Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

Intended purpose

The SERION ELISA Herpes Simplex Virus 1, 2 & 1&2, IgG & IgM are an Enzyme-linked Immunosorbent Assays intended for the detection of human antibodies, in serum or plasma, directed against Herpes Simplex Virus type 1 or 2. The assay supports the diagnosis and aetiology of acute infections, and assists in the differential diagnosis of diseases and conditions which present with similar symptoms. The test delivers quantitative results and there are no variants of the test. The product is intended to be used by qualified clinical laboratory personnel in suitably equipped laboratories and is capable of being performed manually or on a range of suitable laboratory automated instruments (listed in the Instructions For Use -IFU)