SARS-CoV-2 ISO13485 Rapid Neutralizing Antibody Test Kit 96.6%

For professional and in vitro diagnostic use only.

For professional and in vitro diagnostic use only.

Advantage

• It can not only screen in the window period of infection oneset but also indicate the previous infection and reduce the rate of missed diagnosis
• Blood sample detection , simple samplig, simple operation
• Combined with nucleic acid kit to improve the screening rate of suspected patients
• Rapid screening within 10-15minutes, resukts effective for 15minutes
• Single detection, visual interpretation, no equipment, to adapt to the community
• Easy operation, compatible with different samples
• Room temperature storage

[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.