Universidade Federal de São Paulo (UNIFESP), Escola Paulista de Medicina (EPM), Laboratório de Virologia, Departamento de Medicina, Divisão de Doenças Infecciosas, São Paulo, SP, Brazil.
Universidade Federal de São Paulo (UNIFESP), Departamento de Medicina, Disciplina de Medicina de Emergência, São Paulo, SP, Brazil.
Braz J Infect Dis. 2022 Mar-Apr;26(2):102349. doi: 10.1016/j.bjid.2022.102349. Epub 2022 Mar 21.
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.
Specimens from 127 suspected patients were tested by both the Panbio™ COVID-19 Ag test and by RT-PCR.
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.
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.
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.
在巴西圣保罗的急诊环境下,针对 RT-PCR(被认为是 SARS-CoV-2 检测的金标准),评估了 Panbio™ COVID-19 Ag 检测的性能特征。本研究旨在确定与 RT-PCR 相比,该检测的敏感性、特异性、阳性百分一致率(PPA)和阴性百分一致率(NPA)。
对 127 例疑似患者的标本同时进行 Panbio™ COVID-19 Ag 检测和 RT-PCR 检测。
与 Ct 值≤40 作为阳性上限的 RT-PCR 相比,Panbio™ COVID-19 Ag 检测的总敏感性为 84.3%(95%CI 75-93.8%),总特异性为 98.2%(95%CI 96-98.8%)。对于 Ct 值≤25(n=37)的患者,Panbio™ COVID-19 Ag 检测的敏感性为 97%。
Panbio™ COVID-19 Ag 检测与 RT-PCR 在 Ct 值低于 25 时的一致性为 97%,但在较高的 Ct 值时一致性降低。为了控制疾病,识别出现 COVID-19 症状的感染者以及因接触感染者而疑似感染的人非常重要。
Panbio™ COVID-19 Ag 检测适合作为一种诊断检测方法,用于快速筛选出现 COVID-19 症状的患者,或那些因接触感染者而疑似感染的患者,然后再将其收入医院。