Analytical Performances of the COVISTIXTM Antigen Rapid Test for SARS-CoV-2 Detection in an Unselected Population (All-Comers)
Abstract
:1. Introduction
2. Results
3. Discussion
4. Materials and Methods
4.1. Respiratory Specimens
4.2. SARS-CoV-2 Rapid Antigen Test
4.3. RNA Extraction and RT-PCR SARS-CoV-2 Detection
4.4. Illumina Sequencing
4.5. Statistical Analysis
4.6. Patient and Public Involvement
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- WHO. Weekly Epidemiological Update—24 August 2021. Who [Internet]. 2021. Available online: https://www.who.int/publications/m/item/weekly-epidemiological-update (accessed on 2 March 2021).
- Dong, E.; Du, H.; Gardner, L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect. Dis. 2020, 20, 533–534. [Google Scholar] [CrossRef]
- Kretzschmar, M.E.; Rozhnova, G.; Bootsma, M.C.J.; Van Boven, M.; Van De Wijgert, J.H.H.M.; Bonten, M.J.M. Impact of delays on effectiveness of contact tracing strategies for COVID-19: A modelling study. Lancet Public Health 2020, 5, e452–e459. [Google Scholar] [CrossRef]
- Vecino-Ortiz, A.I.; Villanueva Congote, J.; Zapata Bedoya, S.; Cucunuba, Z.M. Impact of contact tracing on COVID-19 mortality: An impact evaluation using surveillance data from Colombia. PLoS ONE 2021, 16, e0246987. [Google Scholar]
- Zitek, T. The appropriate use of testing for COVID-19. West J. Emerg. Med. 2020, 21, 470. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Hanson, K.E.; Caliendo, A.M.; Arias, C.A.; Hayden, M.K.; Englund, J.A.; Lee, M.J.; Loeb, M.; Patel, R.; El Alayli, A.; Altayar, O.; et al. The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing. Clin. Infect. Dis. 2021. [Google Scholar] [CrossRef] [PubMed]
- Peeling, R.W.; Olliaro, P.L.; Boeras, D.I.; Fongwen, N. Scaling up COVID-19 rapid antigen tests: Promises and challenges. Lancet Infect. Dis. 2021, 21, e290–e295. [Google Scholar] [CrossRef]
- Pública ADde, I. Portal de Datos Abiertos de la CDMX. 2021. Available online: https://datos.cdmx.gob.mx/group/covid-19 (accessed on 1 January 2021).
- WHO. Antigen-Detection in the Diagnosis of SARS-CoV-2 Infection Using Rapid Immunoassays. 2020. Available online: https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov2infection-using-rapid-immunoassays (accessed on 11 September 2020).
- Salud, S. Listado de Pruebas de Antígeno, Útiles Para SARS CoV 2 en Puntos de Atención. gob.mx. Available online: https://www.gob.mx/salud/documentos/listado-de-pruebas-de-antigeno-para-sars-cov-2 (accessed on 1 June 2021).
- Youden, W. Index for rating diagnostic tests. Cancer 1950, 3, 32–35. [Google Scholar] [CrossRef]
- Fenollar, F.; Bouam, A.; Ballouche, M.; Fuster, L.; Prudent, E.; Colson, P.; Tissot-Dupont, H.; Million, M.; Drancourt, M.; Raoult, D.; et al. Evaluation of the PanbioTM COVID-19 rapid antigen detection test device for the screening of patients with COVID-19. J. Clin. Microbiol. 2021, 59, e02589-20. [Google Scholar] [CrossRef] [PubMed]
- Xiao, T.; Wang, Y.; Yuan, J.; Ye, H.; Wei, L.; Liao, X.; Wang, H.; Qian, S.; Wang, Z.; Liu, L.; et al. Early Viral Clearance and Antibody Kinetics of COVID-19 Among Asymptomatic Carriers. Front. Med. 2021, 8, 595773. [Google Scholar] [CrossRef] [PubMed]
- Albert, E.; Torres, I.; Bueno, F.; Huntley, D.; Molla, E.; Fernández-Fuentes, M.; Martínez, M.; Poujois, S.; Forqué, L.; Valdivia, A.; et al. Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centers. Clin. Microbiol. Infect. 2021, 27, 472.e7–472.e10. [Google Scholar] [CrossRef] [PubMed]
- Stang, A.; Robers, J.; Schonert, B.; Jöckel, K.; Spelsberg, A.; Keil, U.; Cullen, P. The performance of the SARS-CoV-2 RT-PCR test as a tool for detecting SARS-CoV-2 infection in the population. J. Infect. 2021, 83, 237–279. [Google Scholar] [CrossRef] [PubMed]
- Platten, M.; Hoffmann, D.; Grosser, R.; Wisplinghoff, F.; Wisplinghoff, H.; Wiesmüller, G.; Schildgen, O.; Schildgen, V. SARS-CoV-2, CT-Values, and Infectivity—Conclusions to Be Drawn from Side Observations. Viruses 2021, 13, 1459. [Google Scholar] [CrossRef] [PubMed]
- La Scola, B.; Le Bideau, M.; Andreani, J.; Hoang, V.; Grimaldier, C.; Colson, P.; Gautret, P.; Raoult, D. Viral RNA load as determined by cell culture as a management tool for discharge of SARS-CoV-2 patients from infectious disease wards. Eur. J. Clin. Microbiol. Infect. Dis. 2020, 39, 1059–1061. [Google Scholar] [CrossRef] [PubMed]
- TaqPath™ COVID-19 Combo Kit. Available online: https://assets.thermofisher.com/TFS-Assets/LSG/manuals/MAN0019215_TaqPathCOVID-19_CE-IVD_RT-PCR%20Kit_IFU.pdf (accessed on 30 December 2021).
- Cedro-Tanda, A.; Gómez-Romero, L.; Alcaraz, N.; de Anda-Jauregui, G.; Peñaloza, F.; Moreno, B.; Escobar-Arrazola, M.A.; Ramirez-Vega, O.A.; Munguia-Garza, P.; Garcia-Cardenas, F.; et al. The Evolutionary Landscape of SARS-CoV-2 Variant, B.1.1.519 and Its Clinical Impact in Mexico City. Viruses 2021, 13, 2182. [Google Scholar] [CrossRef] [PubMed]
Sex | Female: 391 (49.9%) | Male: 392 (50.1%) | |
---|---|---|---|
Median Age | 40 Years (IQR: 28–51) | ||
PCR (+) | PCR (−) | Total | |
COVISTIX (+) | 205 | 21 | 226 |
COVISTIX (−) | 49 | 508 | 557 |
Total | 254 | 529 | 783 |
Prevalence | 0.32 | ||
Sensitivity | 0.81 (CI 95%: 0.75–0.85) | ||
Specificity | 0.96 (CI 95%: 0.94–0.98) | ||
LR (+) | 20.25 (CI 95%: 13–31) | ||
LR (−) | 0.2 (CI 95%: 0.16–0.26) | ||
Post-test (+) | 0.91 (CI 95%: 0.86–0.94) | ||
Post-test (−) | 0.12 (CI 95%: 0.07–0.11) | ||
Kappa | 0.8 (CI 95%: 0.72–0.86) | ||
Youden index | 0.77 (CI 95%: 0.72–0.82; SE: 0.026) | ||
Accuracy | 0.91 (CI 95%: 0.89–0.93) | ||
LR: likelihood ratio; Post-test: post-test probability. Kappa: Cohen’s kappa correlation (very good) |
RT-PCR (+) | COVISTIX (+) | COVISTIX (−) | Sensitivity (CI 95%) | ||
---|---|---|---|---|---|
254 | 205 | 49 | 0.81 (0.75–0.85) | ||
Ct ≥ 34 = 25 | 8 | 17 | 0.32 | ||
30 ≥ Ct < 34 = 33 | 21 | 12 | 0.64 | ||
25 ≥ Ct < 30 = 66 | 53 | 13 | 0.80 | 0.90 | |
20 ≥ Ct < 25 = 75 | 70 | 5 | 0.93 | 0.95 | |
Ct < 20 = 55 | 53 | 2 | 0.96 | ||
RT-PCR (−) | COVISTIX (+) | COVISTIX (−) | Specificity (CI 95%) | ||
529 | 21 | 508 | 0.96 (0.94–0.98) |
(A) | |||||
RT-PCR (+) | COVISTIX (+) | COVISTIX (−) | Sensitivity (CI 95%) | ||
125 | 103 | 22 | 0.82 (0.75–0.89) | ||
Ct ≥ 34 = 10 | 3 | 7 | 0.30 | ||
30 ≥ Ct < 34 = 7 | 4 | 3 | 0.57 | ||
25 ≥ Ct < 30 = 30 | 23 | 7 | 0.77 | 0.89 | |
20 ≥ Ct < 25 = 46 | 43 | 3 | 0.94 | 0.94 | |
Ct < 20 = 32 | 30 | 2 | 0.94 | ||
RT-PCR (−) | COVISTIX (+) | COVISTIX (−) | Specificity (CI 95%) | ||
115 | 12 | 103 | 0.90 (0.82–0.94) | ||
(B) | |||||
RT-PCR (+) | COVISTIX (+) | COVISTIX (−) | Sensitivity (CI 95%) | ||
68 | 56 | 12 | 0.82 (0.71–0.90) | ||
Ct ≥ 34 = 11 | 6 | 5 | 0.55 | ||
30 ≥ Ct < 34 = 20 | 15 | 5 | 0.75 | ||
25 ≥ Ct < 30 = 23 | 21 | 2 | 0.91 | 0.95 | |
20 ≥ Ct < 25 = 7 | 7 | 0 | 1.00 | 1.00 | |
Ct < 20 = 7 | 7 | 0 | 1.00 | ||
RT-PCR (−) | COVISTIX (+) | COVISTIX (−) | Specificity (CI 95%) | ||
27 | 4 | 23 | 0.85 (0.66–0.96) | ||
(C) | |||||
RT-PCR (+) | COVISTIX (+) | COVISTIX (−) | Sensitivity (CI 95%) | ||
61 | 46 | 15 | 0.75 (0.63–0.85) | ||
Ct ≥ 34 = 5 | 0 | 5 | 0.0 | ||
30 ≥ Ct < 34 = 5 | 1 | 4 | 0.20 | ||
25 ≥ Ct < 30 = 13 | 9 | 4 | 0.69 | 0.88 | |
20 ≥ Ct < 25 = 22 | 20 | 2 | 0.91 | 0.95 | |
Ct < 20 = 16 | 16 | 0 | 1.00 | ||
RT-PCR (−) | COVISTIX (+) | COVISTIX (−) | Specificity (CI 95%) | ||
387 | 5 | 382 | 0.99 (0.97–1.00) |
PCR (+) | PCR (−) | Total | |
---|---|---|---|
COVISTIX (+) | 85 | 15 | 100 |
COVISTIX (−) | 6 | 845 | 851 |
Total | 91 | 860 | 951 |
Prevalence | 0.096 | ||
Sensitivity | 0.93 (CI 95%: 0.88–0.98) | ||
Specificity | 0.98 (CI 95%: 0.97–0.99) | ||
LR (+) | 0.54 (CI 95%: 0.32–0.89) | ||
LR (−) | 0.07 (CI 95%: 0.03–0.15) | ||
Post-test (+) | 0.85 (CI 95%: 0.77–0.90) | ||
Post-test (−) | 0.01 (CI 95%: 0.00–0.02) | ||
Kappa | 0.88 (CI 95%: 0.81–0.94) | ||
Youden index | 0.92 (SE: 0.026) | ||
Accuracy | 0.98 (CI 95%: 0.97–0.99) | ||
LR: likelihood ratio; Post-test: post-test probability. Kappa: Cohen’s kappa correlation (very good) |
COVISTIXTM | RT-PCR | Interpretation | Observations | |
---|---|---|---|---|
Nasal | NPS | |||
+ | NA | + | Positive | |
- | + | + | Positive | |
+ | − | − | Potential Positive | A sample taken 3 days after must be considered for confirmatory RT-PCR |
− | + | − | Potential Positive | A sample taken 3 days after must be considered for confirmatory RT-PCR |
− | − | − | Negative |
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. |
© 2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
Share and Cite
Garcia-Cardenas, F.; Peñaloza, F.; Bertin-Montoya, J.; Valdéz-Vázquez, R.; Franco, A.; Cortés, R.; Frias-Jimenez, E.; Cedro-Tanda, A.; Mendoza-Vargas, A.; Reyes-Grajeda, J.P.; et al. Analytical Performances of the COVISTIXTM Antigen Rapid Test for SARS-CoV-2 Detection in an Unselected Population (All-Comers). Pathogens 2022, 11, 628. https://doi.org/10.3390/pathogens11060628
Garcia-Cardenas F, Peñaloza F, Bertin-Montoya J, Valdéz-Vázquez R, Franco A, Cortés R, Frias-Jimenez E, Cedro-Tanda A, Mendoza-Vargas A, Reyes-Grajeda JP, et al. Analytical Performances of the COVISTIXTM Antigen Rapid Test for SARS-CoV-2 Detection in an Unselected Population (All-Comers). Pathogens. 2022; 11(6):628. https://doi.org/10.3390/pathogens11060628
Chicago/Turabian StyleGarcia-Cardenas, Francisco, Fernando Peñaloza, Jennifer Bertin-Montoya, Rafael Valdéz-Vázquez, Alba Franco, Ricardo Cortés, Emmanuel Frias-Jimenez, Alberto Cedro-Tanda, Alfredo Mendoza-Vargas, Juan Pablo Reyes-Grajeda, and et al. 2022. "Analytical Performances of the COVISTIXTM Antigen Rapid Test for SARS-CoV-2 Detection in an Unselected Population (All-Comers)" Pathogens 11, no. 6: 628. https://doi.org/10.3390/pathogens11060628
APA StyleGarcia-Cardenas, F., Peñaloza, F., Bertin-Montoya, J., Valdéz-Vázquez, R., Franco, A., Cortés, R., Frias-Jimenez, E., Cedro-Tanda, A., Mendoza-Vargas, A., Reyes-Grajeda, J. P., Hidalgo-Miranda, A., & Herrera, L. A. (2022). Analytical Performances of the COVISTIXTM Antigen Rapid Test for SARS-CoV-2 Detection in an Unselected Population (All-Comers). Pathogens, 11(6), 628. https://doi.org/10.3390/pathogens11060628