Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants.

ABSTRACT:

Background

SARS-CoV-2 antigen-based tests are well-calibrated to infectiousness and have a critical role to play in the COVID-19 public health response. We report the development and performance of a unique lateral flow immunoassay (LFA).

Methods

Combinations of several monoclonal antibodies targeting multiple antigenic sites on the SARS-CoV-2 nucleocapsid protein (NP) were isolated, evaluated, and chosen for the development of a LFA termed CoV-SCAN (BioMedomics, Inc.). Clinical point-of-care studies in symptomatic and asymptomatic individuals were conducted to evaluate positive predictive agreement (PPA) and negative predictive agreement (NPA) with RT-PCR as comparator.

Results

In laboratory testing, CoV-SCAN detected 14 recombinant N-proteins of SARS-CoV-2 variants

SUBMITTER: Liu L 

PROVIDER: S-EPMC9067019 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature