Moyo Sikhulile, Ramogola-Masire Doreen, Moraka Natasha O, Tawe Leabaneng, Noubary Farzad, Motsumi Kesego, Manowe Godiraone, Zuze Boitumelo, Radibe Botshelo, Hungwe Faith T T, Mohammed Terence, Maphorisa Comfort, Shapiro Roger, Gaseitsiwe Simani, Luckett Rebecca
Botswana Harvard Health Partnership, Gaborone, Botswana.
Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Infect Agent Cancer. 2023 May 10;18(1):29. doi: 10.1186/s13027-023-00504-z.
Low- and middle-income countries (LMICs) account for nearly 85% of the global cervical cancer burden, yet have the least access to high-performance screening. International guidelines recommend human papillomavirus testing (HPV) as primary screening, yet implementation is inhibited by the cost of HPV testing. Atila AmpFire® HPV Assay (AmpFire) is both affordable and easy to use, and offers individual genotyping. The objective of this study was to compare the performance of the AmpFire HPV assay to the Xpert® HPV assay in detection of both HPV and clinically significant cervical disease.
We utilized stored cervical specimens from a prospective cohort study of women living with human immunodeficiency virus (HIV) in Botswana conducted from May to July 2018. Positive and negative percent agreement was calculated for the AmpFire and Xpert assays, as was detection of high-grade cervical dysplasia.
63 stored cervical specimens had detectable DNA after thawing and were included in the analysis. The positive percent agreement was 91.2% (95%CI 76.3-98.1) and negative percent agreement was 79.3% (95% CI 60.3-92.0). Six cases positive by AmpFire but negative by Xpert were HPV genotypes 35, 52 (n = 2), 58, 68, and co-infection with HPV 45 and 68. Both Xpert and AmpFire assays detected HPV in all 10 samples of women who had high-grade cervical dysplasia.
The AmpFire HPV assay demonstrated excellent analytic performance in both detection of HPV and clinically significant cervical disease. AmpFire HPV is a promising option to increase access to affordable, type-specific HPV screening for cervical cancer in LMICs.
低收入和中等收入国家（LMICs）承担了全球近85%的宫颈癌负担，但获得高性能筛查的机会最少。国际指南推荐人乳头瘤病毒检测（HPV）作为主要筛查方法，但HPV检测成本阻碍了其实施。Atila AmpFire® HPV检测法（AmpFire）价格实惠且使用简便，还能提供个体基因分型。本研究的目的是比较AmpFire HPV检测法与Xpert® HPV检测法在检测HPV和具有临床意义的宫颈疾病方面的性能。
我们利用了2018年5月至7月在博茨瓦纳对感染人类免疫缺陷病毒（HIV）的女性进行的一项前瞻性队列研究中储存的宫颈标本。计算了AmpFire和Xpert检测法的阳性和阴性百分比一致性，以及高级别宫颈发育异常的检测情况。
63份储存的宫颈标本解冻后可检测到DNA，并纳入分析。阳性百分比一致性为91.2%（95%CI 76.3 - 98.1），阴性百分比一致性为79.3%（95%CI 60.3 - 92.0）。6例AmpFire检测为阳性但Xpert检测为阴性的病例，其HPV基因型为35、52（n = 2）、58、68，以及HPV 45和68的合并感染。Xpert和AmpFire检测法在所有10例患有高级别宫颈发育异常的女性样本中均检测到了HPV。
AmpFire HPV检测法在检测HPV和具有临床意义的宫颈疾病方面均表现出优异的分析性能。AmpFire HPV是一种有前景的选择，可增加LMICs地区获得负担得起的、针对特定类型的HPV宫颈癌筛查的机会。
