Supply Of DENGUE IGM ELISA, HIV 1 & 2 RAPID TEST CONFIRMATION KIT, HEV IGM ELISA TEST, KITS FOR ANTI-HIV 1+2, LEPTOSPIRA IGM ELISA

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Supply Of dengue igm elisa, hiv 1 & 2 rapid test confirmation kit, hev igm elisa test, kits for anti-hiv 1+2, leptospira igm elisa , srphc82670160-hev igm elisa test: 1. assay should be based on the principle of igm capture. 2. the assay should detect igm anti hev antibodies. 3. should be compatible with plasma and serum bot h. 4. the kit size should be 96 tests/kit (in strips of 12x8 wells such that individual strips can be used f or testing and the same are compatible with automated elisa reader and washer. 5. the manufacturer /authorized agent should ensure maintenance of cold chain during storage and transport of kits at 2-8 degree c. 6. original technical data sheet should be provided with each kit. 7. the assay component should include reactive and non-reactive controls sufficient for atleast 4 runs. 8. the assay compon ents should be sufficient for the 96 tests provided in four runs. 9. the assay should have sensitivity g reater than and equal to 99% and specificity greater than and equal to 98%. 10. the kit should have a pproval of the statutory authority from the country of origin. 11. in case of imported kits it should b e registered and licensed by the dcg(i). 12. in case of indigenous manufactures should be licensed by t he competent authority defined under drugs and cosmetics act at 1940 and also be evaluated by the c enters approved by the government of india. 13. the kit should have minimum shelf life of 60% or 12 mo nths(whichever is more) at the time of delivery to consignee. unit:test ] , srphc82670110-dengue igm elisa: 1. assay should be based on the principle of igm capture. 2. the assay should detect igm antibodies against dengue. 3. should be compatible with plasma and ser um both. 4. the kit size should be 96 tests/kit (in strips of 12x8 wells such that individual strips can be used for testing and the same are compatible with standard automated elisa reader and washer. 5. th e manufacturer /authorized agent should ensure maintenance of cold chain during storage and tran sport of kits at 2-8 degree c. 6. original technical data sheet should be provided with each kit. 7. the assay component should include reactive and non-reactive controls sufficient for atleast 4 runs. 8. the assay components should be sufficient for the 96 tests provided in four runs. 9. the assay must be of very high sensitivity greater than and equal to 95% and specificity greater than and equal to 9 8%. 10. the kit should have approval of the statutory authority from the country of origin. 11. in cas e of imported kits it should be registered and licensed by the dcg(i). 12. in case of indigenous manufac tures should be licensed by the competent authority defined under drugs and cosmetics act at 1940 a nd also be evaluated by the centres approved by the government of india. 13. the kit should have mini mum shelf life of 60% or 12 months (whichever is more) at the time of delivery to consignee. unit:test ] , srphc82670205-leptospira igm elisa :1.kit should be able to detect igm antibodies against l eptospira antigen in human serum. 2. should be a solid phase enzyme-linked immunosorbent assay (elisa ) based on the sandwich principle. 3. should be compatible with all common elisa reader. 4. the assay c omponent should include reactive and non- reactive controls. 5.test should have a sensitivity of gre ater than and equal to 97% and specificity of greater than and equal to 99%. 6.adequate documents detailing principle, components, bio safety, methodologies, limitations of assays, manufacturing & expi ry dates should be provided with each kit. 7. the kit to be procured should have approval of the stat utory authority in its country of origin. 8. in case of imported kits it should have been registered and licensed in india by dcg (i). 9. in case of indigenous manufacturers they shall have license issued by the competent authority defined under drugs and cosmetics act, 1940 after appropriate evaluation by the centers approved by dcg (i). 10. the kit should have minimum shelf life of 18 months 1to 30 degree celsius. 11. kit for 96 tests. unit:test ] , srphc82670200-kits for anti-hiv 1+2: 1. should be based on immunofiltration membrane (flo w through). 2. should have antigen immobilised on immunofiltration membrane. 3. should be 3rd gener ation i.e. include detection of to hiv 1 & 2 ab. 3. should have in built quality control band or dot. 4. sh ould have short interpretation time not more than 30 minutes. 5. should have specificity and sensitivit y of 100%. 6. should be approved and evaluated by nib. unit:test ] , srphc82670170-hiv 1 & 2 rapid test confirmation kit unit:test ]