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. 2022 Dec 22:13:1063414.
doi: 10.3389/fmicb.2022.1063414. eCollection 2022.

A diagnostic accuracy study comparing RNA LAMP, direct LAMP, and rapid antigen testing from nasopharyngeal swabs

Guojun Cao  1 , Ke Lin  2 , Jingwen Ai  2 , Jianpeng Cai  2 , Haocheng Zhang  2 , Yiqi Yu  2 , Qihui Liu  2 , Xinyun Zhang  2 , Yi Zhang  2 , Zhangfan Fu  2 , Jieyu Song  2 , Hongyu Wang  2 , Guanmin Yuan  2 , Sen Wang  2   3 , Ming Guan  1   3 , Wenhong Zhang  2   3   4
Affiliations

A diagnostic accuracy study comparing RNA LAMP, direct LAMP, and rapid antigen testing from nasopharyngeal swabs

Guojun Cao et al. Front Microbiol. .

Abstract

Introduction: During the coronavirus disease 2019 (COVID-19) pandemic, the early detection and isolation of individuals infected with severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) through mass testing can effectively prevent disease transmission. SARS-CoV-2 nucleic acid rapid detection based on loop-mediated isothermal amplification (LAMP) may be appropriate to include in testing procedures.

Methods: We used 860 nasopharyngeal specimens from healthcare workers of Huashan Hospital and COVID-19 patients collected from April 7th to 21st, 2022, to assess the clinical diagnostic performance of the LAMP assay marketed by Shanghai GeneSc Biotech and compared it to the result of a rapid antigen test (RAT) head-to-head.

Results: Overall, the diagnostic performance of LAMP assay and RAT were as follows. The LAMP assay represented higher sensitivity and specificity than RAT, especially in the extracted RNA samples. The sensitivity was 70.92% and 92.91% for direct LAMP and RNA-LAMP assay, respectively, while the specificity was 99.86% and 98.33%. The LAMP assay had overall better diagnostic performance on the specimens with relatively lower C t values or collected in the early phase (≤7 days) of COVID-19. The combination of LAMP assay and RAT improved diagnostic efficiency, providing new strategies for rapidly detecting SARS-CoV-2.

Conclusion: The LAMP assay are suitable for mass screenings of SARS-CoV-2 infections in the general population.

Keywords: COVID-19; LAMP assay; SARS-CoV-2; diagnostic accuracy; rapid antigen test.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Operation flow of the LAMP assay.
Figure 2
Figure 2
Diagnostic performance of the RNA-LAMP assay, direct LAMP assay, and RAT.
Figure 3
Figure 3
(A) The sensitivity of the RNA-LAMP assay, direct LAMP assay, and RAT with different RT-PCR cut-off values. (B) The specificity of the RNA-LAMP assay, direct LAMP assay, and RAT with different RT-PCR cut-off values.
Figure 4
Figure 4
(A) The sensitivity of the RNA-LAMP assay among samples collected in different phases of COVID-19. (B) The sensitivity of the direct LAMP assay among samples collected in different phases of COVID-19. (C) The sensitivity of the RAT among samples collected in different phases of COVID-19.
Figure 5
Figure 5
Diagnostic performance of the RNA-LAMP assay, direct LAMP assay, RAT, and joint method.
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