Department of Obstetrics and Gynaecology, Old Main Building, Groote Schuur Hospital, Observatory, University of Cape Town, Cape Town, South Africa.
Cepheid, Inc, Solna, Sweden.
J Low Genit Tract Dis. 2021 Jan 1;25(1):15-21. doi: 10.1097/LGT.0000000000000575.
Self-sampling may increase access to cervical cancer screening in low-resource settings. Using Xpert HPV, we compared test performance of self- and clinician-collected samples in HIV-positive and HIV-negative women in South Africa.
Three hundred thirty HIV-positive and 375 HIV-negative women in the screening group and 202 HIV-negative and 200 HIV-positive women in the referral group, aged 30-65 years, participated in the study. All women self-collected a vaginal sample, and then, a cervical sample was collected by a clinician (both tested using Xpert HPV), followed by colposcopic examination and collection of histologic specimens.
There was good agreement between self- and clinician-collected samples for detection of any high-risk human papillomavirus (HPV, κ = 0.72 [95% CI = 0.669-0.771]). Prevalence of HPV and sensitivity of the test to detect cervical intraepithelial neoplasia 2+ was similar in self- and clinician-collected samples. Specificity was lower in self-collected than in clinician-collected samples in both HIV-negative (self: 77.5% [95% CI = 72.8-81.8] vs clinician: 86.9% [95% CI = 82.9-90.2]) and HIV-positive (self: 44.0% [95% CI = 38.0-50.1] vs clinician: 59.7% [95% CI = 53.6-65.6]) women. Restricting the definition of screen-positive to 3 of 5 channels on HPV Xpert improved specificity in both HIV-negative (self: 83.2% [95% CI = 78.8-87.0] vs clinician: 89.7% [95% CI = 86.1-92.7]) and HIV-positive (self: 54.2% [95% CI = 48.1-60.2] vs clinician: 67.4% [95% CI = 61.5-72.9]) women.
The self-collected sample had good agreement with the clinician-collected sample for the detection of HPV, and restricting the HPV types may improve the specificity in HIV-positive women.
自我采样可能会增加资源匮乏环境下宫颈癌筛查的可及性。我们使用 Xpert HPV 检测，比较了南非 HIV 阳性和 HIV 阴性女性中自我采样和临床医生采集样本的检测性能。
333 名筛查组 HIV 阳性和 375 名 HIV 阴性女性，以及 202 名筛查组 HIV 阴性和 200 名 HIV 阳性女性参与了该研究。所有女性均自我采集阴道样本，然后由临床医生采集宫颈样本（均使用 Xpert HPV 检测），随后进行阴道镜检查和组织学标本采集。
自我采样和临床医生采集样本检测高危型人乳头瘤病毒（HPV）的一致性较好（κ = 0.72 [95% CI = 0.669-0.771]）。自我采样和临床医生采集样本检测宫颈上皮内瘤变 2+的 HPV 患病率和检测敏感性相似。自我采样的特异性低于临床医生采集样本，在 HIV 阴性女性中（自我：77.5% [95% CI = 72.8-81.8] vs 临床医生：86.9% [95% CI = 82.9-90.2]）和 HIV 阳性女性中（自我：44.0% [95% CI = 38.0-50.1] vs 临床医生：59.7% [95% CI = 53.6-65.6]）均如此。将 HPV Xpert 的 5 个通道中 3 个定义为阳性可提高 HIV 阴性女性（自我：83.2% [95% CI = 78.8-87.0] vs 临床医生：89.7% [95% CI = 86.1-92.7]）和 HIV 阳性女性（自我：54.2% [95% CI = 48.1-60.2] vs 临床医生：67.4% [95% CI = 61.5-72.9]）的特异性。
自我采集样本与临床医生采集样本检测 HPV 的一致性较好，限制 HPV 类型可能会提高 HIV 阳性女性的特异性。
