SARS-CoV-2 Neutralizing Antibody Test Kit For Hospital CE Certificate

For professional and in vitro diagnostic use only.

For professional and in vitro diagnostic use only.

2019nCov Ag Rapid Test Kit

SARS-Cov-2 Neutralising Antibody Kits
When someone contracts COVID-19, the host’s immune response can be measured by the presence of neutralising antibodies. Neutralising antibodies prevent the interaction between SARS-CoV-2 virus and receptors on human cells, giving the patient immunity.

Neutralising antibody detection is therefore very important in understanding and treating COVID-19. For example, to:

Test neutralising antibody induction during vaccine development, and how long antibodies are present for after infection
Confirm COVID-19 patient immunity
Allow donor selection in convalescent plasma therapy (using the antibodies of immune patients to help patients with active COVID-19)
Identify compounds that can interfere with the mechanism of viral infection, to prevent or treat COVID-19

[PERFORMANCE CHARACTERISTICS]

Sensitivity

The sensitivity to S-mIgG1 neutralizing antibody can reach 2ug/mL.

Accuracy

A side-by-side comparison was conducted by the results of SARS-Cov-2 Neutralizing Antibody Test Device (Test Reagent) developed by Hangzhou Deangel Biological Engineering Co., Ltd. and cPass^TM from Genscript CO., Ltd. 328 clinical specimens from Professional Point of Care site were evaluated, 105 were positive and others negative. Base on the results from the clinical studies, the statistical analysis was made as follows:

For test reagent, the clinical sensitivity with the “Compared Reagent” was 91.4% (95% CI: 77.7%~100%), the clinical specificity was 99.1% (95% CI: 97.2%~100%), the coincidence rate was 96.6% (95% CI: 92.4%~100%).

[SUMMARY]

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.