使用Xpert人乳头瘤病毒检测法进行自我采集阴道干拭子的准确性。
Accuracy of self-collected vaginal dry swabs using the Xpert human papillomavirus assay.
作者信息
Catarino Rosa, Vassilakos Pierre, Bilancioni Aline, Bougel Stéphanie, Boukrid Meriem, Meyer-Hamme Ulrike, Petignat Patrick
机构信息
Division of Gynaecology, Department of Gynaecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
Geneva Foundation for Medical Education and Research, Geneva, Switzerland.
出版信息
PLoS One. 2017 Jul 27;12(7):e0181905. doi: 10.1371/journal.pone.0181905. eCollection 2017.
BACKGROUND
Polymerase chain reaction-based Xpert human papillomavirus (HPV) assay is a rapid test that detects high-risk HPV (hrHPV) infection. This point-of-care test is usually performed by collecting a cervical specimen in a vial of PreservCyt® transport medium. We compared HPV test positivity and accuracy between self-collected sample with a dry swab (s-DRY) versus physician-collected cervical sampling using a broom like brush and immediate immersion in PreservCyt (dr-WET).
METHODS
In this cross-sectional study, we recruited 150 women ≥ 18 years old attending the colposcopy clinic in the University Hospital of Geneva. Each participant first self-collected a vaginal sample using a dry swab and then the physician collected a cervical specimen in PreservCyt. HPV analysis was performed with Xpert. Part of the PreservCyt-collected sample was used for hrHPV detection with the cobas® HPV test. HPV test positivity and performance of the two collection methods was compared.
RESULTS
HPV positivity was 49.1% for s-DRY, 41.8% for dr-WET and 46.2% for cobas. Good agreement was found between s-DRY and dr-WET samples (kappa±Standard error (SE) = 0.64±0.09,), particularly for low-grade squamous intraepithelial lesions (LSIL+) (kappa±SE = 0.80±0.17). Excellent agreement was found between the two samples for HPV16 detection in general (kappa±SE = 0.91±0.09) and among LSIL+ lesions (kappa±SE = 1.00±0.17). Sensitivities and specificities were, respectively, 84.2% and 47.1%(s-DRY), 73.1% and 58.7%. (dr-WET) and 77.8% and 45.7% (cobas) for CIN2+ detection. The median delay between sampling and HPV analysis was 7 days for the Xpert HPV assay and 19 days for cobas. There were 36 (24.0%) invalid results among s-DRY samples and 4 (2.7%) among dr-WET (p = 0.001). Invalid results happened due to the long interval between collection and analysis.
CONCLUSION
Self-collected vaginal dry swabs are a valid alternative to collecting cervical samples in PreservCyt solution for HPV testing with the Xpert HPV assay.
IMPACT
HPV self-collection with dry cotton swabs might assist in the implementation of an effective screening strategy in developing countries.
TRIAL REGISTRATION
International Standard Randomized Controlled Trial Number Registry ISRCTN83050913.
背景
基于聚合酶链反应的Xpert人乳头瘤病毒（HPV）检测是一种可检测高危型HPV（hrHPV）感染的快速检测方法。这种即时检测通常是通过在PreservCyt®转运培养基瓶中收集宫颈样本进行的。我们比较了使用干拭子自行采集样本（s-DRY）与使用扫帚状刷子由医生采集宫颈样本并立即浸入PreservCyt（dr-WET）两种方式下HPV检测的阳性率和准确性。
方法
在这项横断面研究中，我们招募了150名年龄≥18岁、前往日内瓦大学医院阴道镜门诊就诊的女性。每位参与者首先使用干拭子自行采集阴道样本，然后医生在PreservCyt中采集宫颈样本。使用Xpert进行HPV分析。将PreservCyt采集的部分样本用于通过cobas®HPV检测进行hrHPV检测。比较了两种采集方法的HPV检测阳性率和性能。
结果
s-DRY的HPV阳性率为49.1%，dr-WET为41.8%，cobas为46.2%。s-DRY和dr-WET样本之间具有良好的一致性（kappa±标准误差（SE）=0.64±0.09），尤其是对于低级别鳞状上皮内病变（LSIL+）（kappa±SE = 0.80±0.17）。总体上，两种样本在HPV16检测方面具有极好的一致性（kappa±SE = 0.91±0.09），在LSIL+病变中也是如此（kappa±SE = 1.00±0.17）。对于CIN2+检测，s-DRY的灵敏度和特异度分别为84.2%和47.1%，dr-WET为73.1%和58.7%，cobas为77.8%和45.7%。Xpert HPV检测从采样到HPV分析的中位延迟时间为7天，cobas为19天。s-DRY样本中有36份（24.0%）结果无效，dr-WET样本中有4份（2.7%）结果无效（p = 0.001）。无效结果是由于采集和分析之间的间隔时间过长导致的。
结论
对于使用Xpert HPV检测进行HPV检测，自行采集阴道干拭子是在PreservCyt溶液中采集宫颈样本的有效替代方法。
影响
使用干棉签自行采集HPV样本可能有助于在发展中国家实施有效的筛查策略。
试验注册
国际标准随机对照试验编号注册库ISRCTN83050913 。
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