Details: (elisa) testing kits iv generation. 1. should be solid phase micro plate coated i & ii recombinant and/or synthetic peptide antigens and antibody to 1 p24. 2. the assay should detect 1 and ii antibodies and 1p24 antigen. 3. micro wells coated with a mixture of recombinant antigens gp120, gp41 and gp36 & monoclonal antibodies to p24 antigen. 4. analytical sensitivity of p24 ag should not be less than 20 pg/ml. 5. adequate documents detailing the principle, components, details of antigen for antibody, detection of 1 and 2 antigen, bio- safety, methodologies validity, criteria interpretation of results, performance characteristics, storage conditions, limitation of assays manufacturing, & expiry dates should be provided with each kit. 6. the kit should have approval of the statutory authority in its country of origin. 7. in case of imported kits it should be registered and licensed under the provisions of drugs & cosmetics act and rules/ or medical devices rules 2017 in i
Sector: Medical and Health