Development, Evaluation of the PNA RT-LAMP Assay for Rapid Molecular Detection of SARS-CoV-2

Abstract

Dual-labeled PNA probe used RT-LAMP molecular rapid assay targeting SARS-CoV-2 ORF1ab and N genes was developed, and the analytical, clinical performances for detection of SARS-CoV-2 RNA extracted from clinical nasopharyngeal swab specimens were evaluated in this study. Data showed that this assay is highly specific for SARS-CoV-2, and the absolute detection limit is 1 genomic copy per microliter of viral RNA which can be considered to be comparable to gold-standard molecular diagnostic method real-time reverse transcriptase PCR. Both clinical sensitivity and specificity against a commercial real-time RT-PCR assay were determined as identical. In conclusion, the PNA RT-LAMP assay showed high analytical and clinical accuracy which are identical to real-time RT-PCR which has been routinely used for the detection of SARS-CoV-2.

Artificial genetic polymers against human pathologies

“…2'-amino-LNA are especially interesting since the 2'-amino group can be used for the attachment of fluorophores and other labels [85]. Even in isothermic amplification protocols the use of PNA may be of value [86]. For a broader coverage of AGPs application in diagnostics an excellent review [87] can be recommended.…”