1.Value of high risk human papillomavirus viral load in predicting cervical lesions and triaging for high risk (HR)-HPV-positive women.
Leni KANG ; Fanghui ZHAO ; Feng CHEN ; Wen CHEN ; Jing LI ; Xun ZHANG ; Youlin QIAO
Chinese Journal of Oncology 2014;36(4):316-320
OBJECTIVETo evaluate the value of high risk (HR)-HPV viral load in predicting cervical lesions and triaging for HR-HPV positive women.
METHODSThe study cohort came from a multicenter cervical cancer screening program. HR-HPV was detected by hybrid capture 2 (HC-2) assay, and viral load was measured by the ratio of relative light units to cut off (RLU/CO). Women were divided into 4 groups according to the RLU/CO value, and CIN diagnostic system was used to describe the severity of cervical lesions. Chi-square trend test was used to analyze the association between viral load and CIN. The absolute and relative risks of CIN2+ in different viral load groups were calculated, and the clinical performance to detect CIN2+ at follow-up by different cut-off values of baseline RLU/CO was also calculated.
RESULTS2 725 women with complete results of both baseline and follow-up were included in this analysis. The severity of cervical lesions increased with the increasing viral load (P < 0.001). In women with normal or CIN1 diagnosis at baseline, the absolute risk of one-year accumulative CIN2+ was 0.11% in the HR-HPV-negative group, compared with 3.14% in the moderate viral load group and 6.09% in the high viral load group, and the relative risk of 29.05 (95%CI: 6.07-138.99) in the moderate viral load group and 56.34 (95%CI: 12.89-246.30) in the high viral load group. Raising cut-off value of baseline HR-HPV viral load to 15.00, RLU/CO decreased the number of women who need to be followed up at one-year from 774 to 412, with the sensitivity of 91.30% and specificity of 47.94% in detecting CIN2+ at follow-up.
CONCLUSIONSThe risk of cervical cancer and precancerous lesions increases with the increasing HR-HPV viral load. Raising the cut-off value of HR-HPV viral load can triage for HR-HPV-positive women, therefore help to allocate the health resources more effectively.
Adult ; Aged ; Cervical Intraepithelial Neoplasia ; pathology ; virology ; Disease Progression ; Female ; Follow-Up Studies ; Humans ; Mass Screening ; methods ; Middle Aged ; Papillomaviridae ; isolation & purification ; Papillomavirus Infections ; Risk Factors ; Uterine Cervical Neoplasms ; pathology ; virology ; Viral Load
2.Implication of inverse-probability weighting method in the evaluation of diagnostic test with verification bias
Leni KANG ; Shaokai ZHANG ; Fanghui ZHAO ; Youlin QIAO
Chinese Journal of Epidemiology 2014;35(3):329-332
To evaluate and adjust the verification bias existed in the screening or diagnostic tests.Inverse-probability weighting method was used to adjust the sensitivity and specificity of the diagnostic tests,with an example of cervical cancer screening used to introduce the Compare Tests package in R software which could be implemented.Sensitivity and specificity calculated from the traditional method and maximum likelihood estimation method were compared to the results from Inverse-probability weighting method in the random-sampled example.The true sensitivity and specificity of the HPV self-sampling test were 83.53% (95%CI:74.23-89.93) and 85.86% (95% CI:84.23-87.36).In the analysis of data with randomly missing verification by gold standard,the sensitivity and specificity calculated by traditional method were 90.48% (95%CI:80.74-95.56) and 71.96% (95%CI:68.71-75.00),respectively.Thc adjusted sensitivity and specificity under the use of Inverse-probability weighting method were 82.25% (95% CI:63.11-92.62) and 85.80% (95% CI:85.09-86.47),respectively,whereas they were 80.13 % (95% CI:66.81-93.46) and 85.80% (95% CI:84.20-87.41) under the maximum likelihood estimation method.The inverse-probability weighting method could effectively adjust the scnsitivity and specificity of a diagnostic test when verification bias existed,especially when complex sampling appeared.
3.Distribution of serum antibodies against human papillomavirus 16 and 18 among high-risk women to cervical cancer
Mandong FEI ; Jiayuan LI ; Jingchang DU ; Jia YOU ; Shaokai ZHANG ; Wei HE ; Leni KANG ; Fanghui ZHAO ; Youlin QIAO ; Yuzhi SI ; Xiaoping FAN ; Wen CHEN
Chinese Journal of Epidemiology 2014;(5):514-518
Objective To explore the distribution of serum antibodies against human papillomavirus(HPV)16/18 among women at high-risk for cervical cancer. Methods All women when tested positive for anyone of the cervical cancer screening programs,from Xinmi county of Henan province in 2011,were recruited as the subjects of this study. Cervical exfoliated cells were collected,using cervical brush for HPV DNA testing,and 10 ml venous blood was drawn for HPV-16, 18 serum antibodies testing,by enzyme-linked immunosorbent assay. Results Among the 952 women unders study,230 cases(24.2%)showed HPV DNA positive,with positivity rates of HPV16 and 18 L1 virus-like particle(VLP)antibodies as 23.2%and 6.5%,respectively. The overall positivity rate of any type of HPV16,18 VLP antibodies was 26.8%. Geometric means of HPV16,18 VLP antibody titers were 79.1(Yangshengtang Unit,YU/ml)and 125.0(YU/ml). Positivity rate of HPV16 antibody was significantly associated with age,viral load of HPV DNA,and cervical lesion severity (P<0.05). Seropositvity of HPV18 was also increasing with the increase of viral load (P<0.01) with different cervical lesion significantly showing different titer of HPV18 antibody (P<0.01). Based on the results of HPV DNA detection among the two years of study,women with HPV persistent infection showed significant higher positive rate of HPV16/18 antibodies than women who did not have HPV infection or emerging infection (P<0.001). When comparing to those women without HPV infection,the ones with transient infection showed higher seropositivity rates on both HPV16 antibodies and titer of HPV16 antibody (P<0.001). Conclusion Seroprevalence rates on HPV16 and 18 among the unvaccinated high-risk women in Henan were high. Prevalence of both HPV16 and 18 antibodies were correlated with age,viral load,cervical lesion and history of infection. Women with high viral load,high grade cervical lesion or history of infection would more likely to be seropositive.
4.Evaluation of screening performance of HPV DNA test on specimens from different sites of the female genital tract.
Shaokai ZHANG ; Leni KANG ; Bin LIU ; Jianfeng CUI ; Feng CHEN ; Xinfu LIU ; Hong WANG ; Wen CHEN
Chinese Journal of Oncology 2014;36(5):389-393
OBJECTIVETo evaluate the diagnostic performance of different specimens for detecting CIN2(+), and to find the solution of the problem that why the performance of self-collected specimen is worse than cervical specimen collected by physician.
METHODSThe cervix, lower 1/3 vagina, upper 1/3 vagina and self-collected specimens from each of the 806 women who took part in this multi-center screening program from May 2006 to April 2007 were tested by hybrid capture 2 (HC2) technique. The diagnostic performance of HC2 on the four specimens for detecting CIN2(+) lesions was calculated. Linear array was performed on the four specimens from 489 out of the 806 women and the diagnostic performance of linear array on the four specimens for detecting CIN2(+) lesions was also calculated. Z test was used to compare the area under ROC and McNemar or χ(2) test was used to compare the sensitivity and specificity of different specimens.
RESULTSThe area under ROC of the cervix, 1/3 upper vagina, 1/3 lower vagina and self-collected samples testing by HC2 for detecting CIN2(+) lesions were 0.902, 0.793, 0.769 and 0.773, respectively (P < 0.001). Using 1 RUL/CO as the cut-point of HC2, the sensitivity of the cervix, upper vagina, lower vagina and self-collected samples were 98.0%, 91.8%, 83.7% and 81.6%. Compared with the cervical specimen, the sensitivity of self-collected specimen for detecting CIN2(+) lesions was significantly lower (P = 0.008). Lowering the cutoff value for HC2 test could improve the sensitivity of self-collected specimen, but it significantly compromised the specificity. The sensitivity of self-collected specimen tested by linear array for detecting CIN2(+) lesions was 95.7% and it was not significantly different compared with the sensitivity of cervical specimen (97.9%) tested by HC2.
CONCLUSIONSThe performance of self-collected specimen tested by HC2 for detecting CIN2(+) lesions is lower than that of physician-collected cervical specimen, and lowering the cutoff value can't improve its diagnostic performance. Using linear array as the HPV DNA test can significantly improve the screening diagnostic performance of self-collected specimens.
Adolescent ; Cervical Intraepithelial Neoplasia ; diagnosis ; virology ; Cervix Uteri ; virology ; DNA, Viral ; analysis ; Female ; Human Papillomavirus DNA Tests ; Humans ; Mass Screening ; Papillomaviridae ; isolation & purification ; Papillomavirus Infections ; diagnosis ; virology ; Self-Examination ; Specimen Handling ; methods ; Uterine Cervical Neoplasms ; diagnosis ; virology ; Vagina ; virology
5.Distribution of serum antibodies against human papillomavirus 16 and 18 among high-risk women to cervical cancer.
Mandong FEI ; Jiayuan LI ; Jingchang DU ; Jia YOU ; Shaokai ZHANG ; Wei HE ; Leni KANG ; Fanghui ZHAO ; Youlin QIAO ; Yuzhi SI ; Xiaoping FAN ; Wen CHEN
Chinese Journal of Epidemiology 2014;35(5):514-518
OBJECTIVETo explore the distribution of serum antibodies against human papillomavirus (HPV) 16/18 among women at high-risk for cervical cancer.
METHODSAll women when tested positive for anyone of the cervical cancer screening programs, from Xinmi county of Henan province in 2011, were recruited as the subjects of this study. Cervical exfoliated cells were collected, using cervical brush for HPV DNA testing, and 10 ml venous blood was drawn for HPV-16, 18 serum antibodies testing, by enzyme-linked immunosorbent assay.
RESULTSAmong the 952 women under study, 230 cases (24.2%)showed HPV DNA positive, with positivity rates of HPV16 and 18 L1 virus-like particle (VLP)antibodies as 23.2% and 6.5%, respectively. The overall positivity rate of any type of HPV16, 18 VLP antibodies was 26.8% . Geometric means of HPV16, 18 VLP antibody titers were 79.1 (Yangshengtang Unit,YU/ml) and 125.0(YU/ml). Positivity rate of HPV16 antibody was significantly associated with age, viral load of HPV DNA, and cervical lesion severity (P < 0.05). Seropositivity of HPV18 was also increasing with the increase of viral load (P < 0.01) with different cervical lesion significantly showing different titer of HPV18 antibody (P < 0.01). Based on the results of HPV DNA detection among the two years of study, women with HPV persistent infection showed significant higher positive rate of HPV16/18 antibodies than women who did not have HPV infection or emerging infection (P < 0.001). When comparing to those women without HPV infection, the ones with transient infection showed higher seropositivity rates on both HPV16 antibodies and titer of HPV16 antibody (P < 0.001).
CONCLUSIONSeroprevalence rates on HPV16 and 18 among the unvaccinated high-risk women in Henan were high. Prevalence of both HPV16 and 18 antibodies were correlated with age, viral load, cervical lesion and history of infection.Women with high viral load, high grade cervical lesion or history of infection would more likely to be seropositive.
Adult ; Aged ; Antibodies, Viral ; blood ; China ; epidemiology ; Female ; Human papillomavirus 16 ; immunology ; Human papillomavirus 18 ; immunology ; Humans ; Middle Aged ; Papillomavirus Infections ; epidemiology ; Seroepidemiologic Studies ; Uterine Cervical Neoplasms ; virology
6. Analysis of mortality and leading causes of death in Chinese children under 5-year-old between 2010 and 2016
Zhen LIU ; Xinru LIU ; Chunhua HE ; Lei MIAO ; Leni KANG ; Xiaohong LI ; Jun, ZHU ; Qi LI ; Yan HUANG ; Yanping WANG
Chinese Journal of Preventive Medicine 2019;53(4):411-414
We collected death data of children under 5-year-old in China from the national child mortality surveillance system from 2010 to 2016. The change of mortality rate and causes of death were described. The mortality rate of Chinese children under 5-year-old decreased from 16.4‰ to 10.2‰ in all areas between 2010 and 2016, from 20.1‰ to 12.4 ‰ in rural areas and from 7.3‰ to 5.2‰ in urban areas, respectively, with a greater average annual decreasing rate in rural areas than urban area. During these years, in addition to traffic accidents and sepsis, other 8 cause-specific mortality rates showed a downward trend. There were substantial decreases of mortality rates of premature birth or low birth weight, birth asphyxia and neural tube defects. In urban areas, the mortality rate of premature birth or low birth weight, birth asphyxia decreased, and the mortality rate of congenital heart disease and diarrhea substantially decreased. However, there was a substantial increase of mortality rate of septicemia in urban areas. In rural areas, the change of major cause-specific mortality rates were consistent with the national trend.