Wang Jun, Imade Godwin, Akanmu Alani S, Musa Jonah, Anorlu Rose, Zheng Yinan, Garcia-Bedoya Olga, Sanchez Gloria I, Belinson Jerome, Kim Kyeezu, Maiga Mamoudou, Gursel Demirkan B, Sagay Atiene S, Ogunsola Folasade T, Murphy Robert L, Hou Lifang
Department of Preventive Medicine, Division of Cancer Epidemiology and Prevention, Feinberg School of Medicine, Northwestern University, 680 N Lake Shore Dr, Suite 1400, Chicago, IL, 60611, USA.
Center for Global Oncology, Robert J. Havey MD Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, USA.
Infect Agent Cancer. 2024 Nov 29;19(1):59. doi: 10.1186/s13027-024-00622-2.
Easy-to-use, rapid, scalable, high-throughput, and cost-effective HPV tests are urgently needed for low-resource settings. Atila Biosystems' high-throughput, cost-effective, and clinically validated ScreenFire HPV Risk Stratification (RS) assay identifies 13 high risk HPV (hrHPV) in 4 groups based on their oncogenic risk (i.e., HPV16, HPV18/45, HPV31/33/35/52/58, and HPV51/59/39/56/68). The current standard format is subject to laboratory contamination, which is common for any molecular PCR test. To overcome this drawback, Atila has recently upgraded it into an innovative, contamination-free Zebra BioDome format. The contamination-free feature makes this novel assay format more suitable for large-scale community- and population-based cervical screening. This study evaluated the analytical performance of the Zebra BioDome format.
We conducted a study to test the analytical performance of Zebra Biodome format in comparison to the results of using the ScreenFire HPV RS assay standard format on Biorad CFX-96 real-time PCR instrument. We used overall agreement rate and unweighted kappa value to compare the performance.
The overall agreement for detection of hrHPV was 96.0% with unweighted kappa value 0.94 (95% confidence interval: 0.90-0.98). The agreement rates between hrHPV genotype 16 and risk stratification genotype group (HPV18/45, HPV31/33/35/52/58, and HPV51/59/39/56/68) were all > 97.5%.
The innovative ScreenFire HPV RS assay Zebra BioDome format produced highly concordant results with the standard format. The shared features by the two assay formats, such as easy-to-use, high throughput, cost-appropriate, and no requirements for DNA extraction. The unique contamination-prevention feature along with no requirement of preparation of reagents make the Zebra BioDome format more suitable for large-scale HPV screening to reduce global cervical cancer burden.
资源匮乏地区迫切需要易于使用、快速、可扩展、高通量且具有成本效益的人乳头瘤病毒（HPV）检测方法。阿蒂拉生物系统公司的高通量、具有成本效益且经过临床验证的ScreenFire HPV风险分层（RS）检测方法，根据致癌风险将13种高危型HPV（hrHPV）分为4组（即HPV16、HPV18/45、HPV31/33/35/52/58以及HPV51/59/39/56/68）。当前的标准形式易受实验室污染，这在任何分子聚合酶链反应（PCR）检测中都很常见。为克服这一缺点，阿蒂拉公司最近将其升级为创新的、无污染的斑马生物穹顶形式。无污染特性使这种新型检测形式更适合大规模基于社区和人群的宫颈癌筛查。本研究评估了斑马生物穹顶形式的分析性能。
我们开展了一项研究，在伯乐CFX - 96实时PCR仪上，将斑马生物穹顶形式的分析性能与使用ScreenFire HPV RS检测标准形式的结果进行比较。我们使用总体一致率和未加权kappa值来比较性能。
hrHPV检测的总体一致率为96.0%，未加权kappa值为0.94（95%置信区间：0.90 - 0.98）。hrHPV 16型与风险分层基因型组（HPV18/45、HPV31/33/35/52/58以及HPV51/59/39/56/68）之间的一致率均>97.5%。
创新的ScreenFire HPV RS检测斑马生物穹顶形式与标准形式产生了高度一致的结果。两种检测形式具有共同特点，如易于使用、高通量、成本适宜且无需DNA提取。独特的防污染特性以及无需试剂准备，使斑马生物穹顶形式更适合大规模HPV筛查，以减轻全球宫颈癌负担。
