To develop an effective, low-cost, single-visit cervical screening strategy incorporating a modified Pap test and visual inspection with acetic acid and Lugol’s iodine for low-income settings.
We conducted a prospective cohort trial. Two low-income Muslim Uyghur communities in China’s far western Kashi Prefecture served as pilot and validation study sites, respectively, and 4,049 women (aged 30–59 years) were screened. The conventional Pap test was modified using a cotton swab to collect cervical cells without scraping the cervix using an Ayre spatula, allowing visual inspection with acetic acid (and visual inspection with Lugol’s iodine if visual inspection with acetic acid was negative) to be performed in a single visit. Results from both tests were available within 1–2 hours. Women positive for either or both underwent same-day biopsy that was shipped by a courier service to a central pathology laboratory.
Single-visit screening incorporating both a modified Pap test and visual inspection achieved a sensitivity of 96.0% (95% CI 91.6–100), which was superior to Pap testing (76%, 95% CI 66.3–85.7; P<.001) or visual inspection with acetic acid–visual inspection with Lugol’s iodine (48%, 95% CI 36.7–59.3; P<.001) alone in detecting cervical intraepithelial neoplasia (CIN) 2 or worse lesions. Rapid interpretation of both diagnostic procedures facilitated efficient same-day biopsy that achieved a negative predictive value of 98.2% in detecting CIN 2 or worse lesions. The increased sensitivity and minimized loss of follow-up allowed this approach to identify an extremely high prevalence of CIN 1 (2,741/100,000, 95% CI 2,238–3,245/100,000), CIN 2 or 3 (1,457/100,000, 95% CI 1,088–1,826/100,000), and cervical cancer (395/100,000, 95% CI 202–589/100,000) among these underscreened, at-risk women.
Single-visit cervical screening with both a modified Pap test and visual inspection has greater sensitivity to detect high-grade CINs, reduces loss of follow-up, and could be an efficient low-cost strategy for low-resource settings.
Rapid interpretation of a modified Pap test and visual inspection with acetic acid and Lugol’s iodine allowing for same-day biopsy is a low-cost approach to efficient cervical cancer screening in a low-resource setting.
Departments of Pathology and Obstetrics and Gynecology, the First Affiliated Hospital, Shihezi University School of Medicine, the Key Laboratories for Xinjiang Endemic and Ethnic Diseases and the Department of Public Health, Shihezi University, and the Department of Histology and Embryology, School of Medicine, Shihezi University, Shihezi, Xinjiang, the Department of Pharmacology, Kashi Prefecture First People’s Hospital, and the Department of Surgery, Kashi Prefecture Second People’s Hospital, Kashi Prefecture Health Bureau, Kashi Prefecture, Xinjiang, the Department of Pathology, Chaoyang Hospital, the Capital Medical University, Beijing, and the Department of Epidemiology and Statistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China; and the Australian Institute for Bioengineering and Nanotechnology, University of Queensland, Brisbane, Queensland, Australia.
Corresponding author: Wen Jie Zhang, MD, PhD, Department of Pathology, Shihezi University School of Medicine, 59 North 2nd Road, Shihezi, Xinjiang 832002, China; email: firstname.lastname@example.org.
Supported by grants from the Ministry of Science and Technology of China (2009BAI82B02, 2013GS650104) and the Oasis Scholar Fund of Shihezi University (LZXZ201023). The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Financial Disclosure The authors did not report any potential conflicts of interest.
The authors thank Jiashi County Government, County Health Bureau, Jiangbazi and Hexia’awati Township Administrations, Jiangbazi Township Hospital, and local health workers for field assistance and providing screening facilities.
Each author has indicated that he or she has met the journal’s requirements for authorship.
Peer review history is available at http://links.lww.com/AOG/B192.