Diagnostic Accuracy of a New Antigen Test for SARS-CoV-2 Detection

Background and aims: Quick and reliable diagnostic tools play an important role in controlling the spread of the SARS-Cov-2 pandemic. The aim of this study was to evaluate the diagnostic accuracy of a new cyto-salivary antigen test aimed at detecting the presence of antigens for SARS-CoV-2, as compared by the gold standard RT-PCR and a lateral flow test. Methods: A total of 433 healthy volunteers were enrolled in the study and the sensitivity and specificity of the new cyto-salivary antigen test were calculated, as compared to the RT-PCR nasopharyngeal swab and to the lateral flow test. Results: A total of 433 samples were collected and tested at the Mediterranean Fair in Palermo from February 2021 until April 2021. The new cyto-salivary antigen had a sensitivity of 100% and a specificity of 94.2%. The sensitivity and the specificity of the lateral flow test were 55% and 100%, respectively. Conclusions: The new cyto-salivary antigen test detected more positive cases than the RT-PCR in a sample of asymptomatic subjects, demonstrating to be a promising tool for a more sensitive diagnosis of COVID-19. Further studies are warranted to better characterize its diagnostic accuracy.

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In vitro characterisation and clinical evaluation of the diagnostic accuracy of a new antigen test for SARS-CoV-2 detection.

10.1101/2021.10.28.21265544 ◽

2021 ◽

Author(s):

J.J. Montoya ◽

J.M. Rubio ◽

Y. Ouahid ◽

A. Lopez-Lopez ◽

A. Madejon ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Test System ◽

Lateral Flow ◽

Diagnostic Tools ◽

Test Field ◽

Antigen Test ◽

Rt Pcr ◽

Lateral Flow Test ◽

Lateral Flow Tests

Background and aims: Quick, user-friendly and sensitive diagnostic tools are the key to controlling the spread of the SARS-CoV-2 pandemic in the new epidemiologic landscape. The aim of this work is to characterise a new Covid-19 antigen test that uses an innovative chromatographic Affimer-based technology designed for the qualitative detection of SARS-CoV-2 antigen. As rapid technology to detect Covid-19, the test was extensively characterised in vitro. Once the analytical parameters of performance were set, the test system was challenged in a test field study. The aim of this study was to evaluate its diagnostic accuracy, as compared by the gold standard RT-PCR and other existing lateral flow tests. The study was approved by MiRNAX corporate review board to ensure i) that the test complied with all the ethical requirements, ii) that the rights of participants were protected, and iii) that donors were fully informed about the likelihood that they would not personally benefit from the research. The tests were completed under the frame of Project SENSORNAS RTC-20176501 in collaboration with MiRNAX Biosens Ltd. and Hospital Carlos III and are currently under submission and review from the Ethics Committee of Universidad Autonoma de Madrid. Keywords: respiratory disease COVID-19; SARS-CoV-2; ELISA; RT-PCR; antigen lateral flow test.

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