Evaluation of Liquid Versus Dry Specimen Transport With a Newly Validated Isothermal Amplification High-Risk Human Papillomavirus Assay.
Journal
Journal of lower genital tract disease
ISSN: 1526-0976
Titre abrégé: J Low Genit Tract Dis
Pays: United States
ID NLM: 9704963
Informations de publication
Date de publication:
Jul 2020
Jul 2020
Historique:
entrez:
23
6
2020
pubmed:
23
6
2020
medline:
18
5
2021
Statut:
ppublish
Résumé
The aim of the study was to determine whether the proportion of positive high-risk human papillomavirus (HR-HPV) tests in endocervical specimens transported dry differs from paired specimens transported in liquid media. Five hundred women aged of 30 to 55 years were recruited, Shanxi Bethune Hospital, China. Two samples were collected from the endocervix per patient, one placed into empty vial, the other into a liquid transport solution. All samples were analyzed by AmpFire HR-HPV assay. Total 1,000 samples collected from 500 patients were analyzed by the AmpFire HR-HPV assay. The total invalid rate was 0.2% (2/1,000). The proportion of endocervical samples testing positive for HR-HPV transported dry (42.2%, 210/498 [95% CI = 37.8%-46.6%]) was similar to the proportion of paired endocervical samples testing positive transported in liquid media (40.4%, 201/498 [95% CI = 36.0%-44.8%], p = .18 [McNemar test]). That the 2 transport methods are likely measuring the same positive (and negative) specimens is suggested by the finding that κ value for the correlation of positive HR-HPV in endocervical specimens transported dry with those transported in liquid media was 0.86 (95% CI = 0.81-0.90). Endocervical specimens transported dry have similar proportion of positive HR-HPV tests as those transported in liquid media. Dry brush transport of endocervical samples paired with the special characteristics of AmpFire HR-HPV may become an important addition to population based cervical cancer screening.
Identifiants
pubmed: 32569253
doi: 10.1097/LGT.0000000000000546
pii: 00128360-202007000-00003
doi:
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
243-246Références
Belinson JL, Hu S, Niyazi M, et al. Prevalence of type-specific human papillomavirus in endocervical, upper and lower vaginal, perineal and vaginal self-collected specimens: implications for vaginal self-collection. Int J Cancer 2010;127:1151–7.
Belinson JL, Du H, Yang B, et al. Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing. Int J Cancer 2012;130:1855–60.
Gravitt PE, Belinson JL, Salmeron J, et al. Looking ahead: a case for human papillomavirus testing of self-sampled vaginal specimens as a cervical cancer screening strategy. Int J Cancer 2011;129:517–27.
Arbyn M, Smith SB, Temin S, et al; Collaboration on Self-Sampling and HPV Testing. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses. BMJ 2018;363:k4823.
Tisci S, Shen YH, Fife D, et al. Patient acceptance of self-sampling for human papillomavirus in rural china. J Low Genit Tract Dis 2003;7:107–16.
Arriba LN, Enerson CL, Belinson S, et al. Mexican Cervical Cancer Screening Study II: acceptability of human papillomavirus self-sampler. Int J Gynecol Cancer 2010;20:1415–23.
Levinson KL, Abuelo C, Chyung E, et al. The Peru Cervical Cancer Prevention Study (PERCAPS): Community-Based Participatory Research in Manchay, Peru. Int J Gynecol Cancer 2013;23:141–7.
Wright TC Jr., Stoler MH, Behrens CM, et al. The ATHENA human papillomavirus study: design, methods, and baseline results. Am J Obstet Gynecol 2012;206:46.e1–e11.
Hesselink AT, Meijer CJ, Poljak M, et al. Clinical validation of the Abbott RealTime High Risk HPV assay according to the guidelines for human papillomavirus DNA test requirements for cervical screening. J Clin Microbiol 2013;51:2409–10.
Yi X, Zou J, Xu J, et al. Development and validation of a new HPV genotyping assay based on next-generation sequencing. Am J Clin Pathol 2014;141:796–804.
Atilabiosystems.com [internet]. Mountain view: Multiplex high risk HPV by fluorescent detection. c2019. Available at: https://atilabiosystems.com/multiplex-high-risk-hpv-by-fluorescent-detection/. Accessed December 26, 2019.
Wang L, Chen W. A new technique of isothermal amplification techniques in cervical cancer screening. Eurogin Amsterdam, FC 17-12, October 2017.
Kleeman M, Chen X, Reuter C, et al. Evaluation of a novel isothermal amplification assay for rapid HPV detection and genotyping. Eurogin Lisbon, Poster 00489, December 2018.
Paytubi S, Taberna M, Mena M, et al. Assessment of isothermal amplification AmpFire assay for detection and genotyping of hpv in Formalin-fixed paraffin-embedded head and neck cancer samples. Eurogin 2018. Available at: https://www.eurogin.com/content/dam/Informa/eurogin/pdf/Eurogin2018-Poster.pdf.
Maurer K, Luo H, Shen Z, et al. Evaluation of a new solid media specimen transport card for population based cervical cancer prevention. J Clin Virol 2016;76:14–9.
Luo H, Du H, Maurer K, et al. An evaluation of the Cobas4800 HPV test on cervico-vaginal specimens in liquid versus solid transport media. PLoS One 2016;11:e0148168.
Tang YW, Lozano L, Chen X, et al. An isothermal, multiplex amplification assay for detection and genotyping of human papillomaviruses in formalin-fixed, paraffin-embedded tissues. J Mol Diagn 2020;22:419–28.
Agorastos T, Chatzistamatiou K, Tsertanidou A, et al. Implementation of HPV-based cervical cancer screening combined with self-sampling using a midwifery network across rural Greece: the GRECOSELF study. Cancer Prev Res (Phila) 2019;12:701–10.
Eperon I, Vassilakos P, Navarria I, et al. Randomized comparison of vaginal self-sampling by standard vs dry swabs for human papillomavirus testing. BMC Cancer 2013;13:353.
Haguenoer K, Giraudeau B, Gaudy-Graffin C, et al. Accuracy of dry vaginal self-sampling for detecting high-risk human papillomavirus infection in cervical cancer screening: a cross-sectional study. Gynecol Oncol 2014;134:302–8.
Wolfrum SG, Koutsky LA, Hughes JP, et al. Evaluation of dry and wet transport of at-home self-collected vaginal swabs for human papillomavirus testing. J Med Microbiol 2012;61(Pt 11):1538–45.
Shah KV, Daniel RW, Tennant MK, et al. Diagnosis of human papillomavirus infection by dry vaginal swabs in military women. Sex Transm Infect 2001;77:260–4.
Feng Q, Cherne S, Winer RL, et al. Evaluation of transported dry and wet cervical exfoliated samples for detection of human papillomavirus infection. J Clin Microbiol 2010;48:3068–72.
Sultana F, Gertiga DM, Wrede CD, et al. A pilot study to compare dry cervical sample collection with standard practice of wet cervical samples for human papillomavirus testing. J Clin Virol 2015;69:210–3.
Lin CQ, Zeng X, Cui JF, et al. Stability study of cervical specimens collected by swab and stored dry followed by human papillomavirus DNA detection using the Cobas 4800 test. J Clin Microbiol 2017;55:568–73.
Vassilakos P, Catarino R, Bougel S, et al. Use of swabs for dry collection of self-samples to detect human papillomavirus among Malagasy women. Infect Agent Cancer 2016;11:13.
Catarino R, Vassilakos P, Bilancioni A, et al. Accuracy of self-collected vaginal dry swabs using the Xpert human papillomavirus assay. PLoS One 2017;12:e0181905.