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自我采集的口腔、鼻腔和唾液样本在诊断有症状的门诊患者的 SARS-CoV-2 方面,其敏感性与专业采集的口咽鼻咽拭子相当。

Self-collected oral, nasal and saliva samples yield sensitivity comparable to professionally collected oro-nasopharyngeal swabs in SARS-CoV-2 diagnosis among symptomatic outpatients.

机构信息

Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Institute of Tropical Medicine and International Health, Berlin, Germany.

Robert Koch Institute - center for Biological Threats and Special Pathogens, Division Highly Pathogenic Viruses ZBS1, Berlin, Germany.

出版信息

Int J Infect Dis. 2021 Sep;110:261-266. doi: 10.1016/j.ijid.2021.07.047. Epub 2021 Jul 22.

Abstract

INTRODUCTION

Containing COVID-19 requires broad-scale testing. However, sample collection requires qualified personnel and protective equipment and may cause transmission. We assessed the sensitivity of SARS-CoV-2-rtPCR applying three self-sampling techniques as compared to professionally collected oro-nasopharyngeal samples (cOP/NP).

METHODS

From 62 COVID-19 outpatients, we obtained: (i) multi-swab, MS; (ii) saliva sponge combined with nasal vestibula, SN; (iii) gargled water, GW; (iv) professionally collected cOP/NP (standard). We compared ct-values for E-gene and ORF1ab and analysed variables reducing sensitivity of self-collecting procedures.

RESULTS

The median ct-values for E-gene and ORF1ab obtained in cOP/NP samples were 20.7 and 20.2, in MS samples 22.6 and 21.8, in SN samples 23.3 and 22.3, and in GW samples 30.3 and 29.8, respectively. MS and SN samples showed sensitivities of 95.2% (95%CI, 86.5-99.0) and GW samples of 88.7% (78.1-95.3). Sensitivity was inversely correlated with ct-values, and became <90% for samples obtained more than 8 days after symptom onset. For MS and SN samples, false negativity was associated with language problems, sampling errors, and symptom duration.

CONCLUSION

Conclusions from this study are limited to the sensitivity of self-sampling in mildly to moderately symptomatic patients. Still, self-collected oral/nasal/saliva samples can facilitate up-scaling of testing in early symptomatic COVID-19 patients if operational errors are minimized.

摘要

简介

包含 COVID-19 需要大规模的测试。然而,样本采集需要合格的人员和防护设备,并且可能会导致传播。我们评估了三种自我采样技术(MS、SN 和 GW)与专业采集的口咽/鼻咽样本(cOP/NP)相比,对 SARS-CoV-2-rtPCR 的敏感性。

方法

从 62 名 COVID-19 门诊患者中,我们获得了:(i)多拭子,MS;(ii)唾液海绵联合鼻前庭,SN;(iii)漱口液,GW;(iv)专业采集的 cOP/NP(标准)。我们比较了 E 基因和 ORF1ab 的 ct 值,并分析了降低自我采集程序敏感性的变量。

结果

cOP/NP 样本中 E 基因和 ORF1ab 的中位 ct 值分别为 20.7 和 20.2,MS 样本为 22.6 和 21.8,SN 样本为 23.3 和 22.3,GW 样本为 30.3 和 29.8。MS 和 SN 样本的敏感性分别为 95.2%(95%CI,86.5-99.0)和 GW 样本的 88.7%(78.1-95.3)。敏感性与 ct 值呈负相关,对于症状出现后 8 天以上采集的样本,敏感性<90%。对于 MS 和 SN 样本,假阴性与语言问题、采样错误和症状持续时间有关。

结论

本研究的结论仅限于轻度至中度症状患者的自我采样敏感性。然而,如果操作错误最小化,自我采集的口腔/鼻腔/唾液样本可以促进早期症状 COVID-19 患者的检测扩大。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6f9/8295057/e257dc9e9516/gr1_lrg.jpg

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