Sensitivity of Rapid Antigen Testing and RT-PCR Performed on Nasopharyngeal Swabs versus Saliva Samples in COVID-19 Hospitalized Patients: Results of a Prospective Comparative Trial (RESTART)
Abstract
:1. Introduction
- (1)
- Compare the diagnostic performance of NP RT-PCR and salivary RT-PCR;
- (2)
- Evaluate the reliability of RATs in hospitalized patients;
- (3)
- Compare the sensitivity of RATs performed on NP swab versus saliva in this specific population;
- (4)
- Evaluate the impact of VTM on the diagnostic performance of RATs.
2. Materials and Methods
2.1. Study Population
2.2. Sample Collection and Diagnostic Tests
2.3. Quantitative SARS-CoV-2 PCR and RAT
2.4. In Vitro Testing of Dilution Effect
- (i)
- One Step Immunoassay Exdia® COVID-19 Ag (Precision Biosensor, Daejeon, Korea) and Standard Q® COVID-19 Rapid Antigen Test (Roche-Switzerland, Basel, Switzerland) were performed after mixing 350 µL of VTM with the buffer solution provided in the RAT kit;
- (ii)
- A clean swab was first inoculated in the VTM, then mixed with the buffer solution (according to manufacturer instructions) and tested with the previously mentioned commercial kits; and
- (iii)
- An amount of 300 µL of VTM was used for RT-PCR analysis.
2.5. Statistical Analysis
2.6. Ethics
3. Results
3.1. Patients’ Characteristics
3.2. Diagnostic Performance of RT-PCR (NP versus Saliva) and Rapid Antigen Testing
3.3. In Vitro Dilution Effect
4. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristics | Internal Medicine Patients (n = 26) | ICU Patients (n = 32) | Overall (n = 58) |
---|---|---|---|
Age (y), median (IQR) | 70 (61–77) | 71 (62–78) | 70 (61–77) |
Male, n (%) | 20 (77) | 25 (78) | 45 (77) |
Patients with symptoms upon sampling, n (%) | 21 (81) | 28 (87) | 49 (84) |
Duration of symptoms, median (IQR) | 11 (5–19) | 11 (6–19) | 11 (5–19) |
Type of symptoms, n (%) | |||
Fever | 5 (19) | 5 (16) | 10 (17) |
Cough | 8 (31) | 11 (34) | 19 (33) |
Dyspnea | 7 (27) | 20 (62) | 27 (46) |
Fatigue | 4 (15) | 3 (9) | 7 (12) |
Anosmia/Dysgeusia | 1 (4) | 2 (6) | 3 (5) |
Other | 6 (23) | 8 (25) | 14 (24) |
Viral load, median (IQR) | 43,000 (3700–9,100,000) | 82,000 (4500–12,000,000) | 48,000 (3800–9,900,000) |
Diagnostic Test | Sensitivity (%) (95% CI) | Specificity (%) (95% CI) | PPV (%) (95% CI) | NPV (%) (95% CI) | |
---|---|---|---|---|---|
Nasopharyngeal RT-PCR | 98 (89–100) | 100 (66–100) | 100 (93–100) | 90 (56–98) | |
Salivary RT-PCR PCR | 69 (55–82) | 100 (66–100) | 100 (90–100) | 37.5 (28–48) | |
Nasopharyngeal rapid antigen test | Exdia®(“Wet”) | 41 (27–56) | 100 (63–100) | 100 (83–100) | 22 (18–26) |
Roche® (“Wet”) | 35 (22–50) | 100 (66–100) | 100 (82–100) | 22 (19–26) | |
Roche® (“Dry”) | 47 (35–62) | 100 (66–100) | 100 (86–100) | 26 (21–31) | |
Salivary rapid antigen test | Exdia®(“Wet”) | 8 (2–20) | 100 (66–100) | 100 (51–100) | 17 (15–18) |
Roche®(“Wet”) | 4 (0.5–14) | 100 (66–100) | 100 (18–100) | 16 (15–17) |
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Kritikos, A.; Caruana, G.; Brouillet, R.; Miroz, J.-P.; Abed-Maillard, S.; Stieger, G.; Opota, O.; Croxatto, A.; Vollenweider, P.; Bart, P.-A.; et al. Sensitivity of Rapid Antigen Testing and RT-PCR Performed on Nasopharyngeal Swabs versus Saliva Samples in COVID-19 Hospitalized Patients: Results of a Prospective Comparative Trial (RESTART). Microorganisms 2021, 9, 1910. https://0-doi-org.brum.beds.ac.uk/10.3390/microorganisms9091910
Kritikos A, Caruana G, Brouillet R, Miroz J-P, Abed-Maillard S, Stieger G, Opota O, Croxatto A, Vollenweider P, Bart P-A, et al. Sensitivity of Rapid Antigen Testing and RT-PCR Performed on Nasopharyngeal Swabs versus Saliva Samples in COVID-19 Hospitalized Patients: Results of a Prospective Comparative Trial (RESTART). Microorganisms. 2021; 9(9):1910. https://0-doi-org.brum.beds.ac.uk/10.3390/microorganisms9091910
Chicago/Turabian StyleKritikos, Antonios, Giorgia Caruana, René Brouillet, John-Paul Miroz, Samia Abed-Maillard, Geraldine Stieger, Onya Opota, Antony Croxatto, Peter Vollenweider, Pierre-Alexandre Bart, and et al. 2021. "Sensitivity of Rapid Antigen Testing and RT-PCR Performed on Nasopharyngeal Swabs versus Saliva Samples in COVID-19 Hospitalized Patients: Results of a Prospective Comparative Trial (RESTART)" Microorganisms 9, no. 9: 1910. https://0-doi-org.brum.beds.ac.uk/10.3390/microorganisms9091910