使用预加热步骤对阴道自采样本进行分析，可提高 Aptima HPV 检测的 HPV 检出率。

Increased HPV detection by the use of a pre-heating step on vaginal self-samples analysed by Aptima HPV assay.

机构信息

Department of Obstetrics & Gynecology, Skåne University Hospital, Lund University, Lund, Sweden.

Department of Medical Microbiology, Laboratory Medicine Region Skåne, Lund University, Lund, Sweden.

出版信息

J Virol Methods. 2019 Aug;270:18-20. doi: 10.1016/j.jviromet.2019.04.015. Epub 2019 Apr 16.

DOI:10.1016/j.jviromet.2019.04.015

PMID:31002831

Abstract

BACKGROUND

We recently reported a sensitivity of 85.5% to detect high-grade squamous intraepithelial lesions (HSIL)/adenocarcinoma in situ (AIS)/cancer by the use of self-collected vaginal samples analysed by the Aptima mRNA HPV assay (AHPV).

OBJECTIVES

To increase detection of HPV among self-samples.

STUDY DESIGN

We used a pre-heating step at 90 °C for 1 h on our previously AHPV-negative self-samples (N = 20) among women with AHPV-positive cervical samples. We also analysed AHPV results before and after the heating among a series of self-samples from women who had not attended cervical screening for > 7 years (N = 173).

RESULTS

After heating, 55% (11/20) of the self-samples became AHPV-positive. By updating our original series 93.1% (121/130, 95% CI: 87.3-96.8) of the self-samples were AHPV-positive among women with AHPV-positive cervical samples, and among women with histologically confirmed cervical intraepithelial neoplasia or worse (CIN2+) now 95.3% (61/64, 95% CI: 86.9-99.0) of the self-samples were AHPV-positive. Among the 11 AHPV-positive self-samples we detected high-risk HPV types in 10 of the samples (HPV16 3 cases, HPV18 1, HPV31 1, HPV33 1, HPV 45 1, HPV51 2, HPV 56 and 58 1, HPV42 and 90 1 [low risk]) by multiplex PCR and Luminex assay. Among the self-samples from the non-attenders 16% (27/170) and 5.3% (8/152) were AHPV-positive after and before the heating step, respectively (P = 0.0022). Concerning validity of AHPV-results, 99% (170/172) were valid after the heating step compared to 88% (152/172) before the heating step (P < 0.0001).

CONCLUSIONS

A pre-heating step on vaginal self-samples increased HPV detection by the AHPV assay.

摘要

背景

我们最近报道了使用 Aptima mRNA HPV 检测（AHPV）分析的自我采集阴道样本检测高级别鳞状上皮内病变（HSIL）/原位腺癌（AIS）/癌的灵敏度为 85.5%。

目的

提高自我样本中 HPV 的检测率。

研究设计

我们对之前 AHPV 阴性的自我样本（N=20）进行了 90°C 预热 1 小时，这些自我样本来自 AHPV 阳性的宫颈样本。我们还分析了未参加宫颈筛查超过 7 年的 173 例自我样本（N=173）中 AHPV 检测结果在加热前后的变化。

结果

加热后，55%（11/20）的自我样本 AHPV 检测呈阳性。通过更新我们的原始系列，93.1%（121/130，95%CI：87.3-96.8）的自我样本在 AHPV 阳性的宫颈样本中 AHPV 检测呈阳性，在组织学证实的宫颈上皮内瘤变或更高级别病变（CIN2+）的女性中，现在 95.3%（61/64，95%CI：86.9-99.0）的自我样本 AHPV 检测呈阳性。在 11 例 AHPV 阳性的自我样本中，我们通过多重 PCR 和 Luminex 检测在 10 例样本中检测到高危 HPV 型（HPV16 3 例，HPV18 1 例，HPV31 1 例，HPV33 1 例，HPV45 1 例，HPV51 2 例，HPV56 和 58 1 例，HPV42 和 90 1 例[低危]）。在未参加者的自我样本中，加热后分别有 16%（27/170）和 5.3%（8/152）的样本 AHPV 检测呈阳性（P=0.0022）。关于 AHPV 检测结果的有效性，加热后 99%（170/172）的结果有效，而加热前为 88%（152/172）（P<0.0001）。