Comparison of the performance of Anyplex II HPV HR, the Cobas 4800 human papillomavirus test and Hybrid Capture 2.
BACKGROUND
Anyplex II HPV HR (Anyplex_HR; Seegene, Seoul, Korea) is a new multiplex real-time polymerase chain reaction assay for screening cervical cancer, and it is designed to detect 14 high-risk human papillomaviruses along with all the genotype information in a single tube. The aim of this study was to evaluate the performance of the Anyplex_HR in comparison to that of the Cobas 4800 HPV (Cobas_4800; Roche Molecular Diagnostics, Pleasanton, CA, USA) and the Hybrid capture 2 (HC2; Qiagen GmbH, Hilden, Germany).


METHODS
The performance of the Anyplex_HR for high-risk human papillomavirus genotype detection was prospectively evaluated against that of the HC2 and the Cobas_4800 at the National Cancer Center using 400 cervical samples. All discrepant samples were confirmed by polymerase chain reaction with type-specific primers followed by sequencing.


RESULTS
The overall agreement and kappa value of the Anyplex_HR with the Cobas_4800 were 98.0% and 0.96, respectively. The level of agreement between the two assays and the corresponding kappa values for human papillomavirus16, human papillomavirus18 and other high-risk human papillomaviruses were 99.5%, 99.8% and 98.8%, and 0.98, 0.96 and 0.97, respectively. The agreement and kappa value of the HC2 with the Cobas_4800 were 95.3% and 0.91. The human papillomavirus positivity of the Anyplex_HR and the Cobas_4800 in low-grade squamous intraepithelial lesion/high-grade squamous intraepithelial lesion samples demonstrated 100% concordance. Both the Anyplex_HR and the Cobas_4800 showed excellent results in the precision test.


CONCLUSIONS
The Anyplex_HR is comparable with the Cobas_4800 and the HC2 for human papillomavirus DNA testing, and it may prove more useful for follow-up testing and patient management by providing genotyping information additional to human papillomavirus16 and human papillomavirus18.
Department of Laboratory Medicine, Center for Diagnostic Oncology, National Cancer Center, Goyang-si, South Korea.
Do-Hoon
DH
Lee
Department of Laboratory Medicine, Center for Diagnostic Oncology, National Cancer Center, Goyang-si, South Korea.
Na Rae
NR
Hwang
Center for Uterine Cancer, and Gynecologic Cancer Branch, Research Institute and Hospital, National Cancer Center, Goyang-si, South Korea.
Myong Cheol
MC
Lim
Center for Uterine Cancer, and Gynecologic Cancer Branch, Research Institute and Hospital, National Cancer Center, Goyang-si, South Korea.
Chong Woo
CW
Yoo
Biometric Research Branch, Research Institute and Hospital of National Cancer Center, Goyang-si, South Korea.
Jungnam
J
Joo
Center for Uterine Cancer, and Gynecologic Cancer Branch, Research Institute and Hospital, National Cancer Center, Goyang-si, South Korea Radiation Medicine Branch, Research Institute and Hospital, National Cancer Center, Goyang-si, South Korea.
Joo-Young
JY
Kim
Center for Uterine Cancer, and Gynecologic Cancer Branch, Research Institute and Hospital, National Cancer Center, Goyang-si, South Korea.
Sang-Yoon
SY
Park
Department of Laboratory Medicine and Hematologic Malignancy Branch, Research Institute and Hospital, National Cancer Center, Goyang-si, South Korea mindcatch@ncc.re.kr.
Sang-Hyun
SH
Hwang
D055088:Early Detection of Cancer; D005260:Female; D005838:Genotype; D006801:Humans; D025202:Molecular Diagnostic Techniques; D060885:Multiplex Polymerase Chain Reaction; D027383:Papillomaviridae / Q000235:genetics; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology
DPO; Human papilloma virus; cervical cancer screening; performance evaluation; real-time PCR