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一种基于鼻腔和鼻咽灌洗液的严重急性呼吸综合征冠状病毒2检测方法:一项初步可行性研究。

A Severe Acute Respiratory Syndrome Coronavirus 2 detection method based on nasal and nasopharyngeal lavage fluid: A pilot feasibility study.

作者信息

Frezza Daniele, Fabbris Cristoforo, Franz Leonardo, Vian Elisa, Rigoli Roberto, De Siati Rosalba, Emanuelli Enzo, Bertinato Luigi, Boscolo-Rizzo Paolo, Spinato Giacomo

机构信息

Unit of Otorhinolaryngology AULSS 2-Marca Trevigiana Treviso Italy.

Department of Neurosciences, Section of Otolaryngology University of Padova Treviso Italy.

出版信息

Laryngoscope Investig Otolaryngol. 2021 Jul 27;6(4):646-649. doi: 10.1002/lio2.625. eCollection 2021 Aug.

Abstract

OBJECTIVE

Nose and nasopharyngeal swab is the preferred and worldwide-accepted method to detect the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) within the nose and nasopharynx. This method may be linked with possible difficulties, such as patient's discomfort or complications. This article shows a pilot study of SARS-CoV-2 detection with nasal and nasopharyngeal lavage fluids (level of evidence: 3).

METHODS

Nasal lavage fluid was collected from patients who were submitted to SARS-CoV-2 screening test, due to a preceding positive rapid antigen test. A control group was enrolled among health care professionals whose nasopharyngeal swab tested negative. Nasal lavages were performed using isotonic saline solution injected through a nasal fossa. Both lavage fluid and traditional nasopharyngeal swab were analyzed by real-time (RT) PCR and antigenic test.

RESULTS

A total of 49 positive subjects were enrolled in the study. Results of the analysis on lavages and nasopharyngeal swabs were concordant for 48 cases, regardless of the antigenic and molecular test performed. RT-PCR resulted weakly positive at swab in one case and negative at lavage fluid. Among the control group (44 subjects), nasopharyngeal swab and lavage fluid analyses returned a negative result. Sensitivity of the molecular test based on nasal lavage fluid, compared to traditional nasal swab, was 97.7%, specificity was 100%, and accuracy was 98.9%, with high agreement (Cohen's κ, 0.978).

CONCLUSION

Nasal and nasopharyngeal lavages resulted to be highly reliable and well tolerated. A larger series is needed to confirm these results. This approach may potentially represent a valid alternative to the traditional swab method in selected cases.

LEVEL OF EVIDENCE

摘要

目的

鼻拭子和鼻咽拭子是检测鼻腔和鼻咽部严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的首选且被全球认可的方法。该方法可能存在一些潜在问题,如患者不适或并发症。本文展示了一项关于用鼻腔和鼻咽灌洗液检测SARS-CoV-2的初步研究(证据级别:3)。

方法

收集因快速抗原检测呈阳性而接受SARS-CoV-2筛查试验患者的鼻腔灌洗液。选取鼻咽拭子检测呈阴性的医护人员作为对照组。通过鼻腔向鼻腔内注入等渗盐溶液进行灌洗。对灌洗液和传统鼻咽拭子均进行实时(RT)PCR和抗原检测。

结果

本研究共纳入49例阳性受试者。无论进行抗原检测还是分子检测,灌洗液和鼻咽拭子的分析结果在48例中是一致的。有1例拭子RT-PCR结果弱阳性而灌洗液结果为阴性。在对照组(44名受试者)中,鼻咽拭子和灌洗液分析均为阴性结果。与传统鼻拭子相比,基于鼻腔灌洗液的分子检测灵敏度为97.7%,特异性为100%,准确性为98.9%,一致性较高(Cohen's κ,0.978)。

结论

鼻腔和鼻咽灌洗结果高度可靠且耐受性良好。需要更大规模的研究系列来证实这些结果。在特定情况下,这种方法可能是传统拭子方法的有效替代方案。

证据级别

3。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8457/8356876/1fe7f24570e2/LIO2-6-646-g002.jpg

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