key: cord-0866182-4akfm3v2
authors: Linares, Manuel; Pérez-Tanoira, Ramón; Carrero, Ana; Romanyk, Juan; Pérez-García, Felipe; Gómez-Herruz, Peña; Arroyo, Teresa; Cuadros, Juan
title: Panbio antigen rapid test is reliable to diagnose SARS-CoV-2 infection in the first 7 days after the onset of symptoms
date: 2020-10-16
journal: J Clin Virol
DOI: 10.1016/j.jcv.2020.104659
sha: 8c374e69104d5d12fd8bb863dbf6c22ceb39ab74
doc_id: 866182
cord_uid: 4akfm3v2

BACKGROUND: RT-qPCR is the current recommended laboratory method to diagnose SARS-CoV-2 acute infection, several factors such as requirement of special equipment, time consuming, high cost and skilled staff limit the use of these techniques. A more rapid and high-throughput method is essential. METHODS: We analyzed clinical data and nasopharyngeal samples, collected during September 2020, from patients attended at the emergency department of a secondary hospital and in two primary healthcare centers in Madrid. The performance of the Panbio™ COVID-19 AG Rapid Test Device for the detection of SARS-CoV-2 antigen was compared to RT-qPCR. RESULTS: 255 nasopharyngeal swabs, including 150 from the emergency department and 105 from primary helthcare centers, were tested. 184 patients were symptomatic (72.1 %). Amongst the 60 positive RT-qPCR samples, 40 were detected by the rapid antigen test, given an overall sensitivity of 73.3 %. All the samples detected positive with the rapid antigen test were also positive with RT-qPCR. The median cycle threshold was 23.28 (IQR 18.5–30.16). Patients with less than seven days onset of symptoms showed a higher viral load, and sensitivity for rapid antigen test (86.5 %), compared to those with more days (sensitivity of 53.8 %)(p < 0.004). CONCLUSIONS: The rapid antigen test evaluated in this study showed a high sensitivity and specificity in samples obtained during the first week of symptoms and with high viral loads. This assay seems to be an effective strategy for controlling the COVID-19 pandemic for the rapid identification and isolation of SARS-CoV-2 infected patients.

Specificity and sensitivity with 95% confidence intervals (95%CI) were calculated using the RT-PCR results as gold standard. Sensitivity was evaluated globally and also according to the time from the onset of symptoms (≤ 5days, < 7 days and > 7 days). Agreement between techniques was evaluated using Cohen's kappa score. (11) Continuous variables were presented as median and interquartile range (IQR) and categorical variables as proportions. We used the Mann-Whitney U-test, χ2 test, or Fisher's exact test to compare differences between survivors and non-survivors where appropriate. For these comparisons, a p value of 0.05 or below was considered significant. Statistical analysis was performed with SPSS v20.0 (IBM Corp., Armonk, NY, USA). The RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads (table 2 and table 3 

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The authors declare that they have no conflicts of interest.