Matthew L Faron, Jane M Caldwell, Lavannya Sabharwal, Amorina Purpora, Jennifer Meece, Puspa Bhattarai, Julie O'Neill, Melody Christian, Neelam X Dhiman, Jennifer Halliday, Jessica S Hoff, Carrie V Vause, Paul A Granato
{"title":"热带草原HSV 1+2/VZV检测的临床性能和可重复性验证。","authors":"Matthew L Faron, Jane M Caldwell, Lavannya Sabharwal, Amorina Purpora, Jennifer Meece, Puspa Bhattarai, Julie O'Neill, Melody Christian, Neelam X Dhiman, Jennifer Halliday, Jessica S Hoff, Carrie V Vause, Paul A Granato","doi":"10.1016/j.jmoldx.2025.03.009","DOIUrl":null,"url":null,"abstract":"<p><p>Herpes simplex virus 1 (HSV-1), HSV 2 (HSV-2), and varicella-zoster virus (VZV) cause nondescript cutaneous and mucocutaneous lesions requiring rapid, differential identification for appropriate diagnosis and patient counseling. Decentralized multiplex molecular assays may provide more rapid results than existing methodologies but require clinical validation. This multicenter study evaluated the clinical performance of the Savanna HSV 1+2/VZV Assay against the high-complexity Lyra Direct HSV 1+2/VZV real-time PCR nucleic acid test for the detection of HSV-1, HSV-2, and VZV from clinical specimens. The Savanna HSV 1+2/VZV Assay is an automated, moderate-complexity, real-time PCR assay recently cleared by the US Food and Drug Administration for the simultaneous detection and differentiation of HSV-1, HSV-2, and VZV DNA isolated from lesion swabs. In this study, 744 clinical specimens (531 female, 213 male) were evaluated by Savanna and compared with Lyra. Discrepant result analysis was conducted with the moderate-complexity Solana HSV 1+2/VZV isothermal nucleic acid test. For 744 clinical samples, Savanna exhibited overall, positive, and negative percent agreement of 99.5%, 100%, and 99.3% for HSV-1; 99.9%, 100%, and 99.8% for HSV-2; and 100%, 100%, and 100% for VZV. The Savanna HSV 1+2/VZV Assay exhibited excellent performance in a multicenter, clinical study. Savanna can provide laboratory-equivalent results outside of the central laboratory with the potential to deliver accurate results during the patient visit.</p>","PeriodicalId":50128,"journal":{"name":"Journal of Molecular Diagnostics","volume":" ","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Validation of the Clinical Performance and Reproducibility of the Savanna HSV 1+2/VZV Assay.\",\"authors\":\"Matthew L Faron, Jane M Caldwell, Lavannya Sabharwal, Amorina Purpora, Jennifer Meece, Puspa Bhattarai, Julie O'Neill, Melody Christian, Neelam X Dhiman, Jennifer Halliday, Jessica S Hoff, Carrie V Vause, Paul A Granato\",\"doi\":\"10.1016/j.jmoldx.2025.03.009\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Herpes simplex virus 1 (HSV-1), HSV 2 (HSV-2), and varicella-zoster virus (VZV) cause nondescript cutaneous and mucocutaneous lesions requiring rapid, differential identification for appropriate diagnosis and patient counseling. Decentralized multiplex molecular assays may provide more rapid results than existing methodologies but require clinical validation. This multicenter study evaluated the clinical performance of the Savanna HSV 1+2/VZV Assay against the high-complexity Lyra Direct HSV 1+2/VZV real-time PCR nucleic acid test for the detection of HSV-1, HSV-2, and VZV from clinical specimens. The Savanna HSV 1+2/VZV Assay is an automated, moderate-complexity, real-time PCR assay recently cleared by the US Food and Drug Administration for the simultaneous detection and differentiation of HSV-1, HSV-2, and VZV DNA isolated from lesion swabs. In this study, 744 clinical specimens (531 female, 213 male) were evaluated by Savanna and compared with Lyra. Discrepant result analysis was conducted with the moderate-complexity Solana HSV 1+2/VZV isothermal nucleic acid test. For 744 clinical samples, Savanna exhibited overall, positive, and negative percent agreement of 99.5%, 100%, and 99.3% for HSV-1; 99.9%, 100%, and 99.8% for HSV-2; and 100%, 100%, and 100% for VZV. The Savanna HSV 1+2/VZV Assay exhibited excellent performance in a multicenter, clinical study. Savanna can provide laboratory-equivalent results outside of the central laboratory with the potential to deliver accurate results during the patient visit.</p>\",\"PeriodicalId\":50128,\"journal\":{\"name\":\"Journal of Molecular Diagnostics\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-04-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Molecular Diagnostics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jmoldx.2025.03.009\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PATHOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Molecular Diagnostics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jmoldx.2025.03.009","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PATHOLOGY","Score":null,"Total":0}
Validation of the Clinical Performance and Reproducibility of the Savanna HSV 1+2/VZV Assay.
Herpes simplex virus 1 (HSV-1), HSV 2 (HSV-2), and varicella-zoster virus (VZV) cause nondescript cutaneous and mucocutaneous lesions requiring rapid, differential identification for appropriate diagnosis and patient counseling. Decentralized multiplex molecular assays may provide more rapid results than existing methodologies but require clinical validation. This multicenter study evaluated the clinical performance of the Savanna HSV 1+2/VZV Assay against the high-complexity Lyra Direct HSV 1+2/VZV real-time PCR nucleic acid test for the detection of HSV-1, HSV-2, and VZV from clinical specimens. The Savanna HSV 1+2/VZV Assay is an automated, moderate-complexity, real-time PCR assay recently cleared by the US Food and Drug Administration for the simultaneous detection and differentiation of HSV-1, HSV-2, and VZV DNA isolated from lesion swabs. In this study, 744 clinical specimens (531 female, 213 male) were evaluated by Savanna and compared with Lyra. Discrepant result analysis was conducted with the moderate-complexity Solana HSV 1+2/VZV isothermal nucleic acid test. For 744 clinical samples, Savanna exhibited overall, positive, and negative percent agreement of 99.5%, 100%, and 99.3% for HSV-1; 99.9%, 100%, and 99.8% for HSV-2; and 100%, 100%, and 100% for VZV. The Savanna HSV 1+2/VZV Assay exhibited excellent performance in a multicenter, clinical study. Savanna can provide laboratory-equivalent results outside of the central laboratory with the potential to deliver accurate results during the patient visit.
期刊介绍:
The Journal of Molecular Diagnostics, the official publication of the Association for Molecular Pathology (AMP), co-owned by the American Society for Investigative Pathology (ASIP), seeks to publish high quality original papers on scientific advances in the translation and validation of molecular discoveries in medicine into the clinical diagnostic setting, and the description and application of technological advances in the field of molecular diagnostic medicine. The editors welcome for review articles that contain: novel discoveries or clinicopathologic correlations including studies in oncology, infectious diseases, inherited diseases, predisposition to disease, clinical informatics, or the description of polymorphisms linked to disease states or normal variations; the application of diagnostic methodologies in clinical trials; or the development of new or improved molecular methods which may be applied to diagnosis or monitoring of disease or disease predisposition.