Potential false-negative nucleic acid testing results for Severe Acute Respiratory Syndrome Coronavirus 2 from thermal inactivation of samples with low viral loads.
Identifieur interne : 000356 ( PubMed/Curation ); précédent : 000355; suivant : 000357Potential false-negative nucleic acid testing results for Severe Acute Respiratory Syndrome Coronavirus 2 from thermal inactivation of samples with low viral loads.
Auteurs : Yang Pan [République populaire de Chine] ; Luyao Long [République populaire de Chine] ; Daitao Zhang [République populaire de Chine] ; Tingting Yan [République populaire de Chine] ; Shujuan Cui [République populaire de Chine] ; Peng Yang [République populaire de Chine] ; Quanyi Wang [République populaire de Chine] ; Simei Ren [République populaire de Chine]Source :
- Clinical chemistry [ 1530-8561 ] ; 2020.
Abstract
Corona Virus Disease-2019 (COVID-19) has spread widely throughout the world since the end of 2019. Nucleic acid testing (NAT) has played an important role in patient diagnosis and management of COVID-19. In some circumstances, thermal inactivation at 56 °C has been recommended to inactivate Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) before NAT. However, this procedure could theoretically disrupt nucleic acid integrity of this single-stranded RNA virus and cause false negatives in real-time polymerase chain reaction (RT-PCR) tests.
DOI: 10.1093/clinchem/hvaa091
PubMed: 32246822
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<author><name sortKey="Ren, Simei" sort="Ren, Simei" uniqKey="Ren S" first="Simei" last="Ren">Simei Ren</name>
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<series><title level="j">Clinical chemistry</title>
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<front><div type="abstract" xml:lang="en">Corona Virus Disease-2019 (COVID-19) has spread widely throughout the world since the end of 2019. Nucleic acid testing (NAT) has played an important role in patient diagnosis and management of COVID-19. In some circumstances, thermal inactivation at 56 °C has been recommended to inactivate Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) before NAT. However, this procedure could theoretically disrupt nucleic acid integrity of this single-stranded RNA virus and cause false negatives in real-time polymerase chain reaction (RT-PCR) tests.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">32246822</PMID>
<DateRevised><Year>2020</Year>
<Month>04</Month>
<Day>04</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1530-8561</ISSN>
<JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year>
<Month>Apr</Month>
<Day>04</Day>
</PubDate>
</JournalIssue>
<Title>Clinical chemistry</Title>
<ISOAbbreviation>Clin. Chem.</ISOAbbreviation>
</Journal>
<ArticleTitle>Potential false-negative nucleic acid testing results for Severe Acute Respiratory Syndrome Coronavirus 2 from thermal inactivation of samples with low viral loads.</ArticleTitle>
<ELocationID EIdType="pii" ValidYN="Y">hvaa091</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1093/clinchem/hvaa091</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Corona Virus Disease-2019 (COVID-19) has spread widely throughout the world since the end of 2019. Nucleic acid testing (NAT) has played an important role in patient diagnosis and management of COVID-19. In some circumstances, thermal inactivation at 56 °C has been recommended to inactivate Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) before NAT. However, this procedure could theoretically disrupt nucleic acid integrity of this single-stranded RNA virus and cause false negatives in real-time polymerase chain reaction (RT-PCR) tests.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">We investigated whether thermal inactivation could affect the results of viral NAT. We examined the effects of thermal inactivation on the quantitative RT-PCR results of SARS-CoV-2 particularly with regard to the rates of false-negative results for specimens carrying low viral loads. We additionally investigated the effects of different specimen types, sample preservation times and a chemical inactivation approach on NAT.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Our work showed increased Ct values in specimens from diagnosed COVID-19 patients in RT-PCR tests after thermal incubation. Moreover, about half of the weak-positive samples (7 of 15 samples, 46.7%) were RT-PCR negative after heat inactivation in at least one parallel testing. The use of guanidinium-based lysis for preservation of these specimens had a smaller impact on RT-PCR results with fewer false negatives (2 of 15 samples, 13.3%) and significantly less increase in Ct values than heat inactivation.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Thermal inactivation adversely affected the efficiency of RT-PCR for SARS-CoV-2 detection. Given the limited applicability associated with chemical inactivators, other approaches to ensure the overall protection of laboratory personnel need consideration.</AbstractText>
<CopyrightInformation>© 2020 American Association for Clinical Chemistry.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Pan</LastName>
<ForeName>Yang</ForeName>
<Initials>Y</Initials>
<AffiliationInfo><Affiliation>Institute for Infectious Disease and Endemic Disease Control, Beijing Center for Disease Prevention and Control, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Research Centre for Preventive Medicine of Beijing, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>School of Public Health, Capital Medical University, Beijing, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Long</LastName>
<ForeName>Luyao</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Graduate School, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Zhang</LastName>
<ForeName>Daitao</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Institute for Infectious Disease and Endemic Disease Control, Beijing Center for Disease Prevention and Control, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Research Centre for Preventive Medicine of Beijing, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>School of Public Health, Capital Medical University, Beijing, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Yan</LastName>
<ForeName>Tingting</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>Department of Clinical Laboratory, Beijing Hospital, National Center of Gerontology, Beijing, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cui</LastName>
<ForeName>Shujuan</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Institute for Infectious Disease and Endemic Disease Control, Beijing Center for Disease Prevention and Control, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Research Centre for Preventive Medicine of Beijing, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>School of Public Health, Capital Medical University, Beijing, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Yang</LastName>
<ForeName>Peng</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Institute for Infectious Disease and Endemic Disease Control, Beijing Center for Disease Prevention and Control, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Research Centre for Preventive Medicine of Beijing, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>School of Public Health, Capital Medical University, Beijing, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wang</LastName>
<ForeName>Quanyi</ForeName>
<Initials>Q</Initials>
<AffiliationInfo><Affiliation>Institute for Infectious Disease and Endemic Disease Control, Beijing Center for Disease Prevention and Control, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Research Centre for Preventive Medicine of Beijing, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>School of Public Health, Capital Medical University, Beijing, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ren</LastName>
<ForeName>Simei</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P. R. China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Graduate School, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, China.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2020</Year>
<Month>04</Month>
<Day>04</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Clin Chem</MedlineTA>
<NlmUniqueID>9421549</NlmUniqueID>
<ISSNLinking>0009-9147</ISSNLinking>
</MedlineJournalInfo>
<CitationSubset>IM</CitationSubset>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword>
<Keyword MajorTopicYN="N">False negative</Keyword>
<Keyword MajorTopicYN="N">Nucleic Acid Test</Keyword>
<Keyword MajorTopicYN="N">RT-PCR</Keyword>
<Keyword MajorTopicYN="N">SARS-CoV-2</Keyword>
<Keyword MajorTopicYN="N">Thermal Inactivation</Keyword>
</KeywordList>
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<Month>03</Month>
<Day>06</Day>
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<PubMedPubDate PubStatus="revised"><Year>2020</Year>
<Month>03</Month>
<Day>20</Day>
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<PubMedPubDate PubStatus="accepted"><Year>2020</Year>
<Month>03</Month>
<Day>23</Day>
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<Month>4</Month>
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