title: Evaluation of a compact, rechargeable, magnifying device to triage VIA and HPV positive women in a cervical cancer screening program in rural India.
abstract: OBJECTIVE
  Many limited-resourced countries have either introduced cervical cancer screening programs or are contemplating to do so using visual inspection after acetic acid application (VIA) or human papillomavirus (HPV) detection tests. Both tests have high false-positivity and a suitable triaging strategy is required. Colposcopy triaging is not practicable in most resource-limited settings due to several reasons. We evaluated a portable, battery-operated, magnifying device (GynocularTM) to triage screen positive women in community setting in India.
  
  
  METHODS
  Women positive on VIA or oncogenic HPV test were examined with Gynocular by clinicians in primary health clinics. Findings were documented using the International Federation for Cervical Pathology and Colposcopy (IFCPC) terminology. Swede score was also calculated. Biopsy was performed irrespective of Gynocular findings. The accuracy of Gynocular to detect high-grade lesions or cancer (HSIL+) was estimated. The suitability of Gynocular to correctly triage screen positive cases for immediate ablative treatment was also evaluated by creating simulated scenarios.
  
  
  RESULTS
  Sensitivity and specificity of Gynocular were 96.4 and 47.1 %, respectively, to detect HSIL + at the threshold of IFCPC grade 1 findings. Increasing threshold to grade 2 changed sensitivity and specificity to 92.9 and 94.1 %, respectively. Optimum combination of sensitivity and specificity as determined by the receiver operating curve analysis was at the cut-off Swede score of 5. Triaging of VIA/HPV positive women to treatment using grade 2 criteria would have resulted in modest overtreatment and missing of very few high-grade lesions.
  
  
  CONCLUSIONS
  Gynocular can be used as an effective triaging device for VIA/HPV positive women.
authors: Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer (WHO), 150 cours Albert Thomas, 69372, Lyon Cedex 08, France. BasuP@iarc.fr.
authors: Partha
authors: http://orcid.org/0000-0003-0124-4050
authors: P
authors: Basu
authors: Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.
authors: Dipanwita
authors: D
authors: Banerjee
authors: Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.
authors: Srabani
authors: S
authors: Mittal
authors: Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.
authors: Ranajit
authors: R
authors: Mandal
authors: Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.
authors: Ishita
authors: I
authors: Ghosh
authors: Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.
authors: Pradip
authors: P
authors: Das
authors: Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer (WHO), 150 cours Albert Thomas, 69372, Lyon Cedex 08, France.
authors: Richard
authors: R
authors: Muwonge
authors: Chittaranjan National Cancer Institute, Kolkata, West Bengal, India.
authors: Jaydip
authors: J
authors: Biswas
mesh_terms: D019342:Acetic Acid; D000328:Adult; D001706:Biopsy / Q000379:methods; D003127:Colposcopy; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D006801:Humans; D007194:India; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D011247:Pregnancy; D012424:Rural Population; D014218:Triage; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000821:virology*
chemical_list: D019342:Acetic Acid
keywords: GynocularTM; Human papillomavirus test; Magnifying device; Triaging; Visual inspection after acetic acid application