HCV Seroconversion control Panel for IVD Donor# 64150
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.
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.
Isotype or positive controls by peptides, antibodies and deactivated samples.
Hepatitis C virus (HCV) NS3, NS4, NS genotypes 1, 2, 3, 4, 5, are small (55–65 nm in size), enveloped, positive-sense single-stranded RNA viruses. Hepatitis C virus is the cause of hepatitis C and some cancers such as Liver Cancer (Hepatocellular carcinoma abbreviated HCC) and lymphomas in humans. HCV Core antigens or envelope proteins are used for immunization to obtain diagnostic antibodies.
Recording of pertinent information concerning patient's illness or illnesses.
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