Analytical performance of the ScreenFire HPV RS Zebra BioDome assay on four different qPCR platforms
Rattachement africain : us, Nigéria. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
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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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Analytical performance of the ScreenFire HPV RS Zebra BioDome assay on four different qPCR platforms
- Date Crossref
- 30/04/2025
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Northwestern University Robert J. Havey MD Institute for Global Health pays non établi dans la noticeUniversité ou école supérieure
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Northwestern Medicine pays non établi dans la noticeÉtablissement de santé
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University of Jos University of Jos, Nigéria (code pays fourni par la source)Université ou école supérieure
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University of Lagos University of Lagos, Nigéria (code pays fourni par la source)Université ou école supérieure
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Lagos University Teaching Hospital Lagos University Teaching Hospital, Nigéria (code pays fourni par la source)Établissement de santé
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University of Ibadan University of Ibadan, Nigéria (code pays fourni par la source)Université ou école supérieure
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University College Hospital Ibadan, Nigéria (code pays fourni par la source)Établissement de santé
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Cleveland Clinic pays non établi dans la noticeÉtablissement de santé
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Feinberg School of Medicine Robert J. Havey Institute for Global Health pays non établi dans la noticeUniversité ou école supérieure
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College of Health Sciences Department of Obstetrics and Gynecology University of Jos, Nigéria (pays nommé en fin d’affiliation)Université ou école supérieure
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College of Medicine Department of Hematology and Blood Transfusion Lagos University Teaching Hospital, Nigéria (pays nommé en fin d’affiliation)Université ou école supérieure
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Women's Health Institute pays non établi dans la noticeStructure de recherche
Robert J. Havey MD Institute for Global Health — Northwestern University, Northwestern Medicine et University of Jos (University of Jos, Nigéria), avec 9 autres affiliations. Pays d’affiliation : Nigéria.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.