Clinical evaluation of an innovative isothermal amplification detection system for COVID-19 diagnosis
A pre-integrated system design intended for a point-of-care (POC) and sample-to-result diagnostic platform with nucleic acid amplification has been developed, which is equipment/electricity-free without any permanent instruments or manual sample processing. This semi-integrated system focuses on pan...
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| Veröffentlicht in: | Analytical methods 2022-07, Vol.14 (26), p.2578-2585 |
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| container_title | Analytical methods |
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| creator | Kim, Dami Kim, Se Jin Kim, Yu Kyung Kwon, Ki Tae Kim, Sanghyo |
| description | A pre-integrated system design intended for a point-of-care (POC) and sample-to-result diagnostic platform with nucleic acid amplification has been developed, which is equipment/electricity-free without any permanent instruments or manual sample processing. This semi-integrated system focuses on pandemic situations that are suitable for the Affordable, Sensitive, Specific, User-friendly, Robust and rapid, Equipment-free, and Deliverable to the end-user "ASSURED" concept recommended by the World Health Organization (WHO). Nucleic acid amplification is an essential rate-limiting factor in the performance of integrated systems that involve sample preparation and detection. The ORF1ab (RdRp) gene of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been targeted by RT-LAMP optimization and evaluation using a commercial hot-pack as a heat source that successfully achieves a femto-scale ( |
| doi_str_mv | 10.1039/d2ay00815g |
| format | Article |
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2
copies per rxn) limit of detection (LOD) within 40 min (except for the RNA extraction step). Therefore, the prototype system was assessed using COVID-19-suspected clinical samples (eighty eight) and compared with the results of a commercial real-time reverse transcription polymerase chain reaction (RT-qPCR) assay (Allplex SARS-CoV-2 Assay kit (Seegene, Seoul, Republic of Korea)). These innovative approaches achieved over 95% sensitivity and specificity. In conclusion, the developed system using a hot-pack as a heat source is a promising tool that enables the rapid identification of infectious diseases in the real world.
A sensitive, specific, and convenient method was developed for SARS-CoV-2 detection using a hot-pack-applied isothermal nucleic acid amplification method.</description><identifier>ISSN: 1759-9660</identifier><identifier>EISSN: 1759-9679</identifier><identifier>DOI: 10.1039/d2ay00815g</identifier><language>eng</language><publisher>Cambridge: Royal Society of Chemistry</publisher><subject>Amplification ; Coronaviruses ; COVID-19 ; Infectious diseases ; Nucleic acids ; Optimization ; Pandemics ; Polymerase chain reaction ; Public health ; Reverse transcription ; Sample preparation ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Systems design ; Viral diseases</subject><ispartof>Analytical methods, 2022-07, Vol.14 (26), p.2578-2585</ispartof><rights>Copyright Royal Society of Chemistry 2022</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c314t-950c1a7ff991b260d74418d486b9d1f5c03f5cd850cbbda14100c2909380b5783</citedby><cites>FETCH-LOGICAL-c314t-950c1a7ff991b260d74418d486b9d1f5c03f5cd850cbbda14100c2909380b5783</cites><orcidid>0000-0003-2473-0051 ; 0000-0002-4699-8502 ; 0000-0001-9954-0004 ; 0000-0003-4666-0672</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids></links><search><creatorcontrib>Kim, Dami</creatorcontrib><creatorcontrib>Kim, Se Jin</creatorcontrib><creatorcontrib>Kim, Yu Kyung</creatorcontrib><creatorcontrib>Kwon, Ki Tae</creatorcontrib><creatorcontrib>Kim, Sanghyo</creatorcontrib><title>Clinical evaluation of an innovative isothermal amplification detection system for COVID-19 diagnosis</title><title>Analytical methods</title><description>A pre-integrated system design intended for a point-of-care (POC) and sample-to-result diagnostic platform with nucleic acid amplification has been developed, which is equipment/electricity-free without any permanent instruments or manual sample processing. This semi-integrated system focuses on pandemic situations that are suitable for the Affordable, Sensitive, Specific, User-friendly, Robust and rapid, Equipment-free, and Deliverable to the end-user "ASSURED" concept recommended by the World Health Organization (WHO). Nucleic acid amplification is an essential rate-limiting factor in the performance of integrated systems that involve sample preparation and detection. The ORF1ab (RdRp) gene of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been targeted by RT-LAMP optimization and evaluation using a commercial hot-pack as a heat source that successfully achieves a femto-scale (<6.8 × 10
2
copies per rxn) limit of detection (LOD) within 40 min (except for the RNA extraction step). Therefore, the prototype system was assessed using COVID-19-suspected clinical samples (eighty eight) and compared with the results of a commercial real-time reverse transcription polymerase chain reaction (RT-qPCR) assay (Allplex SARS-CoV-2 Assay kit (Seegene, Seoul, Republic of Korea)). These innovative approaches achieved over 95% sensitivity and specificity. In conclusion, the developed system using a hot-pack as a heat source is a promising tool that enables the rapid identification of infectious diseases in the real world.
A sensitive, specific, and convenient method was developed for SARS-CoV-2 detection using a hot-pack-applied isothermal nucleic acid amplification method.</description><subject>Amplification</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>Infectious diseases</subject><subject>Nucleic acids</subject><subject>Optimization</subject><subject>Pandemics</subject><subject>Polymerase chain reaction</subject><subject>Public health</subject><subject>Reverse transcription</subject><subject>Sample preparation</subject><subject>Severe acute respiratory syndrome</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Systems design</subject><subject>Viral diseases</subject><issn>1759-9660</issn><issn>1759-9679</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNpd0c9LwzAUB_AiCs7pxbsQ8CJC9aVt2uY4Op3CYBcVPJU0P2ZGm8ykHey_N9tkgpe8R_i88Pgmiq4xPGBI6aNI2BagxGR5Eo1wQWhM84KeHvsczqML71cAOU1zPIpk1WqjOWuR3LB2YL22BlmFmEHaGLsJFxuJtLf9l3RdYKxbt1qFib0Uspd83_mt72WHlHWoWny8TmNMkdBsaazX_jI6U6z18uq3jqP356e36iWeL2av1WQe8xRnfUwJcMwKpSjFTZKDKLIMlyIr84YKrAiHNByiDKxpBMMZBuAJBZqW0JCiTMfR3eHdtbPfg_R93WnPZdsyI-3g6yQvQ0wky3b09h9d2cGZsN1OEQI4KSCo-4PiznrvpKrXTnfMbWsM9S7xeppMPveJzwK-OWDn-dH9_Uj6A2mhfOI</recordid><startdate>20220707</startdate><enddate>20220707</enddate><creator>Kim, Dami</creator><creator>Kim, Se Jin</creator><creator>Kim, Yu Kyung</creator><creator>Kwon, Ki Tae</creator><creator>Kim, Sanghyo</creator><general>Royal Society of Chemistry</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7QF</scope><scope>7QO</scope><scope>7QQ</scope><scope>7SE</scope><scope>7SR</scope><scope>7U5</scope><scope>8BQ</scope><scope>8FD</scope><scope>FR3</scope><scope>H8G</scope><scope>JG9</scope><scope>L7M</scope><scope>P64</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-2473-0051</orcidid><orcidid>https://orcid.org/0000-0002-4699-8502</orcidid><orcidid>https://orcid.org/0000-0001-9954-0004</orcidid><orcidid>https://orcid.org/0000-0003-4666-0672</orcidid></search><sort><creationdate>20220707</creationdate><title>Clinical evaluation of an innovative isothermal amplification detection system for COVID-19 diagnosis</title><author>Kim, Dami ; Kim, Se Jin ; Kim, Yu Kyung ; Kwon, Ki Tae ; Kim, Sanghyo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c314t-950c1a7ff991b260d74418d486b9d1f5c03f5cd850cbbda14100c2909380b5783</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Amplification</topic><topic>Coronaviruses</topic><topic>COVID-19</topic><topic>Infectious diseases</topic><topic>Nucleic acids</topic><topic>Optimization</topic><topic>Pandemics</topic><topic>Polymerase chain reaction</topic><topic>Public health</topic><topic>Reverse transcription</topic><topic>Sample preparation</topic><topic>Severe acute respiratory syndrome</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Systems design</topic><topic>Viral diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Dami</creatorcontrib><creatorcontrib>Kim, Se Jin</creatorcontrib><creatorcontrib>Kim, Yu Kyung</creatorcontrib><creatorcontrib>Kwon, Ki Tae</creatorcontrib><creatorcontrib>Kim, Sanghyo</creatorcontrib><collection>CrossRef</collection><collection>Aluminium Industry Abstracts</collection><collection>Biotechnology Research Abstracts</collection><collection>Ceramic Abstracts</collection><collection>Corrosion Abstracts</collection><collection>Engineered Materials Abstracts</collection><collection>Solid State and Superconductivity Abstracts</collection><collection>METADEX</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Copper Technical Reference Library</collection><collection>Materials Research Database</collection><collection>Advanced Technologies Database with Aerospace</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Analytical methods</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, Dami</au><au>Kim, Se Jin</au><au>Kim, Yu Kyung</au><au>Kwon, Ki Tae</au><au>Kim, Sanghyo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical evaluation of an innovative isothermal amplification detection system for COVID-19 diagnosis</atitle><jtitle>Analytical methods</jtitle><date>2022-07-07</date><risdate>2022</risdate><volume>14</volume><issue>26</issue><spage>2578</spage><epage>2585</epage><pages>2578-2585</pages><issn>1759-9660</issn><eissn>1759-9679</eissn><abstract>A pre-integrated system design intended for a point-of-care (POC) and sample-to-result diagnostic platform with nucleic acid amplification has been developed, which is equipment/electricity-free without any permanent instruments or manual sample processing. This semi-integrated system focuses on pandemic situations that are suitable for the Affordable, Sensitive, Specific, User-friendly, Robust and rapid, Equipment-free, and Deliverable to the end-user "ASSURED" concept recommended by the World Health Organization (WHO). Nucleic acid amplification is an essential rate-limiting factor in the performance of integrated systems that involve sample preparation and detection. The ORF1ab (RdRp) gene of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been targeted by RT-LAMP optimization and evaluation using a commercial hot-pack as a heat source that successfully achieves a femto-scale (<6.8 × 10
2
copies per rxn) limit of detection (LOD) within 40 min (except for the RNA extraction step). Therefore, the prototype system was assessed using COVID-19-suspected clinical samples (eighty eight) and compared with the results of a commercial real-time reverse transcription polymerase chain reaction (RT-qPCR) assay (Allplex SARS-CoV-2 Assay kit (Seegene, Seoul, Republic of Korea)). These innovative approaches achieved over 95% sensitivity and specificity. In conclusion, the developed system using a hot-pack as a heat source is a promising tool that enables the rapid identification of infectious diseases in the real world.
A sensitive, specific, and convenient method was developed for SARS-CoV-2 detection using a hot-pack-applied isothermal nucleic acid amplification method.</abstract><cop>Cambridge</cop><pub>Royal Society of Chemistry</pub><doi>10.1039/d2ay00815g</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-2473-0051</orcidid><orcidid>https://orcid.org/0000-0002-4699-8502</orcidid><orcidid>https://orcid.org/0000-0001-9954-0004</orcidid><orcidid>https://orcid.org/0000-0003-4666-0672</orcidid></addata></record> |
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| source | Royal Society Of Chemistry Journals 2008- |
| subjects | Amplification Coronaviruses COVID-19 Infectious diseases Nucleic acids Optimization Pandemics Polymerase chain reaction Public health Reverse transcription Sample preparation Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Systems design Viral diseases |
| title | Clinical evaluation of an innovative isothermal amplification detection system for COVID-19 diagnosis |
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