Introduction

Approach for in vitro diagnosis of SARS-CoV-2 infection through the direct detection of at least one SARS-CoV-2 protein in biological fluid samples from a subject.

Technical features

The invention entails the realization of a device for the rapid test of SARS-CoV-2 infection. The lateral flow approach is based on antibodies against at least one viral protein, so to detect directly the presence of SARS-CoV-2 in small amounts of biological fluids (e.g., saliva, sputum, naso- and oro-pharyngeal swabs). The appearance of a red test line is indicative of a positive result to infection. The control line is indicative of the validity of the test. Results are obtained within twenty minutes, which represents a dramatic reduction of times when compared to molecular diagnostics techniques for virus detection. As opposed to tests presently available, this assay is suitable for population level screening, it can be performed by non-healthcare professionals and the results are immediately available, so to redirect positive subjects to confirm the infection by molecular diagnostics. The accuracy of this assay (90% sensitivity in PoC) is comparable to the one of molecular tests.

Possible Applications

• Whole-population screening;
• Detection of asymptomatic subjects;
• Monitoring of infected subjects;
• Identification of subjects to be assessed by molecular diagnostics.

Advantages

• Rapid;
• Cheap;
• High sensitivity and specificity;
• Direct;
• Non-invasive;
• Competitive as compared to the available diagnostic strategies.