Neutralizing antibody rapid test

COVID-19immunitySARS-COV-2

COVID-19 Neutralizing Antibody Test Kit is use Lateral flow immunochromatographic assays for detection of SARS-COV-2 neutralizing antibody (NAb), which can be used to determine the immunity status after infection or vaccination. LIMITATIONS 1. The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) is for in vitro diagnostic use only. This test should be used for the detection of neutralizing antibodies to SARS-CoV-2 or its vaccines in whole blood, serum, or plasma. 2. The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) will only indicate the presence of neutralizing SARS-CoV-2 antibodies in the specimen and should not be used as the sole criterion for the antibody titer detection method. 3. In the recovered patients, the titer of SARS-CoV-2 neutral antibodies concentrations may be above detectable levels. The positive of this assay could not be considered as a successful vaccination program. 4. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy. 5. Results from immunosuppressed patients should be interpreted with caution. 6. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. PRECISION Intra-Assay Within-run precision has been determined by using 15 replicates of two specimens: a negative, and a spiked RBD antibody positive (5ug/mL). The specimens were correctly identified >99% of the time. Inter-Assay Between-run precision has been determined by 15 independent assays on the same two specimens: a negative, and a positive.