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.