CorDx obtains CE Mark for monkeypox tests

By LabPulse.com staff writers

August 25, 2022 -- CorDx has received the CE Mark for three diagnostic tests to detect the monkeypox virus.

The three tests are the following:

  • The Monkeypox Virus IgM/IgG Ab Test, a lateral flow chromatographic immunoassay used for the qualitative detection of monkeypox virus IgM and IgG antibodies in human whole blood/serum/plasma samples.
  • The Monkeypox Virus Ag Test, a lateral flow chromatographic immunoassay for the qualitative detection of monkeypox virus antigen in human rash exudates and blood samples.
  • The Monkeypox Virus Fluorescence PCR Kit, used for the qualitative detection of monkeypox virus nucleic acid in human rash exudates/whole blood/plasma samples. It is also used for clinical auxiliary diagnosis and treatment.

The CE Mark enables CorDx to market all three tests in the European Union.

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Last Updated mp 8/25/2022 12:47:23 PM



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