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: Hospital; Panbio™ COVID-19 Ag test; SARS-CoV-2.
【저자키워드】 SARS-CoV-2, hospital, Panbio™ COVID-19 Ag test, 【초록키워드】 COVID-19, Brazil, SARS-CoV-2, diagnostic test, Infection, diagnostic, RT-PCR, sensitivity, specificity, Concordance, Characteristics, disease control, Patient, agreement, disease, COVID-19 symptoms, emergency room, Contact, Ct values, COVID-19 symptom, contact with, 95% CI, infected individual, infected individuals, negative, limit, tested, identify, evaluated, determine, presenting, suspected patient, 【제목키워드】 COVID-19, Brazil, Rapid test,