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评价家用自采阴道拭子进行人乳头瘤病毒检测的干、湿运输效果。

Evaluation of dry and wet transport of at-home self-collected vaginal swabs for human papillomavirus testing.

机构信息

The Fenway Institute, Boston, MA, USA.

Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA.

出版信息

J Med Microbiol. 2012 Nov;61(Pt 11):1538-1545. doi: 10.1099/jmm.0.046110-0. Epub 2012 Aug 16.

DOI:10.1099/jmm.0.046110-0
PMID:22899778
Abstract

Our objective was to compare human papillomavirus (HPV) detection in paired self-collected vaginal samples transported by overnight mail in liquid specimen transport medium (STM) (wet) or in dry tubes (dry). Women aged 18-24 years were recruited online to self-collect vaginal swab samples at home for HPV testing and 159 women returned paired wet and dry samples. Dry samples were rehydrated with STM upon arrival at the laboratory. HPV was detected by the Roche Linear Array HPV genotyping test (37 genotypes) and Kappa and McNemar statistics were used to compare wet versus dry samples for detecting HPV. Of the subjects tested in this study, 51 % were HPV-positive (in either sample) and 40 % were positive for high-risk HPV. A total of 216 type-specific infections were detected among the 80 HPV-positive women. Almost perfect agreement was observed between paired samples for detecting any HPV (subject-level positive agreement: 91.9 %, κ: 0.85) or type-specific HPV (positive agreement across types: 90.1 %, κ: 0.90). Similar agreement between sample types was seen when testing for high-risk types and 81.9 % of all type-specific infections were detected in both samples. Among discordant pairs, wet samples were 3.3 times more likely to be positive for type-specific HPV than dry samples (P = 0.02). However, in 63.6 % of wet-positive/dry-negative discordant pairs analysed for viral load, type-specific HPV was either undetectable or detected at a low level (<100 copies) in the wet samples, suggesting that the majority of infections missed by using dry samples are less likely to be clinically relevant. Our results indicate that dry transport is a feasible option for transporting at-home self-collected vaginal samples for HPV DNA testing.

摘要

我们的目的是比较人乳头瘤病毒(HPV)在通过隔夜邮寄的液体标本运输介质(湿)或干管(干)运输的配对自我采集的阴道样本中的检测。18-24 岁的女性在线招募,在家中自我采集阴道拭子样本进行 HPV 检测,有 159 名女性返回了配对的湿样本和干样本。干样本在到达实验室时用 STM 重新水化。HPV 通过罗氏线性阵列 HPV 基因分型检测(37 种基因型)进行检测,并使用 Kappa 和 McNemar 统计数据比较湿样本和干样本检测 HPV 的效果。在本研究中接受测试的受试者中,51%(无论哪种样本)HPV 呈阳性,40%HPV 呈高危型阳性。在 80 名 HPV 阳性女性中,共检测到 216 种特定类型的感染。在检测任何 HPV(个体水平阳性一致性:91.9%,κ:0.85)或特定类型 HPV(跨类型阳性一致性:90.1%,κ:0.90)时,配对样本之间观察到几乎完全一致。在检测高危型时,两种样本类型之间也存在相似的一致性,81.9%的所有特定类型感染都在两种样本中被检测到。在不一致的对中,湿样本检测到特定类型 HPV 的可能性是干样本的 3.3 倍(P=0.02)。然而,在对病毒载量进行分析的 63.6%湿阳性/干阴性不一致对中,湿样本中特定类型 HPV 要么无法检测到,要么检测到的水平较低(<100 拷贝),这表明使用干样本错过的大多数感染不太可能具有临床意义。我们的结果表明,干运输是一种可行的选择,可用于运输家庭自行采集的阴道样本进行 HPV DNA 检测。

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