Valuation Of Application Of Hybri Max Human Papillomavirus Testing In Cervical Lesion Screening

BackgroundAccording to the latest statistics of the world cancer,Cervical cancer is the fourth most common women's cancer in the world,and its mortality is the third in world`s malignant tumor.Cervical cancer is the only gynecology malignant tumor of which the etiology is determinate.Because the screening methods can obviously lessen the cancer`s incidence and mortality.More attentions are paid on the screening methods,especially the HPV testing,for cervical cancer and its precancerous lesion all around the world.In recent years,HPV-DNA testing has become a hot topic,and the testing technology is constantly getting better.The continuous infection of the HR-HPV(High-risk Human Papillomavirus)is the most important risk factor that can cause cervical intraepithelial neoplasia(CIN)and cervical cancer.There are four primary testing HPV methods now authenticated by the American FDA :Hybrid Capture 2?Cervista?cobas 4800 ?Aptima HPV E6 /E7 mRNA.In recent years,the results of several large-scale experiments have proved that testing HPV as the main initial-screening method for cervical cancer and precancerous lesions has more advantage than the cervical cytology test.In 2014.4 the FDA has approved that the Cobas4800HPV-DNA test can also be a initial-screening method for cervical cancer for female aged 25 years or older.As a developing country,China has clinically used various HPV testing methods.Hybri Max empoldered by China is the only method which is certified by China CFDA.It can simultaneously detect and classify 21 kinds of HPV genotypes,including 13 kinds of HR-HPV genotypes.ObjectiveTo evaluate the clinical efficacy of flow-through hybridization and gene(Hybri Max)on cervical cancer and its precancerous lesion screening,and discuss its feasibility being the prime initial screening methods.Method7056 women who received the cervical lesions screening in Dalin Centre Hospital during Dec 2013 to Dec 2015 were selected for 15 HPV genotypes detecting by Hybri Max,including the HPV genotype 16?18?31?33?35?39?45?51?52?53?56?58?59?66?68.Among them 5105 women received the TCT testing at the same time.The 523 women were further examined by colposcope and performed multiple biopsies.The criterions of colposcope examine is 1.the abnormal TCT testing results;2.HPV 16 or HPV 18 positive;3.obvious clinical symptoms.The statistical data was analyzed.To research the infecting situation of different genotypes of HR-HPV,according to the results of Hybri Max testing technology.And analyze the effect of age on the HPV infection and the accuracy of high-level lesions(CIN II and above)diagnosis.To calculate the sensitivity,specificity,positive predictive value and negative predictive value of the CIN II and above lesions using Hybri Max testing and evaluate Hybri Max testing`s feasibility of being the prime initial screening methods.We analyze all the data using the SPSS 13.0,and P<0.05 has statistical significance.Results1.In 7056 women who received Hybri Max,the total infection rate of HR-HPV is 17.96%(1267/7056).The 3 highest infection rate(in decrease sequence)is HPV 16(340)?HPV 58(210)?HPV 52(207),and the infection rate is 4.81%(340/7056)?2.98%(210/7056)?2.93%(207/7056).2.In the group of 50~59 years old,HPV infection rate is the highest,22.70%.In the group of 30~39 years old,HPV infection rate is the lowest,16.44%.HR-HPV total infection rate has statistical significance in different age group.3.The HPV genotype 16?55?33 has the most closely relationship with the high-level cervical lesion(CIN2 or above),on the basis of pathological diagnosis,which account for 70.86%(124/175)in all cervical lesion(CIN2 or above).4.The sensitivity,specificity,positive predictive value and negative predictive value of the CIN2 and above lesions using Hybri Max testing are 4.81%(340/7056)?2.98%(210/7056)2.93%(207/7056).Conclusion1.In this research,the 3 highest infection rate is genotype HPV 16?52?58,which have the closely relationship with the high-level cervical lesion.More attentions should be paid on the infection?prevention and rehabilitation of the HPV genotypes.2.Age is the risk factor of HPV infection.We should pay more attentions on the middle-old women,for HR-HPV infection rate is high.3.Hybri Max testing has great significance in cervical cancer and its precancerous lesion screening by the reason of the high sensitivity and negative predictive value.But as a screening method of cervical cancer should also associate with the TCT or cytology diagnosis due to the low specificity and positive predictive value.