Supply Of ANTI HCV RAPID TEST/CRP TESTS/ANTI HBC TOTAL ELISA TEST/ATEX AGGLUTINATION.
Tender Overview
Project Description
Supply Of anti hcv rapid test/crp tests/anti hbc total elisa test/atex agglutination. , srphc82670065-anti hcv rapid test: 1. should be 3rd generation. 2. based on immunochrom atography / immunofiltration for the qualitative detection of antibodies specific to hcv in human ser um, plasma, or whole blood. 3. should be solid phase / particle coated with recombinant and / or synt hetic peptide antigens for core, ns3, ns 4, and ns5. 4. should have in built quality control band or do t 5. should have short interpretation time not more than 30 minutes 6. should have specificity greate r than and equal to 98% and sensitivity of greater than and equal to99% 7. must be evaluated and ap proved by nib 8. original technical data sheet should be provided with each kit. 9. the kit should hav e minimum shelf life of 60% or 12 months (whichever is more) at the time of delivery to consignee unit :test ] , srphc82670100-crp tests - immunoturbidmetric assay: 1. compatibility: reagents must be f ully compatible with beckman coulter au480 automated clinical chemistry analyser. 2. method: immun oturbidimetric or latexenhanced immunoturbidimetric method. 3. reagent type: ready-to-use, liquidst able r1 and r2 reagents. 4. measuring range: minimum 5.00?200 mg/l. 5. stability: on-board stability sh ould be greater than and equal to 30 days, shelf life greater than and equal to 12?18 months. 6. cal ibration: dedicated crp calibrators (1-point or 2-pint or multi-point) must be provided. 7. controls: n ormal and high crp controls must be supplied or specified as compatible. 8. accuracy: results tracea ble to ifcc/crm 470 reference standard. precision: cv less than and equal to 5% (within-run) and less than and equal to 7% (between-run). 9.loading: barcode-enabled, directly loadable on au480 withou t adapters. 10. labeling: each pack must indicate lot number, expiry date, storage conditions, and ana lyser compatibility. 11. storage: reagents must be stored at 2?8 degree celsius. 12. documentation: m ust have ifu, msds, coa, ce-ivd/iso documentation. 13. support: supplier must provide technical suppor t, troubleshooting, and replacement of defective or unstable lots. 14. compliance: manufacturer au thorization letter and declaration of compatibility with beckman coulter au480 must be submitted. ] , srphc82670035-anti hbc total elisa test--96 tests/kit unit:test ] , srphc82670105-crp-latex agglutination assay (reagent for semi auto analysers) unit:test ]
BOQ
| Sl. No. | Item Description |
|---|---|
| 1 | SRPHC82670065-ANTI HCV RAPID TEST: 1. SHOULD BE 3RD GENERATION. 2. BASED ON IMMUNOCHROM ATOGRAPHY / IMMUNOFILTRATION FOR THE QUALITATIVE DETECTION OF ANTIBODIES SPECIFIC TO HCV IN HUMAN SER UM, PLASMA, OR WHOLE BLOOD. 3. SHOULD BE SOLID PHASE / PARTICLE COATED WITH RECOMBINANT AND / OR SYNT HETIC PEPTIDE ANTIGENS FOR CORE, NS3, NS 4, AND NS5. 4. SHOULD HAVE IN BUILT QUALITY CONTROL BAND OR DO T 5. SHOULD HAVE SHORT INTERPRETATION TIME NOT MORE THAN 30 MINUTES 6. SHOULD HAVE SPECIFICITY GREATE R THAN AND EQUAL TO 98% AND SENSITIVITY OF GREATER THAN AND EQUAL TO99% 7. MUST BE EVALUATED AND AP PROVED BY NIB 8. ORIGINAL TECHNICAL DATA SHEET SHOULD BE PROVIDED WITH EACH KIT. 9. THE KIT SHOULD HAV E MINIMUM SHELF LIFE OF 60% OR 12 MONTHS (WHICHEVER IS MORE) AT THE TIME OF DELIVERY TO CONSIGNEE UNIT :TEST ] |
| 2 | SRPHC82670100-CRP TESTS - IMMUNOTURBIDMETRIC ASSAY: 1. COMPATIBILITY: REAGENTS MUST BE F ULLY COMPATIBLE WITH BECKMAN COULTER AU480 AUTOMATED CLINICAL CHEMISTRY ANALYSER. 2. METHOD: IMMUN OTURBIDIMETRIC OR LATEXENHANCED IMMUNOTURBIDIMETRIC METHOD. 3. REAGENT TYPE: READY-TO-USE, LIQUIDST ABLE R1 AND R2 REAGENTS. 4. MEASURING RANGE: MINIMUM 5.00?200 MG/L. 5. STABILITY: ON-BOARD STABILITY SH OULD BE GREATER THAN AND EQUAL TO 30 DAYS, SHELF LIFE GREATER THAN AND EQUAL TO 12?18 MONTHS. 6. CAL IBRATION: DEDICATED CRP CALIBRATORS (1-POINT OR 2-PINT OR MULTI-POINT) MUST BE PROVIDED. 7. CONTROLS: N ORMAL AND HIGH CRP CONTROLS MUST BE SUPPLIED OR SPECIFIED AS COMPATIBLE. 8. ACCURACY: RESULTS TRACEA BLE TO IFCC/CRM 470 REFERENCE STANDARD. PRECISION: CV LESS THAN AND EQUAL TO 5% (WITHIN-RUN) AND LESS THAN AND EQUAL TO 7% (BETWEEN-RUN). 9.LOADING: BARCODE-ENABLED, DIRECTLY LOADABLE ON AU480 WITHOU T ADAPTERS. 10. LABELING: EACH PACK MUST INDICATE LOT NUMBER, EXPIRY DATE, STORAGE CONDITIONS, AND ANA LYSER COMPATIBILITY. 11. STORAGE: REAGENTS MUST BE STORED AT 2?8 DEGREE CELSIUS. 12. DOCUMENTATION: M UST HAVE IFU, MSDS, COA, CE-IVD/ISO DOCUMENTATION. 13. SUPPORT: SUPPLIER MUST PROVIDE TECHNICAL SUPPOR T, TROUBLESHOOTING, AND REPLACEMENT OF DEFECTIVE OR UNSTABLE LOTS. 14. COMPLIANCE: MANUFACTURER AU THORIZATION LETTER AND DECLARATION OF COMPATIBILITY WITH BECKMAN COULTER AU480 MUST BE SUBMITTED. ] |
| 3 | SRPHC82670035-ANTI HBC TOTAL ELISA TEST--96 TESTS/KIT UNIT:TEST ] |
| 4 | SRPHC82670105-CRP-LATEX AGGLUTINATION ASSAY (REAGENT FOR SEMI AUTO ANALYSERS) UNIT:TEST ] |
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