In Vitro Rapid Antigen Test Performance with the SARS-CoV-2 Variants of Concern B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), and B.1.617.2 (Delta)
Abstract
:1. Introduction
2. Materials and Methods
2.1. Limit of Detection Determination for Cell Culture-Derived SARS-CoV-2
2.2. RNA Quantification by RT-qPCR
2.3. Limit of Detection for SARS-CoV-2 N-Protein (Non-VOC, B.1.1)
2.4. Testing for Cross-Reactivity with Seasonal Human Coronaviruses
3. Results
3.1. Rapid Antigen Test Results with SARS-CoV-2 Variants of Concern
3.2. Limit of Detection for SARS-CoV-2 N-Protein (Non-VOC, B.1.1)
3.3. Testing for Cross-Reactivity with Seasonal Human Coronaviruses
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Ethical Statement
References
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Test | Name | Manufacturer | Lot # | Expiration Date |
---|---|---|---|---|
Test I | SARS-CoV-2 Rapid Antigen Test (self-test) * | Roche, Mannheim, Germany | QCO391041I/Sub I-2 | 12 January 2023 |
Test II | CLINITEST Rapid COVID-19 Antigen Self-Test * | Siemens Healthineers, Erlangen, Germany | 2103544 (a) 2012266 (b) | 28 February 2023 (a) 30 November 2022 (b) |
Test III | Rapid SARS-CoV-2 Antigen Test Card * | Xiamen Boson Biotech Co., Xiamen, China | 21032309 | September 2022 |
Test IV | Panbio COVID-19 Ag RAPID TEST DEVICE (NASAL) | Abbott, Jena, Germany | 41ADG201A SubB (a) 41ADG123A SubA (b) | 18 February 2022 (a) 31 January 2022 (b) |
Dilution in DMEM | ||||||
---|---|---|---|---|---|---|
Test | Virus Lineage | Dilution Levels (RNA copies/mL) a | ||||
1:10 (108/mL) | 1:100 (107/mL) | 1:1000 (106/mL) | 1:10,000 (105/mL) | 1:100,000 (104/mL) | ||
Test I | B.1.1 (Non-VOC) | 5 | 4 | 2 | Neg. | Neg. |
B.1.1.7 (Alpha) | 5 | 3 | 1 | Neg. | Neg. | |
B.1.351 (Beta) | 5 | 4 | 2 | Neg. | Neg. | |
P.1 (Gamma) | 5 | 3 | 1 | Neg. | Neg. | |
B.1.617.2 (Delta) | 5 | 4 | 2 | Neg. | Neg. | |
Test II | B.1.1 (Non-VOC) | 5 | 4 | 2 | 1 | Neg. |
B.1.1.7 (Alpha) | 5 | 3 | 1 | Neg. | Neg. | |
B.1.351 (Beta) | 5 | 3 | 2 | 1 | Neg. | |
P.1 (Gamma) | 5 | 2 | 1 | Neg. | Neg. | |
B.1.617.2 (Delta) | 5 | 3 | 1 | Neg. | Neg. | |
Test III | B.1.1 (Non-VOC) | 5 | 3 | 3 | 1 | Neg. |
B.1.1.7 (Alpha) | 5 | 4 | 2 | 1 | Neg. | |
B.1.351 (Beta) | 5 | 4 | 2 | 1 | Neg. | |
P.1 (Gamma) | 5 | 4 | 2 | 1 b | Neg. | |
B.1.617.2 (Delta) | 5 | 2 | 1 | Neg. | Neg. | |
Test IV | B.1.1 (Non-VOC) | 5 | 4 | 2 | 1 b | Neg. |
B.1.1.7 (Alpha) | 5 | 3 | 2 | Neg. | Neg. | |
B.1.351 (Beta) | 5 | 4 | 2 | 1 b | Neg. | |
P.1 (Gamma) | 5 | 3 | 1 | Neg. | Neg. | |
B.1.617.2 (Delta) | 5 | 4 | 2 | Neg. | Neg. | |
Dilution in Saliva | ||||||
Test I | B.1.1 (Non-VOC) | 5 | 4 | 2 | Neg. | Neg. |
B.1.1.7 (Alpha) | 5 | 3 | 1 | Neg. | Neg. | |
B.1.351 (Beta) | 5 | 4 | 2 | Neg. | Neg. | |
P.1 (Gamma) | 5 | 3 | 1 | Neg. | Neg. | |
B.1.617.2 (Delta) | 5 | 4 | 2 | Neg. | Neg. | |
Test II | B.1.1 (Non-VOC) | 5 | 4 | 2 | 1 | Neg. |
B.1.1.7 (Alpha) | 5 | 3 | 2 | 1 b | Neg. | |
B.1.351 (Beta) | 5 | 4 | 2 | 1 | Neg. | |
P.1 (Gamma) | 5 | 3 | 1 | Neg. | Neg. | |
B.1.617.2 (Delta) | 5 | 3 | 1 | Neg. | Neg. | |
Test III | B.1.1 (Non-VOC) | 5 | 3 | 2 | Neg. | Neg. |
B.1.1.7 (Alpha) | 5 | 3 | 1 | Neg. | Neg. | |
B.1.351 (Beta) | 5 | 3 | 2 | Neg. | Neg. | |
P.1 (Gamma) | 5 | 3 | 2 | Neg. | Neg. | |
B.1.617.2 (Delta) | 5 | 2 | 1 | Neg. | Neg. | |
Test IV | B.1.1 (Non-VOC) | 5 | 4 | 3 | 1 | Neg. |
B.1.1.7 (Alpha) | 5 | 3 | 2 | Neg. | Neg. | |
B.1.351 (Beta) | 5 | 4 | 2 | 1 | Neg. | |
P.1 (Gamma) | 5 | 3 | 2 | Neg. | Neg. | |
B.1.617.2 (Delta) | 5 | 4 | 2 | Neg. | Neg. |
Dilution in DMEM | |||||||
---|---|---|---|---|---|---|---|
Virus Lineage | Initial Preparation Infectivity (TCID50/mL) | Units | 1:10 | 1:100 | 1:1000 | 1:10,000 | 1:100,000 |
B.1.1 (Non-VOC) | 4.28 × 105 | RNA copies/mL | 1.9 × 108 | 2.9 × 107 | 3.5 × 106 | 2.7 × 105 | 1.7 × 104 |
Ct value E gene | 15.7 | 18.7 | 22.0 | 26.1 | 30.4 | ||
B.1.1.7 (Alpha) | 2.85 × 105 | RNA copies/mL | 2.0 × 108 | 2.2 × 107 | 2.9 × 106 | 3.7 × 105 | 5.1 × 104 |
Ct value E gene | 15.7 | 19.1 | 22.3 | 25.6 | 28.7 | ||
B.1.351 (Beta) | 2.16 × 105 | RNA copies/mL | 2.6 × 108 | 3.1 × 107 | 3.4 × 106 | 5.2 × 105 | 6.9 × 104 |
Ct value E gene | 15.3 | 18.6 | 22.1 | 25.0 | 28.2 | ||
P.1 (Gamma) | 1.77 × 105 | RNA copies/mL | 2.1 × 108 | 3.9 × 107 | 5.3 × 106 | 5.8 × 105 | 5.5 × 104 |
Ct value E gene | 15.6 | 18.2 | 21.4 | 24.8 | 28.6 | ||
B.1.617.2 (Delta) | 4.64 × 104 | RNA copies/mL | 2.8 × 108 | 3.7 × 107 | 4.8 × 106 | 5.4 × 105 | 6.9 × 104 |
Ct value E gene | 15.1 | 18.3 | 21.5 | 25.0 | 28.2 | ||
Dilution in Saliva | |||||||
B.1.1 (Non-VOC) | 4.28 × 105 | RNA copies/mL | 2.2 × 108 | 2.4 × 107 | 2.6 × 106 | 2.7 × 105 | 2.7 × 104 |
Ct value E gene | 15.5 | 19.0 | 22.5 | 26.0 | 29.7 | ||
B.1.1.7 (Alpha) | 2.85 × 105 | RNA copies/mL | 1.6 × 108 | 1.4 × 107 | 1.9 × 106 | 2.3 × 105 | 2.5 × 104 |
Ct value E gene | 16.0 | 19.9 | 23.0 | 26.3 | 29.8 | ||
B.1.351 (Beta) | 2.16 × 105 | RNA copies/mL | 1.6 × 108 | 1.0 × 107 | 1.8 × 106 | ≈2 × 105 * | ≈2 × 104 * |
Ct value E gene | 16.0 | 20.3 | 23.1 | N.A. | N.A. | ||
P.1 (Gamma) | 1.77 × 105 | RNA copies/mL | 2.1 × 108 | 2.4 × 107 | 3.1 × 106 | 3.9 × 105 | 4.1 × 104 |
Ct value E gene | 15.6 | 19.0 | 22.2 | 25.5 | 29.0 | ||
B.1.617.2 (Delta) | 4.64 × 104 | RNA copies/mL | 1.8 × 108 | 2.1 × 107 | 2.3 × 106 | 2.8 × 105 | 3.8 × 104 |
Ct value E gene | 15.9 | 19.3 | 22.7 | 26.0 | 29.1 |
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Jungnick, S.; Hobmaier, B.; Mautner, L.; Hoyos, M.; Haase, M.; Baiker, A.; Lahne, H.; Eberle, U.; Wimmer, C.; Hepner, S.; et al. In Vitro Rapid Antigen Test Performance with the SARS-CoV-2 Variants of Concern B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), and B.1.617.2 (Delta). Microorganisms 2021, 9, 1967. https://doi.org/10.3390/microorganisms9091967
Jungnick S, Hobmaier B, Mautner L, Hoyos M, Haase M, Baiker A, Lahne H, Eberle U, Wimmer C, Hepner S, et al. In Vitro Rapid Antigen Test Performance with the SARS-CoV-2 Variants of Concern B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), and B.1.617.2 (Delta). Microorganisms. 2021; 9(9):1967. https://doi.org/10.3390/microorganisms9091967
Chicago/Turabian StyleJungnick, Sabrina, Bernhard Hobmaier, Lena Mautner, Mona Hoyos, Maren Haase, Armin Baiker, Heidi Lahne, Ute Eberle, Clara Wimmer, Sabrina Hepner, and et al. 2021. "In Vitro Rapid Antigen Test Performance with the SARS-CoV-2 Variants of Concern B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), and B.1.617.2 (Delta)" Microorganisms 9, no. 9: 1967. https://doi.org/10.3390/microorganisms9091967