Abstract
Background: COVID-19, which is caused by SARS-CoV-2 and its variants, poses an ongoing global threat, particularly in low-immunization coverage regions. Thus, rapid, accurate, and easy-to-perform diagnostic methods are in urgent demand to halt the spread of the virus.
Objectives: We aimed to validate the clinical performance of the FastProof 30 min-TTR SARS-CoV-2 reverse transcription loop-mediated isothermal amplification (RT-LAMP) method using leftover RNA samples extracted from 315 nasopharyngeal swabs. The sensitivity and specificity of RT-LAMP were determined in comparison with reverse transcriptase-polymerase chain reaction (RT-PCR).
Results: Of 315 nasopharyngeal swabs, viral RNA was detected in 154 samples (48.9%) by RT-PCR assay. Compared with RT-PCR, overall sensitivity and specificity of RT-LAMP were 81.82% (95% CI: 74.81-87.57) and 100% (95% CI: 97.73-100), respectively. A 100% positivity rate was achieved in samples with cycle threshold (Ct) <31 for RT-PCR targeting the ORF1ab gene. However, samples with Ct >31 accounted for false-negative results by RT-LAMP in 28 samples.
Conclusions: RT-LAMP reliably detected viral RNA with high sensitivity and specificity and has potential application for mass screening of patients with acute COVID-19 infection when viral load is high.
Keywords: COVID-19; Colorimetric RT-LAMP; RT-PCR; Sensitivity; Specificity.
【저자키워드】 COVID-19, RT-PCR, sensitivity, specificity, Colorimetric RT-LAMP, 【초록키워드】 SARS-CoV-2, Infection, RT-PCR, virus, variants, Spread, RT-LAMP, Coverage, Viral, Mass screening, Sensitivity and specificity, COVID-19 infection, Loop-mediated isothermal amplification, Viral load, cycle threshold, nasopharyngeal swabs, LAMP, Patient, reverse transcription, isothermal amplification, Viral RNA, diagnostic methods, false-negative results, false-negative, RT-PCR assay, Diagnostic method, ORF1ab gene, reverse transcriptase-polymerase chain reaction, reverse transcriptase, Chain Reaction, 95% CI, false, acute COVID-19, regions, caused, accounted, RNA sample, 【제목키워드】 SARS-COV-2 infection, diagnostic, reverse transcription, isothermal amplification, performance,