A Performance Evaluation of an Optoelectronic Cervical Screening Device in Comparison to Cytology and HPV DNA Testing

Objective: An optoelectronic screening device (OESD) is evaluated for the detection of cervical intra-epithelial neoplasia (CIN) 2+ lesions in comparison to Liquid Based Cytology (LBC) and high-risk HPV DNA (hrHPV) testing. Methods: In total 506 consecutive women referred because of abnormal cervical cytology or a positive high-risk HPV test, had an examination using OESD, LBC, and hrHPV testing. They were screened in 4 colposcopy clinics in New South Wales, Australia. In a retrospective audit, results were compared to the gold standard of colposcopy and biopsies if required. Sensitivity, specificity, area under the receiver operating characteristic (ROC)-curves, and differences using McNemar tests were calculated. All results were available for comparison on 474 patients. Results: The sensitivity to detect CIN II+ lesions by OESD, LBC and hrHPV-testing was 0.72, 0.81, and 0.88, and the specificity was 0.71, 0.95, and 0.76 respectively. The age- and previous-treatment adjusted area under the ROC curve for OESD was 0.83, for LBC 0.94, and for hrHPV testing 0.89. McNemar’s tests showed no significant difference in sensitivity between OESD and LBC (p = 0.26), and no significant difference in specificity between OESD and hrHPV-testing (p = 1.0) amongst patients without previous treatment. Conclusions: The optoelectronic screening device demonstrated comparable sensitivity to high quality cytology conducted in a hospital clinical setting. Specificity was comparable to hrHPV-testing in an approximate primary screening setting. OESD has the advantage of producing an immediate result and being easy to use without need of laboratory equipment. This device can potentially become an important tool in the prevention of cervical cancer, particularly in developing countries and resource-limited settings.

real-time optoelectronic device; cervical screening; CIN; sensitivity; specificity; TruScreen; high risk HPV testing; liquid based cytology

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