SARS-CoV-2 antibody assays from numerous suppliers worldwide are currently being sold without corresponding internal quality controls – mainly due to the lack of available positive plasma on the market.
The controls are important to assess laboratory precision and day-to-day assay performance of the testing systems.
To fill this gap, DiaMex GmbH (a sister company of BIOMEX) has developed an Anti-SARS-CoV-2 IgG and IgM control to be used with several different assays. The controls
– are human plasma-based to mimic patient specimen encountered in a daily testing environment and provide a complete quality solution for SARS-CoV-2 #antibody testing,
– react at an appropriate level within the analytical range of the assays with a high lot to lot consistency,
– can be used as third party controls to verify systematic errors and satisfy regulatory guidelines for use of independent controls.
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