key: cord-0777573-qz3ec3vs
authors: Merino, Paloma; Guinea, Jesús; Muñoz-Gallego, Irene; González-Donapetry, Patricia; Galán, Juan Carlos; Antona, Nerea; Cilla, Gustavo; Hernáez-Crespo, Silvia; Díaz-de Tuesta, José Luis; Torrella, Ana Gual-de; González-Romo, Fernando; Escribano, Pilar; Sánchez-Castellano, Miguel Ángel; Sota-Busselo, Mercedes; Delgado-Iribarren, Alberto; García, Julio; Cantón, Rafael; Muñoz, Patricia; Folgueira, María Dolores; Cuenca-Estrella, Manuel; Oteo-Iglesias, Jesús; Medrano, Sara; Pérez, Alba; Galar, Alicia; Martínez-Expósito, Oscar; Alejo-Cancho, Izaskun; Martín-Higuera, M. Carmen; Rolo, Marta; Estévez, Ma Jesús; Bravo, Tania; Vicente, Diego; Montes, Mila
title: Multicenter evaluation of the Panbio™ COVID-19 rapid antigen-detection test for the diagnosis of SARS-CoV-2 infection
date: 2021-02-16
journal: Clin Microbiol Infect
DOI: 10.1016/j.cmi.2021.02.001
sha: a455e195bcfaf2ace3fcbc640d5e24de6d1736e3
doc_id: 777573
cord_uid: qz3ec3vs

OBJECTIVES: The standard RT-PCR assay for COVID-19 is laborious and time-consuming, limiting the availability of testing. Rapid antigen-detection tests are faster and less expensive; however, the reliability of these tests must be validated before they can be used widely. The objective of this study was to determine the performance of the Panbio(TM) COVID-19 Ag Rapid Test Device (PanbioRT) (Abbott) for SARS-CoV-2 in nasopharyngeal swab specimens. METHODS: This prospective multicenter study was carried out in ten Spanish university hospitals including individuals with clinical symptoms or epidemiological criteria for COVID-19. Only individuals with ≤ 7 days from the onset of symptoms or from exposure to a confirmed case of COVID-19 were included. Two nasopharyngeal samples were taken to perform the PanbioRT, as a point-of-care test, and a diagnostic RT-PCR test. RESULTS: Among the 958 patients studied, 325 (90.5%) had true-positives results. The overall sensitivity and specificity for the PanbioRT were 90.5% (CI 95%: 87.5-93.6) and 98.8% (CI 95%: 98-99.7), respectively. Sensitivity in participants who had a C(T) <25 for the RT-PCR test was 99.5% (CI 95%: 98.4-100), and in participants with ≤5 days of the clinical course was 91.8% (CI 95%: 88.8-94.8). Agreement between techniques was 95.7% (kappa score: 0.90; CI 95%: 0.88–0.93). CONCLUSIONS: The PanbioRT provides good clinical performance, with even more reliable results for patients with a shorter clinical course of the disease or a higher viral load. The results must be interpreted based on the local epidemiological context.

There are ongoing efforts to develop fast, reliable, and inexpensive diagnostic tests 78 specific for detection of SARS-CoV-2 antigens. Rapid antigen-detection tests (RADT), 79 for both laboratory and near-patient use, detect SARS-CoV-2 proteins produced by 80 replicating viruses in respiratory secretions [1] . Currently were women (Table 1 ) and 58 cases were in paediatric patients (≤14 years old).

Among these 958 patients, RT-PCR was positive in 359 (37.5%) and negative in 599 153 (62.5%). PanbioRT was positive in 332 (34.7%) and negative in 626 (65.3%) ( Table 2) 154

The agreement between both methods was 95.7% (kappa score: 0.90; CI 95%: 0.88-155 0.93). In 41 patients the results differed between the two tests, 34 of them were positive 156 with the RT-PCR test but negative with the PanbioRT (false negatives; 3.5% of total 157 cases); the remaining seven discrepancies were false positives of PanbioRT (Table 2,   158 Supplementary material, Table S1 ). All 34 false negatives were in symptomatic Table S1 ).

Based on these data, the overall sensitivity and specificity of the PanbioRT were 90.5% 164 (CI 95%: 87.5-93.6) and 98.8% (CI 95%: 98-99.7), respectively (Table 3) . Sensitivity 165 ranged between hospitals from 67% to 100%, with nine of the 10 participating hospitals 

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