Occurrence and Timing of Subsequent SARS-CoV-2 RT-PCR Positivity Among Initially Negative Patients.
Identifieur interne : 000432 ( Main/Exploration ); précédent : 000431; suivant : 000433Occurrence and Timing of Subsequent SARS-CoV-2 RT-PCR Positivity Among Initially Negative Patients.
Auteurs : Dustin R. Long ; Saurabh Gombar ; Catherine A. Hogan ; Alex L. Greninger ; Vikas Oreilly Shah ; Chloe Bryson-Cahn ; Bryan Stevens ; Arjun Rustagi ; Keith R. Jerome ; Christina S. Kong ; James Zehnder ; Nigam H. Shah ; Noel S. Weiss ; Benjamin A. Pinsky ; Jacob SunshineSource :
- medRxiv : the preprint server for health sciences ; 2020.
Abstract
BACKGROUND
SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) testing remains the cornerstone of laboratory-based identification of patients with COVID-19. As the availability and speed of SARS-CoV-2 testing platforms improve, results are increasingly relied upon to inform critical decisions related to therapy, use of personal protective equipment, and workforce readiness. However, early reports of RT-PCR test performance have left clinicians and the public with concerns regarding the reliability of this predominant testing modality and the interpretation of negative results. In this work, two independent research teams report the frequency of discordant SARS-CoV-2 test results among initially negative, repeatedly tested patients in regions of the United States with early community transmission and access to testing.
METHODS
All patients at the University of Washington (UW) and Stanford Health Care undergoing initial testing by nasopharyngeal (NP) swab between March 2nd and April 7th, 2020 were included. SARS-CoV-2 RT-PCR was performed targeting the N, RdRp, S, and E genes and ORF1ab, using a combination of Emergency Use Authorization laboratory-developed tests and commercial assays. Results through April 14th were extracted to allow for a complete 7-day observation period and an additional day for reporting.
RESULTS
A total of 23,126 SARS-CoV-2 RT-PCR tests (10,583 UW, 12,543 Stanford) were performed in 20,912 eligible patients (8,977 UW, 11,935 Stanford) undergoing initial testing by NP swab; 626 initially test-negative patients were re-tested within 7 days. Among this group, repeat testing within 7 days yielded a positive result in 3.5% (4.3% UW, 2.8% Stanford) of cases, suggesting an initial false negative RT-PCR result; the majority (96.5%) of patients with an initial negative result who warranted reevaluation for any reason remained negative on all subsequent tests performed within this window.
CONCLUSIONS
Two independent research teams report the similar finding that, among initially negative patients subjected to repeat SARS-CoV-2 RT-PCR testing, the occurrence of a newly positive result within 7 days is uncommon. These observations suggest that false negative results at the time of initial presentation do occur, but potentially at a lower frequency than is currently believed. Although it is not possible to infer the clinical sensitivity of NP SARS-CoV-2 RT-PCR testing using these data, they may be used in combination with other reports to guide the use and interpretation of this common testing modality.
DOI: 10.1101/2020.05.03.20089151
PubMed: 32511542
PubMed Central: PMC7274223
Affiliations:
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Greninger</name></author><author><name sortKey="Oreilly Shah, Vikas" sort="Oreilly Shah, Vikas" uniqKey="Oreilly Shah V" first="Vikas" last="Oreilly Shah">Vikas Oreilly Shah</name></author><author><name sortKey="Bryson Cahn, Chloe" sort="Bryson Cahn, Chloe" uniqKey="Bryson Cahn C" first="Chloe" last="Bryson-Cahn">Chloe Bryson-Cahn</name></author><author><name sortKey="Stevens, Bryan" sort="Stevens, Bryan" uniqKey="Stevens B" first="Bryan" last="Stevens">Bryan Stevens</name></author><author><name sortKey="Rustagi, Arjun" sort="Rustagi, Arjun" uniqKey="Rustagi A" first="Arjun" last="Rustagi">Arjun Rustagi</name></author><author><name sortKey="Jerome, Keith R" sort="Jerome, Keith R" uniqKey="Jerome K" first="Keith R" last="Jerome">Keith R. Jerome</name></author><author><name sortKey="Kong, Christina S" sort="Kong, Christina S" uniqKey="Kong C" first="Christina S" last="Kong">Christina S. Kong</name></author><author><name sortKey="Zehnder, James" sort="Zehnder, James" uniqKey="Zehnder J" first="James" last="Zehnder">James Zehnder</name></author><author><name sortKey="Shah, Nigam H" sort="Shah, Nigam H" uniqKey="Shah N" first="Nigam H" last="Shah">Nigam H. Shah</name></author><author><name sortKey="Weiss, Noel S" sort="Weiss, Noel S" uniqKey="Weiss N" first="Noel S" last="Weiss">Noel S. Weiss</name></author><author><name sortKey="Pinsky, Benjamin A" sort="Pinsky, Benjamin A" uniqKey="Pinsky B" first="Benjamin A" last="Pinsky">Benjamin A. Pinsky</name></author><author><name sortKey="Sunshine, Jacob" sort="Sunshine, Jacob" uniqKey="Sunshine J" first="Jacob" last="Sunshine">Jacob Sunshine</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32511542</idno><idno type="pmid">32511542</idno><idno type="doi">10.1101/2020.05.03.20089151</idno><idno type="pmc">PMC7274223</idno><idno type="wicri:Area/Main/Corpus">000626</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000626</idno><idno type="wicri:Area/Main/Curation">000626</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000626</idno><idno type="wicri:Area/Main/Exploration">000626</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Occurrence and Timing of Subsequent SARS-CoV-2 RT-PCR Positivity Among Initially Negative Patients.</title><author><name sortKey="Long, Dustin R" sort="Long, Dustin R" uniqKey="Long D" first="Dustin R" last="Long">Dustin R. Long</name></author><author><name sortKey="Gombar, Saurabh" sort="Gombar, Saurabh" uniqKey="Gombar S" first="Saurabh" last="Gombar">Saurabh Gombar</name></author><author><name sortKey="Hogan, Catherine A" sort="Hogan, Catherine A" uniqKey="Hogan C" first="Catherine A" last="Hogan">Catherine A. Hogan</name></author><author><name sortKey="Greninger, Alex L" sort="Greninger, Alex L" uniqKey="Greninger A" first="Alex L" last="Greninger">Alex L. Greninger</name></author><author><name sortKey="Oreilly Shah, Vikas" sort="Oreilly Shah, Vikas" uniqKey="Oreilly Shah V" first="Vikas" last="Oreilly Shah">Vikas Oreilly Shah</name></author><author><name sortKey="Bryson Cahn, Chloe" sort="Bryson Cahn, Chloe" uniqKey="Bryson Cahn C" first="Chloe" last="Bryson-Cahn">Chloe Bryson-Cahn</name></author><author><name sortKey="Stevens, Bryan" sort="Stevens, Bryan" uniqKey="Stevens B" first="Bryan" last="Stevens">Bryan Stevens</name></author><author><name sortKey="Rustagi, Arjun" sort="Rustagi, Arjun" uniqKey="Rustagi A" first="Arjun" last="Rustagi">Arjun Rustagi</name></author><author><name sortKey="Jerome, Keith R" sort="Jerome, Keith R" uniqKey="Jerome K" first="Keith R" last="Jerome">Keith R. Jerome</name></author><author><name sortKey="Kong, Christina S" sort="Kong, Christina S" uniqKey="Kong C" first="Christina S" last="Kong">Christina S. Kong</name></author><author><name sortKey="Zehnder, James" sort="Zehnder, James" uniqKey="Zehnder J" first="James" last="Zehnder">James Zehnder</name></author><author><name sortKey="Shah, Nigam H" sort="Shah, Nigam H" uniqKey="Shah N" first="Nigam H" last="Shah">Nigam H. Shah</name></author><author><name sortKey="Weiss, Noel S" sort="Weiss, Noel S" uniqKey="Weiss N" first="Noel S" last="Weiss">Noel S. Weiss</name></author><author><name sortKey="Pinsky, Benjamin A" sort="Pinsky, Benjamin A" uniqKey="Pinsky B" first="Benjamin A" last="Pinsky">Benjamin A. Pinsky</name></author><author><name sortKey="Sunshine, Jacob" sort="Sunshine, Jacob" uniqKey="Sunshine J" first="Jacob" last="Sunshine">Jacob Sunshine</name></author></analytic><series><title level="j">medRxiv : the preprint server for health sciences</title><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) testing remains the cornerstone of laboratory-based identification of patients with COVID-19. As the availability and speed of SARS-CoV-2 testing platforms improve, results are increasingly relied upon to inform critical decisions related to therapy, use of personal protective equipment, and workforce readiness. However, early reports of RT-PCR test performance have left clinicians and the public with concerns regarding the reliability of this predominant testing modality and the interpretation of negative results. In this work, two independent research teams report the frequency of discordant SARS-CoV-2 test results among initially negative, repeatedly tested patients in regions of the United States with early community transmission and access to testing.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>All patients at the University of Washington (UW) and Stanford Health Care undergoing initial testing by nasopharyngeal (NP) swab between March 2nd and April 7th, 2020 were included. SARS-CoV-2 RT-PCR was performed targeting the N, RdRp, S, and E genes and ORF1ab, using a combination of Emergency Use Authorization laboratory-developed tests and commercial assays. Results through April 14th were extracted to allow for a complete 7-day observation period and an additional day for reporting.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>A total of 23,126 SARS-CoV-2 RT-PCR tests (10,583 UW, 12,543 Stanford) were performed in 20,912 eligible patients (8,977 UW, 11,935 Stanford) undergoing initial testing by NP swab; 626 initially test-negative patients were re-tested within 7 days. Among this group, repeat testing within 7 days yielded a positive result in 3.5% (4.3% UW, 2.8% Stanford) of cases, suggesting an initial false negative RT-PCR result; the majority (96.5%) of patients with an initial negative result who warranted reevaluation for any reason remained negative on all subsequent tests performed within this window.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Two independent research teams report the similar finding that, among initially negative patients subjected to repeat SARS-CoV-2 RT-PCR testing, the occurrence of a newly positive result within 7 days is uncommon. These observations suggest that false negative results at the time of initial presentation do occur, but potentially at a lower frequency than is currently believed. Although it is not possible to infer the clinical sensitivity of NP SARS-CoV-2 RT-PCR testing using these data, they may be used in combination with other reports to guide the use and interpretation of this common testing modality.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">32511542</PMID><DateRevised><Year>2021</Year><Month>01</Month><Day>15</Day></DateRevised><Article PubModel="Electronic"><Journal><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>May</Month><Day>08</Day></PubDate></JournalIssue><Title>medRxiv : the preprint server for health sciences</Title><ISOAbbreviation>medRxiv</ISOAbbreviation></Journal><ArticleTitle>Occurrence and Timing of Subsequent SARS-CoV-2 RT-PCR Positivity Among Initially Negative Patients.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">2020.05.03.20089151</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1101/2020.05.03.20089151</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) testing remains the cornerstone of laboratory-based identification of patients with COVID-19. As the availability and speed of SARS-CoV-2 testing platforms improve, results are increasingly relied upon to inform critical decisions related to therapy, use of personal protective equipment, and workforce readiness. However, early reports of RT-PCR test performance have left clinicians and the public with concerns regarding the reliability of this predominant testing modality and the interpretation of negative results. In this work, two independent research teams report the frequency of discordant SARS-CoV-2 test results among initially negative, repeatedly tested patients in regions of the United States with early community transmission and access to testing.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">All patients at the University of Washington (UW) and Stanford Health Care undergoing initial testing by nasopharyngeal (NP) swab between March 2nd and April 7th, 2020 were included. SARS-CoV-2 RT-PCR was performed targeting the N, RdRp, S, and E genes and ORF1ab, using a combination of Emergency Use Authorization laboratory-developed tests and commercial assays. Results through April 14th were extracted to allow for a complete 7-day observation period and an additional day for reporting.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 23,126 SARS-CoV-2 RT-PCR tests (10,583 UW, 12,543 Stanford) were performed in 20,912 eligible patients (8,977 UW, 11,935 Stanford) undergoing initial testing by NP swab; 626 initially test-negative patients were re-tested within 7 days. Among this group, repeat testing within 7 days yielded a positive result in 3.5% (4.3% UW, 2.8% Stanford) of cases, suggesting an initial false negative RT-PCR result; the majority (96.5%) of patients with an initial negative result who warranted reevaluation for any reason remained negative on all subsequent tests performed within this window.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Two independent research teams report the similar finding that, among initially negative patients subjected to repeat SARS-CoV-2 RT-PCR testing, the occurrence of a newly positive result within 7 days is uncommon. These observations suggest that false negative results at the time of initial presentation do occur, but potentially at a lower frequency than is currently believed. Although it is not possible to infer the clinical sensitivity of NP SARS-CoV-2 RT-PCR testing using these data, they may be used in combination with other reports to guide the use and interpretation of this common testing modality.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Long</LastName><ForeName>Dustin R</ForeName><Initials>DR</Initials><Identifier Source="ORCID">0000-0001-6365-953X</Identifier></Author><Author ValidYN="Y"><LastName>Gombar</LastName><ForeName>Saurabh</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Hogan</LastName><ForeName>Catherine A</ForeName><Initials>CA</Initials></Author><Author ValidYN="Y"><LastName>Greninger</LastName><ForeName>Alex L</ForeName><Initials>AL</Initials></Author><Author ValidYN="Y"><LastName>OReilly Shah</LastName><ForeName>Vikas</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Bryson-Cahn</LastName><ForeName>Chloe</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Stevens</LastName><ForeName>Bryan</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Rustagi</LastName><ForeName>Arjun</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Jerome</LastName><ForeName>Keith R</ForeName><Initials>KR</Initials></Author><Author ValidYN="Y"><LastName>Kong</LastName><ForeName>Christina S</ForeName><Initials>CS</Initials></Author><Author ValidYN="Y"><LastName>Zehnder</LastName><ForeName>James</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Shah</LastName><ForeName>Nigam H</ForeName><Initials>NH</Initials><Identifier Source="ORCID">0000-0001-9385-7158</Identifier></Author><Author ValidYN="Y"><LastName>Weiss</LastName><ForeName>Noel S</ForeName><Initials>NS</Initials></Author><Author ValidYN="Y"><LastName>Pinsky</LastName><ForeName>Benjamin A</ForeName><Initials>BA</Initials><Identifier Source="ORCID">0000-0001-8751-4810</Identifier></Author><Author ValidYN="Y"><LastName>Sunshine</LastName><ForeName>Jacob</ForeName><Initials>J</Initials></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>K23 DA046686</GrantID><Acronym>DA</Acronym><Agency>NIDA NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D000076942">Preprint</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>05</Month><Day>08</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>medRxiv</MedlineTA><NlmUniqueID>101767986</NlmUniqueID></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="UpdateIn"><RefSource>Clin Infect Dis. 2020 Jun 07;:</RefSource><PMID Version="1">32506118</PMID></CommentsCorrections></CommentsCorrectionsList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>6</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>6</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>6</Month><Day>9</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32511542</ArticleId><ArticleId IdType="doi">10.1101/2020.05.03.20089151</ArticleId><ArticleId IdType="pmc">PMC7274223</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list></list><tree><noCountry><name sortKey="Bryson Cahn, Chloe" sort="Bryson Cahn, Chloe" uniqKey="Bryson Cahn C" first="Chloe" last="Bryson-Cahn">Chloe Bryson-Cahn</name><name sortKey="Gombar, Saurabh" sort="Gombar, Saurabh" uniqKey="Gombar S" first="Saurabh" last="Gombar">Saurabh Gombar</name><name sortKey="Greninger, Alex L" sort="Greninger, Alex L" uniqKey="Greninger A" first="Alex L" last="Greninger">Alex L. Greninger</name><name sortKey="Hogan, Catherine A" sort="Hogan, Catherine A" uniqKey="Hogan C" first="Catherine A" last="Hogan">Catherine A. Hogan</name><name sortKey="Jerome, Keith R" sort="Jerome, Keith R" uniqKey="Jerome K" first="Keith R" last="Jerome">Keith R. Jerome</name><name sortKey="Kong, Christina S" sort="Kong, Christina S" uniqKey="Kong C" first="Christina S" last="Kong">Christina S. Kong</name><name sortKey="Long, Dustin R" sort="Long, Dustin R" uniqKey="Long D" first="Dustin R" last="Long">Dustin R. Long</name><name sortKey="Oreilly Shah, Vikas" sort="Oreilly Shah, Vikas" uniqKey="Oreilly Shah V" first="Vikas" last="Oreilly Shah">Vikas Oreilly Shah</name><name sortKey="Pinsky, Benjamin A" sort="Pinsky, Benjamin A" uniqKey="Pinsky B" first="Benjamin A" last="Pinsky">Benjamin A. Pinsky</name><name sortKey="Rustagi, Arjun" sort="Rustagi, Arjun" uniqKey="Rustagi A" first="Arjun" last="Rustagi">Arjun Rustagi</name><name sortKey="Shah, Nigam H" sort="Shah, Nigam H" uniqKey="Shah N" first="Nigam H" last="Shah">Nigam H. Shah</name><name sortKey="Stevens, Bryan" sort="Stevens, Bryan" uniqKey="Stevens B" first="Bryan" last="Stevens">Bryan Stevens</name><name sortKey="Sunshine, Jacob" sort="Sunshine, Jacob" uniqKey="Sunshine J" first="Jacob" last="Sunshine">Jacob Sunshine</name><name sortKey="Weiss, Noel S" sort="Weiss, Noel S" uniqKey="Weiss N" first="Noel S" last="Weiss">Noel S. Weiss</name><name sortKey="Zehnder, James" sort="Zehnder, James" uniqKey="Zehnder J" first="James" last="Zehnder">James Zehnder</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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