Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.
The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.
Clin Microbiol Infect. 2019 Apr;25(4):496-503. doi: 10.1016/j.cmi.2018.05.025. Epub 2018 Jun 12.
To compare the performance of self-collected vaginal (V) specimens with clinician-collected cervical (C) specimens for detection of high-risk human papillomavirus (hrHPV) and cervical disease using the Cepheid Xpert HPV, Roche Cobas 4800 HPV and Hologic Aptima HPV assays.
Women aged 30-59 years (n = 1005) were recruited at two clinics in Papua New Guinea, and they provided specimens for testing at point-of-care using the Xpert HPV Test, and for subsequent testing using the Cobas HPV (n = 981) and Aptima HPV (n = 983) assays. Liquid-based cytology was performed on C specimens to predict underlying high-grade squamous intraepithelial lesions (HSIL). V specimen results of each assay were evaluated against a constructed reference standard and for detection of HSIL or worse.
There was substantial (κ >0.6) agreement in hrHPV detection between V and C specimens across all three assays. The sensitivity, specificity, and positive and negative predictive values of Xpert HPV using self-collected V specimens for the detection of HPV type 16 according to the constructed reference standard were 92.1%, 93.1%, 63.6% and 98.9%, respectively; compared with 90.4%, 94.3%, 67.8% and 98.7% for Cobas 4800 HPV; and 63.2%, 97.2%, 75.0% and 95.3% for Aptima HPV. Similar results were observed for all hrHPV types (combined) and for HPV types 18/45, on all three assays. The detection of any hrHPV using self-collected specimens had high sensitivity (86%-92%), specificity (87%-94%) and negative predictive value (>98%) on all assays for HSIL positivity.
Xpert HPV, using self-collected vaginal specimens, has sufficient accuracy for use in point-of-care 'test-and-treat' cervical screening strategies in high-burden, low-resource settings.
比较自我采集的阴道（V）标本与临床医生采集的宫颈（C）标本在使用赛沛 Xpert HPV、罗氏 cobas 4800 HPV 和豪洛捷 Aptima HPV 检测高危型人乳头瘤病毒（hrHPV）和宫颈疾病方面的性能。
在巴布亚新几内亚的两家诊所招募了年龄在 30-59 岁的女性（n=1005），并在现场使用 Xpert HPV 检测进行检测，随后使用 Cobas HPV（n=981）和 Aptima HPV（n=983）检测进行后续检测。对 C 标本进行液基细胞学检查，以预测潜在的高级别鳞状上皮内病变（HSIL）。评估每个检测方法的 V 标本结果，与构建的参考标准进行比较，并检测 HSIL 或更差的结果。
在所有三种检测方法中，V 和 C 标本之间的 hrHPV 检测均具有高度一致性（κ>0.6）。根据构建的参考标准，Xpert HPV 使用自我采集的 V 标本检测 HPV 16 型的灵敏度、特异性、阳性预测值和阴性预测值分别为 92.1%、93.1%、63.6%和 98.9%；而 Cobas 4800 HPV 分别为 90.4%、94.3%、67.8%和 98.7%；Aptima HPV 分别为 63.2%、97.2%、75.0%和 95.3%。对于所有 hrHPV 类型（组合）和 HPV 18/45 型，所有三种检测方法均观察到类似的结果。在所有三种检测方法中，使用自我采集的标本检测任何 hrHPV 对 HSIL 阳性的灵敏度（86%-92%）、特异性（87%-94%）和阴性预测值（>98%）均较高。
Xpert HPV 使用自我采集的阴道标本，在高负担、资源匮乏的环境中，在现场“检测-治疗”的宫颈筛查策略中具有足够的准确性。
