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

By LabMedica International staff writers
Posted on 12 Jan 2021

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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.

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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