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J Clin Virol . Clinical COVID-19 diagnostic methods: Comparison of reverse transcription loop-mediated isothermal amplification (RT-LAMP) and quant

tetano

Editor, Senior Moderator
J Clin Virol


. 2021 Mar 26;139:104813.
doi: 10.1016/j.jcv.2021.104813. Online ahead of print.
Clinical COVID-19 diagnostic methods: Comparison of reverse transcription loop-mediated isothermal amplification (RT-LAMP) and quantitative RT-PCR (qRT-PCR)


Heita Kitajima[SUP] 1 [/SUP], Yoshitaka Tamura[SUP] 2 [/SUP], Hiroko Yoshida[SUP] 2 [/SUP], Hitomi Kinoshita[SUP] 2 [/SUP], Hiroki Katsuta[SUP] 2 [/SUP], Chika Matsui[SUP] 2 [/SUP], Akane Matsushita[SUP] 2 [/SUP], Tsuyoshi Arai[SUP] 3 [/SUP], Shoji Hashimoto[SUP] 3 [/SUP], Atsuhiko Iuchi[SUP] 4 [/SUP], Tomonori Hirashima[SUP] 5 [/SUP], Hiroshi Morishita[SUP] 6 [/SUP], Hiroto Matsuoka[SUP] 6 [/SUP], Toshio Tanaka[SUP] 7 [/SUP], Takayuki Nagai[SUP] 3 [/SUP]



Affiliations

Abstract

Background: The coronavirus disease 2019 (COVID-19) pandemic is a major public health concern. Accurate and rapid diagnosis of COVID-19 is critical for disease control. Reverse transcription loop-mediated isothermal amplification (RT-LAMP) is a nucleic acid amplification assay similar to reverse transcription-polymerase chain reaction (RT-PCR), the former being a simple, low cost, and rapid method.
Objectives: This study aimed to compare the RT-LAMP assay with RT-PCR using the Loopamp? SARS-CoV-2 Detection Kit.
Study design: One hundred and fifty-one nasopharyngeal swab and 88 sputum samples obtained from individuals with suspected or confirmed COVID-19 were examined.
Results: RT-LAMP had high specificity (98.5 % (95 % CI: 96.9-100 %)), sensitivity (87.0 % (95 % CI: 82.8-91.3 %)), positive predictive value (97.9 % (95 % CI: 96.1-99.7 %)), negative predictive value (90.2 % (95 % CI: 86.4-94.0 %)), and concordance rate (93.3 % (95 % CI: 90.1-96.5 %)). Nasopharyngeal and sputum samples positive in RT-LAMP contained as few as 10.2 and 23.4 copies per 10 ?L, respectively. RT-LAMP showed similar performance to RT-PCR for samples with cycle threshold value below 36.
Conclusions: These results indicate that RT-LAMP is a highly reliable and at least equivalent to RT-PCR in utility, and potentially applicable in settings that are more diverse as a point-of-care tool.

Keywords: COVID-19; Diagnosis; Polymerase chain reaction; RT-LAMP; SARS-CoV-2; Sputum.
 
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