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用于宫颈癌前筛查中高危型人乳头瘤病毒检测的AmpFire和MA - 6000聚合酶链反应平台的比较

Comparison of the AmpFire and MA-6000 polymerase chain reaction platforms for high-risk human papillomavirus testing in cervical precancer screening.

作者信息

Effah Kofi, Agbemafle Isaac, Essel Nana Owusu, Amuah Joseph Emmanuel, Kotey Erasmus Nikoi, Antwi-Boasiako Ernest, Kemawor Seyram, Gedzah Isaac, Tekpor Ethel, Wormenor Comfort Mawusi, Atuguba Bernard Hayford, Danyo Stephen, Akakpo Patrick Kafui

机构信息

Catholic Hospital, Battor, P. O. Box 2, Battor, via Sogakope, Volta Region, Ghana.

Fred N. Binka School of Public Health, University of Health and Allied Sciences, Ho, Ghana.

出版信息

J Virol Methods. 2023 Jun;316:114709. doi: 10.1016/j.jviromet.2023.114709. Epub 2023 Mar 15.

Abstract

High-risk human papillomavirus (hr-HPV) testing for primary cervical precancer screening offers an opportunity to improve screening in low-middle income countries (LMICs). This study aimed to compare the analytic performances of the AmpFire and MA-6000 platforms for hr-HPV DNA testing in three groups of women screened for hr-HPV types in Ghana: group 1 with 33 GeneXpert-archived ThinPrep/liquid-based samples subjected to both tests, group 2 with 50 AmpFire-archived dry brush samples subjected to MA-6000 testing, and group 3 involving 143 cotton swab samples simultaneously subjected to both tests without archiving. The overall agreement rates were 73 %, 92 %, and 84 %, for groups 1-3, respectively, and 84 % (95 % CI, 78.6-88.6) for the entire group. Neither AmpFire nor MA-6000 was more likely to test hr-HPV positive in all three groups and the combined group. Group 1 showed fair agreement without statistical significance (κ = 0.224, 95 % CI, -0.118 to 0.565), while group 3 showed significant moderate agreement (κ = 0.591, 95% CI, 0.442-0.741). Group 2 showed an almost perfect significant level of agreement (κ = 0.802; 95 % CI, 0.616-0.987). Thus, both platforms showed statistically significant moderate to near-perfect agreement for detecting hr-HPV in cervicovaginal samples, with variation according to archiving conditions and duration between sample collection and retesting. For LMICs using these platforms for COVID-19 testing, as the COVID-19 pandemic subsides, the platforms can become available for running other tests such as hr-HPV DNA testing for cervical precancer screening.

摘要

高危型人乳头瘤病毒(hr-HPV)检测用于原发性宫颈癌前筛查,为改善中低收入国家(LMICs)的筛查工作提供了契机。本研究旨在比较AmpFire和MA-6000平台在加纳三组接受hr-HPV分型筛查的女性中进行hr-HPV DNA检测的分析性能:第1组有33份GeneXpert存档的ThinPrep/液基样本,同时接受两种检测;第2组有50份AmpFire存档的干刷样本,接受MA-6000检测;第3组有143份棉拭子样本,同时接受两种检测且未存档。第1 - 3组的总体一致率分别为73%、92%和84%,整个组的总体一致率为84%(95% CI,78.6 - 88.6)。在所有三组以及合并组中,AmpFire和MA-6000检测hr-HPV呈阳性的可能性都没有更高。第1组显示出一般的一致性,无统计学意义(κ = 0.224,95% CI,-0.118至0.565),而第3组显示出显著的中度一致性(κ = 0.591,95% CI,0.442 - 0.741)。第2组显示出几乎完美的显著一致性水平(κ = 0.802;95% CI,0.616 - 0.987)。因此,两个平台在检测宫颈阴道样本中的hr-HPV方面均显示出具有统计学意义的中度至近乎完美的一致性,且根据存档条件以及样本采集与重新检测之间的时间间隔存在差异。对于在COVID-19检测中使用这些平台的中低收入国家,随着COVID-19大流行的消退,这些平台可用于开展其他检测,如用于宫颈癌前筛查的hr-HPV DNA检测。

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