Abstract:
Objective: To evaluate the methodological merits of the gene chip diagnostic test and Hybrid Capture 2 HPV DNA test in detecting the human cervical papillomavirus (HPV) infection and to investigate the association between multiple-infection, viral load of HPV and cervical lesions at various stages.Methods:During the period from January to De -cember 2009, 360 female participants were screened for HPV using the gene chip diagnostic test and Hybrid Capture 2 test. They were also screened for cervical cancer using the Thin-prep cytology test (liquid-based cytology). DNA sequenc -ing was used as the gold standard to evaluate the sensitivity and specificity of the two detection tests. Results:The sensitivi-ty, specificity and Youden's index were respectively 98.33% ,93.40% and0.917 in the genotyping diagnostic test and 97.56%,98.17% and 0.957 in the Hybrid Capture 2 method. Based on the result of the cervical liquid-based cytology test, the cases were divided into the NSIL, ASC and LSIL groups, as well as the HSIL and SCC groups. The HPV infection rate, high and low-risk HPV infection rates, multi-infection rate and viral load increased with the aggravation of cervical squa-mous intraepithelial lesions. There were statistical differences between the groups with normal cervical squamous epitheli-um and with diseased tissue. However, there was no regular pattern in the changes of the low-risk HPV infection rate. Conclusions: In a comparison of the two HPV detection tests, there is a higher sensitivity in the genotyping diagnostic test, and a higher specificity in the Hybrid Capture 2 test. The gene chip test or TCT can additionally be used in cervical cancer screening, potentially making them more useful than the Hybrid Capture 2 test. The multi-infection rate of HPV and in -crease of the viral load are both associated with the severity of the cervical lesion