Viral antigens, culture fluids, DNA controls and samples should only be opened in a BL2 protected laboratory. Infectious viruses are Biologic Safety level 2 organisms. Viral culture fluids are tested for their Tissue Culture Infective Dose or TCID50. we recommend to use titers higher than10*5 U/ml. LOD or limit of detection determinations , IVD Assay development, molecular diagnostics and other viral based IVD assays can be developed with viral antigens, DNAs and fluid viral samples.
Intended IVD use
Only for research use in virology laboratories with biosafety level 2 rooms. For IVD an ISO 13485 CE certification is needed. Do not use these virus related reagents for production of products witch are mentioned in section 351 of the Public Health Service Act.
Isotype or positive controls by peptides, antibodies and deactivated samples. The detections of the targets with this kit is a type of test that can be performed on any target containing biological samples after clean up of interfering agents. The assay must be performed following the protocol. CE marked for diagnostic use in ISO 13485 certified in Vitro Diagnostic devices IVVD. Available in 1 for diagnostics.
Shiga Toxin 2-S. cerevisiae Recombinant, titered control for LOD limit of determination in
Recombinant, E. coli recombinant proteins are genetic recombinations in Escherichia coli, supplied as white sterile powder lyopillized. Natrols and viral diagnostic antigens advises they will be reconstituted in a buffer soluion or culture medium for cell culture.
Shiga Toxin 2-S. cerevisiae recombinant, titered reference to measure LOD limit on quantification measurement in diagnostic reagens