High Specificity Tests for Important Infectious Diseases

Astra Biotech GmbH is preparing to launch a range of test kits for the diagnosis and monitoring of infectious diseases with the potential for significant pathogenesis. Based on the ELISA principle and characterised by high specificity, these kits detect the presence of IgG antibodies to Herpes simplex virus (HSV), Toxoplasma gondii, Hepatitis B virus and HIV. Additionally, IgG avidity is determined using an Astra Biotech Toxoplasma Test Kit.

The Herpes Simplex Type 1 kit provides quantitative detection of HSV 1 specific IgG, allowing monitoring of antibody concentration and estimation of therapy effectiveness. Whereas IgM tests may give misleading results and cannot distinguish between HSV 1 and HSV 2, this kit is both highly sensitive and highly specific.

Diagnosis of a recently acquired primary Toxoplasma infection is not easy, in that the IgM antibodies (a typical marker for recent infections) developed during toxoplasmosis may persist for many months and even for years. However, recent infections can be identified with Astra Biotech's Toxoplasma-IgG-Avidity kit which measures the avidity of specific IgG. This is possible as the initial IgG antibody response to infection is characterised by antibodies with low avidity. Also available is a Toxoplasma IgG kit which enables diagnosis of the acute phase of the disease and monitoring of the recovery process.

The Astra Biotech range includes two kits which detect and confirm the presence of Hepatitis B surface antigen, and two kits which detect antibodies to HIV-1 and HIV-2. The HIV-HIV-Ag/At product also detects the p24 antigen, a marker appearing as early as 1-3 weeks after contamination and therefore enabling very early diagnosis of HIV infection.

Astra Biotech ELISA test kits are manufactured by incorporating only certified high purity reagents and in accordance with stringent internal quality control procedures. All the assays are IVD-compliant and therefore suitable for direct diagnostic purposes. The standard 96-well plate format fits into all work flows and the assays' high specificity and sensitivity parameters allow consistently accurate results and guarantee high reproducibility.