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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Veröffentlicht in:	Journal of virological methods Jg. 288; S. 114024
Hauptverfasser:	Krüttgen, Alexander, Cornelissen, Christian G., Dreher, Michael, Hornef, Mathias W., Imöhl, Matthias, Kleines, Michael
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Netherlands Elsevier B.V 01.02.2021
Schlagworte:	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
Online-Zugang:	Volltext
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Zusammenfassung:	•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.
Bibliographie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0166-0934 1879-0984 1879-0984
DOI:	10.1016/j.jviromet.2020.114024