Performance of Aptima and Cobas HPV testing platforms in detecting high-grade cervical dysplasia and cancer
Performance of Aptima and Cobas HPV testing platforms in detecting high-grade cervical dysplasia and cancer
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DOI：
10.1002/cncy.21875
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发表时间：
2017-08-01
影响因子：
3.4
通讯作者：
Mody, Dina R.
中科院分区：
文献类型：
--
作者：
Ge, Yimin;Christensen, Paul;Mody, Dina R.
背景人乳头瘤病毒（HPV）检测和基因分型已用于临床风险评估。本研究的目的是分析2种常见HPV检测平台在检测高度宫颈病变（高度鳞状上皮内病变[HSIL]或更严重[HSIL]）方面的性能。方法：在2015年1月1日至12月31日期间，对2041例经活检确认的巴氏（Pap）检测与在Cobas或Aptima平台上进行的HPV检测进行了沿着分析。2级宫颈上皮内瘤变的活检诊断与p16/Ki-67免疫组化证实。结果在Cobas和Aptima平台上分别检测了1866例和175例Pap病例。两种平台对活检证实的HSIL都具有高度敏感性（两者均为97%）。与Aptima相比，Cobas HPV检测在诊断活检良性病变（84% vs 51%）和低度鳞状上皮内病变（89% vs 63%）方面的阳性率更高。Aptima检测对HSIL的特异性显著高于Cobas（41% vs 13%; P < .0001）。总体而言，Aptima平台在检测活检证实的HSIL方面的性能上级Cobas平台，这是因为其阳性预测值（25% vs 16%; P < .03）和总体准确性（50% vs 26%; P < .0001）显著更高。结论：尽管Cobas和Aptima平台都为高级别宫颈病变提供了高度敏感的检测，但对于活检证实的HSIL，Aptima HPV检测的特异性和阳性预测值显著高于Cobas检测。这种显著差异可能与HPV DNA整合后E6/E7表达显著增加有关。Aptima检测HSIL的特异性和总体准确性显著提高，从而识别出需要立即治疗和密切随访的高危人群，这可能有助于临床风险分层。癌症细胞病理学2017;125：652-7。(c)2017美国癌症协会
BACKGROUND Human papillomavirus (HPV) tests and genotyping have been used in clinical risk assessment. The purpose of this study was to analyze the performance of 2 common HPV testing platforms in detecting high-grade cervical lesions (high-grade squamous intraepithelial lesion [HSIL] or worse [HSIL]). METHODS Between January 1 and December 31, 2015, 2041 Papanicolaou (Pap) tests with biopsy confirmation were analyzed along with HPV tests performed on Cobas or Aptima platforms. A biopsy diagnosis of grade 2 cervical intraepithelial neoplasia was confirmed with p16/Ki-67 immunohistochemistry. RESULTS In total, 1866 and 175 Pap cases were tested on Cobas and Aptima platforms, respectively. Both platforms were highly sensitive (97% for both) for biopsy-confirmed HSIL. Cobas HPV testing had higher positive rates for the diagnosis of benign lesions (84% vs 51%) and low-grade squamous intraepithelial lesions (89% vs 63%) on biopsy compared with Aptima. Aptima testing had significantly higher specificity for HSIL than Cobas (41% vs 13%; P < .0001). Overall, performance of the Aptima platform was superior to that of the Cobas platform in detecting biopsy-confirmed HSIL, resulting from its significantly higher positive predictive value (25% vs 16%; P < .03) and overall accuracy (50% vs 26%; P < .0001). CONCLUSIONS Although both the Cobas and Aptima platforms offer highly sensitive tests for high-grade cervical lesions, Aptima HPV testing demonstrated significantly higher specificity and positive predictive value than Cobas testing for biopsy-confirmed HSIL. The considerable difference may be related to the significant increase in E6/E7 expression after HPV DNA integration. The significantly higher specificity and overall accuracy of Aptima testing for HSIL, resulting in the identification of high-risk populations that require immediate treatment and close follow-up, may prove useful in clinical risk stratification. Cancer Cytopathol 2017;125:652-7. (c) 2017 American Cancer Society.