SARS-COV-2 test kit HWTS-RT055A

for infectious diseasesCOVID-19coronavirus

Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Spike RBD Antibody was intended to detect the valence of Antibody of SARS-CoV-2 Spike RBD Antigen in serum/plasma from population inoculated by SARS-CoV-2 vaccine. Certificate CE Epidemiology Coronavirus Disease 2019 (COVID-19) is a pneumonia caused by infection with a new coronavirus named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 was a strain in beta-CoV virus capsulated particulates in round or elliptical shape with diameters about 60nm-140nm. COVID-19 is an acute respiratory infectious disease, and the population is generally susceptible. Currently known infection source of COVID-19 are infected COVID-19 cases and asymptomatic carrier of SARS-CoV-2. Population inoculated by SARS-CoV-2 vaccine can generate spike RBD antibody or S antibody of SARS-CoV-2 detectable in serum and plasma, which can be as indicator to evaluate the efficiency of inoculating SARS-CoV-2 vaccine. Technical Parameters Storage 2-8℃ Shelf-life 12 months Specimen Type human serum, plasma, samples with anticoagulant of EDTA, heparin sodium and sodium citrate CV ≤15.0% LoD The kit was validated by manufacturer’s LOD references with agreement rate 100%. Specificity Elevated interfering substances in specimen do not influence performance of the kit for detecting SARS-CoV-2 spike RBD antibody. The tested interfering substances included hemoglobin (500mg/dL), bilirubin (20mg/dL), triglyceride (1500 mg/dL), heterophil antibody (150U/mL), rheumatoid factors (100U/mL), 10%(v/v) human blood, phenylephrine (2mg/mL),