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

Area of Science:

• Oncology
• Medical Imaging
• Public Health

Background:

• Cervical cancer remains a significant global health issue for women.
• Current screening methods like Naked Eye (NE) visual screening and Pap tests have limitations including low sensitivity and subjective interpretation.
• The Smart Scope® (SS) visual screening test offers a novel approach using a handheld device to capture cervical images.

Purpose of the Study:

• To evaluate and compare the diagnostic performance of the Smart Scope® (SS) visual screening test against conventional Naked Eye (NE) visual screening and Pap tests for cervical cancer detection.

Main Methods:

• A prospective observational study involving 509 women aged 25-65 was conducted over 16 months at a tertiary care hospital in India.
• Participants underwent all three screening tests: SS test, NE test, and Pap test.
• Screen-positive individuals were advised colposcopy and biopsy for histopathological confirmation.

Main Results:

• The SS test demonstrated 100% sensitivity and 100% negative predictive value (NPV), with 45.4% positive predictive value (PPV) and 36.8% specificity.
• The NE test showed 90% sensitivity, 88.2% NPV, 43.9% PPV, and 39.5% specificity.
• The Pap test yielded 25% sensitivity, 68.08% NPV, 45.5% PPV, and 84.2% specificity, based on 58 histopathology results.

Conclusions:

• The Smart Scope® (SS) test exhibits superior sensitivity and NPV compared to NE and Pap tests.
• Its high performance suggests significant potential as a primary cervical cancer screening tool, particularly in low-resource settings.
• The SS test offers a promising, accessible alternative for improving cervical cancer screening outcomes.