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两种人乳头瘤病毒检测方法的临床比较:GenoFlow 与反向线杂交。

Clinical comparison of two human papillomavirus detection assays: GenoFlow and reverse line blot.

机构信息

Department of Infection and Immunity, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia 2 College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.

Department of Pathology and Laboratory Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.

出版信息

J Infect Dev Ctries. 2020 Jan 31;14(1):97-103. doi: 10.3855/jidc.11769.

DOI:10.3855/jidc.11769
PMID:32088690
Abstract

INTRODUCTION

Human papillomavirus (HPV) infection is typically critical in the oncogenesis of cervical cancer. However, available HPV detection kits differ in their ability and sensitivity to detect various types of HPV, and this variability has led to inconsistencies in the reporting of the geographic prevalence of HPV types, especially in developing countries. Here, we compared results of the recently developed GenoFlow HPV array test, which detects 33 HPV genotypes, to those of the well-established reverse line blot (RLB) assay, which detects 23 HPV types.

METHODOLOGY

In total, 608 cervical specimens with cytology results ranging from normal to cancer were collected using an endocervical brush from women attending outpatient clinics in Riyadh, Saudi Arabia.

RESULTS

Sixty-nine specimens (11%) were positive for HPV. HPV genotype detection using the GenoFlow test had a sensitivity of 62% and a specificity of 100%. Overall agreement between the two HPV genotyping methods was 97%, with a concordance rate of 95%. Among the GenoFlow test results, 2% indicated additional HPV types that were not detected in the RLB assay, whereas the GenoFlow test missed 0.3% of the HPV types that were detected by the RLB; however, both tests were in agreement in detecting all major HPV types.

CONCLUSION

The GenoFlow test was reliable, with results comparable to the RLB test. However, because the GenoFlow test is less labor-intensive and takes less total time (3 hours), it is a promising, affordable alternative to the RLB for HPV diagnosis and screening programs.

摘要

简介

人乳头瘤病毒(HPV)感染通常是宫颈癌发生的关键。然而,现有的 HPV 检测试剂盒在检测各种 HPV 类型的能力和灵敏度上存在差异,这种变异性导致 HPV 类型的地理流行率报告不一致,尤其是在发展中国家。在这里,我们比较了最近开发的 GenoFlow HPV 基因芯片检测法(可检测 33 种 HPV 基因型)和成熟的反向线杂交(RLB)检测法(可检测 23 种 HPV 类型)的结果。

方法

共采集 608 例来自沙特阿拉伯利雅得门诊女性的宫颈刷样本,其细胞学检查结果从正常到癌症不等。

结果

69 例(11%)HPV 阳性。GenoFlow 检测法检测 HPV 基因型的灵敏度为 62%,特异性为 100%。两种 HPV 基因分型方法的总体一致性为 97%,一致性率为 95%。在 GenoFlow 检测结果中,有 2%的样本显示出 RLB 检测未检测到的额外 HPV 类型,而 GenoFlow 检测漏检了 RLB 检测到的 0.3%HPV 类型;然而,两种检测方法都能一致地检测到所有主要的 HPV 类型。

结论

GenoFlow 检测法可靠,结果与 RLB 检测法相当。然而,由于 GenoFlow 检测法的劳动强度较低,总耗时(3 小时)较短,因此它是 HPV 诊断和筛查计划中 RLB 的一种有前途、经济实惠的替代方法。

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