Lorenzo Biasioli, Roberto Rossotti, Alessandro Tavelli, Anna De Bona, Camilla Tincati, Daniele Calzavara, Pietro Vinti, Chiara Baiguera, Federico D’Amico, Alice Nava, Roberto Repossi, Simona Bossolasco, Camilla Muccini, Giovanni Mulè, Daniele Tesoro, Antonella d'Arminio Monforte, Massimo Cernuschi
{"title":"对 PrEP 用户进行肛门 HPV 筛查的自控护理点测试的性能评估:来自社区 PrEP 服务机构的数据","authors":"Lorenzo Biasioli, Roberto Rossotti, Alessandro Tavelli, Anna De Bona, Camilla Tincati, Daniele Calzavara, Pietro Vinti, Chiara Baiguera, Federico D’Amico, Alice Nava, Roberto Repossi, Simona Bossolasco, Camilla Muccini, Giovanni Mulè, Daniele Tesoro, Antonella d'Arminio Monforte, Massimo Cernuschi","doi":"10.1136/sextrans-2023-055939","DOIUrl":null,"url":null,"abstract":"Objectives In this study, we compared the performance of a self-administered point-of-care test (POCT) for anal human papillomavirus (HPV) screening with laboratory gold-standard test in pre-exposure prophylaxis (PrEP) users and evaluated its feasibility. Methods We enrolled PrEP users from a local community-based PrEP service. Each participant self-collected an anal swab to test anal HPV with a PCR POCT capable of detecting 14 high-risk HPV genotypes. Anonymous questionnaires on self-sampling feasibility were completed. Participants were then referred to local clinics to undergo standard viral genotyping. Concordance between POCT and gold-standard test was measured with absolute agreement and Cohen’s kappa. Receiver operating characteristic (ROC) curves were used to calculate POCT sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Results 179 subjects got a valid POCT result, most of them men (98.3%) and men who have sex with men (90.4%). 68.2% tested positive for at least one high-risk HPV genotype on POCT. 150 feasibility questionnaires were collected: 92.7% of compilers found the self-swab easy to perform. For 178 subjects, a gold-standard test valid result was also available: 77% tested positive for at least one high-risk HPV genotype. The median time elapsed between the two tests was 9.8 months, due to COVID-19-related service interruptions. Agreement between POCT and gold-standard test was 79.3% (Cohen’s kappa=0.49). POCT showed a sensitivity of 81.0%, a specificity of 73.8%, a PPV of 91.0% and an NPV of 54.4%. Conclusions POCT showed a moderate agreement with gold-standard test and a discrete sensitivity and specificity, suggesting that it could be a useful and feasible additional tool for HPV screening, especially in low-resource and community-based settings.","PeriodicalId":21624,"journal":{"name":"Sexually Transmitted Infections","volume":null,"pages":null},"PeriodicalIF":3.6000,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Performance evaluation of a self-administered point-of-care test for anal HPV screening in PrEP users: data from a community-based PrEP service\",\"authors\":\"Lorenzo Biasioli, Roberto Rossotti, Alessandro Tavelli, Anna De Bona, Camilla Tincati, Daniele Calzavara, Pietro Vinti, Chiara Baiguera, Federico D’Amico, Alice Nava, Roberto Repossi, Simona Bossolasco, Camilla Muccini, Giovanni Mulè, Daniele Tesoro, Antonella d'Arminio Monforte, Massimo Cernuschi\",\"doi\":\"10.1136/sextrans-2023-055939\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Objectives In this study, we compared the performance of a self-administered point-of-care test (POCT) for anal human papillomavirus (HPV) screening with laboratory gold-standard test in pre-exposure prophylaxis (PrEP) users and evaluated its feasibility. Methods We enrolled PrEP users from a local community-based PrEP service. Each participant self-collected an anal swab to test anal HPV with a PCR POCT capable of detecting 14 high-risk HPV genotypes. Anonymous questionnaires on self-sampling feasibility were completed. Participants were then referred to local clinics to undergo standard viral genotyping. Concordance between POCT and gold-standard test was measured with absolute agreement and Cohen’s kappa. Receiver operating characteristic (ROC) curves were used to calculate POCT sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Results 179 subjects got a valid POCT result, most of them men (98.3%) and men who have sex with men (90.4%). 68.2% tested positive for at least one high-risk HPV genotype on POCT. 150 feasibility questionnaires were collected: 92.7% of compilers found the self-swab easy to perform. For 178 subjects, a gold-standard test valid result was also available: 77% tested positive for at least one high-risk HPV genotype. The median time elapsed between the two tests was 9.8 months, due to COVID-19-related service interruptions. Agreement between POCT and gold-standard test was 79.3% (Cohen’s kappa=0.49). POCT showed a sensitivity of 81.0%, a specificity of 73.8%, a PPV of 91.0% and an NPV of 54.4%. Conclusions POCT showed a moderate agreement with gold-standard test and a discrete sensitivity and specificity, suggesting that it could be a useful and feasible additional tool for HPV screening, especially in low-resource and community-based settings.\",\"PeriodicalId\":21624,\"journal\":{\"name\":\"Sexually Transmitted Infections\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.6000,\"publicationDate\":\"2024-04-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Sexually Transmitted Infections\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/sextrans-2023-055939\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Sexually Transmitted Infections","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/sextrans-2023-055939","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Performance evaluation of a self-administered point-of-care test for anal HPV screening in PrEP users: data from a community-based PrEP service
Objectives In this study, we compared the performance of a self-administered point-of-care test (POCT) for anal human papillomavirus (HPV) screening with laboratory gold-standard test in pre-exposure prophylaxis (PrEP) users and evaluated its feasibility. Methods We enrolled PrEP users from a local community-based PrEP service. Each participant self-collected an anal swab to test anal HPV with a PCR POCT capable of detecting 14 high-risk HPV genotypes. Anonymous questionnaires on self-sampling feasibility were completed. Participants were then referred to local clinics to undergo standard viral genotyping. Concordance between POCT and gold-standard test was measured with absolute agreement and Cohen’s kappa. Receiver operating characteristic (ROC) curves were used to calculate POCT sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Results 179 subjects got a valid POCT result, most of them men (98.3%) and men who have sex with men (90.4%). 68.2% tested positive for at least one high-risk HPV genotype on POCT. 150 feasibility questionnaires were collected: 92.7% of compilers found the self-swab easy to perform. For 178 subjects, a gold-standard test valid result was also available: 77% tested positive for at least one high-risk HPV genotype. The median time elapsed between the two tests was 9.8 months, due to COVID-19-related service interruptions. Agreement between POCT and gold-standard test was 79.3% (Cohen’s kappa=0.49). POCT showed a sensitivity of 81.0%, a specificity of 73.8%, a PPV of 91.0% and an NPV of 54.4%. Conclusions POCT showed a moderate agreement with gold-standard test and a discrete sensitivity and specificity, suggesting that it could be a useful and feasible additional tool for HPV screening, especially in low-resource and community-based settings.
期刊介绍:
Sexually Transmitted Infections is the world’s longest running international journal on sexual health. It aims to keep practitioners, trainees and researchers up to date in the prevention, diagnosis and treatment of all STIs and HIV. The journal publishes original research, descriptive epidemiology, evidence-based reviews and comment on the clinical, public health, sociological and laboratory aspects of sexual health from around the world. We also publish educational articles, letters and other material of interest to readers, along with podcasts and other online material. STI provides a high quality editorial service from submission to publication.