COVID-19 rapid antigen tests are found to be less sensitive for the Omicron variant compared to the earlier circulating virus variants (1), necessitating a reassessment of the diagnostic performance of current EUA-approved test devices (2). To ensure tests continue to perform as intended, Leadgene conducted a comprehensive epitope binning study and identified the next-generation of COVID-19’s antibody pairs (Table 1).
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Table 1. Anti-SARS-CoV-2 nucleocapsid (NP) antibody pairs for detection of Omicron. Identified by comprehensive screening, these pairs have been successfully used to develop lateral-flow-based rapid test devices for the Omicron variant (BA.4/ BA.5).
Lateral flow assays using these next-generation antibody pairs exhibit outstanding results for the detection towards the inactivated virus of Omicron, with the sensitivity of >95% in samples with a Ct value of less than 27 found in PCR tests.
The limit of detection for nucleocapsid protein was reported at a range of 25~100 pg/mL.
References:
1. Microbiol Spectr. 2022 Aug 31;10(4):e0085322.
2. FDA, Medical Devices 09/14/2022, SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests
