Model KDX1509 - Covid-19 ELISA
Enzyme Immunoassay for the Quantitative Estimation of IgG Antibodies to Human SARS-CoV-2 (Covid-19) in human serum and plasma, respiratory specimens and cell culture supernatant.
Details
During the current coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS–CoV-2), there has been an unprecedented level of global collaboration that has led to a rapid characterization of SARS–CoV-2. SARS–CoV-2 has a single-stranded, plus-sense, RNA genome of approximately 30?kb, which includes five major open reading frames encoding nonstructural replicase polyproteins and structural proteins (1), namely, spike (S) (4–6), envelope (E), membrane (M), and nucleocapsid (N) (7), and they are in the same order and of approximately the same sizes as those in SARSCoV. The SARS–CoV-2 S gene has 76% amino acid similarity to the SARS-CoV S gene, and nonsynonymous mutations developed in the S protein as the SARS-CoV epidemic progressed. In contrast, the N gene is more conserved and stable, with 90% amino acid homology and fewer mutations over time. N proteins of many coronaviruses are highly immunogenic and are expressed abundantly during infection. High levels of IgG antibodies against N have been detected in sera from SARS patients, and the N protein is a representative antigen for the T-cell response in a vaccine setting, inducing SARS-specific T-cell proliferation and cytotoxic activity. There is no standard reference SARS-CoV-2 antigen material available; accordingly, absolute analytical sensitivity cannot be calculated. We have used antibodies from Sino Biological Inc. which have hown very high specificity as per The SARS-CoV-2 Antibody has not been defined or standardized worldwide. Hence this assay uses standards optimized for the linear range in the assay as AU/ml.
The assay allows the quantitative determination of samples of an unknown concentration titer (immunological titer) and the calibration of the kit standards. It is also important to note that the polyclonal antibody used as standard is interpreted as ng/ml. However, in the absence of standardization of the SARS-CoV-2 antibodies worldwide, the same are expressed as AU/ml in the kit
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