在液体与固体运输介质中对Cobas4800人乳头瘤病毒检测法检测宫颈阴道样本的评估
An Evaluation of the Cobas4800 HPV Test on Cervico-Vaginal Specimens in Liquid versus Solid Transport Media.
作者信息
Luo Hongxue, Du Hui, Maurer Kathryn, Belinson Jerome L, Wang Guixiang, Liu Zhihong, Zhang Lijie, Zhou Yanqiu, Wang Chun, Tang Jinlong, Qu Xinfeng, Wu Ruifang
机构信息
Department of obstetrics/gynaecology, Peking University Shenzhen Hospital, Shenzhen, PR China.
Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
出版信息
PLoS One. 2016 Feb 1;11(2):e0148168. doi: 10.1371/journal.pone.0148168. eCollection 2016.
OBJECTIVES
Determine the ability of the Cobas 4800 assay to detect high-risk human papillomavirus (HrHPV) and high-grade cervical lesions when using cervico-vaginal samples applied to liquid medium and solid media cards compared to a direct cervical sample.
METHODS
Two cervico-vaginal specimens (pseudo self-collected) were obtained from 319 women. One was applied to an iFTA Card (FTA) then the brush placed in liquid-based medium (LSELF); the other was applied to a new solid media: POI card (POI). The clinical performance of Cobas4800 assay using the three aforementioned specimens was compared to direct collected endocervical specimens in liquid media (LDOC).
RESULTS
The overall agreements of HrHPV detection were 84.2% (LSELF vs. LDOC), 81.0% (FTA vs. LDOC), and 82.3% (POI vs. LDOC). LSELF, FTA and POI identified 98.0%, 79.6%, and 97.5% positive cases of LDOC. Sensitivity to identify CIN2+ were 98.4% (LSELF), 73.8% (FTA), 95.1% (POI), and 93.4% (LDOC) respectively. FTA had 78.1% and 90.4% agreement with the LSELF samples for all HrHPV and HPV16/18 detection respectively, while POI had 91.6% for both.
CONCLUSIONS
Cobas4800 HPV test combined with cervico-vaginal specimens applied to both liquid media and POI solid card are accurate to detect HrHPV infection and high-grade cervical lesions as compared with direct endocervical samples in liquid media.
目的
与直接宫颈样本相比，确定在使用应用于液体培养基和固体培养基卡的宫颈阴道样本时，Cobas 4800检测法检测高危型人乳头瘤病毒（HrHPV）和高级别宫颈病变的能力。
方法
从319名女性中获取两份宫颈阴道标本（模拟自我采集）。一份应用于iFTA卡（FTA），然后将刷子置于液基培养基（LSELF）中；另一份应用于一种新的固体培养基：POI卡（POI）。将使用上述三种标本的Cobas4800检测法的临床性能与直接采集于液体培养基中的宫颈管标本（LDOC）进行比较。
结果
HrHPV检测的总体一致性分别为84.2%（LSELF与LDOC）、81.0%（FTA与LDOC）和82.3%（POI与LDOC）。LSELF、FTA和POI分别识别出LDOC阳性病例的98.0%、79.6%和97.5%。识别CIN2+的敏感性分别为98.4%（LSELF）、73.8%（FTA）、95.1%（POI）和93.4%（LDOC）。FTA在所有HrHPV检测和HPV16/18检测中与LSELF样本的一致性分别为78.1%和90.4%，而POI在两者中均为91.6%。
结论
与液体培养基中的直接宫颈管样本相比，Cobas4800 HPV检测法结合应用于液体培养基和POI固体卡的宫颈阴道标本，在检测HrHPV感染和高级别宫颈病变方面是准确的。
Zotero 插件