E-Bid For Rate Contract Cum Supply And Empanelment Of Surgical , Hiv (Elisa) Testing Kits Iv Generation. 1. Should Be Solid Phase Micro Plate Coated Hiv I & Ii Recombinant And/Or Synthetic Peptide Antigens And Antibody To Hiv 1 P24. 2. The Assay Should Detect Hiv 1 And Ii Antibodies And Hiv 1P24 Antigen. 3. Micro Wells Coated With A Mixture Of Recombinant Hiv Antigens Gp120, Gp41 And Gp36 & Monoclonal Antibodies To Hiv P24 Antigen. 4. Analytical Sensitivity Of P24 Ag Should Not Be Lessthan 20 Pg/Ml. 5. Adequate Documents Detailing The Principle, Components, Details Of Antigen For Antibody, Detection Of Hiv 1 And 2 Antigen, Bio- Safety, Methodologies Validity, Criteria Interpretation Of Results, Performance Characteristics, Storage Conditions, Limitation Of Assays Manufacturing, & Expiry Dates Should Be Provided With Each Kit. 6. The Kit Should Have Approval Of The Statutory Authority In Its Country Of Origin. 7. In Case Of Imported Kits It Should Be Registered And Licensed Under The Provisions Of Drugs & Cosmetics Act And Rules/ Or Medical Devices Rules 2017 In India. 8 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, 9. The Kit Should Have Minimum Remaining Shelf- Life Of 5/6 Or 12 Months {Whichever Is More) The Port Of Discharge Of Consignees, 10. The Assay Component Should Include Reactive (For Both Antibody As Well As Antigen) And Non- Reactive Controls With Each Kit. 11. The Assay Should Have Sensitivity Level Of 100% And Specificity Level Of More Than Or Equal To 99%. 12. The Manufacturer Should Ensure Maintenance Of Cold Chain During Storage & Transport The Kits At 2°C - 8°C. The Temperature Indicator Should Be Placed On Every Pack Of Kit. 13. The Pack Size Should Be 96 Tests/Kit. , Hepatitis B Surface Antigen (Elisa) Testing Kits Iv Generation/High Sensitive 1. An Elisa Reader Based Qualitative Test 2. Should Have Polyclonal Antibodies Coated On The Solid. Phase & Monoclonal Antibodies In The Conjugate To Detect All Subtypes & Mutant Strains. The Assay Should Be Able To Detect Surface Antigen To Hepatitis B Virus. 3. Total Incubation Time Should Not Be More Than 90Minutes. 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. 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. , Hcv (Elisa) Testing Kits Iv Generation 1. Microplate Elisa Coated With Recombinant/ Synthetic Peptide Antigens For Core. Ns3 Ns4 And Nss And Antibody To Hcv Core Antigen. 2. Should Be Based On Indirect Assay For Antibody Detection & Sandwich For Antigen Detection. 3. Total Incubation Time Should Not Be More Than 150 Minutes. 4. Positive & Negative Controls For Antigen & Antibody Should Be Ready To Use. 5. 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. 6. The Kit To Be Procured Should Have Approval Of The Statutory Authority In Its Country Of Origin. 7. 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. 8. 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. 9. The Kit Should Have Minimum Shelf- Life Of 5/61Hor 12 Months (Whichever Is More) At The Port Of Discharge Of Consignees. 10. The Assay Component Should Include Reactive (For Both Antibody And Antigen) And Non- Reactive Controls. 11. The Assay Should Have A Sensitivity Of 100% And Specificity Of More Than Or Equal To 98%. 12. The Manufacturer Should Ensure Maintenance Of Cold Chain During Storage & Transport The Kits At 2°C - 8°C. The Time Temperature Indicator Should Be Placed On Every Pack Of Kits. 13. The Pack Size Should Be 96 Tests/Kit. , Hiv (Rapid) Testing Kits 1. Test Should Be A Solid Coated Hiv 1 & Hiv Ii Recombinant And/Or Synthetic Peptide Antigens. 2. The Assay/Test Assay Should Detect Total Antibodies (Lgg, Lgm & Lga) Specific To Hiv-1 & Hiv-2 In Human Serum, Plasma & Whole Blood. 3. The Assay Should Utilize Recombinant Hiv-1 Capture Antigens I.E. Gp41 And Gp120) For Detection Of Hiv 1 Antibodies & Recombinant Hiv-2 Capture Antigen I.E. Gp36 Detection Of Hiv 2 Antibodies. 4. Adequate Documents Detailing The Principle, Components, Details Of Antigen For Antibody Detection Of Hiv 1 And 2, Bio- Safety Methodologies Validity Criteria Interpretation Of Results Performance Characteristics Storage Conditions Limitation Of Assays Manufacturing & Expiry Dates Should Be Provided 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 5/61Hor 12 Months (Whichever Is More) At The Port Of Discharge Of Consignees. 9. The Time Required Of Performing The Test Should Not Be More Than 20 Minutes. 10. The Control Dot/ Band Should Be Able To Detect The Presence Of Human Immunoglobulin And Should Not Be Just A Procedural Control Or Meant For Merely Checking The Flow Of Reagents Or Integrity Of The Antigen. Except For Lateral Flow Assays 11. The Assay Should Have Sensitivity Of 100% And Specificity Of 99 % Or More With Documentary Evidence. 12. The Test Kit Should Be Packed Such That There Is A Provision To Conduct Single Test At A Time. 13. The Pack Size Should Not Be More Than 50 Tests/Kits. 14. The Storage & Transport Temperature Of The Kit Should Be 2-30°C. , Hepatitis B Surface Antigen (Rapid) Testing Kits 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. The Assay Should Be Able To Detect All 11 Sub Types Of Hbsag. 4. The Assay Should Utilize The Combination Of Monoclonal & Polyclonal Antibodies To Hbsag For Detection. 5. 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. 6. The Kit Should Have Approval Of The Statutory Authority In Its Country Of Origin. 7. 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. 8. 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, 9. The Kit Should Have Minimum Shelf- Life Of 5/6Th Or 12 Months (Whichever Is More) At The Port Of Discharge Of Consignees. 10. The Total Procedure Time Shall Not Be More Than 30 Minutes. 11. Assay Should Have Sensitivity 100% & Specificity 100% Or More With Documentary Evidence. 12. The Storage & Transport Temperature Of The Kit Should Be 2-30°C. 13. The Pack Size Should Not Be More Than 50 Tests Wherein Each Test Is Individually Packed. , Hcv (Ragid) Testing Kits 1. Should Be Solid Phase/ Particle Coated With Recombinant And / Or Synthetic Peptide Antigens For Core, Ns3, Ns4 And Nss. 2. The Assay Should Able To Detect Total Antibodies (Lgg, Lgm & Lga) Specific To Hcv In Human Serum, Plasma Or Whole Blood. 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. 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 Niedical 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 5/6 Or 12 Months (Whichever Is More) At The Port Of Discharge Of Consignees. 9. The Total Procedure Time Shall Not Be More Than 20 Minutes. 10. Assay Should Have Sensitivity 100% & Specificity 100% Or Morewith Documentary Evidence 11. The Storage & Transport Temperature Of The Kit Should Be 2-30°C. 12. The Pack Size Should Not Be More Than 50 Tests Wherein Each Test Is Individually Evidence. , Syphilisantibody (Rapid) Detection Kits 1. The Assay Should Be Based On Rapid Chromatographic Immunoassay For Qualitative Detection Of Antibodies (Lgg, Lga & Lgm) To Tp In Serum, Plasma & Whole Blood. 2. The Assay Should Utilize Recombinant Treponemal Antigens I.E. Tp15, Tpl7, Tp47 Against Syphilis. 3. The Assay Should Be In Card Format. 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 5/6Th Or 12 Months (Whichever Is More) At The Port Of Discharge Of Consignees. 9. Read Result Time Should Not Be More Than 20 Minutes. 10. Assay Should Have Sensitivity 100% & Specificity 99 %Or More With Documentary Evidence. 11. The Storage & Transport Temperature Of The Kit Should Be 2-30°C. 12. The Pack Size Should Not Be More Than 50 Tests Wherein Each Test Is Individually , Malaria Antigen (Rapid) Detection Test 1. Test Should Be Based On Lmmunochromatographic Assay. 2. The Test Should Able To Differentially Detects Antigen Of P. Falciparum (Hrp-2/ Ldh) And Pan Plasmodia Against P. Falciparum, P. Vivax, P. Ovale, P. Malariae (Ldh) From Human Whole Blood.In Two Different Brand/Lines. 3. The Test Band & Control Band Should Have Different Colours/Same Coloursfor Differentiation Of Control & Test Band With Respect To Use Of Whole Blood As A Sample. 4. The Membrane Strip Should Be Pre-Coated With The Antibodies Specific To Histidine-Rich Protein Ii (Hrp Ii) Of P. Falciparum On Pf Test Line And Specific To The Lactate Dehydrogenase (Pldh) Plasmodium Species (P. Falciparum, P. Vivax, P. Malariae, P. Ovale) On Pan Test Line Separately 5. The Test Should Be In Card Format Not In Strip. 6. 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. 7. The Kit Should Have Approval Of The Statutory Authority In Its Country Of Origin. 8. 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. 9. 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. 10. The Kit Should Have Minimum Shelf- Life Of 5/6Th Or 12 Months (Whichever Is More) At The Port Of Discharge Of Consignees. 11. Read Result Time Should Not Be More Than 30 Minutes. 12. The Storage & Transport Temperature Of The Kit Should Be 2-30°C. 13. The Pack Size Should Not Be More Than 50 Tests Wherein Each Test Is Individually Packed.
