Analytical performance of the ScreenFire HPV RS Zebra BioDome assay on four different qPCR platforms.

IF 3.1 2区医学 Q3 IMMUNOLOGY

Infectious Agents and Cancer Pub Date : 2025-04-30 DOI:10.1186/s13027-025-00651-5

Jun Wang, Godwin Imade, Alani S Akanmu, Jonah Musa, Rose Anorlu, Yinan Zheng, Brian Joyce, Isaac Adewole, Imran O Morhason-Bello, Jerome Belinson, 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

Objectives: Cervical cancer is one of the most frequently diagnosed cancers and a leading cause of cancer-related deaths in women in low- and middle-income countries (LMICs), accounting for nearly 85% of the global cervical cancer burden. High-risk human papillomavirus (hrHPV) infection is the main cause of cervical cancer. Easy-to-use, rapid, scalable, high-throughput, and cost-effective HPV tests are urgently needed for low-resource settings. Atila Biosystems' clinically validated ScreenFire HPV Risk Stratification (RS) assay identifies 13 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). While the current standard format is subject to laboratory contamination Atila has developed an innovative, contamination-preventive Zebra BioDome format. Recently we published the analytical performance of ScreenFire RS Zebra BioDome on the BioRad CFX-96 real-time PCR instrument. This current study evaluated its analytical performance on three additional qPCR platforms: Atila Portable iAMP-PS96, Atila Powergene9600 Plus, and Thermo Fisher Quantstudio-7.

Methods: We tested 173 DNA samples from Nigerian women with cervical cancer. These samples were tested simultaneously using the ScreenFire HPV Zebra BioDome assay (M5FHPV-96) on four different real-time PCR machines (Atila portable iAMP-PS96, Atila Powergene9600 Plus, Thermo Fisher QuantStudio-7, and BioRad CFX-96). We used overall agreement rate and unweighted kappa values to compare different platforms.

Results: The overall agreement for detection of hrHPV using Atila portable iAMP-PS96 was 96.5% with kappa value 0.95 (95% confidence interval: 0.91-0.99) compared to Thermo Fisher QuantStudio-7, and 97.1% with kappa value 0.96 (95% confidence interval: 0.92-0.99) compared to BioRad CFX-96. For genotype HPV16 and risk stratification (RS) genotype groups (HPV18/45, HPV31/33/35/52/58, and HPV51/59/39/56/68) agreement rates were all > 98.3%. For Atila Powergene9600 Plus the overall agreement was 98.8% with a kappa value of 0.98 (95% confidence interval: 0.96-1.0) compared to Thermo Fisher QuantStudio-7, and 96.5% with a kappa value of 0.96 (95% confidence interval: 0.94-0.99) compared to BioRad CFX-96. The agreements for the HPV16 and RS genotype groups (HPV18/45, HPV31/33/35/52/58, and HPV39/51/56/59/68) were at least 98.3%.

Conclusion: The novel ScreenFire HPV Zebra BioDome format produced highly concordant hrHPV positivity and RS genotype results on all four qPCR platforms. The data suggests that this innovative technology has the potential to improve HPV testing uptake in low-resource settings without further investment in purchasing new equipment.

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ScreenFire HPV RS Zebra BioDome检测在四种不同qPCR平台上的分析性能

目标：宫颈癌是低收入和中等收入国家妇女最常诊断的癌症之一，也是癌症相关死亡的主要原因，占全球宫颈癌负担的近85%。高危人乳头瘤病毒（hrHPV）感染是宫颈癌的主要原因。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hrHPV分为4组。虽然目前的标准格式受到实验室污染，但Atila开发了一种创新的，防止污染的Zebra BioDome格式。最近，我们发表了ScreenFire RS Zebra BioDome在BioRad CFX-96实时PCR仪上的分析性能。本研究评估了其在另外三个qPCR平台上的分析性能：Atila Portable iAMP-PS96， Atila Powergene9600 Plus和Thermo Fisher Quantstudio-7。方法：对173例尼日利亚宫颈癌妇女的DNA样本进行检测。这些样品在四种不同的实时PCR仪（Atila portable iAMP-PS96, Atila Powergene9600 Plus， Thermo Fisher QuantStudio-7和BioRad CFX-96）上同时使用ScreenFire HPV Zebra BioDome assay （M5FHPV-96）进行检测。我们使用总体协议率和未加权kappa值来比较不同的平台。结果：与赛默飞世尔QuantStudio-7相比，使用Atila便携式iAMP-PS96检测hrHPV的总体一致性为96.5%，kappa值为0.95(95%置信区间：0.91-0.99)；与BioRad CFX-96相比，使用Atila便携式iAMP-PS96检测hrHPV的总体一致性为97.1%，kappa值为0.96（95%置信区间：0.92-0.99）。HPV16基因型与风险分层（RS）基因型组（HPV18/45、HPV31/33/35/52/58、HPV51/59/39/56/68）的符合率均为98.3%。与赛默飞世尔QuantStudio-7相比，Atila Powergene9600 Plus的总体一致性为98.8%，kappa值为0.98(95%可信区间：0.96- 0.99)；与BioRad CFX-96相比，总体一致性为96.5%，kappa值为0.96（95%可信区间：0.94-0.99）。HPV16和RS基因型组（HPV18/45、HPV31/33/35/52/58和HPV39/51/56/59/68）的一致性至少为98.3%。结论：新型ScreenFire HPV Zebra BioDome格式在所有四个qPCR平台上产生高度一致的hrHPV阳性和RS基因型结果。数据表明，这种创新技术有潜力在资源匮乏的环境中提高HPV检测的接受程度，而无需进一步投资购买新设备。

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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.