Suppr超能文献

采用 GLINE-2019-nCoV Ag 试剂盒对前鼻拭子标本进行快速抗原检测用于诊断 COVID-19 的临床评估。

Clinical evaluation of anterior nasal cavity swab specimens by a rapid antigen test using a GLINE-2019-nCoV Ag Kit to diagnose COVID-19.

机构信息

Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.

Department of Clinical Laboratory, Saitama Medical University Hospital, Saitama, Japan.

出版信息

J Infect Chemother. 2023 Aug;29(8):825-828. doi: 10.1016/j.jiac.2023.05.010. Epub 2023 May 13.

Abstract

The promising diagnostic performance of rapid antigen tests (RATs) using non-invasive anterior nasal (AN) swab specimens to diagnose COVID-19 has been reported. A large number of RATs are commercially available; however, the careful assessment of RATs is essential prior to their implementation in clinical practice. We evaluated the clinical performance of the GLINE-2019-nCoV Ag Kit as a RAT using AN swabs in a prospective, blinded study. Adult patients who visited outpatient departments and received SARS-CoV-2 tests between August 16 and September 8, 2022, were eligible for this study. Patients who were aged under 18 years and patients without appropriate specimens were excluded. Two sets of AN and nasopharyngeal (NP) swabs were collected from all patients. Each set of specimens was tested by the RAT and quantitative reverse-transcription polymerase chain reaction (RT-qPCR). Of the 138 recruited patients, 84 were positive and 54 were negative by RT-qPCR using NP swabs. The positive agreement rate between RT-qPCR using NP swabs and RAT using AN swabs was 78.6% (95% confidence interval [CI], 68.3%-86.8%), the negative agreement rate was 98.1% (95% CI, 90.1%-99.9%), and the overall agreement rate was 86.2% (95% CI, 79.3%-91.5%), with a κ coefficient of 0.73. The positive agreement rate in the early phase (≤3 days from symptom onset) was >80%, but this fell to 50% in the late phase (≥4 days). This study demonstrates that the GLINE-2019-nCoV Ag Kit using AN swabs has good clinical performance and might be a reliable alternative method for diagnosing COVID-19.

摘要

使用非侵入性前鼻(AN)拭子标本的快速抗原检测(RAT)对 COVID-19 的诊断性能已得到证实。有大量的 RAT 可在商业上获得;然而,在将 RAT 应用于临床实践之前,对其进行仔细评估是必不可少的。我们使用 AN 拭子评估了 GLINE-2019-nCoV Ag 试剂盒作为 RAT 的临床性能,这是一项前瞻性、盲法研究。符合以下条件的成年患者有资格参加这项研究:2022 年 8 月 16 日至 9 月 8 日期间在门诊就诊并接受 SARS-CoV-2 检测的患者。年龄在 18 岁以下的患者和没有适当标本的患者被排除在外。所有患者均采集了两组 AN 和鼻咽(NP)拭子。每组标本均采用 RAT 和定量逆转录聚合酶链反应(RT-qPCR)进行检测。在 138 名入组患者中,84 名患者的 NP 拭子 RT-qPCR 结果为阳性,54 名患者的 NP 拭子 RT-qPCR 结果为阴性。NP 拭子 RT-qPCR 与 AN 拭子 RAT 的阳性符合率为 78.6%(95%置信区间[CI],68.3%-86.8%),阴性符合率为 98.1%(95%CI,90.1%-99.9%),总符合率为 86.2%(95%CI,79.3%-91.5%),κ 系数为 0.73。早期(症状出现后≤3 天)的阳性符合率>80%,但晚期(≥4 天)阳性符合率下降至 50%。这项研究表明,使用 AN 拭子的 GLINE-2019-nCoV Ag 试剂盒具有良好的临床性能,可能是诊断 COVID-19 的一种可靠替代方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/17ca/10182653/db8b26d8d1e2/gr1_lrg.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验