Comparative evaluation of six immunoassays for the detection of antibodies against SARS-CoV-2
Abstract Objectives: Serologic techniques can serve as a complement to diagnose SARS-CoV-2 infection. The objective of our study was to compare the diagnostic performance of six immunoassays to detect antibodies against SARS-CoV-2: three lateral flow immunoassays (LFAs), one ELISA and two chemiluminescence assays (CLIAs).Methods: We evaluated three LFAs (Alltest, One Step and SeroFlash), one ELISA (Dia.Pro) and 34 two CLIAs (Elecsys and COV2T). To assess the specificity, 60 pre-pandemic sera were 35 used. To evaluate the sensitivity, we used 80 serum samples from patients with 36 positive PCR for SARS-CoV-2. Agreement between techniques was evaluated using the kappa score (k).Results All immunoassays showed a specificity of 100% except for SeroFlash (96.7%). Overall sensitivity was 61.3%, 73.8%, 67.5%, 85.9%, 88.0% and 92.0% for Alltest, One Step, SeroFlash, Dia.Pro, Elecsys and COV2T, respectively. Sensitivity increased throughout the first two weeks from the onset of symptoms, reaching sensitivities over 85% from 14 days for all LFAs, being One Step the most sensitive (97.6%), followed by SeroFlash (95.1%). Dia.Pro, Elecsys and COV2T showed sensitivities over 97% from 14 days, being 100% for COV2T. One Step showed the best agreement results among LFAs, showing excellent agreement with Dia.Pro (agreement=94.2%, k=0.884), COV2T (99.1%, k=0.981) and Elecsys (97.3%, k=0.943). Dia.Pro, COV2T and Elecsys also showed excellent agreement between them.Conclusion One Step, Dia.Pro, Elecsys and COV2T obtained the best diagnostic performanc e results. All these techniques showed a specificity of 100% and sensitivities over 97% from 14 days after the onset of symptoms, as well as excellent levels of agreement..
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Preprint| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
bioRxiv.org - (2021) vom: 13. Feb. Zur Gesamtaufnahme - year:2021 |
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| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pérez-García, Felipe [VerfasserIn] |
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| Links: |
Volltext [kostenfrei] |
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| doi: |
10.1101/2020.09.08.20190488 |
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| PPN (Katalog-ID): |
XBI01871840X |
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| 245 | 1 | 0 | |a Comparative evaluation of six immunoassays for the detection of antibodies against SARS-CoV-2 |
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| 520 | |a Abstract Objectives: Serologic techniques can serve as a complement to diagnose SARS-CoV-2 infection. The objective of our study was to compare the diagnostic performance of six immunoassays to detect antibodies against SARS-CoV-2: three lateral flow immunoassays (LFAs), one ELISA and two chemiluminescence assays (CLIAs).Methods: We evaluated three LFAs (Alltest, One Step and SeroFlash), one ELISA (Dia.Pro) and 34 two CLIAs (Elecsys and COV2T). To assess the specificity, 60 pre-pandemic sera were 35 used. To evaluate the sensitivity, we used 80 serum samples from patients with 36 positive PCR for SARS-CoV-2. Agreement between techniques was evaluated using the kappa score (k).Results All immunoassays showed a specificity of 100% except for SeroFlash (96.7%). Overall sensitivity was 61.3%, 73.8%, 67.5%, 85.9%, 88.0% and 92.0% for Alltest, One Step, SeroFlash, Dia.Pro, Elecsys and COV2T, respectively. Sensitivity increased throughout the first two weeks from the onset of symptoms, reaching sensitivities over 85% from 14 days for all LFAs, being One Step the most sensitive (97.6%), followed by SeroFlash (95.1%). Dia.Pro, Elecsys and COV2T showed sensitivities over 97% from 14 days, being 100% for COV2T. One Step showed the best agreement results among LFAs, showing excellent agreement with Dia.Pro (agreement=94.2%, k=0.884), COV2T (99.1%, k=0.981) and Elecsys (97.3%, k=0.943). Dia.Pro, COV2T and Elecsys also showed excellent agreement between them.Conclusion One Step, Dia.Pro, Elecsys and COV2T obtained the best diagnostic performanc e results. All these techniques showed a specificity of 100% and sensitivities over 97% from 14 days after the onset of symptoms, as well as excellent levels of agreement. | ||
| 700 | 1 | |a Pérez-Tanoira, Ramón |e verfasserin |4 aut | |
| 700 | 1 | |a Esther Iglesias, María |e verfasserin |4 aut | |
| 700 | 1 | |a Romanyk, Juan |e verfasserin |4 aut | |
| 700 | 1 | |a Arroyo, Teresa |e verfasserin |4 aut | |
| 700 | 1 | |a Gómez-Herruz, Peña |e verfasserin |4 aut | |
| 700 | 1 | |a González, Rosa |e verfasserin |4 aut | |
| 700 | 1 | |a Cuadros-González, Juan |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t bioRxiv.org |g (2021) vom: 13. Feb. |
| 773 | 1 | 8 | |g year:2021 |g day:13 |g month:02 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1101/2020.09.08.20190488 |z kostenfrei |3 Volltext |
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