HIV Seroconversion control Panel for IVD Donor# 66048
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.
The human immunodeficiency virus (HIV) is a lentivirus (a subgroup of retrovirus) that causes HIV infection and over time acquired immunodeficiency syndrome(AIDS). AIDS is a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. Without treatment, average survival time after infection with HIV is estimated to be 9 to 11 years, depending on the HIV subtype. Infection with HIV occurs by the transfer of blood, semen, vaginal fluid, pre-ejaculate, or breast milk. Within these bodily fluids, HIV is present as both free virus particles and virus within infected immune cells. recombinant HIV 1 and 2 gag gene proteins p24, p17, p55 immunodominant epitopes and envelope glycoproteins, gp120 are used for production of diagnostic detection antibodies.
Scope note:Recording of pertinent information concerning patient's illness or illnesses.
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