Evaluation of the performance of kits for rapid antigen testing of SARS-CoV-2 in COVID-19 diagnosis

Abstract

Introduction: In the context of the pandemic caused by SARS-CoV-2, one of the key points to control disease spread was early diagnosis. Thus, several rapid diagnostic kits, such as nasopharyngeal and nasal antigen tests, were commercialized. Objectives: To evaluate the performance of four SARS-CoV-2 rapid antigen test kits, comparing them with the Real-time Reverse Transcription-Polymerase Chain Reaction (RT-qPCR), as the gold standard method. Materials and methods: Results from four rapid test kits performed on nasal or nasopharyngeal swabs from patients who attended the Febrile Urgent Unit of Durand Hospital (Buenos Aires, Argentina) between July 2021 and February 2022 were analyzed and compared with RT-qPCR in nasopharyngeal swabs. Results: A total of 13735 samples were analyzed. The sensitivity, specificity, and positive and negative predictive values of each test were as follows: Panbio™ COVID-19 ANTÍGENO ABBOTT in nasopharyngeal swab: 56.41%, 99.92%, 98.60% and 95.65% respectively; Panbio™ COVID-19 ANTÍGENO ABBOTT in nasal swab: 65.20%, 100%, 100% and 98.80% respectively; COVID-19 Jus- Chek in nasal swab: 77.89%, 99.30%, 93.09% and 97.39% respectively; and GeneFinder™ COVID-19 Ag Plus in nasopharyngeal swab: 78.21%, 99.57%, 97.90% and 100% respectively. Conclusions: The performances for the four kits were similar and had optimal specificity, and positive and negative predictive values. The sensitivity values in the study group were lower than the ones specified by the manufacturer with statistically significant differences.