Performance of colorimetric reverse transcription loop-mediated isothermal amplification as a diagnostic tool for SARS-CoV-2 infection during the fourth wave of COVID-19 in Thailand
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...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-03-01
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| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971221012522 |
| _version_ | 1819279372817793024 |
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| author | Thanyarat Promlek Maytawan Thanunchai Uraporn Phumisantiphong Tonsan Hansirisathit Chayanit Phuttanu Sunisa Dongphooyao Wipawee Thongsopa Pornlada Nuchnoi |
| author_facet | Thanyarat Promlek Maytawan Thanunchai Uraporn Phumisantiphong Tonsan Hansirisathit Chayanit Phuttanu Sunisa Dongphooyao Wipawee Thongsopa Pornlada Nuchnoi |
| author_sort | Thanyarat Promlek |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-24T00:26:52Z |
| format | Article |
| id | doaj.art-1bb7d120f5944d92a18e04c4814cd7f4 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-12-24T00:26:52Z |
| publishDate | 2022-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-1bb7d120f5944d92a18e04c4814cd7f42022-12-21T17:24:24ZengElsevierInternational Journal of Infectious Diseases1201-97122022-03-01116133137Performance of colorimetric reverse transcription loop-mediated isothermal amplification as a diagnostic tool for SARS-CoV-2 infection during the fourth wave of COVID-19 in ThailandThanyarat Promlek0Maytawan Thanunchai1Uraporn Phumisantiphong2Tonsan Hansirisathit3Chayanit Phuttanu4Sunisa Dongphooyao5Wipawee Thongsopa6Pornlada Nuchnoi7Department of Clinical Pathology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand; Corresponding author: Thanyarat Promlek, Department of Clinical Pathology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, 681 Samsen Road, Dusit, Bangkok 10300, Thailand. Tel.: +66863143396.Department of Clinical Pathology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, ThailandDepartment of Clinical Pathology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, ThailandDepartment of Central Laboratory, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, ThailandDepartment of Central Laboratory, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, ThailandDepartment of Central Laboratory, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, ThailandDepartment of Central Laboratory, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, ThailandCenter for Research and Innovation, Faculty of Medical Technology, Mahidol University, Bangkok, ThailandABSTRACT: 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.http://www.sciencedirect.com/science/article/pii/S1201971221012522Colorimetric RT-LAMPRT-PCRSensitivitySpecificityCOVID-19 |
| spellingShingle | Thanyarat Promlek Maytawan Thanunchai Uraporn Phumisantiphong Tonsan Hansirisathit Chayanit Phuttanu Sunisa Dongphooyao Wipawee Thongsopa Pornlada Nuchnoi Performance of colorimetric reverse transcription loop-mediated isothermal amplification as a diagnostic tool for SARS-CoV-2 infection during the fourth wave of COVID-19 in Thailand International Journal of Infectious Diseases Colorimetric RT-LAMP RT-PCR Sensitivity Specificity COVID-19 |
| title | Performance of colorimetric reverse transcription loop-mediated isothermal amplification as a diagnostic tool for SARS-CoV-2 infection during the fourth wave of COVID-19 in Thailand |
| title_full | Performance of colorimetric reverse transcription loop-mediated isothermal amplification as a diagnostic tool for SARS-CoV-2 infection during the fourth wave of COVID-19 in Thailand |
| title_fullStr | Performance of colorimetric reverse transcription loop-mediated isothermal amplification as a diagnostic tool for SARS-CoV-2 infection during the fourth wave of COVID-19 in Thailand |
| title_full_unstemmed | Performance of colorimetric reverse transcription loop-mediated isothermal amplification as a diagnostic tool for SARS-CoV-2 infection during the fourth wave of COVID-19 in Thailand |
| title_short | Performance of colorimetric reverse transcription loop-mediated isothermal amplification as a diagnostic tool for SARS-CoV-2 infection during the fourth wave of COVID-19 in Thailand |
| title_sort | performance of colorimetric reverse transcription loop mediated isothermal amplification as a diagnostic tool for sars cov 2 infection during the fourth wave of covid 19 in thailand |
| topic | Colorimetric RT-LAMP RT-PCR Sensitivity Specificity COVID-19 |
| url | http://www.sciencedirect.com/science/article/pii/S1201971221012522 |
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