Saliva as a testing specimen with or without pooling for SARS-CoV-2 detection by multiplex RT-PCR test
Sensitive and high throughput molecular detection assays are essential during the coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vast majority of the SARS-CoV-2 molecular assays use nasopharyngeal swab (NPS) or oropharyng...
Gespeichert in:
| Veröffentlicht in: | PloS one 2021-02, Vol.16 (2), p.e0243183-e0243183 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | e0243183 |
|---|---|
| container_issue | 2 |
| container_start_page | e0243183 |
| container_title | PloS one |
| container_volume | 16 |
| creator | Sun, Qing Li, Jonathan Ren, Hui Pastor, Larry Loginova, Yulia Madej, Roberta Taylor, Kristopher Wong, Joseph K Zhang, Zhao Zhang, Aiguo Lu, Chuanyi M Sha, Michael Y |
| description | Sensitive and high throughput molecular detection assays are essential during the coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vast majority of the SARS-CoV-2 molecular assays use nasopharyngeal swab (NPS) or oropharyngeal swab (OPS) specimens collected from suspected individuals. However, using NPS or OPS as specimens has apparent drawbacks, e.g. the collection procedures for NPS or OPS specimens can be uncomfortable to some people and may cause sneezing and coughing which in turn generate droplets and/or aerosol particles that are of risk to healthcare workers, requiring heavy use of personal protective equipment. There have been recent studies indicating that self-collected saliva specimens can be used for molecular detection of SARS-CoV-2 and provides more comfort and ease of use for the patients. Here we report the performance of QuantiVirus™ SARS-CoV-2 test using saliva as the testing specimens with or without pooling.
Development and validation studies were conducted following FDA-EUA and molecular assay validation guidelines. Using SeraCare Accuplex SARS-CoV-2 reference panel, the limit of detection (LOD) and clinical performance studies were performed with the QuantiVirus™ SARS-CoV-2 test. For clinical evaluation, 85 known positive and 90 known negative clinical NPS samples were tested. Additionally, twenty paired NPS and saliva samples collected from recovering COVID-19 patients were tested and the results were further compared to that of the Abbott m2000 SARS-CoV-2 PCR assay. Results of community collected 389 saliva samples for COVID-19 screening by QuantiVirus™ SARS-CoV-2 test were also obtained and analyzed. Additionally, testing of pooled saliva samples was evaluated.
The LOD for the QuantiVirus™ SARS-CoV-2 test was confirmed to be 100-200 copies/mL. The clinical performance studies using contrived saliva samples indicated that the positive percentage agreement (PPA) of the QuantiVirus™ SARS-CoV-2 test is 100% at 1xLOD, 1.5xLOD and 2.5xLOD. No cross-reactivity was observed for the QuantiVirus™ SARS-CoV-2 test with common respiratory pathogens. Testing of clinical samples showed a positive percentage agreement (PPA) of 100% (95% CI: 94.6% to 100%) and a negative percentage agreement (NPA) of 98.9% (95% CI: 93.1% to 99.9%). QuantiVirus™ SARS CoV-2 test had 80% concordance rate and no significant difference (p = 0.13) between paired saliva and NPS specimens by Wilc |
| doi_str_mv | 10.1371/journal.pone.0243183 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_plos_</sourceid><recordid>TN_cdi_plos_journals_2492638339</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A652794675</galeid><doaj_id>oai_doaj_org_article_c51f42a3d8e44a04950dc788b5fd6ccc</doaj_id><sourcerecordid>A652794675</sourcerecordid><originalsourceid>FETCH-LOGICAL-c692t-675fc9d9e942c9a4fd239921840962a859b14afc56f405461491c9647a9ed48c3</originalsourceid><addsrcrecordid>eNqNk11r2zAUhs3YWLtu_2BshsHYLpzpy7J1MwhhH4FCR9L1ViiylKjIlmvJXfvvJyduiUcvhi9kjp_zHp3X5yTJWwhmEBfwy7Xru0bYWesaNQOIYFjiZ8kpZBhlFAH8_Oj9JHnl_TUAOS4pfZmcYEwRRBSfJnotrLkVqfCpSIPywTTb1LdKmlo16R8Tdqnr9qfrQ9o6ZwdAx9h6vlpnC3eVobRSQclgXJNu7tO6t8G0Vt2lq8vs12K1V32dvNDCevVmPM-S39-_XS5-ZucXP5aL-XkmKUMho0WuJauYYgRJJoiuEGYMwZIARpEoc7aBRGiZU01ATigkDEpGSSGYqkgp8Vny_qDbWuf5aJHniLDYbYkxi8TyQFROXPO2M7Xo7rkThu8Drtty0QUjreIyh5oggatSESIAYTmoZFGWm1xXVMqh2texWr-pVSVVEzphJ6LTL43Z8a275QUDsChhFPg0CnTupo8-8dp4qawVjXL9_t4YAFQyHNEP_6BPdzdSWxEbMI12sa4cRPmc5qhgJFocqdkTVHwqVRsZ50mbGJ8kfJ4kRCaou7AVvfd8uV79P3txNWU_HrE7JWzYeWf7YZb8FCQHUHbO-07pR5Mh4MM6PLjBh3Xg4zrEtHfHP-gx6WH-8V-cbANf</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2492638339</pqid></control><display><type>article</type><title>Saliva as a testing specimen with or without pooling for SARS-CoV-2 detection by multiplex RT-PCR test</title><source>PubMed Central Free</source><source>MEDLINE</source><source>DOAJ Directory of Open Access Journals</source><source>Public Library of Science (PLoS) Journals Open Access</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Free Full-Text Journals in Chemistry</source><creator>Sun, Qing ; Li, Jonathan ; Ren, Hui ; Pastor, Larry ; Loginova, Yulia ; Madej, Roberta ; Taylor, Kristopher ; Wong, Joseph K ; Zhang, Zhao ; Zhang, Aiguo ; Lu, Chuanyi M ; Sha, Michael Y</creator><contributor>Kalendar, Ruslan</contributor><creatorcontrib>Sun, Qing ; Li, Jonathan ; Ren, Hui ; Pastor, Larry ; Loginova, Yulia ; Madej, Roberta ; Taylor, Kristopher ; Wong, Joseph K ; Zhang, Zhao ; Zhang, Aiguo ; Lu, Chuanyi M ; Sha, Michael Y ; Kalendar, Ruslan</creatorcontrib><description>Sensitive and high throughput molecular detection assays are essential during the coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vast majority of the SARS-CoV-2 molecular assays use nasopharyngeal swab (NPS) or oropharyngeal swab (OPS) specimens collected from suspected individuals. However, using NPS or OPS as specimens has apparent drawbacks, e.g. the collection procedures for NPS or OPS specimens can be uncomfortable to some people and may cause sneezing and coughing which in turn generate droplets and/or aerosol particles that are of risk to healthcare workers, requiring heavy use of personal protective equipment. There have been recent studies indicating that self-collected saliva specimens can be used for molecular detection of SARS-CoV-2 and provides more comfort and ease of use for the patients. Here we report the performance of QuantiVirus™ SARS-CoV-2 test using saliva as the testing specimens with or without pooling.
Development and validation studies were conducted following FDA-EUA and molecular assay validation guidelines. Using SeraCare Accuplex SARS-CoV-2 reference panel, the limit of detection (LOD) and clinical performance studies were performed with the QuantiVirus™ SARS-CoV-2 test. For clinical evaluation, 85 known positive and 90 known negative clinical NPS samples were tested. Additionally, twenty paired NPS and saliva samples collected from recovering COVID-19 patients were tested and the results were further compared to that of the Abbott m2000 SARS-CoV-2 PCR assay. Results of community collected 389 saliva samples for COVID-19 screening by QuantiVirus™ SARS-CoV-2 test were also obtained and analyzed. Additionally, testing of pooled saliva samples was evaluated.
The LOD for the QuantiVirus™ SARS-CoV-2 test was confirmed to be 100-200 copies/mL. The clinical performance studies using contrived saliva samples indicated that the positive percentage agreement (PPA) of the QuantiVirus™ SARS-CoV-2 test is 100% at 1xLOD, 1.5xLOD and 2.5xLOD. No cross-reactivity was observed for the QuantiVirus™ SARS-CoV-2 test with common respiratory pathogens. Testing of clinical samples showed a positive percentage agreement (PPA) of 100% (95% CI: 94.6% to 100%) and a negative percentage agreement (NPA) of 98.9% (95% CI: 93.1% to 99.9%). QuantiVirus™ SARS CoV-2 test had 80% concordance rate and no significant difference (p = 0.13) between paired saliva and NPS specimens by Wilcoxon matched pairs signed rank test. Positive test rate was 1.79% for 389 saliva specimens collected from local communities for COVID-19 screening. Preliminary data showed that saliva sample pooling up to 6 samples (1:6 pooling) for SARS-CoV-2 detection is feasible (sensitivity 94.8% and specificity 100%).
The studies demonstrated that the QuantiVirus™ SARS-CoV-2 test has a LOD of 200 copies/mL in contrived saliva samples. The clinical performance of saliva-based testing is comparable to that of NPS-based testing. Pooling of saliva specimens for SARS-CoV-2 detection is feasible. Saliva based and high-throughput QuantiVirus™ SARS-CoV-2 test offers a highly desirable testing platform during the ongoing COVID-19 pandemic.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0243183</identifier><identifier>PMID: 33621263</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Assaying ; Biology and Life Sciences ; Coronaviridae ; Coronaviruses ; COVID-19 ; COVID-19 diagnostic tests ; Disease transmission ; DNA probes ; Editing ; Electronic mail ; Female ; Genes ; Genomes ; Health care ; Humans ; Infections ; Laboratories ; Mail ; Male ; Medicine and Health Sciences ; Methods ; Middle Aged ; Multiplex Polymerase Chain Reaction - methods ; Multiplexing ; Pandemics ; Patients ; Personal protective equipment ; Polymerase chain reaction ; Research and analysis methods ; Respiratory diseases ; Reverse Transcriptase Polymerase Chain Reaction - methods ; Reverse transcription ; Ribonucleic acid ; RNA ; Saliva ; Saliva - virology ; Salivary diagnostics ; SARS-CoV-2 - pathogenicity ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Specimen Handling - methods ; Sputum ; Viral diseases ; Young Adult</subject><ispartof>PloS one, 2021-02, Vol.16 (2), p.e0243183-e0243183</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Sun et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2021 Sun et al 2021 Sun et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-675fc9d9e942c9a4fd239921840962a859b14afc56f405461491c9647a9ed48c3</citedby><cites>FETCH-LOGICAL-c692t-675fc9d9e942c9a4fd239921840962a859b14afc56f405461491c9647a9ed48c3</cites><orcidid>0000-0002-5906-2543 ; 0000-0002-4552-6079 ; 0000-0001-9896-0605 ; 0000-0002-2385-1006</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7901781/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7901781/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33621263$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Kalendar, Ruslan</contributor><creatorcontrib>Sun, Qing</creatorcontrib><creatorcontrib>Li, Jonathan</creatorcontrib><creatorcontrib>Ren, Hui</creatorcontrib><creatorcontrib>Pastor, Larry</creatorcontrib><creatorcontrib>Loginova, Yulia</creatorcontrib><creatorcontrib>Madej, Roberta</creatorcontrib><creatorcontrib>Taylor, Kristopher</creatorcontrib><creatorcontrib>Wong, Joseph K</creatorcontrib><creatorcontrib>Zhang, Zhao</creatorcontrib><creatorcontrib>Zhang, Aiguo</creatorcontrib><creatorcontrib>Lu, Chuanyi M</creatorcontrib><creatorcontrib>Sha, Michael Y</creatorcontrib><title>Saliva as a testing specimen with or without pooling for SARS-CoV-2 detection by multiplex RT-PCR test</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Sensitive and high throughput molecular detection assays are essential during the coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vast majority of the SARS-CoV-2 molecular assays use nasopharyngeal swab (NPS) or oropharyngeal swab (OPS) specimens collected from suspected individuals. However, using NPS or OPS as specimens has apparent drawbacks, e.g. the collection procedures for NPS or OPS specimens can be uncomfortable to some people and may cause sneezing and coughing which in turn generate droplets and/or aerosol particles that are of risk to healthcare workers, requiring heavy use of personal protective equipment. There have been recent studies indicating that self-collected saliva specimens can be used for molecular detection of SARS-CoV-2 and provides more comfort and ease of use for the patients. Here we report the performance of QuantiVirus™ SARS-CoV-2 test using saliva as the testing specimens with or without pooling.
Development and validation studies were conducted following FDA-EUA and molecular assay validation guidelines. Using SeraCare Accuplex SARS-CoV-2 reference panel, the limit of detection (LOD) and clinical performance studies were performed with the QuantiVirus™ SARS-CoV-2 test. For clinical evaluation, 85 known positive and 90 known negative clinical NPS samples were tested. Additionally, twenty paired NPS and saliva samples collected from recovering COVID-19 patients were tested and the results were further compared to that of the Abbott m2000 SARS-CoV-2 PCR assay. Results of community collected 389 saliva samples for COVID-19 screening by QuantiVirus™ SARS-CoV-2 test were also obtained and analyzed. Additionally, testing of pooled saliva samples was evaluated.
The LOD for the QuantiVirus™ SARS-CoV-2 test was confirmed to be 100-200 copies/mL. The clinical performance studies using contrived saliva samples indicated that the positive percentage agreement (PPA) of the QuantiVirus™ SARS-CoV-2 test is 100% at 1xLOD, 1.5xLOD and 2.5xLOD. No cross-reactivity was observed for the QuantiVirus™ SARS-CoV-2 test with common respiratory pathogens. Testing of clinical samples showed a positive percentage agreement (PPA) of 100% (95% CI: 94.6% to 100%) and a negative percentage agreement (NPA) of 98.9% (95% CI: 93.1% to 99.9%). QuantiVirus™ SARS CoV-2 test had 80% concordance rate and no significant difference (p = 0.13) between paired saliva and NPS specimens by Wilcoxon matched pairs signed rank test. Positive test rate was 1.79% for 389 saliva specimens collected from local communities for COVID-19 screening. Preliminary data showed that saliva sample pooling up to 6 samples (1:6 pooling) for SARS-CoV-2 detection is feasible (sensitivity 94.8% and specificity 100%).
The studies demonstrated that the QuantiVirus™ SARS-CoV-2 test has a LOD of 200 copies/mL in contrived saliva samples. The clinical performance of saliva-based testing is comparable to that of NPS-based testing. Pooling of saliva specimens for SARS-CoV-2 detection is feasible. Saliva based and high-throughput QuantiVirus™ SARS-CoV-2 test offers a highly desirable testing platform during the ongoing COVID-19 pandemic.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Assaying</subject><subject>Biology and Life Sciences</subject><subject>Coronaviridae</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 diagnostic tests</subject><subject>Disease transmission</subject><subject>DNA probes</subject><subject>Editing</subject><subject>Electronic mail</subject><subject>Female</subject><subject>Genes</subject><subject>Genomes</subject><subject>Health care</subject><subject>Humans</subject><subject>Infections</subject><subject>Laboratories</subject><subject>Mail</subject><subject>Male</subject><subject>Medicine and Health Sciences</subject><subject>Methods</subject><subject>Middle Aged</subject><subject>Multiplex Polymerase Chain Reaction - methods</subject><subject>Multiplexing</subject><subject>Pandemics</subject><subject>Patients</subject><subject>Personal protective equipment</subject><subject>Polymerase chain reaction</subject><subject>Research and analysis methods</subject><subject>Respiratory diseases</subject><subject>Reverse Transcriptase Polymerase Chain Reaction - methods</subject><subject>Reverse transcription</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>Saliva</subject><subject>Saliva - virology</subject><subject>Salivary diagnostics</subject><subject>SARS-CoV-2 - pathogenicity</subject><subject>Severe acute respiratory syndrome</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Specimen Handling - methods</subject><subject>Sputum</subject><subject>Viral diseases</subject><subject>Young Adult</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNqNk11r2zAUhs3YWLtu_2BshsHYLpzpy7J1MwhhH4FCR9L1ViiylKjIlmvJXfvvJyduiUcvhi9kjp_zHp3X5yTJWwhmEBfwy7Xru0bYWesaNQOIYFjiZ8kpZBhlFAH8_Oj9JHnl_TUAOS4pfZmcYEwRRBSfJnotrLkVqfCpSIPywTTb1LdKmlo16R8Tdqnr9qfrQ9o6ZwdAx9h6vlpnC3eVobRSQclgXJNu7tO6t8G0Vt2lq8vs12K1V32dvNDCevVmPM-S39-_XS5-ZucXP5aL-XkmKUMho0WuJauYYgRJJoiuEGYMwZIARpEoc7aBRGiZU01ATigkDEpGSSGYqkgp8Vny_qDbWuf5aJHniLDYbYkxi8TyQFROXPO2M7Xo7rkThu8Drtty0QUjreIyh5oggatSESIAYTmoZFGWm1xXVMqh2texWr-pVSVVEzphJ6LTL43Z8a275QUDsChhFPg0CnTupo8-8dp4qawVjXL9_t4YAFQyHNEP_6BPdzdSWxEbMI12sa4cRPmc5qhgJFocqdkTVHwqVRsZ50mbGJ8kfJ4kRCaou7AVvfd8uV79P3txNWU_HrE7JWzYeWf7YZb8FCQHUHbO-07pR5Mh4MM6PLjBh3Xg4zrEtHfHP-gx6WH-8V-cbANf</recordid><startdate>20210223</startdate><enddate>20210223</enddate><creator>Sun, Qing</creator><creator>Li, Jonathan</creator><creator>Ren, Hui</creator><creator>Pastor, Larry</creator><creator>Loginova, Yulia</creator><creator>Madej, Roberta</creator><creator>Taylor, Kristopher</creator><creator>Wong, Joseph K</creator><creator>Zhang, Zhao</creator><creator>Zhang, Aiguo</creator><creator>Lu, Chuanyi M</creator><creator>Sha, Michael Y</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>COVID</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-5906-2543</orcidid><orcidid>https://orcid.org/0000-0002-4552-6079</orcidid><orcidid>https://orcid.org/0000-0001-9896-0605</orcidid><orcidid>https://orcid.org/0000-0002-2385-1006</orcidid></search><sort><creationdate>20210223</creationdate><title>Saliva as a testing specimen with or without pooling for SARS-CoV-2 detection by multiplex RT-PCR test</title><author>Sun, Qing ; Li, Jonathan ; Ren, Hui ; Pastor, Larry ; Loginova, Yulia ; Madej, Roberta ; Taylor, Kristopher ; Wong, Joseph K ; Zhang, Zhao ; Zhang, Aiguo ; Lu, Chuanyi M ; Sha, Michael Y</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-675fc9d9e942c9a4fd239921840962a859b14afc56f405461491c9647a9ed48c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Assaying</topic><topic>Biology and Life Sciences</topic><topic>Coronaviridae</topic><topic>Coronaviruses</topic><topic>COVID-19</topic><topic>COVID-19 diagnostic tests</topic><topic>Disease transmission</topic><topic>DNA probes</topic><topic>Editing</topic><topic>Electronic mail</topic><topic>Female</topic><topic>Genes</topic><topic>Genomes</topic><topic>Health care</topic><topic>Humans</topic><topic>Infections</topic><topic>Laboratories</topic><topic>Mail</topic><topic>Male</topic><topic>Medicine and Health Sciences</topic><topic>Methods</topic><topic>Middle Aged</topic><topic>Multiplex Polymerase Chain Reaction - methods</topic><topic>Multiplexing</topic><topic>Pandemics</topic><topic>Patients</topic><topic>Personal protective equipment</topic><topic>Polymerase chain reaction</topic><topic>Research and analysis methods</topic><topic>Respiratory diseases</topic><topic>Reverse Transcriptase Polymerase Chain Reaction - methods</topic><topic>Reverse transcription</topic><topic>Ribonucleic acid</topic><topic>RNA</topic><topic>Saliva</topic><topic>Saliva - virology</topic><topic>Salivary diagnostics</topic><topic>SARS-CoV-2 - pathogenicity</topic><topic>Severe acute respiratory syndrome</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Specimen Handling - methods</topic><topic>Sputum</topic><topic>Viral diseases</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sun, Qing</creatorcontrib><creatorcontrib>Li, Jonathan</creatorcontrib><creatorcontrib>Ren, Hui</creatorcontrib><creatorcontrib>Pastor, Larry</creatorcontrib><creatorcontrib>Loginova, Yulia</creatorcontrib><creatorcontrib>Madej, Roberta</creatorcontrib><creatorcontrib>Taylor, Kristopher</creatorcontrib><creatorcontrib>Wong, Joseph K</creatorcontrib><creatorcontrib>Zhang, Zhao</creatorcontrib><creatorcontrib>Zhang, Aiguo</creatorcontrib><creatorcontrib>Lu, Chuanyi M</creatorcontrib><creatorcontrib>Sha, Michael Y</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Opposing Viewpoints in Context (Gale)</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Ecology Abstracts</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Meteorological & Geoastrophysical Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>Advanced Technologies & Aerospace Collection</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Coronavirus Research Database</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Meteorological & Geoastrophysical Abstracts - Academic</collection><collection>ProQuest Engineering Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Agricultural Science Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Advanced Technologies & Aerospace Database</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sun, Qing</au><au>Li, Jonathan</au><au>Ren, Hui</au><au>Pastor, Larry</au><au>Loginova, Yulia</au><au>Madej, Roberta</au><au>Taylor, Kristopher</au><au>Wong, Joseph K</au><au>Zhang, Zhao</au><au>Zhang, Aiguo</au><au>Lu, Chuanyi M</au><au>Sha, Michael Y</au><au>Kalendar, Ruslan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Saliva as a testing specimen with or without pooling for SARS-CoV-2 detection by multiplex RT-PCR test</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2021-02-23</date><risdate>2021</risdate><volume>16</volume><issue>2</issue><spage>e0243183</spage><epage>e0243183</epage><pages>e0243183-e0243183</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Sensitive and high throughput molecular detection assays are essential during the coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vast majority of the SARS-CoV-2 molecular assays use nasopharyngeal swab (NPS) or oropharyngeal swab (OPS) specimens collected from suspected individuals. However, using NPS or OPS as specimens has apparent drawbacks, e.g. the collection procedures for NPS or OPS specimens can be uncomfortable to some people and may cause sneezing and coughing which in turn generate droplets and/or aerosol particles that are of risk to healthcare workers, requiring heavy use of personal protective equipment. There have been recent studies indicating that self-collected saliva specimens can be used for molecular detection of SARS-CoV-2 and provides more comfort and ease of use for the patients. Here we report the performance of QuantiVirus™ SARS-CoV-2 test using saliva as the testing specimens with or without pooling.
Development and validation studies were conducted following FDA-EUA and molecular assay validation guidelines. Using SeraCare Accuplex SARS-CoV-2 reference panel, the limit of detection (LOD) and clinical performance studies were performed with the QuantiVirus™ SARS-CoV-2 test. For clinical evaluation, 85 known positive and 90 known negative clinical NPS samples were tested. Additionally, twenty paired NPS and saliva samples collected from recovering COVID-19 patients were tested and the results were further compared to that of the Abbott m2000 SARS-CoV-2 PCR assay. Results of community collected 389 saliva samples for COVID-19 screening by QuantiVirus™ SARS-CoV-2 test were also obtained and analyzed. Additionally, testing of pooled saliva samples was evaluated.
The LOD for the QuantiVirus™ SARS-CoV-2 test was confirmed to be 100-200 copies/mL. The clinical performance studies using contrived saliva samples indicated that the positive percentage agreement (PPA) of the QuantiVirus™ SARS-CoV-2 test is 100% at 1xLOD, 1.5xLOD and 2.5xLOD. No cross-reactivity was observed for the QuantiVirus™ SARS-CoV-2 test with common respiratory pathogens. Testing of clinical samples showed a positive percentage agreement (PPA) of 100% (95% CI: 94.6% to 100%) and a negative percentage agreement (NPA) of 98.9% (95% CI: 93.1% to 99.9%). QuantiVirus™ SARS CoV-2 test had 80% concordance rate and no significant difference (p = 0.13) between paired saliva and NPS specimens by Wilcoxon matched pairs signed rank test. Positive test rate was 1.79% for 389 saliva specimens collected from local communities for COVID-19 screening. Preliminary data showed that saliva sample pooling up to 6 samples (1:6 pooling) for SARS-CoV-2 detection is feasible (sensitivity 94.8% and specificity 100%).
The studies demonstrated that the QuantiVirus™ SARS-CoV-2 test has a LOD of 200 copies/mL in contrived saliva samples. The clinical performance of saliva-based testing is comparable to that of NPS-based testing. Pooling of saliva specimens for SARS-CoV-2 detection is feasible. Saliva based and high-throughput QuantiVirus™ SARS-CoV-2 test offers a highly desirable testing platform during the ongoing COVID-19 pandemic.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>33621263</pmid><doi>10.1371/journal.pone.0243183</doi><tpages>e0243183</tpages><orcidid>https://orcid.org/0000-0002-5906-2543</orcidid><orcidid>https://orcid.org/0000-0002-4552-6079</orcidid><orcidid>https://orcid.org/0000-0001-9896-0605</orcidid><orcidid>https://orcid.org/0000-0002-2385-1006</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2021-02, Vol.16 (2), p.e0243183-e0243183 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2492638339 |
| source | PubMed Central Free; MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; Free Full-Text Journals in Chemistry |
| subjects | Adolescent Adult Aged Aged, 80 and over Assaying Biology and Life Sciences Coronaviridae Coronaviruses COVID-19 COVID-19 diagnostic tests Disease transmission DNA probes Editing Electronic mail Female Genes Genomes Health care Humans Infections Laboratories Male Medicine and Health Sciences Methods Middle Aged Multiplex Polymerase Chain Reaction - methods Multiplexing Pandemics Patients Personal protective equipment Polymerase chain reaction Research and analysis methods Respiratory diseases Reverse Transcriptase Polymerase Chain Reaction - methods Reverse transcription Ribonucleic acid RNA Saliva Saliva - virology Salivary diagnostics SARS-CoV-2 - pathogenicity Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Specimen Handling - methods Sputum Viral diseases Young Adult |
| title | Saliva as a testing specimen with or without pooling for SARS-CoV-2 detection by multiplex RT-PCR test |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-01T03%3A45%3A41IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Saliva%20as%20a%20testing%20specimen%20with%20or%20without%20pooling%20for%20SARS-CoV-2%20detection%20by%20multiplex%20RT-PCR%20test&rft.jtitle=PloS%20one&rft.au=Sun,%20Qing&rft.date=2021-02-23&rft.volume=16&rft.issue=2&rft.spage=e0243183&rft.epage=e0243183&rft.pages=e0243183-e0243183&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0243183&rft_dat=%3Cgale_plos_%3EA652794675%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2492638339&rft_id=info:pmid/33621263&rft_galeid=A652794675&rft_doaj_id=oai_doaj_org_article_c51f42a3d8e44a04950dc788b5fd6ccc&rfr_iscdi=true |