9/20/2023 0 Comments Semi quant total ab![]() ![]() ![]() Efficient and accurate testing is critical to understand the full breadth of impact and to developing countermeasures to limit future infections.ĭetection of SARS-CoV-2 infection relies predominantly on two approaches: nucleic acid testing, which detects viral RNA, and serological testing, which detects antibodies elicited against SARS-CoV2 antigens. As of November 10, 2020, over 51 million cases and over 1.2 million deaths have been reported due to COVID-19, and the disease continues to be a source of economic and societal strain. Officially named severe acute respiratory coronavirus 2 (SARS-CoV-2) by the International Committee on Taxonomy of Viruses due to its phylogenetic relatedness to SARS and SARS-like coronaviruses 3, the virus causes coronavirus disease 2019 (COVID-19). In the ensuing months the virus became established internationally through travel and community transmission, leading to the declaration of a pandemic by the WHO on Ma2. In December 2019, a novel coronavirus emerged in Wuhan, China, causing severe respiratory disease with initial reported fatality rates of 2–3% 1. In a broader sense, BLI-ISA can be developed as a novel diagnostic platform to evaluate antibodies and other biomolecules in clinical specimens. Importantly, our method can be immediately implemented on existing BLI platforms for urgent COVID-19 studies, such as serosurveillance and the evaluation of vaccine candidates. BLI-ISA meets or exceeds the performance of high complexity methods such as Enzyme-Linked Immunosorbent Assay (ELISA) and Chemiluminescent Immunoassay. Complete semi-quantitative results are obtained in less than 20 min. Our biolayer interferometry immunosorbent assay (BLI-ISA) utilizes single-use biosensors in an automated “dip-and-read” format, providing real-time optical measurements of antigen loading, plasma antibody binding, and antibody isotype detection. Here, we describe a novel application of biolayer interferometry for the rapid detection of antigen-specific antibody levels in plasma samples, and demonstrate its utility for quantification of SARS-CoV-2 antibodies. Rates of response decay will be produced overall, and stratified by HIV status, booster type and baseline CD4 cell count.Serological testing to evaluate antigen-specific antibodies in plasma is generally performed by rapid lateral flow test strips that lack quantitative results or by high complexity immunoassays that are time- and labor-intensive but provide semi-quantitative results. Univariate linear regression will be used to estimate rates of antibody levels decay, among individuals with at least two antibody measurements, including one after the booster dose. In the sub-population of individuals who received a COVID vaccine booster, vaccination and antibody response will be characterized at least 3 weeks after the booster is received. Among individuals with at least two antibody measurements, rates of antibody levels decay will be estimated using univariate linear regression, overall and stratified by HIV status, vaccine type and baseline CD4 cell count. Incidence rates of COVID vaccine response levels (i.e., adequate, low, non-response) will be estimated using univariate Poisson regression, overall and by vaccine type. The study population will include adults who were fully vaccinated against SARS-CoV-2 virus (i.e., two doses of Pfizer or Moderna vaccines or one dose of the J&J vaccine), and have received a Roche SARS-CoV-2 Semi-Quant Spike Ig Ab test at least 3 weeks after full vaccination as part of their usual clinical care at AHF Midtown Manhattan Healthcare Center. The aim of this study is to assess levels of COVID-19 vaccine response through measuring surrogate Ig spike antibody measurements, to determine the rates of antibody level decay after vaccination, and to measure the efficacy of utilizing these antibody measurements to help guide the timing of booster doses among HIV-negative and HIV-positive patients. Why Should I Register and Submit Results?. ![]()
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