Gynocular^TM as a Field Colposcope: Real-life Experiences from a VIA and HPV DNA-based Cervical Cancer Screening Program in Rural India

Abstract

Introduction:Gynocular™ is a battery-operated, portable field colposcope with three-step magnification and green filter. The present study was conducted in a community setting to evaluate accuracy and also asess the advantages and limitations of Gynocular™ as a field colposcope. Materials and methods:Women between 30 and 60 years were screened in the rural clinics in India using visual inspection on acetic acid (VIA) and human papillomavirus deoxyribonucleic acid (HPV DNA) test performed by trained health workers. Women positive on either test had evaluation by Gynocular™ by cervical punch biopsy irrespective of their Gynocular™ findings. A total of 12,727 women were screened using both VIA and hybrid capture 2 (HC2) test from April 2014 to February 2016.Result: A total of 1,021 women positive on either VIA or HC2 test were examined by Gynocular™. A total number of 231 cases of cervical intraepithelial neoplasm 1 (CIN1), 23 cases of CIN2, 13 cases of CIN3, and 7 cases of invasive cancers were detected on histology. The sensitivity and specificity of Gynocular™ at Swede Score (SS) ≥ 5 were 97.7% [95% confidence interval (CI): 87.7-99.9%] and 78.6% (95% CI: 75.9-81.2%) respectively. Raising the threshold to ≥6 resulted in drop in the sensitivity to 93.0% (95% CI: 80.9-98.5%), but a large improvement in specificity at 94.5% (95% CI: 92.8-95.8%). Conclusion:There is a great need for a technically less demanding and inexpensive colposcope to be used for programs in low-and middle-income countries (LMICs). The portability of the device, long battery back-up and ability to capture images using mobile phone are the advantages for using this device in field settings.