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在疑似新冠肺炎患者唾液样本中使用比色逆转录环介导等温扩增(RT-LAMP)方法检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)病毒的性能

The Performance of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus Using the Colorimetric Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) Method in Saliva Specimens of Suspected COVID-19 Patients.

作者信息

Turbawaty Dewi Kartika, Sudjadi Andy, Lismayanti Leni, Rostini Tiene, Logito Verina

机构信息

Department of Clinical Pathology, Faculty of Medicine Padjadjaran University/ Dr. Hasan Sadikin General Hospital, Bandung, West Java, Indonesia.

出版信息

Int J Gen Med. 2024 Jul 26;17:3329-3335. doi: 10.2147/IJGM.S461613. eCollection 2024.

Abstract

INTRODUCTION

Corona Virus Disease-19 (COVID-19) is a disease caused by Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2). The most reliable and widely accepted method for diagnosing this infection, despite facing various challenges, is the Reverse Transcription Polymerase Chain Reaction (RT-PCR) method, which utilizes nasopharyngeal swab sample. Reverse-transcription loop mediated isothermal amplification (RT-LAMP) is a simpler nucleic acid amplification method compared to the RT-PCR method. This method has several advantages, including: of amplification at constant temperature, faster results, and potentially greater examination capacity.

PURPOSE

This study aimed to compare the validity of the RT-LAMP method using saliva specimens with that of the RT-PCR method using nasopharyngeal smears.

METHODS

This was an analytical observational study with a cross-sectional design. The participants were inpatients in the COVID-19 special isolation building of Hasan Sadikin General Hospital, Indonesia with a probable (clinical symptoms of covid, but not confirm NAAT examination) or confirmed diagnosis of COVID-19 from September 2021 to February 2022. The inclusion criteria are COVID-19 patients with symptoms, adult subjects, and composite mentions. Patients who were unable to secrete saliva were also excluded.

RESULTS

In total, 118 specimens were collected. The validity test results of the saliva specimens using the RT-LAMP method showed sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), of 65.5%, 100%, 100%, and 75%, respectively. The results increased in subjects treated between 3 and 7 days after symptom onset ie 73.2%, 100%, 100%, and 82.3%, respectively.

CONCLUSION

The very strong specificity accompanied by good sensitivity and NPV in the group of subjects treated 3-7 days after the onset of symptoms indicates that the RT-LAMP method using saliva specimens can be an efficient and reliable alternative tool in detecting the SARS-CoV-2 virus.

摘要

引言

冠状病毒病-19(COVID-19)是由严重急性呼吸综合征冠状病毒2(SARS-CoV-2)引起的疾病。尽管面临各种挑战,但诊断这种感染最可靠且被广泛接受的方法是逆转录聚合酶链反应(RT-PCR)法,该方法使用鼻咽拭子样本。逆转录环介导等温扩增(RT-LAMP)是一种比RT-PCR法更简单的核酸扩增方法。该方法具有几个优点,包括:在恒温下扩增、结果更快以及潜在的更大检测能力。

目的

本研究旨在比较使用唾液标本的RT-LAMP法与使用鼻咽涂片的RT-PCR法的有效性。

方法

这是一项采用横断面设计的分析性观察研究。研究对象为印度尼西亚哈山·萨迪金综合医院COVID-19特殊隔离病房的住院患者,这些患者在2021年9月至2022年2月期间可能(有新冠临床症状,但核酸扩增检测未确诊)或已确诊感染COVID-19。纳入标准为有症状的COVID-19患者、成年受试者以及综合提及的情况。无法分泌唾液的患者也被排除。

结果

总共收集了118份标本。使用RT-LAMP法对唾液标本进行有效性测试的结果显示,敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV)分别为65.5%、100%、100%和75%。在症状出现后3至7天接受治疗的受试者中,这些结果有所提高,分别为73.2%、100%、100%和82.3%。

结论

在症状出现后3至7天接受治疗的受试者组中,特异性非常强,同时伴有良好的敏感性和NPV,这表明使用唾液标本进行RT-LAMP法可以成为检测SARS-CoV-2病毒的一种高效且可靠的替代工具。

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