Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room
Background: We assessed the sensitivity, specificity and positive and negative predictive value (PPV and NPV) of molecular and serological tests for the diagnosis of SARS-CoV-2 infection. Methods: A total of 346 patients were enrolled in the emergency room. We evaluated three Reverse Transcriptase-r...
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-09-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/10/9/669 |
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| author | Zeno Bisoffi Elena Pomari Michela Deiana Chiara Piubelli Niccolò Ronzoni Anna Beltrame Giulia Bertoli Niccolò Riccardi Francesca Perandin Fabio Formenti Federico Gobbi Dora Buonfrate Ronaldo Silva |
| author_facet | Zeno Bisoffi Elena Pomari Michela Deiana Chiara Piubelli Niccolò Ronzoni Anna Beltrame Giulia Bertoli Niccolò Riccardi Francesca Perandin Fabio Formenti Federico Gobbi Dora Buonfrate Ronaldo Silva |
| author_sort | Zeno Bisoffi |
| collection | DOAJ |
| description | Background: We assessed the sensitivity, specificity and positive and negative predictive value (PPV and NPV) of molecular and serological tests for the diagnosis of SARS-CoV-2 infection. Methods: A total of 346 patients were enrolled in the emergency room. We evaluated three Reverse Transcriptase-real time PCRs (RT-PCRs) including six different gene targets, five serologic rapid diagnostic tests (RDT) and one ELISA. The final classification of infected/non-infected patients was performed using Latent Class Analysis combined with clinical re-assessment of incongruous cases. Results: Out of these, 24.6% of patients were classified as infected. The molecular test RQ-SARS-nCoV-2 showed the highest performance with 91.8% sensitivity, 100% specificity, 100.0% PPV and 97.4% NPV respectively. Considering the single gene targets, <i>S</i> and <i>RdRp</i> of RQ-SARS-nCoV-2 had the highest sensitivity (94.1%). The in-house <i>RdRp</i> presented the lowest sensitivity (62.4%). The specificity ranged from 99.2% for in-house <i>RdRp</i> and <i>N2</i> to 95.0% for <i>E</i>. The PPV ranged from 97.1% of <i>N2</i> to 85.4% of <i>E</i> and the NPV from 98.1% of <i>S</i> to 89.0% of in-house <i>RdRp</i>. All serological tests had < 50% sensitivity and low PPV and NPV. VivaDiag IgM (RDT) had 98.5% specificity, with 84.0% PPV, but 24.7% sensitivity. Conclusion: Molecular tests for SARS-CoV-2 infection showed excellent specificity, but significant differences in sensitivity. Serological tests have limited utility in a clinical context. |
| first_indexed | 2024-03-10T16:35:57Z |
| format | Article |
| id | doaj.art-844dd98e54fe4a4183d2f2c5c4ecf3f7 |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-10T16:35:57Z |
| publishDate | 2020-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-844dd98e54fe4a4183d2f2c5c4ecf3f72023-11-20T12:28:59ZengMDPI AGDiagnostics2075-44182020-09-0110966910.3390/diagnostics10090669Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency RoomZeno Bisoffi0Elena Pomari1Michela Deiana2Chiara Piubelli3Niccolò Ronzoni4Anna Beltrame5Giulia Bertoli6Niccolò Riccardi7Francesca Perandin8Fabio Formenti9Federico Gobbi10Dora Buonfrate11Ronaldo Silva12Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyDepartment of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, ItalyBackground: We assessed the sensitivity, specificity and positive and negative predictive value (PPV and NPV) of molecular and serological tests for the diagnosis of SARS-CoV-2 infection. Methods: A total of 346 patients were enrolled in the emergency room. We evaluated three Reverse Transcriptase-real time PCRs (RT-PCRs) including six different gene targets, five serologic rapid diagnostic tests (RDT) and one ELISA. The final classification of infected/non-infected patients was performed using Latent Class Analysis combined with clinical re-assessment of incongruous cases. Results: Out of these, 24.6% of patients were classified as infected. The molecular test RQ-SARS-nCoV-2 showed the highest performance with 91.8% sensitivity, 100% specificity, 100.0% PPV and 97.4% NPV respectively. Considering the single gene targets, <i>S</i> and <i>RdRp</i> of RQ-SARS-nCoV-2 had the highest sensitivity (94.1%). The in-house <i>RdRp</i> presented the lowest sensitivity (62.4%). The specificity ranged from 99.2% for in-house <i>RdRp</i> and <i>N2</i> to 95.0% for <i>E</i>. The PPV ranged from 97.1% of <i>N2</i> to 85.4% of <i>E</i> and the NPV from 98.1% of <i>S</i> to 89.0% of in-house <i>RdRp</i>. All serological tests had < 50% sensitivity and low PPV and NPV. VivaDiag IgM (RDT) had 98.5% specificity, with 84.0% PPV, but 24.7% sensitivity. Conclusion: Molecular tests for SARS-CoV-2 infection showed excellent specificity, but significant differences in sensitivity. Serological tests have limited utility in a clinical context.https://www.mdpi.com/2075-4418/10/9/669SARS-CoV-2diagnosisserologyRT-PCRaccuracy |
| spellingShingle | Zeno Bisoffi Elena Pomari Michela Deiana Chiara Piubelli Niccolò Ronzoni Anna Beltrame Giulia Bertoli Niccolò Riccardi Francesca Perandin Fabio Formenti Federico Gobbi Dora Buonfrate Ronaldo Silva Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room Diagnostics SARS-CoV-2 diagnosis serology RT-PCR accuracy |
| title | Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room |
| title_full | Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room |
| title_fullStr | Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room |
| title_full_unstemmed | Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room |
| title_short | Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room |
| title_sort | sensitivity specificity and predictive values of molecular and serological tests for covid 19 a longitudinal study in emergency room |
| topic | SARS-CoV-2 diagnosis serology RT-PCR accuracy |
| url | https://www.mdpi.com/2075-4418/10/9/669 |
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