia two or more (≥CIN2, N=119) and controls defined as women with two subsequent negative cytology results (N=834).RESULTS: The Papilloplex HR-HPV test has non-inferior sensitivity for detection of cervical precancer (p=0.0001 for ≥CIN2 and p=0.0005 for ≥CIN3) and non-inferior specificity, compared with GP5+/6+EIA (pni=0.0167)). The assay also showed excellent or good agreement for overall hrHPV and nearly all individual HPV types as compared with GP5+/6+EIA/Luminex.CONCLUSION: The Papilloplex HR-HPV applied on cervical specimens stored in SurePath medium fulfils the international clinical accuracy criteria for use in cervical cancer screening.
AB - AIM: The Papilloplex high-risk human papillomavirus (hrHPV) test (Genefirst, Oxford, UK) is a single tube real-time HPV test which provides multiplex detection and separate identification of 14 hrHPV types. Here, we present the clinical validation of the test in SurePath samples in comparison to a clinically validated reference test, the GP5+/6+Enzyme ImmunoAssay (GP5+/6+EIA) using the VALGENT (VALidation of HPV GENotyping Tests) framework.METHODS: Clinical performance was assessed using 998 unselected, cervical screening samples enriched with 297 cytologically abnormal specimens (100 atypical squamous cells of unspecified significance, 100 low-grade squamous intraepithelial lesions, 97 high-grade squamous intraepithelial lesions). Cases were defined as women diagnosed with histologically confirmed cervical intraepithelial neoplasia two or more (≥CIN2, N=119) and controls defined as women with two subsequent negative cytology results (N=834).RESULTS: The Papilloplex HR-HPV test has non-inferior sensitivity for detection of cervical precancer (p=0.0001 for ≥CIN2 and p=0.0005 for ≥CIN3) and non-inferior specificity, compared with GP5+/6+EIA (pni=0.0167)). The assay also showed excellent or good agreement for overall hrHPV and nearly all individual HPV types as compared with GP5+/6+EIA/Luminex.CONCLUSION: The Papilloplex HR-HPV applied on cervical specimens stored in SurePath medium fulfils the international clinical accuracy criteria for use in cervical cancer screening.
KW - Early Detection of Cancer/methods
KW - Female
KW - Human Papillomavirus Viruses
KW - Humans
KW - Papillomaviridae/genetics
KW - Papillomavirus Infections/diagnosis
KW - Sensitivity and Specificity
KW - Uterine Cervical Dysplasia/diagnosis
KW - Uterine Cervical Neoplasms/pathology
KW - papillomavirus Infections
KW - HPV
KW - diagnostic screening programs
KW - polymerase chain reaction
UR - http://www.scopus.com/inward/record.url?scp=85148479504&partnerID=8YFLogxK
U2 - 10.1136/jclinpath-2021-207864
DO - 10.1136/jclinpath-2021-207864
M3 - Journal article
C2 - 34782423
SN - 0021-9746
VL - 76
SP - 172
EP - 176
JO - Journal of Clinical Pathology
JF - Journal of Clinical Pathology
IS - 3
M1 - jclinpath-2021-207864
ER -