Evaluation of the Panbio™ COVID-19 ag rapid test at an emergency room in a hospital in São Paulo, Brazil

Faíco-Filho, Klinger Soares; Finamor Júnior, Francisco Estivallet; Moreira, Luiz Vinícius Leão; Lins, Paulo Ricardo Gessolo; Justo, Alberto Fernando Oliveira; Bellei, Nancy

doi:10.1016/j.bjid.2022.102349

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Brazilian Journal of Infectious Diseases

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Original Article • Braz J Infect Dis 26 (02) • 2022 • https://doi.org/10.1016/j.bjid.2022.102349 copy

Evaluation of the Panbio™ COVID-19 ag rapid test at an emergency room in a hospital in São Paulo, Brazil

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Background

The performance characteristics of the Panbio™ COVID-19 Ag test was evaluated at an emergency room setting against RT-PCR, considered the gold-standard for the detection of SARS-CoV-2, in São Paulo, Brazil. The study aimed to determine the sensitivity, specificity, Positive Percent Agreement (PPA), and Negative Percent Agreement (NPA) as compared to RT-PCR.

Methods

Specimens from 127 suspected patients were tested by both the Panbio™ COVID-19 Ag test and by RT-PCR.

Results

In relation to RT-PCR using Ct values ≤ 40 as the upper limit for positivity, the Panbio™ COVID-19 Ag test showed an overall sensitivity of 84.3% (95% CI 75‒93.8%) and 98.2% (95% CI 96‒98.8%) overall specificity. For Ct values ≤ 25 (n= 37), the Panbio™ COVID-19 Ag test showed 97% sensitivity.

Discussion

The concordance between the Panbio™ COVID-19 Ag test and RT-PCR was 97% at Ct values below 25 but decreased at higher Ct values. For disease control, it is very important to identify infected individuals who present COVID-19 symptoms and also those who are suspected of infection due to contact with infected individuals.

Conclusion

The Panbio™ COVID-19 Ag test is suitable for use as a diagnostic test for rapid screening of patients presenting COVID-19 symptoms, or those suspected of being infected, prior to being admitted to hospital.

Keywords
SARS-CoV-2; Panbio™ COVID-19 Ag test; Hospital

	PCR negative (n= 57)	PCR positive (n= 70)	p-value	Total (n= 127)
Age (mean ± SD)	54.74 ± 19.25	64.31 ± 14.83	0.002	60 ± 17.5
Male sex (%)	29 (50.9%)	40 (57.1%)	0.481	69 (54.3%)
Time of symptoms (days, mean)	5 (3; 7)	6 (4; 7)	0.06	5 (4; 7)
Ct value (mean, range)	40 (40; 40)	25 (21.75; 28)	< 0.001	32 (25; 40)

	Antigen negative (n= 67)	Antigen positive (n= 60)	p-value	Total (n= 127)
Age (mean ± SD)	55.94 ± 18.60	64.57 ± 15.19	0.005	60 ± 17.5
Male sex (%)	35 (52.2%)	34 (56.7%)	0.617	69 (54.3%)
Time of symptoms (days, mean)	5 (3; 7)	6 (4; 7)	0.178	5 (4; 7)
Ct Value (mean, range)	40 (40; 40)	24.5 (21; 28)	< 0.001	32 (25; 40)

Sample	Ct value	Days post onset of symptoms
1	21	8
2	26	2
3		4
4		7
5	28	10
6	30	7
7	31	11
8	32	4
9 and 10	34	5
9 and 10	34	6

Panbio^TM COVID-19 Ag test	≤ 25	≤ 30	≤ 35	≤ 40
Positive	36	52	57	59
Negative	1	7	11	11
Sensitivity (%)	97.3	88.1	83.8	84.3
PPV (%)	60.0	86.7	95.0	98.3
NPV (%)	98.5	89.5	83.6	83.6
Accuracy (%)	80.3	81.2	89.0	90.6
Kappa	0.78	0.76	0.59	0.27

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E-mail: bjid@bjid.org.br

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[1] ⁎Corresponding author at: Laboratório de Virologia, Division of Infectious Diseases, Department of Medicine, Escola Paulista de Medicina (EPM), Rua Pedro de Toledo 781 -15 andar CEP- 04039 032, São Paulo, Brazil. E-mail address: nbellei@uol.com.br (N. Bellei).