{"doi":"10.1186/s13027-024-00622-2","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' 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.","journal":"Infectious Agents and Cancer","year":2024,"id":449649,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":5,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9643,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":371009,"name":"Godwin Imade","orcid":"0000-0001-5221-7699","position":1,"is_corresponding":false},{"id":247431,"name":"Sulaimon Akanmu","orcid":"0000-0001-7424-6060","position":2,"is_corresponding":false},{"id":447614,"name":"Jonah Musa","orcid":"0000-0002-7836-0976","position":3,"is_corresponding":false},{"id":371008,"name":"Rose Anorlu","orcid":"0000-0003-4563-654X","position":4,"is_corresponding":false},{"id":291153,"name":"Yinan Zheng","orcid":"0000-0002-2006-7320","position":5,"is_corresponding":false},{"id":870813,"name":"Olga Garcia‐Bedoya","orcid":null,"position":6,"is_corresponding":false},{"id":1269437,"name":"Gloria Inés Sánchez","orcid":"0000-0001-5992-0475","position":7,"is_corresponding":false},{"id":415255,"name":"Jerome L. Belinson","orcid":"0000-0003-1399-1053","position":8,"is_corresponding":false},{"id":820617,"name":"Kyeezu Kim","orcid":"0000-0002-9094-9011","position":9,"is_corresponding":false},{"id":588509,"name":"Mamoudou Maiga","orcid":null,"position":10,"is_corresponding":false},{"id":319045,"name":"Demirkan Gursel","orcid":null,"position":11,"is_corresponding":false},{"id":371013,"name":"Atiene S. Sagay","orcid":"0000-0002-5715-8365","position":12,"is_corresponding":false},{"id":371014,"name":"Folasade Ogunsola","orcid":"0000-0001-7734-685X","position":13,"is_corresponding":false},{"id":12095,"name":"Robert L. Murphy","orcid":"0000-0003-3936-2052","position":14,"is_corresponding":false},{"id":218546,"name":"Lifang Hou","orcid":"0000-0003-4877-0031","position":15,"is_corresponding":false},{"id":378944,"name":"Jun Wang","orcid":"0000-0002-2678-2456","position":0,"is_corresponding":true}],"reference_count":11,"raw_metadata":null,"created_at":"2026-07-19T02:02:20.585759Z","pmid":"39614290","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}