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

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

doi:10.1186/s13027-024-00622-2

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

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^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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.

Original language	English (US)
Article number	59
Journal	Infectious Agents and Cancer
Volume	19
Issue number	1
DOIs	https://doi.org/10.1186/s13027-024-00622-2
State	Published - Dec 2024

Funding

Research findings reported in this manuscript were supported by the National Cancer Institute of the National Institutes of Health under award number U54CA221205, D43CA260658, and U01CA275129, and by the Fogarty International Center of the National Institutes of Health under award number D43TW009575. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Keywords

Atila SceenFire HPV risk-stratification (RS) assay
High-risk human papillomavirus (HPV)
Isothermal amplification
Zebra BioDome HPV assay

ASJC Scopus subject areas

Epidemiology
Oncology
Infectious Diseases
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1186/s13027-024-00622-2

Cite this

Wang, J., Imade, G., Akanmu, A. S., Musa, J., Anorlu, R., Zheng, Y., Garcia-Bedoya, O., Sanchez, G. I., Belinson, J., Kim, K., Maiga, M., Gursel, D. B., Sagay, A. S., Ogunsola, F. T., Murphy, R. L., & Hou, L. (2024). Analytic performance of ScreenFire HPV RS assay Zebra BioDome format and its potential for large-scale population HPV screening. Infectious Agents and Cancer, 19(1), Article 59. https://doi.org/10.1186/s13027-024-00622-2

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title = "Analytic performance of ScreenFire HPV RS assay Zebra BioDome format and its potential for large-scale population HPV screening",

abstract = "Background: Easy-to-use, rapid, scalable, high-throughput, and cost-effective HPV tests are urgently needed for low-resource settings. Atila Biosystems{\textquoteright} 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.",

keywords = "Atila SceenFire HPV risk-stratification (RS) assay, High-risk human papillomavirus (HPV), Isothermal amplification, Zebra BioDome HPV assay",

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

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

year = "2024",

month = dec,

doi = "10.1186/s13027-024-00622-2",

language = "English (US)",

volume = "19",

journal = "Infectious Agents and Cancer",

issn = "1750-9378",

publisher = "BioMed Central",

number = "1",

}

Wang, J, Imade, G, Akanmu, AS, Musa, J, Anorlu, R, Zheng, Y, Garcia-Bedoya, O, Sanchez, GI, Belinson, J, Kim, K, Maiga, M , Gursel, DB, Sagay, AS, Ogunsola, FT, Murphy, RL & Hou, L 2024, 'Analytic performance of ScreenFire HPV RS assay Zebra BioDome format and its potential for large-scale population HPV screening', Infectious Agents and Cancer, vol. 19, no. 1, 59. https://doi.org/10.1186/s13027-024-00622-2

TY - JOUR

T1 - Analytic performance of ScreenFire HPV RS assay Zebra BioDome format and its potential for large-scale population HPV screening

AU - Wang, Jun

AU - Imade, Godwin

AU - Akanmu, Alani S.

AU - Musa, Jonah

AU - Anorlu, Rose

AU - Zheng, Yinan

AU - Garcia-Bedoya, Olga

AU - Sanchez, Gloria I.

AU - Belinson, Jerome

AU - Kim, Kyeezu

AU - Maiga, Mamoudou

AU - Gursel, Demirkan B.

AU - Sagay, Atiene S.

AU - Ogunsola, Folasade T.

AU - Murphy, Robert L.

AU - Hou, Lifang

PY - 2024/12

Y1 - 2024/12

N2 - 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.

AB - 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.

KW - Atila SceenFire HPV risk-stratification (RS) assay

KW - High-risk human papillomavirus (HPV)

KW - Isothermal amplification

KW - Zebra BioDome HPV assay

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U2 - 10.1186/s13027-024-00622-2

DO - 10.1186/s13027-024-00622-2

M3 - Article

C2 - 39614290

AN - SCOPUS:85211182966

SN - 1750-9378

VL - 19

JO - Infectious Agents and Cancer

JF - Infectious Agents and Cancer

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M1 - 59

ER -

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

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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