Snibe Diagnostic’s Maglumi SARS-CoV-2 Neutralizing Antibody Assay Receives CE Mark

By LabMedica International staff writers
Posted on 12 Jan 2021

Snibe Diagnostic (Shenzhen, China) has received CE marking for its Maglumi SARS-CoV-2 Neutralizing Antibody Assay.

The fully automated test can detect neutralizing antibodies against SARS-CoV-2 within 20 minutes when used with the company’s Maglumi analyzers. Designed for highly sensitive and specific detection of SARS-CoV-2 neutralizing antibodies, the assay aims to address the urgent need for assessing immunity during the COVID-19 pandemic. It can be used to determine the immune status of COVID-19 patients and individuals who have been vaccinated against the virus. By evaluating immunity in individuals and the community, the test can provide “immunity certification” for those returning to the society.

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The new assay shows a high agreement rate with the gold standard Virus Neutralization Test (VNT/PRNT), indicating that it could be a useful tool for assessment of the immunity to SARS-CoV-2 infection. The Maglumi SARS-CoV-2 Neutralizing Antibody Assay could also serve as an important tool for assessment of the efficacy of COVID-19 vaccines.

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