tetano
Editor, Senior Moderator
Int J Infect Dis
. 2021 Dec 24;S1201-9712(21)01252-2.
doi: 10.1016/j.ijid.2021.12.351. Online ahead of print.
Performance of colorimetric RT-LAMP as a diagnostic tool for SARS-CoV-2 infection during the fourth wave of COVID-19 in Thailand
Thanyarat Promlek[SUP] 1 [/SUP], Maytawan Thanunchai[SUP] 2 [/SUP], Uraporn Phumisantiphong[SUP] 2 [/SUP], Tonsan Hansirisathit[SUP] 3 [/SUP], Chayanit Phuttanu[SUP] 3 [/SUP], Sunisa Dongphooyao[SUP] 3 [/SUP], Wipawee Thongsopa[SUP] 3 [/SUP], Pornlada Nuchnoi[SUP] 4 [/SUP]
Affiliations
Abstract
Background: Coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (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.
Objective: 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 ribonucleic acid (RNA) samples extracted from 315 nasopharyngeal swabs. The sensitivity and specificity of RT-LAMP were determined in comparison with RT-PCR.
Result: Out of 315 nasopharyngeal swabs, viral RNA was detected in 154 (48.9%) samples 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.
Conclusion: 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; RT-PCR; Sensitivity; Specificity; colorimetric RT-LAMP.
. 2021 Dec 24;S1201-9712(21)01252-2.
doi: 10.1016/j.ijid.2021.12.351. Online ahead of print.
Performance of colorimetric RT-LAMP as a diagnostic tool for SARS-CoV-2 infection during the fourth wave of COVID-19 in Thailand
Thanyarat Promlek[SUP] 1 [/SUP], Maytawan Thanunchai[SUP] 2 [/SUP], Uraporn Phumisantiphong[SUP] 2 [/SUP], Tonsan Hansirisathit[SUP] 3 [/SUP], Chayanit Phuttanu[SUP] 3 [/SUP], Sunisa Dongphooyao[SUP] 3 [/SUP], Wipawee Thongsopa[SUP] 3 [/SUP], Pornlada Nuchnoi[SUP] 4 [/SUP]
Affiliations
- PMID: 34958929
- DOI: 10.1016/j.ijid.2021.12.351
Abstract
Background: Coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (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.
Objective: 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 ribonucleic acid (RNA) samples extracted from 315 nasopharyngeal swabs. The sensitivity and specificity of RT-LAMP were determined in comparison with RT-PCR.
Result: Out of 315 nasopharyngeal swabs, viral RNA was detected in 154 (48.9%) samples 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.
Conclusion: 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; RT-PCR; Sensitivity; Specificity; colorimetric RT-LAMP.