Fast and Sensitive Detection of SARS-CoV-2 Nucleic Acid Using a Rapid Detection System Free of RNA Extraction
Objectives. To establish and evaluate the analytical and clinical performance of the Flash20 SARS-CoV-2 nucleic acid rapid detection system free of RNA extraction. Methods. The limit of detection (LoD) was determined using a negative nasopharyngeal swab matrix spiked with different concentrations of...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-01-01
|
| Series: | International Journal of Analytical Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2023/8053524 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832549750715449344 |
|---|---|
| author | Liang Ma Yanyan Fan Xiaomu Kong Yongwei Jiang Hong Huang Meimei Zhao Yi Liu Peng Gao Yong Cui Yongtong Cao |
| author_facet | Liang Ma Yanyan Fan Xiaomu Kong Yongwei Jiang Hong Huang Meimei Zhao Yi Liu Peng Gao Yong Cui Yongtong Cao |
| author_sort | Liang Ma |
| collection | DOAJ |
| description | Objectives. To establish and evaluate the analytical and clinical performance of the Flash20 SARS-CoV-2 nucleic acid rapid detection system free of RNA extraction. Methods. The limit of detection (LoD) was determined using a negative nasopharyngeal swab matrix spiked with different concentrations of SARS-CoV-2 virus; a total of 734,337 reference sequences of viral genomes from GenBank were used for the in-silico analysis to assess the inclusivity of the assay. The specificity of the system was evaluated by testing 27 medically relevant organisms. A total of 115 clinical specimens were collected and tested on the Flash20 SARS-CoV-2 detection system and with an FDA-approved comparator test to assess the clinical performance of the system. Results. The LoD of the Flash20 SARS-CoV-2 detection system is 250 copies/mL with a positive rate ≥90% (n = 20); alignments results showed that over 99% identity of the primer and probe of the Flash20 SARS-CoV-2 nucleic acid rapid detection system to the available SARS-CoV-2 sequences; the omicron samples tested 100% positive. None of the 27 organisms showed cross-reactivity with the Flash20 SARS-CoV-2 nucleic acid rapid detection system. Among all the 215 clinical samples, the Flash20 SARS-CoV-2 nucleic acid rapid detection system exhibits a high sensitivity of 99.24% (131/132) and 100% (83/83) specificity. Conclusion. The nucleic acid rapid detection system provides sensitive and accurate detection of SARS-CoV-2 free of RNA extraction. The high sensitivity and short time to results of approximately 35 minutes may impact earlier infection control and disease management. |
| format | Article |
| id | doaj-art-cf30bf8691f6435eb60ef0841c339365 |
| institution | Kabale University |
| issn | 1687-8779 |
| language | English |
| publishDate | 2023-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | International Journal of Analytical Chemistry |
| spelling | doaj-art-cf30bf8691f6435eb60ef0841c3393652025-02-03T06:08:39ZengWileyInternational Journal of Analytical Chemistry1687-87792023-01-01202310.1155/2023/8053524Fast and Sensitive Detection of SARS-CoV-2 Nucleic Acid Using a Rapid Detection System Free of RNA ExtractionLiang Ma0Yanyan Fan1Xiaomu Kong2Yongwei Jiang3Hong Huang4Meimei Zhao5Yi Liu6Peng Gao7Yong Cui8Yongtong Cao9Department of Clinical LaboratoryDepartment of Pulmonary & Critical Care MedicineDepartment of Clinical LaboratoryDepartment of Clinical LaboratoryCoyote Bioscience USA Inc.Department of Clinical LaboratoryDepartment of Clinical LaboratoryDepartment of Clinical LaboratoryDepartment of DermatologyDepartment of Clinical LaboratoryObjectives. To establish and evaluate the analytical and clinical performance of the Flash20 SARS-CoV-2 nucleic acid rapid detection system free of RNA extraction. Methods. The limit of detection (LoD) was determined using a negative nasopharyngeal swab matrix spiked with different concentrations of SARS-CoV-2 virus; a total of 734,337 reference sequences of viral genomes from GenBank were used for the in-silico analysis to assess the inclusivity of the assay. The specificity of the system was evaluated by testing 27 medically relevant organisms. A total of 115 clinical specimens were collected and tested on the Flash20 SARS-CoV-2 detection system and with an FDA-approved comparator test to assess the clinical performance of the system. Results. The LoD of the Flash20 SARS-CoV-2 detection system is 250 copies/mL with a positive rate ≥90% (n = 20); alignments results showed that over 99% identity of the primer and probe of the Flash20 SARS-CoV-2 nucleic acid rapid detection system to the available SARS-CoV-2 sequences; the omicron samples tested 100% positive. None of the 27 organisms showed cross-reactivity with the Flash20 SARS-CoV-2 nucleic acid rapid detection system. Among all the 215 clinical samples, the Flash20 SARS-CoV-2 nucleic acid rapid detection system exhibits a high sensitivity of 99.24% (131/132) and 100% (83/83) specificity. Conclusion. The nucleic acid rapid detection system provides sensitive and accurate detection of SARS-CoV-2 free of RNA extraction. The high sensitivity and short time to results of approximately 35 minutes may impact earlier infection control and disease management.http://dx.doi.org/10.1155/2023/8053524 |
| spellingShingle | Liang Ma Yanyan Fan Xiaomu Kong Yongwei Jiang Hong Huang Meimei Zhao Yi Liu Peng Gao Yong Cui Yongtong Cao Fast and Sensitive Detection of SARS-CoV-2 Nucleic Acid Using a Rapid Detection System Free of RNA Extraction International Journal of Analytical Chemistry |
| title | Fast and Sensitive Detection of SARS-CoV-2 Nucleic Acid Using a Rapid Detection System Free of RNA Extraction |
| title_full | Fast and Sensitive Detection of SARS-CoV-2 Nucleic Acid Using a Rapid Detection System Free of RNA Extraction |
| title_fullStr | Fast and Sensitive Detection of SARS-CoV-2 Nucleic Acid Using a Rapid Detection System Free of RNA Extraction |
| title_full_unstemmed | Fast and Sensitive Detection of SARS-CoV-2 Nucleic Acid Using a Rapid Detection System Free of RNA Extraction |
| title_short | Fast and Sensitive Detection of SARS-CoV-2 Nucleic Acid Using a Rapid Detection System Free of RNA Extraction |
| title_sort | fast and sensitive detection of sars cov 2 nucleic acid using a rapid detection system free of rna extraction |
| url | http://dx.doi.org/10.1155/2023/8053524 |
| work_keys_str_mv | AT liangma fastandsensitivedetectionofsarscov2nucleicacidusingarapiddetectionsystemfreeofrnaextraction AT yanyanfan fastandsensitivedetectionofsarscov2nucleicacidusingarapiddetectionsystemfreeofrnaextraction AT xiaomukong fastandsensitivedetectionofsarscov2nucleicacidusingarapiddetectionsystemfreeofrnaextraction AT yongweijiang fastandsensitivedetectionofsarscov2nucleicacidusingarapiddetectionsystemfreeofrnaextraction AT honghuang fastandsensitivedetectionofsarscov2nucleicacidusingarapiddetectionsystemfreeofrnaextraction AT meimeizhao fastandsensitivedetectionofsarscov2nucleicacidusingarapiddetectionsystemfreeofrnaextraction AT yiliu fastandsensitivedetectionofsarscov2nucleicacidusingarapiddetectionsystemfreeofrnaextraction AT penggao fastandsensitivedetectionofsarscov2nucleicacidusingarapiddetectionsystemfreeofrnaextraction AT yongcui fastandsensitivedetectionofsarscov2nucleicacidusingarapiddetectionsystemfreeofrnaextraction AT yongtongcao fastandsensitivedetectionofsarscov2nucleicacidusingarapiddetectionsystemfreeofrnaextraction |