E-BID FOR RATE CONTRACT CUM SUPPLY AND EMPANELMENT OF SURGICAL AND SUTURE ITEMS

HBsAg (Rapid Test)

Anti-HCV Antibody (Rapid Test)

Hepatitis B Surface Antigen (Elisa) Testing Kits IV Generation/High sensitive 1. An ELISA reader based qualitative test 2. Should have monoclonal antibodies coated on the solid. Phase & polyclonal antibodies in the conjugate. The assay should be able to detect all the 11 subtypes (ad & ay subtype) including mutant strains. The assay should be able to detect surface antigen to hepatitis B virus. 3. Total incubation time should not be more than 90 minutes. 4. Adequate documents detailing the principle components, bio- safety methodologies, validity criteria, interpretation of results, performance characteristics storage conditions, limitation of assays manufacturing & expiry dates should be provides with each kit. 5. The kit should have approval of the statutory authority in its country of origin. 6. In case of imported kits it should be registered and licensed under the provisions of Drugs & Cosmetics act and rules and/or medical devices rules 2017 in India, 7. In case of indigenous manufacturers should be licensed under the provisions of Drugs & cosmetics Act and rules and or medical devices rules 2017 issued by the competent authority defined under Drugs and cosmetics act, 1940. 8. The kit should have minimum shelf- life of 5/61h or 12 months (whichever is more) at the port of discharge of consignees. 9. The assay component should include reactive and non- reactive controls. 10. The assay should have sensitivity of 100% and specificity of more than or equal to 99% 11. The assay should have analytical sensitivity of detecting less than or equal to 50pg/ml. (0.05ng/ml) 12. All the reagents should in ready to use form. Only wash buffer concentrate to be reconstituted before use. The manufacturer should ensure maintenance of cold chain during storage & transport the kits at 2°c - 8°C. Temperature indicator to be placed on every box of kits. 13. The kit size should be 96 tests/kit. The kit should have been evaluated by reference institute in India like NIB Noida, NARI-Pune, NIMHANS-Bangalore. The kit should be approved by Drug Controller General of India (DCGI) for in Vitro Diagnostic use.