Comparison of the Abbott RealTime High Risk HPV test and the Roche cobas 4800 HPV test using urine samples.
Human papillomavirus (HPV) testing based on cervical samples is important for use in cervical cancer screening. However, cervical sampling is invasive. Therefore, non-invasive methods for detecting HPV, such as urine samples, are needed.



For HPV detection in urine samples, two real-time PCR (RQ-PCR) tests, Roche cobas 4800 test (Roche_HPV; Roche Molecular Diagnostics) and Abbott RealTime High Risk HPV test (Abbott_HPV; Abbott Laboratories) were compared to standard cervical samples.



The performance of Roche_HPV and Abbott_HPV for HPV detection was evaluated at the National Cancer Center using 100 paired cervical and urine samples. The tests were also compared using urine samples stored at various temperatures and for a range of durations.



The overall agreement between the Roche_HPV and Abbott_HPV tests using urine samples for any hrHPV type was substantial (86.0% with a kappa value of 0.7173), and that for HPV 16/18 was nearly perfect (99.0% with a kappa value of 0.9668). The relative sensitivities (based on cervical samples) for HPV 16/18 detection using Roche_HPV and Abbott_HPV with urine samples were 79.2% (95% CI; 57.9-92.9%) and 81.8% (95% CI; 59.7-94.8%), respectively. When the cut-off CTvalue for Abbott_HPV was extended to 40 for urine samples, the relative sensitivity of Abbott_HPV increased to 91.7% from 81.8% for HPV16/18 detection and to 87.0% from 68.5% for other hrHPV detection. The specificity was not affected by the change in the CTthreshold.



Roche_HPV and Abbott_HPV showed high concordance. However, HPV DNA detection using urine samples was inferior to HPV DNA detection using cervical samples. Interestingly, when the cut-off CTvalue was set to 40, Abbott_HPV using urine samples showed high sensitivity and specificity, comparable to those obtained using cervical samples. Fully automated DNA extraction and detection systems, such as Roche_HPV and Abbott_HPV, could reduce the variability in HPV detection and accelerate the standardization of HPV detection in urine. Thus, urine samples may be an effective alternative for HPV detection in women who hesitate to participate in cervical cancer screening programs.
Center for Uterine Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea; Gynecologic Cancer Branch, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea.
Myong Cheol
MC
Lim
Department of Laboratory Medicine, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea.
Do-Hoon
DH
Lee
Department of Laboratory Medicine, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea; Hematologic Malignancy Branch, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea. Electronic address: mindcatch@ncc.re.kr.
Sang-Hyun
SH
Hwang
Department of Laboratory Medicine, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea.
Na Rae
NR
Hwang
National Cancer Control Institute, National Cancer Center, Goyang-si 410-769, Republic of Korea.
Bomyee
B
Lee
National Cancer Control Institute, National Cancer Center, Goyang-si 410-769, Republic of Korea.
Hye Young
HY
Shin
National Cancer Control Institute, National Cancer Center, Goyang-si 410-769, Republic of Korea.
Jae Kwan
JK
Jun
Center for Uterine Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea; Gynecologic Cancer Branch, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea.
Chong Woo
CW
Yoo
Center for Uterine Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea.
Dong Ock
DO
Lee
Center for Uterine Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea.
Sang-Soo
SS
Seo
Center for Uterine Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea; Gynecologic Cancer Branch, Research Institute and Hospital, National Cancer Center, Goyang-si 410-769, Republic of Korea.
Sang-Yoon
SY
Park
Biometric Research Branch, Research Institute and Hospital of National Cancer Center, Goyang-si 410-769, Republic of Korea.
Jungnam
J
Joo
D002584:Cervix Uteri / Q000821:virology; D005260:Female; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D014556:Urine / Q000821:virology*
Cervical cancer; Human papillomavirus; Real-time PCR; Self-sampling; Urine