HPV self-sampling in CIN2+ detection: sensitivity and specificity of different RLU cut-off of HC2 in specimens from 786 women.
OBJECTIVE
Mortality for cervical cancer varies between the different regions of the world, with high rates in low-income countries where screening programmes are not present and organised. However, increasing screening coverage is still a priority in all countries: one way to do that is to base screening on self-sampled screening. The success of a self-sampling screening strategy depends on capacity to recruit unscreened women, on the performance and acceptability of the device and on the clinical performance of the high-risk human papillomavirus (HPV) test.


METHODS
This study based on 786 enrolled women investigates the best cut-off value of Hybrid Capture 2 HPV test (HC2) for self-sampled specimens in terms of sensitivity and specificity.


RESULTS
In this population, we found that the sensitivity and the specificity for cervical intraepithelial neoplasia grade 2 or more detection of HC2 performed on self-sampled specimens were 82.5% and 82.8%, respectively considering the relative light units (RLU) cut-off value of 1. Increasing the cut-off value the sensitivity decreases and the specificity raises and the best area under the curve for the RLU cut-off value is 1.


CONCLUSIONS
Our results confirm that the cut-off value of 1 suggested by Qiagen for PreservCyt specimen is the best cut-off value also for self-sampled specimens.
Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy.
F
F
Bottari
Preventive Gynecology Unit, European Institute of Oncology, Milan, Italy.
S
S
Igidbashian
Preventive Gynecology Unit, European Institute of Oncology, Milan, Italy.
S
S
Boveri
Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy.
A
A
Tricca
Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy.
C
C
Gulmini
Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy.
M
M
Sesia
Preventive Gynecology Unit, European Institute of Oncology, Milan, Italy.
N
N
Spolti
M
M
Sideri
Preventive Gynecology Unit, European Institute of Oncology, Milan, Italy.
F
F
Landoni
Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy.
M T
MT
Sandri
D000328:Adult; D000368:Aged; D019540:Area Under Curve; D005260:Female; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis*; D012372:ROC Curve; D012016:Reference Values; D016353:Self-Examination / Q000379:methods*; D012680:Sensitivity and Specificity; D014626:Vaginal Smears / Q000379:methods*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000821:virology*
CERVICAL CANCER; HPV; LABORATORY TESTS