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Evaluation of Pre-Analytical Variables for Human Papillomavirus Primary Screening from Self-Collected Vaginal Swabs.
Qi, Michelle; Naranjo, Anissa R; Duque, Abigail J; Lorey, Thomas S; Schapiro, Jeffrey M; Suh-Burgmann, Betty J; Rummel, Michael; Salipante, Stephen J; Wentzensen, Nicolas; Greene, Dina N.
Afiliación
  • Qi M; LetsGetChecked Laboratories, Monrovia, California.
  • Naranjo AR; LetsGetChecked Laboratories, Monrovia, California.
  • Duque AJ; The Permanente Medical Group, Northern California Kaiser Permanente Regional Reference Laboratory, Oakland, California.
  • Lorey TS; The Permanente Medical Group, Northern California Kaiser Permanente Regional Reference Laboratory, Oakland, California.
  • Schapiro JM; The Permanente Medical Group, Northern California Kaiser Permanente Regional Reference Laboratory, Oakland, California.
  • Suh-Burgmann BJ; Department of Research, The Permanente Medical Group, Oakland, California.
  • Rummel M; LetsGetChecked Laboratories, Monrovia, California.
  • Salipante SJ; Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington.
  • Wentzensen N; Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland.
  • Greene DN; LetsGetChecked Laboratories, Monrovia, California; Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington. Electronic address: dngreene@uw.edu.
J Mol Diagn ; 26(6): 487-497, 2024 Jun.
Article en En | MEDLINE | ID: mdl-38494078
ABSTRACT
Human papillomavirus (HPV) primary screening is an effective approach to assessing cervical cancer risk. Self-collected vaginal swabs can expand testing access, but the data defining analytical performance criteria necessary for adoption of self-collected specimens are limited, especially for those occurring outside the clinic, where the swab remains dry during transport. Here, we evaluated the performance of self-collected vaginal swabs for HPV detection using the Cobas 6800. There was insignificant variability between swabs self-collected by the same individual (n = 15 participants collecting 5 swabs per participant), measured by amplification of HPV and human ß-globin control DNA. Comparison of self-collected vaginal swab and provider-collected cervical samples (n = 144 pairs) proved highly concordant for HPV detection (total agreement = 90.3%; positive percentage agreement = 84.2%). There was no relationship between the number of dry storage days and amplification of HPV (n = 68; range, 4 to 41 days). Exposure of self-collected dry swabs to extreme summer and winter temperatures did not affect testing outcomes. A second internal control (RNase P) demonstrated that lack of amplification for ß-globin from self-collected specimens was consistent with poor, but not absent, cellularity. These data suggest that self-collected vaginal samples enable accurate clinical HPV testing, and that extended ambient dry storage or exposure to extreme temperatures does not influence HPV detection. Furthermore, lack of ß-globin amplification in HPV-negative samples accurately identified participants who required recollection.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Manejo de Especímenes / Infecciones por Papillomavirus / Virus del Papiloma Humano Límite: Adult / Female / Humans / Middle aged Idioma: En Revista: J Mol Diagn Asunto de la revista: BIOLOGIA MOLECULAR Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Manejo de Especímenes / Infecciones por Papillomavirus / Virus del Papiloma Humano Límite: Adult / Female / Humans / Middle aged Idioma: En Revista: J Mol Diagn Asunto de la revista: BIOLOGIA MOLECULAR Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos