Menchinelli Giulia, De Angelis Giulia, Cacaci Margherita, Liotti Flora Marzia, Candelli Marcello, Palucci Ivana, Santangelo Rosaria, Sanguinetti Maurizio, Vetrugno Giuseppe, Franceschi Francesco, Posteraro Brunella
Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.
Dipartimento di Scienze di Laboratorio e Infettivologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.
Diagnostics (Basel). 2021 Jul 5;11(7):1211. doi: 10.3390/diagnostics11071211.
SARS-CoV-2 antigen detection has currently expanded the testing capacity for COVID-19, which yet relies on the SARS-CoV-2 RNA RT-PCR amplification.
To report on a COVID-19 testing algorithm from a tertiary care hospital emergency department (ED) that combines both antigen (performed on the ED) and RT-PCR (performed outside the ED) testing.
Between December 2020 and January 2021, in a priori designated, spatially separated COVID-19 or non-COVID-19 ED areas, respectively, symptomatic or asymptomatic patients received SARS-CoV-2 antigen testing on nasopharyngeal swab samples. Antigen results were promptly accessible to guide subsequent, outside performed confirmatory (RT-PCR) testing.
Overall, 1083 (100%) of 1083 samples in the COVID-19 area and 1815 (49.4%) of 3670 samples in the non-COVID-19 area had antigen results that required confirmation by RT-PCR. Antigen positivity rates were 12.4% (134/1083) and 3.7% (66/1815), respectively. Compared to RT-PCR testing results, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of antigen testing were, respectively, 68.0%, 98.3%, 88.8%, and 94.1% in the COVID-19 area, and 41.9%, 97.3%, 27.3%, and 98.6% in non-COVID-19 area. Practically, RT-PCR tests were avoided in 50.6% (1855/3670) of non-COVID-19 area samples (all antigen negative) from patients who, otherwise, would have needed antigen result confirmation.
Our algorithm had value to preserve RT-PCR from avoidable usage and, importantly, to save time, which translated into a timely RT-PCR result availability in the COVID-19 area.
严重急性呼吸综合征冠状病毒2(SARS-CoV-2)抗原检测目前扩大了新型冠状病毒肺炎(COVID-19)的检测能力,但仍依赖于SARS-CoV-2 RNA逆转录聚合酶链反应(RT-PCR)扩增。
报告一家三级医疗机构急诊科(ED)的COVID-19检测算法,该算法结合了抗原检测(在急诊科进行)和RT-PCR检测(在急诊科外进行)。
2020年12月至2021年1月期间,在预先指定的、空间上分开的COVID-19或非COVID-19急诊科区域,有症状或无症状的患者分别接受鼻咽拭子样本的SARS-CoV-2抗原检测。抗原检测结果可立即获取,以指导后续在外部进行的确认性(RT-PCR)检测。
总体而言,COVID-19区域的1083份样本中有1083份(100%)以及非COVID-19区域的3670份样本中有1815份(49.4%)的抗原检测结果需要通过RT-PCR进行确认。抗原阳性率分别为12.4%(134/1083)和3.7%(66/1815)。与RT-PCR检测结果相比,抗原检测在COVID-19区域的敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV)分别为68.0%、98.3%、88.8%和94.1%,在非COVID-19区域分别为41.9%、97.3%、27.3%和98.6%。实际上,在非COVID-19区域的样本中,50.6%(1855/3670)原本需要抗原结果确认的患者(所有抗原检测均为阴性)避免了进行RT-PCR检测。
我们的算法对于避免RT-PCR的不必要使用具有价值,重要的是,还能节省时间,这使得COVID-19区域能够及时获得RT-PCR检测结果。