E Tender For Procurement Of Kits, Chemicals And Reagents For Two Years From The Date Of Award Of Contract (Aoc) And Its Extension, If Required , Hiv (Detection Of Both Ag & Ab) Elisa Kit - 4Th Gen Technical Specification: 1. Kit Needs To Detect Antibodies Against Hiv 1+2 And P24 Ag Against Hiv-1. 2. Kit Needs To Be Based On Sandwich Elisa With Monoclonal Abs Against P24 Ag And Gp160 And Gp36 Recombinant Proteins On The Solid Phase 3. Kit Needs To Detect All The Three Classes Of Antibodies To Hiv I.E. Igm, Igg And Iga Simultaneously Providing Highest Early Sero-Conversion Sensitivity. 4. The Analytical Sensitivity Of P-24 Ag Detection Needs To Be = 25 Pg/Ml Or 1.0 Iu/Ml Of Who Standard.A Valid Certificate Of Analysis(Coa) From A Reference Laboratory And A Declaration Certificate From The Manufacturer Are Required To Be Produced.5. Kit Sensitivity Needs To Be 100% 6. Kit Specificity Needs To Be = 99.5% For Both Antigen As Well As Antibody Without Compromising The Assay Sensitivity. 7. Kit Needs To Have Preferabe Colour Coded Reagents With Od Norms For Reagents Addition Verification On Automation As Well As Manual Procedure (Optional). 8. Sample Volume Need To Be =100 ?L Without Any Predilution Step. 9. Kits Needs To Have Reactive And Non-Reactive Controls With Separate Positive Control For Antigen And Antibody 10. Kit Needs To Be Ce Approved And Certificate Of Analysis Needs To Be Provided For Each Batch Of The Product 11. Total Incubation Needs To Be =2 Hrs 12. Kit Needs To Be Programmable & Compatible For Automated System. 13. Supplier Needs To Provide The Certificate Of Analysis From Nib For Each Supplied Batch. 14. Supplier Needs To Be Able To Provide Antibody Confirmatory Kit For Further Analysis Of Reactive Cases On Demand (Optional). 15. Strip Of Microplate Needs To Be Numbered And Microplate Frame Needs To Have Name Of The Assay For Easy Identification And Differentiation (Optional). 16. Reagents In The Kit Box Need To Have Barcode Label With Information Of Lot No And Expiry To Manage The Traceability In Automation (Optional). 17.Package Should Contain Lot Specific Additional Control (Positive & Negative Control). , Hcv (Detection Of Both Ag & Ab) Elisa Kit - 4Th Gen Technical Specification: 1. Kit Needs To Be Able To Detect Both Antibody (Core, Ns3 And Ns4) And Antigen (Capsid) Against Hepatitis C Virus. 2. Monoclonal Abs Against Capsid Proteins, And Recombinant Protein Or Antigens Or Synthetic Peptides For Ns3, Ns4 And Capsid Needs To Be Coated On The Solid Phase. 3. Kits Needs To Have Separate Positive Control For Antigen And Antibody. 4. Kit Needs To Have 2 Separate Conjugates For Antigen As Well As Antibody Detection. 5. Reagents Needs To Be Colour Coded With Od Norms For Reagents Addition Verification On Automation As Well As Manual Procedure Due To Colour Change On Addition Of Samples/Reagents In The Wells. 6. Sample Volume Needs To Be = 50 ?L Without Any Predilution Step. 7. Total Incubation Time Of Assay Needs To Be = 2.5 Hrs. 8. Kit Needs To Have Sensitivity Of 100% 9. Kit Needs To Have Specificity Of = 99.5% For Both Antigen As Well As Antibody Without Compromising The Assay Sensitivity. 10. Kit Needs To Be Ce Approved And Certificate Of Analysis Should Be Provided For Each Batch Of The Product 11. Kit Needs To Be Programmable & Compatible For Automated Systems. 12. Supplier Needs To Provide The Certificate Of Analysis From Nib For Each Supplied Batch. 13. Supplier Needs To Be Able To Provide Confirmatory Kit For Further Analysis Of Reactive Cases On Demand. 14. Strip Of Microplate Needs To Be Numbered And Microplate Frame Needs To Have Name Of The Assay For Easy Identification And Differentiation. 15. Reagents In The Kit Box Need To Have Barcode Label With Information Of Lot No And Expiry To Manage The Traceability In Automation. , Hbsag Elisa Kit Technical Specification: 1. Kit Needs To Detect Surface Antigen Of Hepatitis B Virus. 2. Kit Needs To Be Based On One Step Sandwich Elisa. 3. Kit Needs To Be Able To Detect All Known Major Subtypes - Adr, Adw, Ayr, Ayw As Well As Most Of The Mutants Like (Supported By Publications). 4. Kit Needs To Have Minimum Analytical Sensitivity Of 0.060 Ng/Ml Or 0.05 Iu/Ml For Who Standard. 5. Kit Needs To Have Sensitivity Of 100% 6. Specificity Of The Kit Needs To Be More Than 99.4%. 7. Kit Needs To Have Combination Of Monoclonal & Polyclonal Antibodies On Solid Phase And In The Conjugate To Enable Best Coverage Of All The Subtypes 8. Kit Needs To Have Colour Coded Reagents With Od Norms For Reagents Addition Verification On Automation As Well As Manual Procedure 9. Kit Needs To Be Programmable & Compatible For Automated Systems. 10. Kit Needs To Be Ce Approved And Certificate Of Analysis Needs To Be Provided For Each Batch Of The Product 11. Sample Volume Needs To Be = 100 ?L Without Any Predilution Step. 12. Supplier Needs To Provide The Certificate Of Analysis From Nib For Each Supplied Batch. 13. Supplier Needs To Be Able To Provide Neutralization Kit For Confirmation Of Reactive Cases On Demand. 14. Total Incubation Time Of The Assay Needs To Be = 2 Hrs. 15. Strip Of Microplate Needs To Be Numbered And Microplate Frame Needs To Have Name Of The Assay For Easy Identification And Differentiation. 16. Reagents In The Kit Box Need To Have Barcode Label With Information Of Lot No And Expiry To Manage The Traceability In Automation. , Hbsag (Rapid) Kit Specification: 1. Should Be Solid Phase/Particle Coated With Monoclonal Antibodies To Hbsag. 2. The Assay Should Be Able To Detect Surface Antigen To Hepatitis B Virus. 3. 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 Provided With Each Kit. 4. The Kit To Be Procured Should Have Approval Of The Statutory Authority In Its Country Of Origin. 5. In Case Of Imported Kits It Should Be Registered And Licensed In India By Dcg(I) . 6. In Case Of Indigenous Manufacturers They Should Be Licensed By The Competent Authority Defined Under Drugs And Cosmetics Act, 1940, After Appropriate Evaluation By The Centers Approved By Dcg(I). 7. The Kit Should Have Minimum Shelf –Life Of 60% Or 12 Months (Whichever Is More) At The Port Of Discharge Of Consignees. 8. The Total Procedure Time Shall Not Be More Than 30 Minutes. 9. The Assay Component Should Include Positive And Negative Control In Each Pack Of 50 Tests. 10. The Assay Should Have Sensitivity Of More Than Or Equal To 99% And Specificity Of More Than Or Equal To 98%. 11. The Assay Should Have Analytical Sensitivity Of Detecting Less Than Or Equal To 0.5Ng/Ml. 12. The Manufacturer/Authorized Agent Should Ensure Maintenance Of Cold Chain During Storage & Transport The Kits At 2°C - 8°C . The Cumulative Time Temperature Indicator Technology Used Should Be Pre-Qualified By Who. 13. The Pack Size Should Not Be More Than 50 Tests Wherein Each Test In Individually Packed. 14. The Item Should Be Up Graded From Iii Generation To Iv Generation Test Kit In The Light Of Bts Trg Recommendation Dated 12Th January 2015. , Hcv (Rapid) Kit Specification: 1. Should Be Solid Phase/Particle Coated With Recombinant And / Or Synthetic Peptide Antigens For Core,Ns3,Ns4 And Ns5. 2. 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 Provide With Each Kit. 3. The Kit To Be Procured Should Have Approval Of The Statutory Authority In Its Country Of Origin 4. In Case Of Imported Kits It Should Have Been Registered And Licensed In India By Dcg(I). 5. In Case Of Indigenous Manufactures They Should Be Licensed By The Competent Authority Defined Under Drugs And Cosmetics Act, 1940, After Appropriate Evaluation By The Centers Approved By Dcg(I). 6. The Kit Should Have Minimum Shelf-Life Of 60% Or 12 Months (Whichever Is More) At The Port Of Discharge Of Consignees. 7. The Total Procedure Time Shall Not Be More Than 30 Minutes. 8. The Assay Component Should Include Positive And Negative Control In Each Pack Of 50 Tests. 9. The Assay Should Have Sensitivity Of More Than Or Equal To 99% And Specificity Or More Than Or Equal To 98%. 10. The Manufacture / Authorized Agent Should Ensure Maintenance Of Cold Chain During Storage & Transport The Kits At 2°C - 8°C. The Cumulative Time Temperature Indicator Technology Used Should Be Pre-Qualified By Who. 11. The Pack Size Should Not Be More Than 50 Tests Wherein Each Test Is Individually Packed. 12.The Item Should Be Up Graded From Iii Generation To Iv Generation Test Kit In The Light Of Bts Trg Recommendations Dated 12Th January 2015. , Hiv (Rapid) Testing Kits [By Principal Of Enzyme Immuno Assay, Agglutination, Or Any Other Principle] Specification :- 1. Should Be A Solid Phase Coated Hiv I & Hiv Ii Recombinant And / Or Synthetic Peptide Antigens. 2. The Assay Should Detect Hiv I & Ii Antibodies In Plasma,Serum Or Whole Blood. 3. Adequte Documents Detailing The Principle , Components, Details Of Antigen For Antibody Detection Of Hiv I & Ii, Bio-Safety, Methodologies, Validity Criteria, Interpretation Of Results, Performance Characteristics, Storage Conditions, Limitation Of Assays, Manufacturing & Expiry Dates Should Be Provided With Each Kit. 4. The Kit Should Have Approval Of The Statutory Authority From The Country Of Origin. 5. In Case Of Imported Kits It Should Be Registered And Licensed By Dcg(I). 6. In Case Of Indigenous Manufacturers Should Be Licensed By The Competent Authority Defined Under Drugs And Cosmetics Act 1940,Also Be Evaluated By The Centers Approved By Dcg(I). 7. The Kit Should Have Minimum Shelf-Life Of 60% Or 12 Months (Whichever Is More) At The Port Of Discharge Of Consignees. 8. The Time Required For Performing The Test Should Not Be More Than 30 Minutes. 9. The Control Dot/Band Should Be Able To Detect The Presence Of Human Immunoglobulins And Should Not Be Just A “Procedural Control” Or Meant For Merely Checking The Flow Of Reagents Or Integrity Of The Antigen. 10. The Assay Should Have Sensitivity Of More Than Or Equal To 99.5% And Specificity Of More Than Or Equal To 98%. 11. The Manufacturers Should Ensure That : A. The Test Kit Should Be Packed Such That There Is A Provision To Conduct Single Test At A Time; B. The Assay Components Should Include Hiv Positive And Negative Serum Control Sufficient For Conducting 20% Of The Tests (10% Negative And 10% Positive Controls);And C. The Pack Size Of Hiv Rapid Test Kits Should Not Be More That 50 Tests Per Kit. 12. The Manufacturer/Authorized Agent Should Ensure Maintenance Of Cold Chain During Storage & Transport The Kits At 2°C - 8°C. The Cumulative Time Temperature Indicator Technology Used Should Be Pre-Qualified By Who. 13. The Item Should Be Up Graded From Iii Generation To Iv Generation Test Kit In The Light Of Bts Trg Recommendation Dated 12Th January 2015. , Whole Blood Finger Prick Hbv Card Test Kit For Detection Of Hbsag Specification : 1) The Assay Should Be Able To Detect Hbsag By Immunochromatographic Assay Or Any Other Principle. 2) Test Should Have A Sensitivity Of 99% -100% And A Specificity Of 99%-100%. 3) The Total Test Procedure Up To The Result Will Not Exceed 30 Minutes 4) The Packing Should Be In A Manner Enabling Performance Of A Single Test At A Time. 5) Storage Of The Test Kits At Room Temperature Should Be Possible Upto 40 Degrees Celsius 6) Pack Size Should Be For 50 Tests. 7) Shelf Life- Minimum 18 Months From Manufacture , Important Note: 1. All Prospective Bidders Are Requested To Quote The Rate In Boq As Per Accounting Unit & Item Specification As Mentioned In The Table-A. Wrong Quoting Of The Rate In Boq Will Be Dealt With As Per Penal Provisions Of The T&C Of The Tender. 2. Tendered Quantity Is Just A Tentative Quantity And Should Not Be Treated As Final. It May Increase Or Decrease, As Per Need Of The State. Keeping This In Mind, The Supplier Is Not Allowed To Seek Termination Of The Rate Contract After Finishing Supply Of Tendered Quantity. 3. Quality Of The Product Supplied, May Be Ascertained By Testing / Physical Examination By The Experts At Any Stage Of The Tender Period. 4. The Prospective Bidders Of The Said Tender Are Requested To Make A Declaration In Affidavit Under Annexure Vi(B)In Case Of Sole Manufacturer/Importer (I.E. Proprietary In Nature). 5. If The Item(S) Under Sole Manufacturer / Importer Is (Are) Proprietary In Nature, Quarterly Intimation Is Solicited From The Approved Bidders Positively Regarding The Status Of Their Item(S) Proprietary In Nature, Otherwise Their Item(S) Will Be Blocked In The Smis.
