Influenza Rapid Test Validation control Panel for IVD
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. Influenza A and B H1N1 H3N2 Hemagglutinin-nucleoprotein recombinant proteins, peptides and antibodies detect a virus commonly known as "the flu". Influenza is an infectious disease caused by an influenza virus. Symptoms can be mild to severe. The most common symptoms include a high fever, runny nose, sore throat, muscle pains, headache, coughing, and feeling tired. These symptoms typically begin two days after exposure to the virus and most last less than a week. The cough, however, may last for more than two weeks. In children, there may be nausea and vomiting, but these are not common in adults.
Recording of pertinent information concerning patient's illness or illnesses.
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