NATrol molecular control control Panel for IVD for Human Hepatitis B Virus HBV 400 IU/mL
Caution when handling viruses
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. Hepatitis a, b, c, d, e recombinant surface viral antigens to genotype 1, 2, 3, 4, 5 are used for antibody production to make diagnostic poly or monoclonal antibodies. Hepatitis is a disease of the liver characterized by the presence of inflammatory cells in the tissue of the organ. Hepatitis may occur without symptoms, but can lead to jaundice (a yellow discoloration of the skin, mucous membranes, and conjunctiva of the eyes), poor appetite, and fatigue. Depending on the cause, hepatitis can manifest either as an acute or as a chronic disease.
Human proteins, cDNA and human recombinants are used in human reactive ELISA kits and to produce anti-human mono and polyclonal antibodies. Modern humans (Homo sapiens, primarily ssp. Homo sapiens sapiens). Depending on the epitopes used human ELISA kits can be cross reactive to many other species. Mainly analyzed are human serum, plasma, urine, saliva, human cell culture supernatants and biological samples.
NATrol molecular control control Panel for IVD for Hepatitis B Virus HBV 400 IU/
Virus, Humans, Viruses
NATrol molecular reference control Panel to measure IVD to measure H. sapiens Hepatitis B Virus Hepatitis B virus 400 IU/milliliter
Scope note:Recording of pertinent information concerning patient's illness or illnesses.
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