ABSTRACT
Objective@#To evaluate the clinical performance of HPV genotyping with cytology for detecting cervical precancer among women attending co-testing.@*Methods@#A total of 2 883 females who participated in cervical cancer screening program were recruited from Erdos in 2016. All the participants were tested by cytology and HPV genotyping. In 2017, women with abnormal cytology results or HPV positive were followed up. Pathological cervical intraepithelial neoplasia (CIN) 2+ was the study end-point. Clinical performance indexes were calculated, including sensitivity, specificity, positive predictive value, negative predictive value, referral rate and missed cases.@*Results@#INNO-LiPA resulted in a detection rate of 18.87%(544/2 883) for the 14-type high risk HPV. HPV16 was the most common infectious genotype (4.06%), followed by HPV52 (3.61%), HPV51 (2.50%), HPV58 (1.98%), and HPV18 (1.56%). With more HPV genotypes added into the group, sensitivity increased and the specificity decreased. Addition of HPV16, 58, 33, 39, 52, 18, 31 for detection lead to the maximun value of area under the curve (AUC)=0.913 (95%CI: 0.882-0.944). Compared with traditional screening method by cytology, cotesting decreased the number of missed diagnosis. Meanwhile, the fifth method (co-testing: triage of women with HPV16/18+ , cytological minor abnormalities and HPV58, 33, 39, 52, 31+ or cytological high grade abnormalities) did not increase referral rate (8.99% vs. 8.71%, P=0.525), with five cases of missed diagnosis (sensitivity of 92.1% and specificity of 93.2%).@*Conclusions@#Co-testing with triage of women with HPV16/18+ , cytological minor abnormalities and HPV58, 33, 39, 52, 31+ or cytological high grade abnormalities would provide better clinical performance. In co-testing, triage of HPV16/18 was used in women with normal cytology; triage of HPV58, 33, 39, 52 and 31 was used in women with low-grade abnormal cytology; referral colposcopy was used in women with high-grade abnormal cytology, which would provide better clinical performance.
ABSTRACT
Objective@#To explore the relationship between high risk HPV (HR-HPV) DNA load and cervical lesions in HR-HPV single/ multiple infections.@*Methods@#Two thousand six hundred and forty-six women from Shanxi, Henan and Xinjiang were recruited into a cervical cancer screening program. Cervical exfoliated cell specimens collected from all of the participants were detected by hybrid capture Ⅱ (HC2), cytological diagnosis was performed according to the Bethesda System, and pathological diagnosis was interpreted using cervical intraepithelial neoplasia (CIN) terminology.Totally 571 cervical specimens were selected and retested to ascertain the HPV types and single/ multiple infections by liner array, a PCR-based method. Semi-quantitative result of HR-HPV DNA load (pg/ml) was estimated by HR HC2.According to the taxonomy of "International Human Papillomavirus Reference Center" , 13 HR-HPVs, including HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68, which could be detected by HR HC2 were divided into 4 subgroups.@*Results@#The positive rate of HR-HPV in normal cervix (436 cases), CIN1 (88 cases), CIN2+ (47 cases) group were 29.82%, 85.23% and 100%, respectively. The overall prevalence and median viral load increased coordinating with the pathological degree of cervical lesions (P<0.001). The positive rate and viral load of single infection with HR-HPV belongs to α9 species increased coordinating with the pathological degree of cervical lesions (P<0.05). The viral load of single infection with HR-HPV belongs to α7 species in CIN1 group was higher than those of normal group and CIN2+ group, but without statistical significance (P=0.130). The viral load of multiple infections in CIN1 group was 559.13 pg/ml, significantly higher than 37.73 pg/ml of normal histology (P=0.025), but without significant difference of 332.91 pg/ml of CIN2+ group (P=0.790). The median viral load of HPV single infection in CIN1 group was 167.93 pg/ml, significantly lower than 559.73 pg/ml of multiple infections (P=0.044). The incidence of co-infection with HR-HPVs belong to α9 species was 80.56%, dominated in all patterns of multiple infections and their median viral load increased coordinating with the pathological degree of cervical lesions, but without significant difference (P>0.05). The incidence of co-infection with HR-HPVs belong to α7 species was 66.67%, their median viral load in CIN1 group was higher than that of CIN2+ group, but without statistical significance (P>0.05).@*Conclusions@#Viral loads of single/ multiple infections with HR-HPVs belong to different species show different tendencies coordinating with the pathological degree of cervical lesions. Women with high grade of cervical lesion were dominantly infected with high viral load of HR-HPVs belong to α9 species, and the viral load of multiple infections is higher than that of single infection in low grade of cervical lesion.
ABSTRACT
Objective@#To evaluate the feasibility and effectiveness of isothermal human papillomavirus (HPV) DNA amplification test as a primary screening test in the early detection of cervical cancer.@*Methods@#From June to August 2016, 2, 774 women aged 30-64 years old from Inner Mongolia were recruited for cervical cancer screening. HPV DNA was detected by Isomega and cobas4800. INNO-LiPA HPV Genotyping Extra was served as a reference method for the cases whose results were inconsistent by using these two methods. Histological diagnosis was considered as a gold standard to estimate the effectiveness and accuracy of Isomega and cobas4800 for detecting CIN2 or greater.@*Results@#The concordance of Isomega and cobas4800 was 94.84% (Kappa=0.82) for high risk HPV (HR-HPV), 99.68% (Kappa=0.95) for HPV16, 99.78% (Kappa=0.91) for HPV18 and 94.34% (Kappa=0.76) for other HR-HPV types. The concordances of Isomega and the reference were 99.71% (Kappa=0.96), 99.86% (Kappa=0.94) and 96.76% (Kappa=0.87) for HPV16, 18 and other HR-HPV, respectively, while the concordances of cobas4800 and the reference were 99.82% (Kappa=0.97), 99.86% (Kappa=0.94) and 97.51% (Kappa=0.90), respectively. The sensitivity and specificity of Isomega for detecting CIN2+ (including CIN2, CIN3 and squamous cell carcinoma) were 87.76% and 82.94%, respectively, while those of cobas4800 were 89.80% and 85.06%, respectively.@*Conclusions@#The concordances of Isomega and cobas4800 is confident. These two methods can accurately detect the HPV16 and 18 genotyping, and have good sensitivity and specificity for clinical diagnosis and population screening of cervical cancer.