Evaluation of three immunochromatographic tests in COVID-19 serologic diagnosis and their clinical usefulness
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BRIEF REPORT
Evaluation of three immunochromatographic tests in COVID-19 serologic diagnosis and their clinical usefulness Manuela Pegoraro 1 & Valentina Militello 1 & Gian Luca Salvagno 2 & Stefania Gaino 2 & Antonella Bassi 2 & Cecilia Caloi 1 & Angelo Peretti 1 & Silvia Bizzego 1 & Laura Poletto 1 & Chiara Bovo 3 & Giuseppe Lippi 2 & Giuliana Lo Cascio 1 Received: 26 June 2020 / Accepted: 10 September 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Results of three rapid immunochromatographic tests (ICTs) were compared with those obtained with two automated immunoassays for evaluation of their usefulness. One hundred fifty-nine patients and 67 healthy volunteers were included. Different assays demonstrate 41–45% of diagnostic sensitivities and 91–98% of specificities, with substantial agreement (89.3–91.2%), but a high percentage of weak positive results (13–22%) was observed with ICTs. ICTs performances were comparable to those of automated immunoassays. ICTs could have a role as screening approach due to their easy usability. Subjective interpretation, significant rate of uncertain results, uncertainty on viral antigens source are undoubtedly drawbacks. Keywords SARS-CoV-2 . Immunochromatographic . Serology . COVID-19 . ELISA . CLIA
As COVID-19 pandemic is still ongoing [1], specific antibodies detection is of outmost importance. Besides the availability of immunoenzymatic (ELISA) and chemiluminescence (CLIA) anti SARS-CoV-2 antibodies immunoassays, many other rapid antibody-detecting tests based on immunochromatographic techniques have been recently commercialized. Although the WHO does not clearly endorse their use for patient management, interest is raising around these devices, mainly supported by their easy usability [2, 3]. The aim of this study was to compare diagnostic perform ances of three rapid immunochromatographic tests with those of an automated ELISA and CLIA immunoassays, in order to evaluate their potential usefulness as diagnostic and/or epidemiological tools. Study population consisted of 159 patients (78 males; 81 females; median age 58 ± 20 years; range 6–97 years) admitted to the emergency room, medical, and intensive care units (ICUs) of the Azienda Ospedaliera Universitaria Integrata of Giuseppe Lippi and Giuliana Lo Cascio contributed equally to this work. * Manuela Pegoraro [email protected] 1
Microbiology and Virology Unit, Department of Pathology, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy
2
Section of Clinical Biochemistry, University of Verona, Verona, Italy
3
Medical Direction, University Hospital of Verona, Verona, Italy
Verona with symptoms suggestive of SARS-CoV-2 infection, between the end of February and the beginning of April. Control group consisted of 67 healthy volunteer’s (10 males; 57 females; median age 49 ± 9 years; range 26–66 years). For each patient, upper respiratory specimen and blood sample were collected for COVID-19 molecular and serologic diagnosis, respectively. Negative and inconclusi
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