Efficacy of a real time optoelectronic device (TruScreen ) in detecting cervical intraepithelial pathologies: A prospective observational study

Abstract

Objective: To assess the effect of TruScreen (an objective optoelectronic cervical screening device) in improving the sensitivity of cervicalscreening programs either alone or in combination with Papanicolaou (PAP) smear or human papilloma virus (HPV) DNA screening.Material and Methods: Our study was performed in 285 patients with abnormal Pap test results. TruScreen and HPV screening methodswere performed in all participants. Consistency and differences between the tests were compared with cervical biopsy results.Results: TruScreen was found to be an approach method in the determination of cervical pathologies (ROC curve area underlined=0.606)and with an 89.5% negative predictive value. HPV screening remains a counterpart to TruScreen with a 0.620 area underlined in the ROC curveand an 83% negative predictive value.Conclusion: As determined in our study, TruScreen with a sensitivity of 86.1% can be used as a screening test with instant and not professionaldependent results for cervical cancer screening. Avoiding from subjectivity in interpretation of Pap smears and requirement for pathologists, Tru -Screen can be a used for cervical cancer screening especially in countries with a low socio-economic status. The combination of TruScreen and HPV screening was not able to demonstrate a significant rise of effectiveness in screening.