Results come out in 15 minutes! Two SARS-CoV-2 antibody detection kits of Sansure Biotech received CE mark
2021-12-14 yang, rongchang

Results come out in 15 minutes! Two SARS-CoV-2 antibody detection kits of Sansure Biotech received CE mark


Sansure Biotech Dec 14,2021

On December 8, Sansure Biotech’s SARS-CoV-2 Neutralizing Antibodies Test (Colloidal Gold) and SARS-CoV-2 S-RBD Antibodies Test (Colloidal Gold) passed CE certification and received the certificate. This is the first batch of antibody products in the company’s immune product line to receive international authoritative registration certificate following the antigen detection kits receiving CE certification, which further enriches the company’s immune product line. 

Although a variety of SARS-CoV-2 vaccines have been approved worldwide and are being administered to a wide range of people, issues such as their protectiveness and duration of protection are still worth exploring, and the evaluation of vaccine effectiveness has been a focus in the vaccine industry. The SARS-CoV-2 Neutralizing Antibodies/S-RBD Antibodies Test reflects the rate of infection in the population, the recovery of individuals, and the effectiveness of the vaccine.

The CE-certified SARS-CoV-2 Neutralizing Antibodies/S-RBD Antibodies Test of Sansure Biotech, based on immunochromatography assay, enables the detection of neutralizing antibody or S-RBD antibody in human blood samples within 15 minutes, and allows the reading of results with the naked eye: a positive result indicates the presence of neutralizing antibody/S-RBD antibody in the human body, while a negative result indicates that the human body has not been vaccinated or needs to be revaccinated. The product is tailored for rapid detection in different scenarios, simple and convenient to operate without the help of instruments. Due to its short time consumption and low threshold, this product is more suitable for SARS-CoV-2 outbreaks with rapid transmission and wide infection coverage than traditional detection methods by virus neutralization assay.