基于环介导等温扩增技术的新型冠状病毒2分子即时检测：一项前瞻性单中心验证研究

SARS-CoV-2 molecular diagnostic point-of-care testing based on loop-mediated isothermal amplification: A prospective, single-center validation study.

作者信息

Moon Sung Hun, Kim Sang-Chul, Kim Byung Woo, Park Gwan-Jin, Chai Hyun-Seok, Kim Young Min, Kim Hee Sung, Park Hee Sue

机构信息

Department of Emergency Medicine, Chungbuk National University Hospital, 776, 1st Sunhwan-ro, Seowon-gu, Cheongju-si, Chungcheongbuk-do 28646, Republic of Korea.

Department of Emergency Medicine, College of Medicine, Chungbuk National University, 1 Chungdae-ro, Seowongu, Cheongju-si, Chungcheongbuk-do 28646, Republic of Korea.

出版信息

Heliyon. 2023 Mar;9(3):e14564. doi: 10.1016/j.heliyon.2023.e14564. Epub 2023 Mar 15.

DOI:10.1016/j.heliyon.2023.e14564

PMID:36942218

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10014123/

Abstract

OBJECTIVES

Rapid and accurate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic tests are crucial for controlling the spread of infections in emergency settings. This study evaluated the diagnostic accuracy of a point-of-care (POC) test based on loop-mediated isothermal amplification (LAMP) that produces rapid results within 30 min.

METHODS

We prospectively included adult patients (age >19 years) who were diagnosed with SARS-CoV-2 infection within the last 3 days and symptomatic patients who had visited the emergency room. Posterior nasopharyngeal (PNP) swabs and throat swabs collected by physicians were used to test the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and Cohen's Kappa coefficient (k) of the POC index and reference reverse transcription quantitative polymerase chain reaction (RT-qPCR) test devices.

RESULTS

Of the 352 participants, 102 (29.0%) tested positive via the RT-PCR-based reference test device; the RT-LAMP-based POC test had a sensitivity of 70.6% and specificity of 98.0%, with 93.5% PPV, 89.1% NPV, 35.5% PLR, and 3.4% NLR. Cohen's k correlation of results from the two devices was 0.74. The cycle threshold value between the positive and negative POC test results differed (17.6 vs. 24.6, < 0.001).

CONCLUSIONS

The RT-LAMP POC test in the emergency medical setting has a fair predictive value in high viral load cases in terms of infectivity.

摘要

目的

快速准确的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）诊断检测对于控制紧急情况下的感染传播至关重要。本研究评估了一种基于环介导等温扩增（LAMP）的即时检测（POC）试验的诊断准确性，该试验可在30分钟内得出快速结果。

方法

我们前瞻性纳入了过去3天内被诊断为SARS-CoV-2感染的成年患者（年龄>19岁）以及前往急诊室就诊的有症状患者。由医生采集的后鼻咽（PNP）拭子和咽拭子用于检测POC指标和参考逆转录定量聚合酶链反应（RT-qPCR）检测设备的敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）、准确性和科恩卡帕系数（k）。

结果

在352名参与者中，102名（29.0%）通过基于RT-PCR的参考检测设备检测为阳性；基于RT-LAMP的POC检测的敏感性为70.6%，特异性为98.0%，PPV为93.5%，NPV为89.1%，阳性似然比（PLR）为35.5%，阴性似然比（NLR）为3.4%。两种设备结果的科恩k相关性为0.74。POC检测阳性和阴性结果之间的循环阈值存在差异（17.6对24.6，<0.001）。