Comparison of the SARS-CoV-2 Rapid antigen test to the real star Sars-CoV-2 RT PCR kit

•The sensitivity and specificity of the new Roche SARS-CoV-2 Rapid Antigen Test was evaluated.•We found a specificity of 96 %.•The sensitivity with samples with a Ct of < 25 was 100 % and gradually decreases to 22.2 % with cycle thresholds > = 35.•The new test might be useful to rapidly identi...

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Vydáno v:	Journal of virological methods Ročník 288; s. 114024
Hlavní autoři:	Krüttgen, Alexander, Cornelissen, Christian G., Dreher, Michael, Hornef, Mathias W., Imöhl, Matthias, Kleines, Michael
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	Netherlands Elsevier B.V 01.02.2021
Témata:	Antigen antigen detection antigens Antigens, Viral - immunology COVID-19 COVID-19 - diagnosis COVID-19 - virology COVID-19 Testing - methods COVID-19 Testing - standards Humans Immunoassay Lateral flow assay patients rapid methods Reagent Kits, Diagnostic Reverse Transcriptase Polymerase Chain Reaction RNA, Viral SARS-CoV-2 SARS-CoV-2 - genetics SARS-CoV-2 - immunology Sensitivity and Specificity Severe acute respiratory syndrome coronavirus 2 Short Communication COVID-19 Antigen Lateral flow assay SARS-CoV-2
ISSN:	0166-0934, 1879-0984, 1879-0984
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Abstract	•The sensitivity and specificity of the new Roche SARS-CoV-2 Rapid Antigen Test was evaluated.•We found a specificity of 96 %.•The sensitivity with samples with a Ct of < 25 was 100 % and gradually decreases to 22.2 % with cycle thresholds > = 35.•The new test might be useful to rapidly identify contagious individuals. There is an ongoing need for reliable antigen assays for timely and easy detection of individuals with acute SARS-CoV-2 infection. Using 75 swabs from patients previously tested positive by SARS-CoV-2 PCR and 75 swabs from patients previously tested negative by SARS-CoV-2 PCR, we investigated the sensitivity and specificity of the SARS-CoV-2 Rapid Antigen Test (Roche). We determined a specificity of 96 %. The assay’s sensitivity with samples with a cycle threshold of < 25, 25 - <30, 30 - <35, and> = 35 was 100 %, 95 %, 44.8 % and 22.2 %, respectively. We conclude that sensitivity and specificity of the antigen assay is inferior to the PCR assay. However, the antigen assay may be a quick and easy to perform alternative for differentiation of individuals contagious for SARS-CoV-2 from non-contagious individuals.
AbstractList	There is an ongoing need for reliable antigen assays for timely and easy detection of individuals with acute SARS-CoV-2 infection. Using 75 swabs from patients previously tested positive by SARS-CoV-2 PCR and 75 swabs from patients previously tested negative by SARS-CoV-2 PCR, we investigated the sensitivity and specificity of the SARS-CoV-2 Rapid Antigen Test (Roche). We determined a specificity of 96 %. The assay's sensitivity with samples with a cycle threshold of < 25, 25 - <30, 30 - <35, and> = 35 was 100 %, 95 %, 44.8 % and 22.2 %, respectively. We conclude that sensitivity and specificity of the antigen assay is inferior to the PCR assay. However, the antigen assay may be a quick and easy to perform alternative for differentiation of individuals contagious for SARS-CoV-2 from non-contagious individuals. • The sensitivity and specificity of the new Roche SARS-CoV-2 Rapid Antigen Test was evaluated. • We found a specificity of 96 %. • The sensitivity with samples with a Ct of < 25 was 100 % and gradually decreases to 22.2 % with cycle thresholds > = 35. • The new test might be useful to rapidly identify contagious individuals. There is an ongoing need for reliable antigen assays for timely and easy detection of individuals with acute SARS-CoV-2 infection. Using 75 swabs from patients previously tested positive by SARS-CoV-2 PCR and 75 swabs from patients previously tested negative by SARS-CoV-2 PCR, we investigated the sensitivity and specificity of the SARS-CoV-2 Rapid Antigen Test (Roche). We determined a specificity of 96 %. The assay’s sensitivity with samples with a cycle threshold of < 25, 25 - <30, 30 - <35, and> = 35 was 100 %, 95 %, 44.8 % and 22.2 %, respectively. We conclude that sensitivity and specificity of the antigen assay is inferior to the PCR assay. However, the antigen assay may be a quick and easy to perform alternative for differentiation of individuals contagious for SARS-CoV-2 from non-contagious individuals. There is an ongoing need for reliable antigen assays for timely and easy detection of individuals with acute SARS-CoV-2 infection. Using 75 swabs from patients previously tested positive by SARS-CoV-2 PCR and 75 swabs from patients previously tested negative by SARS-CoV-2 PCR, we investigated the sensitivity and specificity of the SARS-CoV-2 Rapid Antigen Test (Roche). We determined a specificity of 96 %. The assay's sensitivity with samples with a cycle threshold of < 25, 25 - <30, 30 - <35, and> = 35 was 100 %, 95 %, 44.8 % and 22.2 %, respectively. We conclude that sensitivity and specificity of the antigen assay is inferior to the PCR assay. However, the antigen assay may be a quick and easy to perform alternative for differentiation of individuals contagious for SARS-CoV-2 from non-contagious individuals.There is an ongoing need for reliable antigen assays for timely and easy detection of individuals with acute SARS-CoV-2 infection. Using 75 swabs from patients previously tested positive by SARS-CoV-2 PCR and 75 swabs from patients previously tested negative by SARS-CoV-2 PCR, we investigated the sensitivity and specificity of the SARS-CoV-2 Rapid Antigen Test (Roche). We determined a specificity of 96 %. The assay's sensitivity with samples with a cycle threshold of < 25, 25 - <30, 30 - <35, and> = 35 was 100 %, 95 %, 44.8 % and 22.2 %, respectively. We conclude that sensitivity and specificity of the antigen assay is inferior to the PCR assay. However, the antigen assay may be a quick and easy to perform alternative for differentiation of individuals contagious for SARS-CoV-2 from non-contagious individuals. •The sensitivity and specificity of the new Roche SARS-CoV-2 Rapid Antigen Test was evaluated.•We found a specificity of 96 %.•The sensitivity with samples with a Ct of < 25 was 100 % and gradually decreases to 22.2 % with cycle thresholds > = 35.•The new test might be useful to rapidly identify contagious individuals. There is an ongoing need for reliable antigen assays for timely and easy detection of individuals with acute SARS-CoV-2 infection. Using 75 swabs from patients previously tested positive by SARS-CoV-2 PCR and 75 swabs from patients previously tested negative by SARS-CoV-2 PCR, we investigated the sensitivity and specificity of the SARS-CoV-2 Rapid Antigen Test (Roche). We determined a specificity of 96 %. The assay’s sensitivity with samples with a cycle threshold of < 25, 25 - <30, 30 - <35, and> = 35 was 100 %, 95 %, 44.8 % and 22.2 %, respectively. We conclude that sensitivity and specificity of the antigen assay is inferior to the PCR assay. However, the antigen assay may be a quick and easy to perform alternative for differentiation of individuals contagious for SARS-CoV-2 from non-contagious individuals.
ArticleNumber	114024
Author	Hornef, Mathias W. Imöhl, Matthias Cornelissen, Christian G. Dreher, Michael Kleines, Michael Krüttgen, Alexander
Author_xml	– sequence: 1 givenname: Alexander surname: Krüttgen fullname: Krüttgen, Alexander organization: LaboratoryDiagnostic CEnter, University Hospital RWTH Aachen, Germany – sequence: 2 givenname: Christian G. surname: Cornelissen fullname: Cornelissen, Christian G. organization: Department of Pneumology and Intensive Care Medicine, University Hospital RWTH Aachen, Germany – sequence: 3 givenname: Michael surname: Dreher fullname: Dreher, Michael organization: Department of Pneumology and Intensive Care Medicine, University Hospital RWTH Aachen, Germany – sequence: 4 givenname: Mathias W. surname: Hornef fullname: Hornef, Mathias W. organization: Institute of Medical Microbiology, University Hospital RWTH Aachen, Germany – sequence: 5 givenname: Matthias surname: Imöhl fullname: Imöhl, Matthias organization: LaboratoryDiagnostic CEnter, University Hospital RWTH Aachen, Germany – sequence: 6 givenname: Michael surname: Kleines fullname: Kleines, Michael email: mkleines@ukaachen.de organization: LaboratoryDiagnostic CEnter, University Hospital RWTH Aachen, Germany
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Cites_doi	10.1038/s41586-020-2012-7 10.1056/NEJMoa2001017 10.1016/j.jcv.2020.104654 10.1016/j.jcv.2020.104394 10.1016/j.jcv.2020.104381
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Snippet	•The sensitivity and specificity of the new Roche SARS-CoV-2 Rapid Antigen Test was evaluated.•We found a specificity of 96 %.•The sensitivity with samples... There is an ongoing need for reliable antigen assays for timely and easy detection of individuals with acute SARS-CoV-2 infection. Using 75 swabs from patients... • The sensitivity and specificity of the new Roche SARS-CoV-2 Rapid Antigen Test was evaluated. • We found a specificity of 96 %. • The sensitivity with...
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SubjectTerms	Antigen antigen detection antigens Antigens, Viral - immunology COVID-19 COVID-19 - diagnosis COVID-19 - virology COVID-19 Testing - methods COVID-19 Testing - standards Humans Immunoassay Lateral flow assay patients rapid methods Reagent Kits, Diagnostic Reverse Transcriptase Polymerase Chain Reaction RNA, Viral SARS-CoV-2 SARS-CoV-2 - genetics SARS-CoV-2 - immunology Sensitivity and Specificity Severe acute respiratory syndrome coronavirus 2 Short Communication
Title	Comparison of the SARS-CoV-2 Rapid antigen test to the real star Sars-CoV-2 RT PCR kit
URI	https://dx.doi.org/10.1016/j.jviromet.2020.114024 https://www.ncbi.nlm.nih.gov/pubmed/33227341 https://www.proquest.com/docview/2464144403 https://www.proquest.com/docview/2636396981 https://pubmed.ncbi.nlm.nih.gov/PMC7678421
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