Wide Real-Life Data Support Reduced Sensitivity of Antigen Tests for Omicron SARS-CoV-2 Infections
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Population
2.2. Ethics
2.3. SARS-CoV-2 Antigen Diagnostic Tests
- Group 1 ADT: Lateral Flow Immunochromatography rapid assay
- Group 2 ADT: Microfluidic-based rapid assay
- Group 3 ADT: Chemiluminescence-based assay
2.4. SARS-CoV-2 RT-PCR Analysis
2.5. SARS-CoV-2 Genome Sequencing
2.6. Bioinformatic Analysis of Genome Sequences
2.7. Nucleocapsid (N) Protein Mutation Analysis
2.8. Statistical Analysis
3. Results
3.1. Evaluation of ADT Performance in Delta versus Omicron VOCs Period
3.2. Evaluation of Nucleocapsid Protein Mutations in Delta and Omicron Variants
3.3. Mouth versus Nose Viral Load in Omicron-Infected Patients
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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ADT Group | Commercial Name | Manufacture | Assay Type | Target Protein | Sampling Site | Sensitivity | Specificity |
---|---|---|---|---|---|---|---|
1 | STANDARD Q COVID-19 Ag Test 2.0 | SD Biosensor, Inc. Korea | Lateral Flow, Immuno-chromatography Rapid ADT | N | Nasal swab | 94.94% | 100% |
1 | Panbio™ COVID-19 Ag Rapid Test Device | Abbott Rapid Diagnostics Jena GmbH, Germany | Lateral Flow, Immuno-chromatography Rapid ADT | N | Nasal swab | 98.1% | 99.8% |
1 | Green Spring SARS-CoV-2 Antigen Rapid Test Kit | Shenzhen Lvshiyuan Biotechnology Co. Ltd., China | Lateral Flow, Immuno-chromatography Rapid ADT | N | Nasal swab | 96.77% | 100% |
2 | FREND™ COVID-19 Ag | NanoEntek, South Korea | Microfluidic-based rapid ADT | N | Nasophar. Swab | 94.12% | 94.12% |
3 | MAGLUMI® SARS-CoV-2 Ag | Shenzhen New Industries Biomedical Engineering Co., Ltd. China | Laboratory-chemiluminescence-based ADT | N | Nasophar. Swab | 97.7% | 99.6% |
3 | LIAISON® SARS-CoV-2 Ag | DiaSorin, Inc | Laboratory chemiluminescence-based ADT | N | Nasal swab | 99.0% | 98.0% |
Delta Wave | Omicron Wave | ||||
---|---|---|---|---|---|
Demographics | Count (n) | Value (%) | Count (n) | Value (%) | |
Population | 2726 | 2449 | |||
Gender | |||||
Female | 1319 | 48.38 | 1216 | 49.65 | |
Male | 1407 | 51.61 | 1233 | 50.34 | |
Age (years) | Female | Male | Female | Male | |
Lower 95% CI | 46.71 | 46.81 | 39.01 | 41.20 | |
Upper 95% CI | 49.68 | 49.71 | 42.02 | 44.33 | |
Median | 48.00 | 52.00 | 37.00 | 41.00 |
Delta | Omicron | Delta | Omicron | |||||||
---|---|---|---|---|---|---|---|---|---|---|
TP/(TP + FN) | SE (95% CI) | TP/(TP + FN) | SE (95% CI) | p | TN/(TN + FP) | SP (95% CI) | TN/(TN + FP) | SP (95% CI) | p | |
Overall | 122/192 | 63.5 (56.3, 74.0) | 65/195 | 33.3 (26.8, 44.0) | <0.001 | 2512/2534 | 99.1 (98.7, 99.5) | 2253/2254 | 99.9 (99.8, 100) | <0.001 |
Group 1 | 27/54 | 50 (36.1, 63.9) | 32/96 | 33.3 (24.0, 43.7) | 0.045 | 549/550 | 99.8 (99.0, 100) | 1496/1497 | 99.9 (99.6, 100) | 0.460 |
Group 2 | 73/112 | 65.2 (55.6, 73.9) | 22/62 | 35.5 (23.7, 48.7) | <0.001 | 1822/1838 | 99.1 (98.6, 99.5) | 614/614 | 100 (99.4, 100) | 0.020 |
Group 3 | 22/26 | 84.6 (65.1, 95.6) | 11/37 | 29.7 (15.9, 47.0) | <0.001 | 141/146 | 96.6 (92.2, 98.9) | 143/143 | 100 (97.5, 100) | 0.026 |
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Piubelli, C.; Treggiari, D.; Lavezzari, D.; Deiana, M.; Dishnica, K.; Tosato, E.M.S.; Mazzi, C.; Cattaneo, P.; Mori, A.; Pomari, E.; et al. Wide Real-Life Data Support Reduced Sensitivity of Antigen Tests for Omicron SARS-CoV-2 Infections. Viruses 2024, 16, 657. https://doi.org/10.3390/v16050657
Piubelli C, Treggiari D, Lavezzari D, Deiana M, Dishnica K, Tosato EMS, Mazzi C, Cattaneo P, Mori A, Pomari E, et al. Wide Real-Life Data Support Reduced Sensitivity of Antigen Tests for Omicron SARS-CoV-2 Infections. Viruses. 2024; 16(5):657. https://doi.org/10.3390/v16050657
Chicago/Turabian StylePiubelli, Chiara, Davide Treggiari, Denise Lavezzari, Michela Deiana, Klevia Dishnica, Emma Maria Sole Tosato, Cristina Mazzi, Paolo Cattaneo, Antonio Mori, Elena Pomari, and et al. 2024. "Wide Real-Life Data Support Reduced Sensitivity of Antigen Tests for Omicron SARS-CoV-2 Infections" Viruses 16, no. 5: 657. https://doi.org/10.3390/v16050657