Comparative Study of Smart Scope(®) Visual Screening Test with Naked Eye Visual Screening and Pap Test

BACKGROUND: Cervical cancer is a major contributor to mortality and morbidity in women. Naked eye visual screening (NE test) and Pap test are commonly used for cervical cancer screening. Both tests have inherent limitations like low sensitivity (Pap test) and subjectivity in interpretation, lack of permanent record and overestimation (NE test). Here, Smart Scope(®) visual screening test (SS test) was compared with NE and Pap tests. Smart Scope(®) is a small, hand-held device that captures cervical images attached to a tablet to store data. OBJECTIVE: To compare SS test with Pap and NE tests. STUDY DESIGN: This prospective observational study was conducted at a tertiary care hospital in India, over 16 months. A total of 509 women in the age group of 25 to 65 years were included in the study as per the inclusion criteria. All the participants underwent Pap test, NE test and SS test. Screen positives on any one test were advised colposcopy and biopsy. RESULTS: Out of 154 screen-positive women, 49 visited for follow-up colposcopy-guided biopsy. Nine incidental biopsies of screen-negative women were included in the data. Thus, statistical analysis was carried out based on 58 available histopathology results. Out of 58 biopsies, 8 were normal, 30 were benign lesions, 18 were precancerous and 2 were cancerous lesions. SS test was found to have a sensitivity and NPV of 100% each, PPV of 45.4% and a specificity of 36.8%. Sensitivity and specificity of NE test was 90% and 39.5% respectively, PPV was 43.9% and NPV was 88.2%. Pap smear had a sensitivity of 25% and specificity of 84.2%, PPV of 45.5% and NPV of 68.08%. CONCLUSION: SS test has great potential to be a primary screening test in low-resource settings due to its better sensitivity and NPV as compared to NE and Pap tests.