Analytic performance of ScreenFire HPV RS assay Zebra BioDome format and its potential for large-scale population HPV screening.

IF 3.1 2区医学 Q3 IMMUNOLOGY Infectious Agents and Cancer Pub Date : 2024-11-29 DOI:10.1186/s13027-024-00622-2

Jun Wang, Godwin Imade, Alani S Akanmu, Jonah Musa, Rose Anorlu, Yinan Zheng, Olga Garcia-Bedoya, Gloria I Sanchez, Jerome Belinson, Kyeezu Kim, Mamoudou Maiga, Demirkan B Gursel, Atiene S Sagay, Folasade T Ogunsola, Robert L Murphy, Lifang Hou

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引用次数: 0

Abstract

Background: 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.

Methods: 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.

Results: 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%.

Conclusion: 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.

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ScreenFire HPV RS检测的分析性能及其在大规模人群HPV筛查中的潜力。

背景：在资源匮乏的环境中，迫切需要易于使用、快速、可扩展、高通量和具有成本效益的HPV检测。Atila Biosystems公司的高通量、高成本效益、经临床验证的ScreenFire HPV风险分层（RS）检测根据其致癌风险（即HPV16、HPV18/45、HPV31/33/35/52/58和HPV51/59/39/56/68）将13种高危HPV （hrHPV）分为4组。目前的标准格式受到实验室污染，这是常见的任何分子PCR测试。为了克服这一缺点，阿提拉公司最近将其升级为一种创新的、无污染的Zebra BioDome格式。无污染的特点，使这种新颖的分析格式更适合大规模的社区和人口为基础的子宫颈筛查。本研究评估了Zebra BioDome格式的分析性能。方法：在Biorad CFX-96实时荧光定量PCR仪上，采用ScreenFire HPV RS检测标准格式与Zebra Biodome格式进行对比分析。我们使用总体协议率和未加权kappa值来比较性能。结果：hrHPV检测的总体符合率为96.0%，未加权kappa值为0.94（95%置信区间：0.90-0.98）。hrHPV基因型16与风险分层基因型HPV18/45、HPV31/33/35/52/58、HPV51/59/39/56/68的符合率均为97.5%。结论：创新的ScreenFire HPV RS检测Zebra BioDome格式与标准格式的检测结果高度一致。两种分析格式的共同特点，如易于使用，高通量，成本合适，不需要DNA提取。独特的防污染特性以及不需要制备试剂，使Zebra BioDome格式更适合大规模HPV筛查，以减轻全球宫颈癌负担。

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来源期刊

Infectious Agents and Cancer ONCOLOGY-IMMUNOLOGY

CiteScore

5.80

自引率

2.70%

发文量

期刊介绍： Infectious Agents and Cancer is an open access, peer-reviewed online journal that encompasses all aspects of basic, clinical, epidemiological and translational research providing an insight into the association between chronic infections and cancer. The journal welcomes submissions in the pathogen-related cancer areas and other related topics, in particular: • HPV and anogenital cancers, as well as head and neck cancers; • EBV and Burkitt lymphoma; • HCV/HBV and hepatocellular carcinoma as well as lymphoproliferative diseases; • HHV8 and Kaposi sarcoma; • HTLV and leukemia; • Cancers in Low- and Middle-income countries. The link between infection and cancer has become well established over the past 50 years, and infection-associated cancer contribute up to 16% of cancers in developed countries and 33% in less developed countries. Preventive vaccines have been developed for only two cancer-causing viruses, highlighting both the opportunity to prevent infection-associated cancers by vaccination and the gaps that remain before vaccines can be developed for other cancer-causing agents. These gaps are due to incomplete understanding of the basic biology, natural history, epidemiology of many of the pathogens that cause cancer, the mechanisms they exploit to cause cancer, and how to interrupt progression to cancer in human populations. Early diagnosis or identification of lesions at high risk of progression represent the current most critical research area of the field supported by recent advances in genomics and proteomics technologies.