Establishment of early diagnosis models for cervical precancerous lesions using large-scale cervical cancer screening datasets.

BACKGROUND: Human papilloma virus (HPV) DNA test was applied in cervical cancer screening as an effective cancer prevention strategy. The viral load of HPV generated by different assays attracted increasing attention on its potential value in disease diagnosis and progression discovery. METHODS: In this study, three HPV testing datasets were assessed and compared, including Hybrid Capture 2 (n = 31,954), Aptima HPV E6E7 (n = 3269) and HPV Cobas 4800 (n = 13,342). Logistic regression models for diagnosing early cervical lesions of the three datasets were established and compared. The best variable factor combination (VL + BV) and dataset (HC2) were used for the establishment of six machine learning models. Models were evaluated and compared, and the best-performed model was validated. RESULTS: Our results show that viral load value was significantly correlated with cervical lesion stages in all three data sets. Viral Load and Bacterial Vaginosis were the best variable factor combination for logistic regression model establishment, and models based on the HC2 dataset performed best compared with the other two datasets. Machine learning method Xgboost generated the highest AUC value of models, which were 0.915, 0.9529, 0.9557, 0.9614 for diagnosing ASCUS higher, ASC-H higher, LSIL higher, and HSIL higher staged cervical lesions, indicating the acceptable accuracy of the selected diagnostic model. CONCLUSIONS: Our study demonstrates that HPV viral load and BV status were significantly associated with the early stages of cervical lesions. The best-performed models can serve as a useful tool to help diagnose cervical lesions early.

Nationwide Prevalence and Genotype Distribution of High-Risk Human Papillomavirus Infection in China.

OBJECTIVES: Extended high-risk human papillomavirus (hrHPV) genotype testing has recently been introduced in routine cervical cancer screening. Changes in national and regional hrHPV genotype prevalence offer an objective baseline indicator of the future impact of mass HPV vaccination and HPV-based cervical screening. METHODS: This retrospective study reports nationwide hrHPV genotyping results from July 2018 to June 2019 in 29 KingMed Diagnostics laboratories throughout China. RESULTS: In total, 2,458,227 hrHPV genotyping results were documented from KingMed's nationwide laboratory database during the study period. The overall prevalence of hrHPV-positive results was 19.1%, with twin peaks for highest hrHPV infection rates in women younger than 30 years of age (22.0%) and 50 years of age and older (21.8%). The most frequently detected hrHPV genotypes were HPV-52 (4.7%), HPV-16 (3.4%), HPV-53 (2.5%), HPV-58 (2.4%), HPV-51 (2.0%), and HPV-68 (1.6%). Overall, hrHPV-positive results varied regionally from 15.3% to 24.4%. CONCLUSIONS: Nationwide hrHPV genotyping results from KingMed laboratories offer a baseline for measuring the future impact of large-scale HPV vaccination. High hrHPV infection rates in older (≥50 years) Chinese women likely reflect the limited extent of cervical screening in China. High rates of hrHPV infection and variable regional hrHPV genotype distribution may represent limiting factors for cost-effective implementation of hrHPV-based cervical screening in China.

Previous Papanicolaou and Hybrid Capture 2 human papillomavirus testing results of 5699 women with histologically diagnosed cervical intraepithelial neoplasia 2/3.

INTRODUCTION: Cervical cancer remains an important public health problem in Chinese women owing to the lack of a national screening program. The aim of the present study was to evaluate human papillomavirus (HPV) and Papanicolaou (Pap) test results preceding the histologic diagnosis of cervical intraepithelial neoplasia 2/3 (CIN2/3) in China's largest College of American Pathologists-certified clinical laboratory. MATERIALS AND METHODS: All cases of CIN2/3 histologically diagnosed from January 2011 to August 2016 were retrieved from the pathology department records. The Pap cytology and HPV test results from the 6 months before the CIN2/3 diagnoses were analyzed. RESULTS: A total of 5699 patients with histologically diagnosed CIN2/3 had previous Pap and/or HPV Hybrid Capture 2 testing results within the previous 6 months. The average age was 39.5 years (range, 16-82 years). Of these patients, 4288 had Pap test findings (average, 1.5 months) available. The results were high-grade squamous intraepithelial lesion in 44.1%, low-grade squamous intraepithelial lesion in 20.0%, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion, in 16.0%, atypical squamous cells of undetermined significance, in 12.3%, atypical glandular cells in 0.7%, and negative in 6.9%. Of the 5699 patients, 2546 had HPV Hybrid Capture 2 test results (average, 1.4 months) available. Of these, 91.7% had positive results and 8.3% had negative results. Of 1135 patients with both previous Pap and HPV results, 7.1% had negative HPV results and 8.0% had negative Pap results (P = 0.38). Only 21 patients (1.9%) had double negative results. CONCLUSIONS: The present study has reported the previous results of HPV testing and Pap cytology for patients with high-grade cervical squamous precursor lesions in a population of women in China who had not undergone intensive previous screening. Both high-risk HPV and Pap cytology had similar negative testing rates for these women, although double negative results were less common. These results support the value of combined testing in the detection of cervical cancer precursors.

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.

The largest CAP-certified Chinese reference laboratory experience with the Bethesda system for reporting thyroid cytopathology: correlation with histologic and BRAF data.

INTRODUCTION: Thyroid fine needle aspiration biopsy (FNAB) has not been widely used in most areas of China. We investigated a large cohort of thyroid FNAB using the Bethesda system for reporting thyroid cytopathology (TBSRTC) from the largest College of American Pathology (CAP)-certified reference laboratory in China. MATERIALS AND METHODS: Patients with thyroid FNAB between 2014 and 2016 from Guangzhou Kingmed Diagnostics were retrospectively retrieved and the histologic follow-up results and BRAF results were collected and analyzed. RESULTS: A total of 7355 thyroid FNAB cases were identified. The average age of these patients was 48.03 years (range: 5-90 years). A total of 875 cases (11.9%) were reported as nondiagnostic, 4041 (54.9%) cases were benign, 736 cases (10.0%) were atypia of undetermined significance/follicular lesion of undetermined significance (AUS/FLUS), 53 cases (0.7%) were suspicious for follicular neoplasm, 615 cases (8.4%) were suspicious for malignancy, and 1035 cases (14.1%) were positive for malignancy. Histologic follow-up was available on 552 patients. Among 13 cases of AUS/FLUS, 8 (61.5%) had malignancy on histology; 195 (92.0%) of the suspicious for malignancy cases had malignancies on histology, and 320 (98.5%) of the positive for malignancy cases had malignancies on histology. BRAF analysis was performed on 578 cases. Sixty cases with BRAF data had histologic follow-up, all 4 benign cases had negative BRAF, one follicular adenoma had negative BRAF, and 37 of the 55 PTC cases (67.3%) had positive BRAF. BRAF mutation has a 100% positive predictive value of malignancy for the indeterminate thyroid FNABs. CONCLUSIONS: This is the largest cohort of thyroid FNA reported using TBSRTC in China and the data are helpful for better understanding the status of thyroid FNA in China.

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.

Polymerase Chain Reaction Human Papillomavirus (HPV) Detection and HPV Genotyping in Invasive Cervical Cancers With Prior Negative HC2 Test Results.

OBJECTIVES: Recently, three large Chinese cohort studies showed that 7.5% to 15.5% of patients with cervical carcinoma had negative high-risk human papillomavirus (hrHPV) test results on prior cytology specimens. These studies raise the question as to whether these negative hrHPV results represent truly hrHPV-negative carcinomas or false-negative hrHPV test results due to limitations in the testing of cytology specimens. This is increasingly an important question with increasing push to use hrHPV testing alone to screen for cervical cancer. METHODS: We investigated the hrHPV status on the surgical specimens from these same patients with cervical carcinoma using three polymerase chain reaction methods and a linear assay genotyping method. RESULTS: A variety of HPV genotypes were detected in 28 (45.9%) of 61 cases, all belonging to carcinogenic or possibly carcinogenic categories. HPV 16 was the most common genotype detected in positive cases (66.7%). HPV was detected in 25 (50%) of 50 squamous cell carcinomas and two (66.7%) of three adenosquamous carcinomas and only one (12.5%) of eight endocervical adenocarcinomas. CONCLUSIONS: Our findings demonstrate that negative hrHPV testing on cervicovaginal cytology specimens in women later diagnosed with cervical carcinoma can be explained by the occurrence of truly HPV-negative carcinomas in more than half of patients. These results should be considered in the development of future cervical cancer screening guidelines.

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.

Prevalence and Genotype Distribution of HPV Infection in China: Analysis of 51,345 HPV Genotyping Results from China's Largest CAP Certified Laboratory.

INTRODUCTION: The prevalence of cervical Human Papillomavirus (HPV) infection varies greatly worldwide and data regarding HPV prevalence and genotypes in China are limited. METHODS: HPV testing results were retrospectively examined at KingMed Diagnostics, the largest independent pathology laboratory in China, from January 2011 to June 2014. All testing was performed using the 26 HPV Genotyping Panel of Tellgenplex (TM) xMAP™ HPV DNA Test assay (TELLGEN, Shanghai, China). Overall prevalence, age-specific prevalence and genotype distributions were analyzed. RESULTS: A total of 51,345 samples were tested and the overall HPV prevalence was 26%, with 21.12% positive for high risk (HR) HPV and 8.37% positive for low risk HPV. 80% of HPV positive cases were positive for a single HPV type. The three most common HR HPV types detected were HPV-52, -16, and -58, in descending order. HPV-18 was only the 6(th) most common type. When women were divided into three age groups: <30, 30-49, ≥50 years, HR HPV had the highest prevalence rate in women <30 years, and the lowest rate in women 30-49 years of age. The distribution of HR HPV genotypes also varied among these three age groups. CONCLUSIONS: To the best of our knowledge, this is largest routine clinical practice report of HPV prevalence and genotypes in a population of women having limited cervical cancer screening. HPV-52 was the most prevalent HR HPV type in this population of women followed by HPV-16 and HPV-58. The overall and age-specific prevalence and genotype distribution of HR HPV are different in this Chinese population compared to that reported from Western countries.

Prevalence of High-Risk Human Papillomavirus Infection in China: Analysis of 671,163 Human Papillomavirus Test Results From China's Largest College of American Pathologists-Certified Laboratory.

OBJECTIVES: This study on human papillomavirus (HPV) testing in China's largest independent laboratory accredited by the international Laboratory Accreditation Program of the College of American Pathologists extends previous reports on cervical screening test results from this Chinese facility. METHODS: A retrospective laboratory database search from 2007 to 2014 documented high-risk HPV test results using either Hybrid Capture 2 (HC2; Qiagen, Hilden, Germany) or multiplex polymerase chain reaction fluorescence testing (MPFT) methods. RESULTS: During the study period, HPV testing steadily increased, with 643,702 HC2 and 27,641 MPFT HPV tests performed. The mean ages of the tested women were 35.0 years using HC2 and 38.3 years using MPFT. The HC2 HPV-positive rate was 21.7%, significantly higher than 15.7% with MPFT (P < .0001), with bimodal peak incidence in adolescents and women aged 60 to 69 years. CONCLUSIONS: Use of HPV testing in cervical screening is increasing in China. HC2 HPV-positive rates around 20% in all age groups from more than 500,000 tested Chinese women are consistent with previous reports from China and significantly higher than published HC2 HPV-positive rates in populations with more widespread cervical screening. MPFT HPV-positive rates were slightly lower in every age group. The high HPV-positive rate likely reflects limited routine cervical screening and high cervical cancer incidence in China.

Cervical Cytology Reporting Rates from China's Largest College of American Pathologists-Certified Laboratory with a Focus on Squamous Cell Carcinoma Cytology and Its Histopathological Follow-Up Results.

OBJECTIVE: No organized cervical screening programs or national cervical cytology quality control standards currently exist in China. This study reported cervical cytology performance in China's largest independent laboratory with accreditation from the College of American Pathologists. DESIGN: Results from over 2 million Papanicolaou (Pap) tests by the KingMed Diagnostics Laboratory were categorized according to The Bethesda System (TBS) from 2007 and 2014. Pap reports and histopathologic follow-up results of squamous cell carcinomas (SCC) were analyzed. RESULTS: Data on 676,445 conventional Pap smears (CPS) and 1,696,284 liquid-based cytology (LBC) specimens were available. Abnormality rates reported were significantly higher with LBC than with CPS in all TBS categories (p < 0.001). A total of 800 SCC cytology reports were identified, representing a laboratory SCC reporting rate of 0.0337%. The SCC reporting rate with LBC (0.0457%) was significantly higher than the reporting rate with CPS. Histopathologic invasive cervical carcinoma and cervical intraepithelial neoplasia 2/3 were diagnosed in 80.7 and 17.6% of the 119 patients with SCC Pap cytology. CONCLUSIONS: Reporting rates for most TBS categories from this CAP-accredited laboratory in China were within the CAP benchmark ranges except for low atypical glandular cell and unsatisfactory case rates. Histological follow-up results in patients with SCC cytology reports demonstrate very high specificity of SCC Pap cytology.

Prior high-risk HPV testing and Pap test results for 427 invasive cervical cancers in China's largest CAP-certified laboratory.

BACKGROUND: Cervical cancer and its precursor lesions are caused by a persistent high-risk human papillomavirus (hrHPV) infection. hrHPV testing has been reported to have higher sensitivity than Papanicolaou (Pap) testing for the detection of cervical precursor lesions. However, limited data are available for prior human papillomavirus (HPV) testing results for patients later diagnosed with invasive cervical cancer, especially in countries lacking a national cervical cancer screening program such as China. This study investigated prior hrHPV testing results for patients with invasive cervical cancer in China. METHODS: Cases with a histologic diagnosis of invasive cervical carcinoma were retrieved from Guangzhou KingMed Diagnostics (the largest independent pathology laboratory in China); prior hrHPV and Pap test results obtained within the year before the cancer diagnosis were recorded. RESULTS: HPV testing was negative in 7.5% of 427 cases of invasive cervical carcinoma, including squamous cell carcinoma (5%) and adenocarcinoma (25%). In 155 cervical cancer cases with prior hrHPV and Pap testing, the negative rate for Pap testing was 1.9%, and the negative rate for HPV was 9.7%. Furthermore, when only cases of adenocarcinoma (n = 18) were examined, both the hrHPV-negative rate and the Pap-negative rate were higher at 33% and 5.6%, respectively. CONCLUSIONS: These data demonstrate a considerable prior hrHPV-negative rate and a lower prior Pap-negative rate in patients with invasive cervical carcinoma (especially adenocarcinoma) from a population of women without access to an established screening program.

Bethesda System reporting rates for conventional Papanicolaou tests and liquid-based cytology in a large Chinese, College of American Pathologists-certified independent medical laboratory: analysis of 1394389 Papanicolaou test reports.

CONTEXT: Reports that use the Bethesda System categories for Chinese Papanicolaou test results are rare. OBJECTIVE: To document and analyze rates reported in the Bethesda System for conventional Papanicolaou tests and liquid-based cytology between 2007 and 2012 in China's largest College of American Pathologists-accredited laboratory. DESIGN: Results from 1,394,389 Papanicolaou tests, rendered between 2007 and 2012 by the Guangzhou Kingmed Diagnostics Cytology Laboratory, were documented by the Bethesda System report categories and Papanicolaou test methodology, which included both conventional Papanicolaou tests and 4 different liquid-based cytology preparations. RESULTS: Results were documented for 326,297 conventional Papanicolaou tests and 1,068,092 liquid-based cytology specimens, which included 928,884 ThinPrep (Hologic, Bedford, Massachusetts), 63,465 SurePath (BD Diagnostics, Franklin Lakes, New Jersey), 50,422 Liqui-Prep (LGM International, Melbourne, Florida), and 25,321 Lituo liquid-cytology (Lituo Biotechnology Co, Hunan, China) specimens. Abnormality rates reported were significantly higher with liquid-based cytology than they were with conventional Papanicolaou tests in all the Bethesda System categories (P < .001). Reporting rates were within the 2006 benchmark ranges from the College of American Pathologists, except for atypical glandular cells (low) and unsatisfactory rates for conventional Papanicolaou tests (low). CONCLUSION: Participation in the international College of American Pathologists Laboratory Accreditation Program provides laboratory quality standards not otherwise available in many international settings.

PPV of an HSIL cervical cytology result in China's largest CAP-certified laboratory.

INTRODUCTION: Cervical cancer remains a major health problem in China, where no uniform national standards for cervical cytology quality control exist. This study extends previously reported findings on cervical cytology performance in China's largest independent laboratory to have achieved accreditation under the international Laboratory Accreditation Program of the College of American Pathologists. MATERIALS AND METHODS: A retrospective study identified high-grade squamous intraepithelial lesion (HSIL) cervical cytology reports between 2007 and 2013 from the Cytology Laboratory, Guangzhou Kingmed Diagnostics. Four liquid-based cytology (LBC) preparations were used in 73% of cases and conventional Papanicolaou tests (CPT) in 27%. Follow-up histopathologic diagnoses after HSIL reports were identified in the laboratory database. The positive predictive value for laboratory HSIL cytology results was determined for follow-up histopathologic diagnoses of cervical intraepithelial neoplasia 2 or worse (CIN2+), a recognized international quality control monitor. RESULTS: Of 1,804,108 cervical cytology reports, 11,929 HSIL reports (0.66%) were identified. The LBC HSIL rate was 0.79%, which was higher than the CPT HSIL rate of 0.33% (P < 0.001). Follow-up CIN2+ histopathologic diagnoses within 6 months after HSIL were identified in 1994 of 2414 patients (82.6%), including 1860 of 2246 LBC HSIL (82.8%) and 134 of 168 CPT HSIL (79.8%). Cervical cancers were diagnosed on follow-up in 244 of 2414 HSIL cases (10.1%). CONCLUSIONS: The positive predictive value of HSIL cervical cytology results for follow-up histopathologic CIN2+ was within currently recognized benchmark ranges for cytology laboratories. The high rate of cervical cancer diagnoses likely reflects the largely unscreened population. The College of American Pathologists Laboratory Accreditation Program provided quality standards not otherwise available in many international settings.

HPV genotypes and associated cervical cytological abnormalities in women from the Pearl River Delta region of Guangdong province, China: a cross-sectional study.

BACKGROUND: It is important to understand the specific HPV genotype distribution in screen-detected lesions. HPV Genotype is helpful for separating HPV-positive women at greater risk of cancer from those who can regress spontaneously and for preventing cervical cancer at early stage. The aim of this study was to investigate the high-risk HPV genotype distribution among cervical cytology abnormality in Pearl River Delta Region, Southern China METHODS: 5585 HPV-infected women were screened from 77069 women in Pearl River Delta Region. Information was obtained from 3226 screened subjects through questionnaires and personal interviews. Exfoliated cervical cells were collected by doctors for HPV test with MassARRAY (Sequenom, Sandiego, CA) technique based on the matrix-assisted laser desorption/ionization time-of flight (MALDI-TOF) mass spectrometry (MS). The ThinPrep cytology test was performed to screen for cervical cancer. Unconditional logistic was used to determine the most common HPV carcinogenic types. RESULTS: Of the 3226 HPV-positive samples tested, 1744 (54.1%) with normal cervical cytology, 1482 (45.9%) with abnormal cytology. The five most common HPV types in this study were HPV16 (20.2%), HPV52 (17.1%), HPV58 (13.2%), HPV18 (9.5%), HPV6 (7.6%). Overall, HPV16 (OR = 10.5, 95% CI: 3.7 ~ 29.6), HPV33 (OR = 9.1, 95% CI: 2.8 ~ 29.2), HPV58 (OR = 6.3, 95% CI: 2.1 ~ 18.6), HPV31 (OR = 4.5, 95% CI: 1.3 ~ 15.5), multiple genotype infection (OR = 3.0, 95% CI: 1.7 ~ 14.7), especially HPV16 and HPV33, increased the risk of cytology abnormalities. CONCLUSIONS: HPV16, HPV31, HPV33, HPV58, and multiple HPV genotype infection increased the risk of cytology abnormalities in Pearl River Delta Region and might be useful for the screening, preventing, treating, and monitoring of pre-cancer lesions in southern China.

[A comparison of human papillomavirus detection and ThinPrep cytology test for women in Guangdong province].

OBJECTIVE: To evaluate the etiological significance of human papillomavirus (HPV) in cervical cancer and the clinical utility of HPV detection in cervical cancer screening. METHODS: Hybrid capture II test was used to detect 13 high-risk HPV genotypes from cervical scrapes of 2636 women. Cervical cytology was also evaluated in 454 of them by ThinPrep Pap smear. RESULTS: Among 2636 women, 699 (26.5%) were found to be high-risk HPV positive. The highest infection rate (59.4%) was found in the age group of < or = 20 years and the lowest infection rate in the age group of 41 approximately 50 years (21.0%). Significant differences in HPV infection rate were found between different cities in Guangdong province, such as those between Xinhui and Guangzhou, Xinhui and Shenzhen, Xinhui and Dongguan (P < 0.01). Fifteen out of 16 women (93.8%) with cervical carcinoma were infected with high-risk HPV versus 24 out of 125 women (19.2%) attending routine cervical cancer screening (P < 0.001). The HPV infection rate was 30.8% (142 out of 461) in women with cervical erosion, which was significantly lower than that in patients with cervical carcinoma (P < 0.001). HPV DNA were detected in 100% (2/2) of squamous cell carcinoma (SCC), 100% (12/12) high grade squamous intraepithelial lesion (HSIL), 88.9% (16/18) of low grade squamous intraepithelial lesion (LSIL) and 37.8% (28/74) of atypical squamous cells (ASC). CONCLUSION: High-risk HPV genotypes are the major causes of cervical cancers and HPV detection is a reliable adjuvant tool for cervical cancer screening.