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EVALUATION STUDY
JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
[Evaluation of gene chip technology for high risk type human papillomavirus in cervical cancer screening].
Zhonghua Yi Xue za Zhi [Chinese medical journal] 2006 Februrary 8
OBJECTIVE: To investigate the clinical value of gene chips technology for human papillomavirus (HPV) in cervical cancer screening.
METHODS: A population-based cross-sectional screening study was conducted among 1137 women aged 15-59 in a community, Shenzhen city. Hybrid capture 2 (hc2) and gene chip technology were performed to examine the high risk type human papillomavirus in the exfoliated cervical cells. Liquid-based cytology test (LCT) was also performed at the same time. The HPV-positive women with LCT > or = atypical squamous cells of undetermined sign (ASCUS) and the HPV-negative women with LCT > or = low grade squamous intraepithelial lesion (LSIL) underwent biopsy under colposcopy. The pathological results were used as the gold standard to evaluate the two HPV test methods.
RESULTS: Totally 122 biopsy specimens were obtained. Pathological examination showed no cervical cancer case, 3 cases of grade III cervical intraepithelial neoplasia (CIN), 11 cases of grade II CIN, 36 cases of grade I CIN, 69 cases of chronic cervicitis and metaplasia of squamous epithelium, and 3 cases of normal cervix. The HPV-positive rate was 14.0% by hc2 and 9.8% by gene chips with a HPV-positive rate by hc2 higher than that by gene chips (P < 0.001) and an mediocre accordance rate between these methods (kappa = 0.498). The. HPV-positive rate increased along with the increase of the grade of cervical lesions (P < 0.05). The sensitivity, specificity, accuracy, positive prevalue, negative prevalue, positive likelihood ratio and negative likelihood ratio of hc2 for high-risk HPV were 100%, 87.1%, 87.3%, 8.8%, 100%, 7.7 and 0.000, respectively; and those of gene chips were 78.6%, 91.1%, 90.9%, 9.9%, 99.7%, 8.8 and 0.235 respectively.
CONCLUSION: At present hc2 high risk HPV testing is still the better method for cervical cancer screening. Gene chips technology is able to rival hc2 except that its sensitivity for cervical high grade lesions need be improved.
METHODS: A population-based cross-sectional screening study was conducted among 1137 women aged 15-59 in a community, Shenzhen city. Hybrid capture 2 (hc2) and gene chip technology were performed to examine the high risk type human papillomavirus in the exfoliated cervical cells. Liquid-based cytology test (LCT) was also performed at the same time. The HPV-positive women with LCT > or = atypical squamous cells of undetermined sign (ASCUS) and the HPV-negative women with LCT > or = low grade squamous intraepithelial lesion (LSIL) underwent biopsy under colposcopy. The pathological results were used as the gold standard to evaluate the two HPV test methods.
RESULTS: Totally 122 biopsy specimens were obtained. Pathological examination showed no cervical cancer case, 3 cases of grade III cervical intraepithelial neoplasia (CIN), 11 cases of grade II CIN, 36 cases of grade I CIN, 69 cases of chronic cervicitis and metaplasia of squamous epithelium, and 3 cases of normal cervix. The HPV-positive rate was 14.0% by hc2 and 9.8% by gene chips with a HPV-positive rate by hc2 higher than that by gene chips (P < 0.001) and an mediocre accordance rate between these methods (kappa = 0.498). The. HPV-positive rate increased along with the increase of the grade of cervical lesions (P < 0.05). The sensitivity, specificity, accuracy, positive prevalue, negative prevalue, positive likelihood ratio and negative likelihood ratio of hc2 for high-risk HPV were 100%, 87.1%, 87.3%, 8.8%, 100%, 7.7 and 0.000, respectively; and those of gene chips were 78.6%, 91.1%, 90.9%, 9.9%, 99.7%, 8.8 and 0.235 respectively.
CONCLUSION: At present hc2 high risk HPV testing is still the better method for cervical cancer screening. Gene chips technology is able to rival hc2 except that its sensitivity for cervical high grade lesions need be improved.
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