{"doi":"10.1016/j.jcv.2024.105657","title":"Human papillomavirus negative high grade cervical lesions and cancers: Suggested guidance for HPV testing quality assurance","abstract":"BACKGROUND: Some high-grade cervical lesions and cervical cancers (HSIL+) test negative for human papillomavirus (HPV). The HPV-negative fraction varies between 0.03 % and 15 % between different laboratories. Monitoring and extended re-analysis of HPV-negative HSIL+ could thus be helpful to monitor performance of HPV testing services. We aimed to a) provide a real-life example of a quality assurance (QA) program based on re-analysis of HPV-negative HSIL+ and b) develop international guidance for QA of HPV testing services based on standardized identification of apparently HPV-negative HSIL+ and extended re-analysis, either by the primary laboratory or by a national HPV reference laboratory (NRL). METHODS: There were 116 initially HPV-negative cervical specimens (31 histopathology specimens and 85 liquid-based cytology samples) sent to the Swedish HPV Reference Laboratory for re-testing. Based on the results, an international QA guidance was developed through an iterative consensus process. RESULT: Standard PCR testing detected HPV in 55.2 % (64/116) of initially \"HPV-negative\" samples. Whole genome sequencing of PCR-negative samples identified HPV in an additional 7 samples (overall 61.2 % HPV positivity). Reasons for failure to detect HPV in an HSIL+ lesion are listed and guidance to identify cases for extended re-testing, including which information should be included when referring samples to an NRL are presented. CONCLUSION: Monitoring the proportion of and reasons for failure to detect HPV in HSIL+ will help support high performance and quality improvement of HPV testing services. We encourage implementation of QA strategies based on re-analysis of \"HPV negative\" HSIL+ samples.","journal":"Journal of Clinical Virology","year":2024,"id":437859,"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":10,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9637,"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":1247354,"name":"Laila Sara Arroyo Mühr","orcid":"0000-0003-2498-5206","position":1,"is_corresponding":false},{"id":914278,"name":"Kate Cuschieri","orcid":"0000-0002-2604-3928","position":2,"is_corresponding":false},{"id":1247355,"name":"Marı́a Dolores Fellner","orcid":"0000-0003-1609-8893","position":3,"is_corresponding":false},{"id":1247356,"name":"Rita Mariel Correa","orcid":"0000-0002-8241-1924","position":4,"is_corresponding":false},{"id":708550,"name":"Marı́a Alejandra Picconi","orcid":"0000-0002-5930-9040","position":5,"is_corresponding":false},{"id":914277,"name":"Suzanne M. 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