Atypical Squamous Cells of Undetermined Significance Cervical Cytology Report Rate and Histologic Follow-up Findings From the Largest College of American Pathologists-Certified Laboratory in China.

CONTEXT.­: Reports for atypical squamous cells of undetermined significance (ASC-US) and histologic findings are rare in China. OBJECTIVE.­: To analyze the correlation findings of ASC-US cytology with high-risk human papillomavirus (hrHPV) test and histopathologic follow-ups. DESIGN.­: ASC-US cases with hrHPV test and histologic follow-ups between 2011 and 2015 were analyzed at a College of American Pathologists-certified laboratory. RESULTS.­: A total of 2 206 588 Papanicolaou (Pap) tests were performed, including 1 513 265 liquid-based cytology preparations (68.58%), and 693 323 conventional Pap tests (31.42%). The overall ASC-US reporting rate was 3.77% (83 199 of 2 206 588), with the highest in women aged 40 to 49 years. Of 18 574 women with ASC-US Pap and HPV testing, the hrHPV positivity rate was 34.98% (6498 of 18 574) with the highest in women younger than 30 years. A total of 6012 women with ASC-US Pap test findings had histologic follow-ups within 6 months; the overall cervical intraepithelial neoplasia 2 and above (CIN2+) detection rate was 7.87% (473 of 6012). One thousand nine hundred nine women with ASC-US Pap and HPV testing had histologic results. CIN2+ lesion was found in 13.98% (124 of 887) of women with ASC-US Pap/HPV-positive test results, significantly higher than 2.84% (29 of 1022) for women with ASC-US Pap/HPV-negative test results. Cervical squamous cell carcinoma was found in 3.95% (35 of 887) of women with ASC-US/HPV-positive test results. CONCLUSIONS.­: This is one of the largest studies to investigate HPV and histologic follow-up findings in women with ASC-US in China. The ASC-US reporting rate, HPV positivity rate, and CIN2+ detection rate were all within the currently recognized benchmark ranges. These findings may contribute to establishing a baseline for better understanding of the status of cervical screening in China.

Conventional Pap smear cervical cancer screening in 11 rural counties in Hainan Province, China: analysis of Bethesda system reporting rates for 218,195 women (predominantly ages 35-64 years) screened in China's National Cervical Cancer Screening Program in Rural Areas (NCCSPRA).

OBJECTIVE: Recently the Chinese government has introduced support for cervical screening in rural areas. The College of American Pathologists (CAP)-certified Guangzhou Kingmed Diagnostics laboratory supported rural screening program in Hainan Providence utilizing low-cost conventional Papanicolaou smears (CPS). STUDY DESIGN: This was a retrospective study of CPS screening results from 2011 to 2014 in 11 rural counties in Hainan Province. Women, most previously unscreened, volunteered to attend free CPS screening. The targeted population was women aged 35-65 years. RESULTS: Among total 218,195 conventional Papanicolaou smears, the reported abnormal rate was 4.4% of all smears, with 0.5% for high-grade squamous intraepithelial lesion (HSIL), 0.9% for low-grade squamous intraepithelial lesion (LSIL), 2.6% for atypical squamous cells of undetermined significance, and 0.3% for atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion. Reporting rates for different TBS categories were generally within CAP benchmark ranges, except for low reporting rates for unsatisfactory smears and for atypical glandular cells. Abnormal cytology rates varied among counties. Comparing different age groups, the LSIL rate was significantly higher in women <50 years than in women ≥50 years (1.04% versus 0.64%). The HSIL rate was significantly higher in women ≥40 years than in women <40 years (5.3% versus 0.38%). A total of 2286 women with abnormal Papanicolaou smears had documented colposcopic and histopathologic follow-up. Cervical cancer was diagnosed in 23 of 2286 (1.01%) of screened and biopsied patients. Histopathologic HSIL results were confirmed in 80% of biopsied women with HSIL Papanicolaou tests. CONCLUSIONS: CPS offered a low cost method to introduce cervical screening in rural China. The international College of American Pathologists Laboratory Accreditation Program provided laboratory quality control standards not otherwise readily available. Educational training programs have been instituted to address areas identified for quality improvement.

HPV test results and histological follow-up results of patients with LSIL Cervical Cytology from the Largest CAP-certified laboratory in China.

BACKGROUND: Age-adjusted evaluations have explored the possible utility of (HPV test results in women with LSIL Pap. We investigated HPV test results and histopathologic follow-up results of LSIL patients from China's largest CAP-certified laboratory. METHODS: Patients with LSIL between 2011 and 2015 from the Guangzhou Kingmed Diagnostics were retrospectively retrieved and their hrHPV test results and histological follow-up results were collected and analyzed. RESULTS: LSIL result was identified in 37,895 cases from 2,206,588 Pap tests (1.7%) including 1,513,265 liquid-based cytology and 693,323 conventional Pap tests. The average of these women was 38.4 years (15-88). The LSIL reporting rate in women <30 years was significantly higher than that in women > 30 years (2.1% vs 1.7%). The age specific reporting LSIL rates declined with increased age. 8,014 of 37,895 (21.2%) women with LSIL cytology also had HC2 HPV test results. 75.8% of women with LSIL Pap tests were hrHPV+ and the HPV+ rates declined with increased age except in patients older than 60 years. Overall histopathologic diagnoses within 6 months after LSIL were identified in 5,987 of 37,895 patients at Guangzhou Kingmed Diagnostics. CIN2/3 was identified in 15.2% patients, CIN1 in 66.9%, negative in 14.9% patients. No invasive carcinoma was found in all patients. Of 8014 patients with LSIL Pap test and HPV testing results, 1727 patients had histological follow-up within 6 months after Pap cytology test and HPV testing. The detection rate of CIN2/3 was significantly higher in patients with positive HPV testing result than that in patients with negative HPV testing result (17.8% vs. 8.1%). Among patients with LSIL/HPV negative tests, CIN2/3 was detected in 1 of 30 (3.3%) women aged 50 years and above, appearing lower than those in women less than 50 years (8.0%, 28/351, P=0.357). CONCLUSION: This is the largest histological follow-up study in women with LSIL Pap from China and the data are helpful in establishing a baseline for better understanding the status of cervical screening in China. The 85.1% positive predict value of LSIL Pap cytology for follow-up CIN lesion was within currently recognized benchmark ranges.