Identification of SARS-CoV-2 in a Proficiency Testing Program
Abstract Objectives At the onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in the United States, testing was limited to the Centers for Disease Control and Prevention–developed reverse transcription polymerase chain reaction assay. The urgent and massive demand for...
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| Veröffentlicht in: | American journal of clinical pathology 2020-10, Vol.154 (4), p.475-478 |
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| container_title | American journal of clinical pathology |
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| creator | Edson, Daniel C Casey, Danielle L Harmer, Susan E Downes, Frances P |
| description | Abstract
Objectives
At the onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in the United States, testing was limited to the Centers for Disease Control and Prevention–developed reverse transcription polymerase chain reaction assay. The urgent and massive demand for testing prompted swift development of assays to detect SARS-CoV-2. The objective of this study was to assess the accuracy of these newly developed tests.
Methods
The American Proficiency Institute sent 2 test samples to 346 clinical laboratories in order to assess the accuracy of SARS-CoV-2 assays. The positive sample, containing 5,175 viral copies/mL, was fully extractable with SARS-CoV-2 viral capsid protein and RNA. The negative sample, with 3,951 viral copies/mL, contained recombinant virus particles with sequences for targeting human RNAase P gene sequences.
Results
Of the laboratories submitting results, 97.4% (302/310) correctly detected the virus when present and 98.3% (296/301) correctly indicated when the virus was not present. Among incorrect results reported in this proficiency challenge, 76.9% (10/13) were likely related to clerical error. This accounts for 1.6% (10/611) of all reported results.
Conclusions
Overall performance in this SARS-CoV-2 RNA detection challenge was excellent, providing confidence in the results of these new molecular tests and assurance for the clinical and public health decisions based on these test results. |
| doi_str_mv | 10.1093/ajcp/aqaa128 |
| format | Article |
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Objectives
At the onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in the United States, testing was limited to the Centers for Disease Control and Prevention–developed reverse transcription polymerase chain reaction assay. The urgent and massive demand for testing prompted swift development of assays to detect SARS-CoV-2. The objective of this study was to assess the accuracy of these newly developed tests.
Methods
The American Proficiency Institute sent 2 test samples to 346 clinical laboratories in order to assess the accuracy of SARS-CoV-2 assays. The positive sample, containing 5,175 viral copies/mL, was fully extractable with SARS-CoV-2 viral capsid protein and RNA. The negative sample, with 3,951 viral copies/mL, contained recombinant virus particles with sequences for targeting human RNAase P gene sequences.
Results
Of the laboratories submitting results, 97.4% (302/310) correctly detected the virus when present and 98.3% (296/301) correctly indicated when the virus was not present. Among incorrect results reported in this proficiency challenge, 76.9% (10/13) were likely related to clerical error. This accounts for 1.6% (10/611) of all reported results.
Conclusions
Overall performance in this SARS-CoV-2 RNA detection challenge was excellent, providing confidence in the results of these new molecular tests and assurance for the clinical and public health decisions based on these test results.</description><identifier>ISSN: 0002-9173</identifier><identifier>EISSN: 1943-7722</identifier><identifier>DOI: 10.1093/ajcp/aqaa128</identifier><identifier>PMID: 32687172</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Betacoronavirus - genetics ; Betacoronavirus - isolation & purification ; Capsid protein ; Clinical Laboratory Services - standards ; Clinical Laboratory Techniques - methods ; Clinical Laboratory Techniques - standards ; Coronavirus Infections - diagnosis ; Coronaviruses ; COVID-19 ; COVID-19 Testing ; Diagnostic services ; Evaluation ; Humans ; Laboratories ; Laboratory Proficiency Testing ; Methods ; Original ; Pandemics ; Pathological laboratories ; Pneumonia, Viral - diagnosis ; Polymerase chain reaction ; Public health ; Reverse transcription ; Ribonucleic acid ; RNA ; RNA, Viral - analysis ; RNA, Viral - isolation & purification ; SARS-CoV-2 ; Severe acute respiratory syndrome coronavirus 2 ; United States</subject><ispartof>American journal of clinical pathology, 2020-10, Vol.154 (4), p.475-478</ispartof><rights>American Society for Clinical Pathology, 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 2020</rights><rights>American Society for Clinical Pathology, 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><rights>COPYRIGHT 2020 Oxford University Press</rights><rights>American Society for Clinical Pathology, 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c539t-cf369f1c257897fca832880dc6f0d37761db550f07a6550c4a6e039097a13f193</citedby><cites>FETCH-LOGICAL-c539t-cf369f1c257897fca832880dc6f0d37761db550f07a6550c4a6e039097a13f193</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32687172$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Edson, Daniel C</creatorcontrib><creatorcontrib>Casey, Danielle L</creatorcontrib><creatorcontrib>Harmer, Susan E</creatorcontrib><creatorcontrib>Downes, Frances P</creatorcontrib><title>Identification of SARS-CoV-2 in a Proficiency Testing Program</title><title>American journal of clinical pathology</title><addtitle>Am J Clin Pathol</addtitle><description>Abstract
Objectives
At the onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in the United States, testing was limited to the Centers for Disease Control and Prevention–developed reverse transcription polymerase chain reaction assay. The urgent and massive demand for testing prompted swift development of assays to detect SARS-CoV-2. The objective of this study was to assess the accuracy of these newly developed tests.
Methods
The American Proficiency Institute sent 2 test samples to 346 clinical laboratories in order to assess the accuracy of SARS-CoV-2 assays. The positive sample, containing 5,175 viral copies/mL, was fully extractable with SARS-CoV-2 viral capsid protein and RNA. The negative sample, with 3,951 viral copies/mL, contained recombinant virus particles with sequences for targeting human RNAase P gene sequences.
Results
Of the laboratories submitting results, 97.4% (302/310) correctly detected the virus when present and 98.3% (296/301) correctly indicated when the virus was not present. Among incorrect results reported in this proficiency challenge, 76.9% (10/13) were likely related to clerical error. This accounts for 1.6% (10/611) of all reported results.
Conclusions
Overall performance in this SARS-CoV-2 RNA detection challenge was excellent, providing confidence in the results of these new molecular tests and assurance for the clinical and public health decisions based on these test results.</description><subject>Betacoronavirus - genetics</subject><subject>Betacoronavirus - isolation & purification</subject><subject>Capsid protein</subject><subject>Clinical Laboratory Services - standards</subject><subject>Clinical Laboratory Techniques - methods</subject><subject>Clinical Laboratory Techniques - standards</subject><subject>Coronavirus Infections - diagnosis</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 Testing</subject><subject>Diagnostic services</subject><subject>Evaluation</subject><subject>Humans</subject><subject>Laboratories</subject><subject>Laboratory Proficiency Testing</subject><subject>Methods</subject><subject>Original</subject><subject>Pandemics</subject><subject>Pathological laboratories</subject><subject>Pneumonia, Viral - diagnosis</subject><subject>Polymerase chain reaction</subject><subject>Public health</subject><subject>Reverse transcription</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>RNA, Viral - analysis</subject><subject>RNA, Viral - isolation & purification</subject><subject>SARS-CoV-2</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>United States</subject><issn>0002-9173</issn><issn>1943-7722</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</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><recordid>eNp9kU1r3DAQhkVpaTbb3nouhh7aQ5yMJMuyDiksSz8CgZYm7VVMZGmrxZY28rqQfx-Z3YSkhKDDwMwz78zoJeQdhWMKip_g2mxO8BqRsuYFmVFV8VJKxl6SGQCwUlHJD8jhMKwBMgLVa3LAWd1IKtmMnJ61Nmy98wa3PoYiuuJi8euiXMY_JSt8KLD4mWIuexvMTXFph60Pqym3Sti_Ia8cdoN9u49z8vvrl8vl9_L8x7ez5eK8NIKrbWkcr5WjhgnZKOkMNpw1DbSmdtByKWvaXgkBDiTWOZoKawtcgZJIuaOKz8nnne5mvOpta_LKCTu9Sb7HdKMjev24EvxfvYr_tKxExRRkgU97gRSvx3yE7v1gbNdhsHEcNKuYEIoK0WT0w3_oOo4p5PMylVelCuABtcLOah9czHPNJKoXdSWggcmIOTl-gsqvtb03MVjnc_5Rw9GuwaQ4DMm6-xsp6MluPdmt93Zn_P3Df7mH7_zNwMcdEMfN81K3-0awzg</recordid><startdate>20201001</startdate><enddate>20201001</enddate><creator>Edson, Daniel C</creator><creator>Casey, Danielle L</creator><creator>Harmer, Susan E</creator><creator>Downes, Frances P</creator><general>Oxford University Press</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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20201001</creationdate><title>Identification of SARS-CoV-2 in a Proficiency Testing Program</title><author>Edson, Daniel C ; Casey, Danielle L ; Harmer, Susan E ; Downes, Frances P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c539t-cf369f1c257897fca832880dc6f0d37761db550f07a6550c4a6e039097a13f193</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Betacoronavirus - genetics</topic><topic>Betacoronavirus - isolation & purification</topic><topic>Capsid protein</topic><topic>Clinical Laboratory Services - standards</topic><topic>Clinical Laboratory Techniques - methods</topic><topic>Clinical Laboratory Techniques - standards</topic><topic>Coronavirus Infections - diagnosis</topic><topic>Coronaviruses</topic><topic>COVID-19</topic><topic>COVID-19 Testing</topic><topic>Diagnostic services</topic><topic>Evaluation</topic><topic>Humans</topic><topic>Laboratories</topic><topic>Laboratory Proficiency Testing</topic><topic>Methods</topic><topic>Original</topic><topic>Pandemics</topic><topic>Pathological laboratories</topic><topic>Pneumonia, Viral - diagnosis</topic><topic>Polymerase chain reaction</topic><topic>Public health</topic><topic>Reverse transcription</topic><topic>Ribonucleic acid</topic><topic>RNA</topic><topic>RNA, Viral - analysis</topic><topic>RNA, Viral - isolation & purification</topic><topic>SARS-CoV-2</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Edson, Daniel C</creatorcontrib><creatorcontrib>Casey, Danielle L</creatorcontrib><creatorcontrib>Harmer, Susan E</creatorcontrib><creatorcontrib>Downes, Frances P</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest SciTech 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>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biological Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>American journal of clinical pathology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Edson, Daniel C</au><au>Casey, Danielle L</au><au>Harmer, Susan E</au><au>Downes, Frances P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Identification of SARS-CoV-2 in a Proficiency Testing Program</atitle><jtitle>American journal of clinical pathology</jtitle><addtitle>Am J Clin Pathol</addtitle><date>2020-10-01</date><risdate>2020</risdate><volume>154</volume><issue>4</issue><spage>475</spage><epage>478</epage><pages>475-478</pages><issn>0002-9173</issn><eissn>1943-7722</eissn><abstract>Abstract
Objectives
At the onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in the United States, testing was limited to the Centers for Disease Control and Prevention–developed reverse transcription polymerase chain reaction assay. The urgent and massive demand for testing prompted swift development of assays to detect SARS-CoV-2. The objective of this study was to assess the accuracy of these newly developed tests.
Methods
The American Proficiency Institute sent 2 test samples to 346 clinical laboratories in order to assess the accuracy of SARS-CoV-2 assays. The positive sample, containing 5,175 viral copies/mL, was fully extractable with SARS-CoV-2 viral capsid protein and RNA. The negative sample, with 3,951 viral copies/mL, contained recombinant virus particles with sequences for targeting human RNAase P gene sequences.
Results
Of the laboratories submitting results, 97.4% (302/310) correctly detected the virus when present and 98.3% (296/301) correctly indicated when the virus was not present. Among incorrect results reported in this proficiency challenge, 76.9% (10/13) were likely related to clerical error. This accounts for 1.6% (10/611) of all reported results.
Conclusions
Overall performance in this SARS-CoV-2 RNA detection challenge was excellent, providing confidence in the results of these new molecular tests and assurance for the clinical and public health decisions based on these test results.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>32687172</pmid><doi>10.1093/ajcp/aqaa128</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Betacoronavirus - genetics Betacoronavirus - isolation & purification Capsid protein Clinical Laboratory Services - standards Clinical Laboratory Techniques - methods Clinical Laboratory Techniques - standards Coronavirus Infections - diagnosis Coronaviruses COVID-19 COVID-19 Testing Diagnostic services Evaluation Humans Laboratories Laboratory Proficiency Testing Methods Original Pandemics Pathological laboratories Pneumonia, Viral - diagnosis Polymerase chain reaction Public health Reverse transcription Ribonucleic acid RNA RNA, Viral - analysis RNA, Viral - isolation & purification SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 United States |
| title | Identification of SARS-CoV-2 in a Proficiency Testing Program |
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