General Remarks

All preparations are medical products. They meet the definitions and requirements of the Directive 98/79/EC (IVD Directive) and therefore carry the CE label.

Test Reagents, Enteroclons and Test Sera

The test reagents are composed of a mixture of rabbit antisera and monoclonal antibodies, or solely of monoclonal antibodies. Test reagents which only contain monoclonal antibodies carry SIFIN's product name Enteroclon.
The monoclonal antibodies (MAb) are obtained by immunising mice and fusion of the spleen cells with a mouse myeloma cell line. Compared with the polyclonal test sera, Enteroclons represent a new generation of serological diagnostic materials, displaying the following characteristics:

• uniformity: the antibodies they contain are uniform with respect to structure, stability, antigen binding site and avidity

• standardisability: their effectiveness can be standardised by reproducible adjustment of the antibody concentration

• freedom from unwanted accompanying antibodies

• cross-reactions due to antigen relatedness have been avoided to the greatest possible extent by selection and charactierisation of the cell clones. Cross-reactions due to antigen identity cannot be completely excluded even for monoclonal antibodies - details are given in the instructions for use

• independence from immune serum donors

• isolation of antibody specificities that cannot be produced polyclonally (for example, O 13, H 1, H e, Hg, H n)

The test sera are produced by immunising rabbits with killed bacteria of selected serovars. Where necessary, unwanted accompanying antibodies are removed by absorption.

Applications

The test reagents and test sera are intended for use in microbiological diagnostics laboratories, for the serological detection and serotyping of pathogenic Enterobacteriaceae from test material of human and other origin. They are designed for slide agglutination.

Test Antigens and Control Sera

The test antigens are used for identifying specific agglutinins in patient sera. The corresponding control sera are used to check the agglutinability of the test antigens and the system controls.