Evaluation of the Performance Characteristics for SARS-CoV-2 S-RBD IgG Antibody Rapid Test Cassette (Fingerstick Whole Blood) by Comparing CLIA Test

Background: SARS-CoV-2, a branch of coronavirus, is a positive-strand RNA virus with four major proteins and several auxiliary proteins wrapped with genetic material. It mediates the invasion of the virus mainly through the binding of the S protein to host cell receptors and determines the organization of virus and host tropism. Human coronaviruses are one of the fastest-developing viruses due to their high genomic nucleotide substitution rate and recombination ability. Human coronaviruses are associated with a variety of respiratory diseases of varying severity, such as colds, pneumonia, and bronchitis. On January 30 2020, the World Health Organization (WHO) declared that the COVID-19 outbreak caused by SARS-CoV2 constituted a public health emergency of international concern (PHEIC) and characterized as a pandemic on March 11 2020. In an effort to expedite the availability of in vitro diagnostics (IVDs) needed in public health emergencies, the WHO has opened the development of an emergency use checklist process, which aims to assist procurement agencies and Member States in deciding whether a specific IVD is suitable for use based on a minimum set of available quality, safety and performance data. IVDs with guaranteed quality, safety and performance are a key component of the overall strategy to control the pandemic.Objective: The main purpose of this evaluation report is to investigate the sensitivity of the SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood) for diagnosis during COVID-19. Method: The SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood) is a rapid chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human fingerstick whole blood approximately 10 days after vaccination. Result: Through the clinical evaluation of vaccinated, unvaccinated, and virus-uninfected populations, the results show that the overall relative sensitivity of SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood) is 97.7%, the relative specificity is 99.0%, and the relative accuracy is 98.5%. Conclusion: CITEST SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Fingerstick Whole Blood) is a rapid test that is a qualitative membrane-based immunoassay intended to detect IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in fingerstick whole blood. The product is simple to operate and has been validated against an industry leading commercial CLIA test to give results within 10 minutes of the sample being tested. A comparison of 1257 samples showed an accuracy of 98.5% and an excellent sensitivity of 97.7%. People can use the test kits to get accurate results and determine if they have antibodies in their bodies after they have been vaccinated.