Supply Of LEPTOSPIRA IGM ELISA / KITS FOR ANTI-HIV / HIV 1 & 2 RAPID TEST.
Tender Overview
Project Description
Supply Of leptospira igm elisa / kits for anti-hiv / hiv 1 & 2 rapid 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 ]
BOQ
| Sl. No. | Item Description |
|---|---|
| 1 | 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 ] |
| 2 | 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 ] |
| 3 | SRPHC82670170-HIV 1 & 2 RAPID TEST CONFIRMATION KIT UNIT:TEST ] |
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