Department of Clinical Laboratory, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuannanli, Beijing, 100021, People's Republic of China.
Department of Pathology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.
Virol J. 2020 Nov 9;17(1):171. doi: 10.1186/s12985-020-01417-8.
The SureX HPV genotyping test (SureX HPV test), which targets the human papillomavirus (HPV) E6/E7 genes was compared with the Cobas 4800 and Venus HPV tests for detecting 14 high-risk HPV (HR-HPV) types in clinical referral and follow-up patients to evaluate its value for cervical cancer screening.
Two different populations were enrolled in the study. The first population comprised 185 cases and was used for comparing the SureX HPV test (Health, China) with the Cobas 4800 test (Roche, USA). The second population comprised 290 cases and was used for comparing the SureX HPV test (Health, China) with the Venus HPV test (Zhijiang, China). Polymerase chain reaction (PCR) sequencing was performed for further confirmation of discordant results.
In the first population, the overall agreement rate was 95.6% for 14 high-risk HPV types. Eight discordant cases were confirmed by PCR sequencing, which showed that the agreement rates were 75.0% between the SureX HPV test and PCR sequencing and 25.0% between the Cobas 4800 test and PCR sequencing (P < 0.01). In the second population, the overall agreement rate was 95.5%. Thirteen discordant cases were confirmed by PCR sequencing, which showed that the agreement rates were 76.9% between the SureX HPV test and PCR sequencing and 23.1% between the Venus HPV test and PCR sequencing (P < 0.01). With cervical intraepithelial neoplasia grade 2+ (CIN2+) as the reference standard, the sensitivity values of the SureX HPV test and the Venus HPV test were 93.5% and 92.0%, (P > 0.05), while the specificity values were 43.3% and 46.7%, respectively (P > 0.05).
The SureX HPV test had good consistency with both the Cobas 4800 and Venus HPV tests for 14 HR-HPV types. In addition, it avoided some false negatives and false positives. Therefore, the SureX HPV test can be used for cervical cancer screening.
SureX HPV 基因分型检测（SureX HPV 检测）针对人乳头瘤病毒（HPV）E6/E7 基因，与 Cobas 4800 和 Venus HPV 检测比较，用于检测临床转诊和随访患者中的 14 种高危型 HPV（HR-HPV），评估其用于宫颈癌筛查的价值。
本研究纳入了两个不同的人群。第一人群包括 185 例患者，用于比较 SureX HPV 检测（中国，华大健康）与 Cobas 4800 检测（美国，罗氏）。第二人群包括 290 例患者，用于比较 SureX HPV 检测（中国，华大健康）与 Venus HPV 检测（中国，浙江）。聚合酶链反应（PCR）测序用于进一步确认不一致的结果。
第一人群中，14 种高危型 HPV 的总符合率为 95.6%。8 例不一致的病例经 PCR 测序证实，SureX HPV 检测与 PCR 测序的符合率为 75.0%，Cobas 4800 检测与 PCR 测序的符合率为 25.0%（P<0.01）。第二人群中，总符合率为 95.5%。13 例不一致的病例经 PCR 测序证实，SureX HPV 检测与 PCR 测序的符合率为 76.9%，Venus HPV 检测与 PCR 测序的符合率为 23.1%（P<0.01）。以宫颈上皮内瘤变 2+（CIN2+）为参考标准，SureX HPV 检测和 Venus HPV 检测的灵敏度分别为 93.5%和 92.0%（P>0.05），特异度分别为 43.3%和 46.7%（P>0.05）。
SureX HPV 检测与 Cobas 4800 和 Venus HPV 检测在检测 14 种 HR-HPV 类型方面具有良好的一致性。此外，它避免了一些假阴性和假阳性。因此，SureX HPV 检测可用于宫颈癌筛查。
