E-Tender For Empanelment Of Nabl Laboratory For Testing Of Drugs, Kit, Chemicals And Reagents And Consumables For Two Years From The Date Of A.O.C. ( 2021-2023 ) By The Deputy Director Of Health Services ( E S ) , Central Medical Stores., KOLKATA-West Bengal

E-Tender For Empanelment Of Nabl Laboratory For Testing Of Drugs, Kit, Chemicals And Reagents And Consumables For Two Years From The Date Of A.O.C. ( 2021-2023 ) By The Deputy Director Of Health Services ( E S ) , Central Medical Stores. , Barium Chloride Powder , Barium Sulphate Powder ( 175Gm ) , Basic Fuchsin , Benedict Solution , Bile Esculin Disc , Bile Salt , Bivalent Antigen-Detecting Rapid Diagnostic Tests ( Rdts ) For P. Falciparum And P. Vivax Malaria Undr Nvbdcp Technical Specifications: - A. Description Of The Test Kit: The Bivalent Rapid Diagnostic Test ( Rdt ) For Malaria Should Comprise Of Test Card ( Cassette ) And Reagents Including Buffer Solution In A Dropping Bottle. The Test Kit Should Be Able To Rapidly Diagnose Both P. Falciparum And P. Vivax. The Test Should Be Based On The Principle Of Capture Of Parasite Antigen From Blood Using Monoclonal Antibodies Specific For Antigen Targets. Each Test Kit Should Contain All The Materials Required For Performing The Test Including Individually Packed Sterile Lancets For Pricking, Heparinised Capillary Tubes ( Diameter-1Mm ) With Relevant Markings And Reaction Tubes With Stand / Wells As Required. The Manufacturer Should Have Specified International Organisation For Standardization ( Iso ) Certification. One Should Be Able To Perform The Test With The Blood Taken By Finger Prick Of The Patient. Temperature Stability Data: Information On Thermal Stability Data For The Lab Product Should Be Available. Type Of Rdt- The Rdt Should Be Able To Detect P. Falcciparaum Histidine –Rich Protein – 2 ( Hrp2 ) And P. Vivax Lactate Dehyydrogenase ( Pldh ) And Not Aldolase. Rdtperformance Criteria :- The Products Should Conform To The Following Set Of Criteria ( A-D ) , Based On The Results Of The Evaluation Of The Who Malaria Rdt Product Testing. A. For The Detection Of Plasmodium Falciparum ( Pf ) In All Transmission Settings The Panel Detection Score ( Pds ) Against Pf Samples Should Be At Least 75% At 200 Parasites / Ul. B. For The Detection Of Plasmodium Vivax ( Pv ) In All Transmission Settings The Panel Detection Score ( Pds ) Against Pv Samples Should Be At Least 75% At 200 Parasites / Ul. C. The False Positive Rate Should Be Less Than 10% . D. The Invalid Rate Should Be Less Than 5%. Each Lot Of Rdt Should Be Tested At A Designed Lot Testing Laboratory By Using Who Protocol At The Time Of Delivery. Only Those Lots With Pass Report Will Be Accepted For Delivery. Content Of Kit And Packaging: Each Kit Should Be Hermetically Sealed In Non-Permeable Pouch And Should Have Moisture Absorbent Material. 10 Such Test Cards ( Cassette ) , Or Lesser Quantity As Required By The Programme Should Be Packed In A Box Containing The Reagents And The Test Plates. Adequate Literature Detailing The Test Kit Components, Principle , Methodologies And Validity Criteria As Specified Under ‘Rdt Performance Criteria’ Should Be Provided In The Kit Inserts With The Test Kits. Storage Conditions, Expiry Dates And Limitations Of Test Should Be Provided. The Small Box Should Be Packed In Bigger Cardboard Carton Containing 5 Such Small Boxes. The Carton Should Be Sealed With A Sealing Tape. C. Shelf Life : Shelf Life From Manufacturing Date To Expiry Date Should Be At Least 2 Years And The Rdts Should Not Have Lost More Than 1 / 6Th Of Their Effective Life From The Date At The Time The Material Is Offered For Inspection .Losses Due To Premature Deterioration As A Result Of Biological And Other Activities During The Life Of Potency Of The Rapid Diagnostic Tests Will Be Made Good By The Firm At Its Own Cost. D. Stability Requirements At Temperatures Of Intended Storage, Transport And Use : Rdts Should Have High Thermal Stability For Use In Areas With Very High Ambient Temperatures As Per The Evaluation By Who Malaria Rdt Product Testing Against A Single Cultured P. Falciparum Isolate At 200 Parasites / Ul At Based Line And After 60 Days Of Incubation At Room Temperature, 35°C And 45° C. E. Quality Assurance :- The Product Should Comply With Iso 13485. F. Marking / Labelling: I. Each Card ( Cassette ) Should Have Space For Recording Particulars Of Patients, Time And Date Of The Test. Ii. The Large Carton ( Containing 10 Small Boxes ) And Small Box ( Containing 10 Tests ) Should Have The Following Markings: A. Name Of The Test B. Lot Number C. Manufacturing And Expiry Date D. Name Of The Manufacturer With Address E. Details Of The Contents F. Storage Conditions. G. Handling Procedures H. Disposal Instruction For The Box And Its Contents I. Goi, Nvbdcp Supply –Not For Sale G. Details Regarding Approval Of License: I. Manufacturing And Marketing License For Manufacturing Of Rapid Malaria Diagnostic Tests Should Have Been Obtained From The Concerned Regulatory Authority In The Country By The Manufacturer. Ii. The Bidders Must Submit Scientific Study Report In Support Of Their Claim Of Performance Criteria Of The Offered Product, I.E. Who Findreport Mentioning The Panel Detection Score, False Positivity Rate, Invalid Rate, Ease Of Use , Thermal Stability Data Etc. Claim Should Be Supported By Reports Of Actual Shelf Life Studies. Iii. Reports Of Proven Performance Of The Offered Product In Conditions Similar To Indian Field Conditions ( Room Temperature Up To 40° C ) With Certification Of No Adverse Report For The Offered Product From The End Users During The Last Five Years Must Be Submitted With The Bid. Iv. The Bidders Must Submit A Sample Of Their Product ( For Example As Two Kits To Procurement Agent For Assessment Of User Friendliness By The Procurement Agent. V. Recommended Conditions For Storage ( E.G. Room Temperature ) And Shelf Life Should Clearly Be Mentioned On The Label Of Rdt. H. Shipping From Manufacturer : Before Shipping : The Manufacturer Should Provide To The Consignees The Details Of Airway Bill Numbers, Airline Carrier, Flight Number, Numbers Of Containers, Expectedarrival Tiem . These Details Should Be Sent By Email And Flowed Up By Fax. The Shipper ( Air Carrier ) Should Be Notified Of Temperature Storage Requirements By The Manufacturer In Writing And By Clear Markings On Cartons And Related Documents. ( Stowage Of The Shipment Closeto The Skin Of Some Aircraft May Result In Freezing. ) The Manufacturer Should Initiate Shipment Only When The Consignee Has Confirmed The Receipt Of Shipping Notification. Manufacturer Should Ensure / Arrange To Have Customs Agents Or Other Personnel On Site To Receive Materials. Shipments Should Be Moved Immediately To Moderate Temperature Storage Places ( Less Than 30° C ) .Leaving Materials On Airport Tarmacs, In Customs Sheds , Or In Vehicles Should Be Avoided. I. Ground Transportation : Ground Transportation Should Be Carried Out During Any Stage Of Delivery Without Delay, Maintaining Temperature Requirements While The Vehicle Is Moving And Is Parked. Avoid Leaving Rdts In Vehicles Parked In The Sun. , Bleaching Powder - Is1065 / 1989 [ Containing Not Less Than 30% W / W Of Available Chlorine & Stability ( Max. ) = 1 / 15 ] , Boric Acid Ip. , Bovine Albumin I.P. ( 10 Ml Vial ) , Brain Heart Infusion Agar , Brain Heart Infusion Broth , Calcium Reagent Test Kit , Canada Balsam , Cea Elisa Kit , Cedarwoodoil 25 Gms. , Cedarwood Oil 30 Ml , Cefaclor Antibiotic Disc , Cefadroxyl Antibiotic Disc , Cefazolin Antibiotic Disc , Cefdinir Antibiotic Disc , Cefepime Antibiotic Disc , Cefixime Antibiotic Disc , Cefoperazone Antibiotic Disc , Cefoperazone / Salbactam Antibiotic Disc , Cefotaxime Antibiotic Disc , Cefpirome Antibiotic Disc , Cefpodoxime Antibiotic Disc , Cefprozil Antibiotic Disc , Ceftazidime Antibiotic Disc , Ceftizoxime Antibiotic Disc , Ceftriaxone / Salbactum Antibiotic Disc , Ceftriaxone Antibiotic Disc , Cefuroxime Antibiotic Disc , Cefuroxime Sodium Antibiotic Disc , Cephalexin Antibiotic Disc , Cephaloridine Antibiotic Disc , Cephalothin Antibiotic Disc , Chloramphenicol Antibiotic Disc , Chlorhexidine Gluconate 4% W / V For Surgical Scrubbing , Chloroform A.G. , Chlorohexidine Gluconate3% ( W / V ) And Strong Cetrimide 6%Solution , Cholesterol - Test Kit , Ciprofloxacin Antibiotic Disc , Citric Acid , Citrosteril Disinfectant Chemical Lotion , Clarithromycin Antibiotic Disc , Clindamycin Antibiotic Disc , Cloxacillin Antibiotic Disc , Collodian , Conc. Hydrochloric Acid , Conc. Sulphuric Acid , Coombs Diluents ( Gel System ) , Cord Blood Processing Kit ( Cbp Kit ) For The Cord Blood Bank 1. The Cbp Kit Must Consist Of Three Bags Integrally Connected By Tubing, Two Of Which Are Pvc Bags-One Larger Bag & One Smaller Bag And A Third Smallest Bag Which Is The Cryo Bag / Freezing Bag. 2. The Larger Bag Should Have A Fill Volume Of 200Ml With An Attached Spike For Transferring Content From A Different Collection Bag. It Must Have One Leak Proof Access Port For Injecting Chemicals Inside Or Taking Out Sample. One Additional Entry Port To This Bag Is Preferred For Injecting Chemicals Only Through The Nozzle Of The Syringe Without Using Needle With Very Narrow Calibre Connecting Tubing For Administration Of Cryoprotectant ( S ) . 3. Other Smaller Bag Should Have A Fill Volume Of 150Ml. It Must Have One Leak Proof Access Port For Injecting Chemicals Inside Or Taking Samples From The Bag. 4. The Third Integrally Attached Bag ( Cryo Bag / Freezing Bag ) Consists Of Eva Material Or Approved Material For Storing Stem Cells At Ultra Low Temperature ( Minus 196°C ) Of Liquid Nitrogen. It Must Be A 3D Bag ( 3 Dimensional ) With Two Compartments Of 20Ml & 5Ml Capacity With Intercommunication. 5. Length Of This Cryo Bag / Freezing Bag Is 85-87Mm & Width 63-65Mm ( However The Total Width Is 71-73Mm Including The Height Of The Two Ports ( For Connecting Spike For Transplant ) Of The Bag One Connected With The 20Ml Part And Other Connected With The 5Ml Part. This Cryo Bag / Freezing Bag Along With At Least 90Mm Integral Tube Segment Should Fit Inside The Metal Cassette With Dimension 91-92Mm ( Length ) X 84-85Mm ( Width ) X 8-9Mm ( Thickness ) For Preservation. 6. Temperature Range Of Storage Should Be Minus 196°C Plus 40°C. 7. Easily Manipulative Clamp Must Be Present On Every Connecting Tubing From Bag To Bag And From Bag To Spike And Bag To Entry Or Exit Ports. 8. The Kit Should Have An Expiry Of At Least 2 Years From The Date Of Manufacture. 9. The Kit Manufacturing Process Should Follow The National And Or International Standards Like Iso Etc. So That The Bags Are Pyrogen Free, Sterilised, Animal Pathogenicity Test Passed, Can Withstand The Shearing Force During Centrifugation Etc. 10. Should Provide Copy Of The Supply Order To Other National Or International Cord Blood Banks. 11. Should Provide Customer Satisfaction Certificate For The Product. 12. Specimen Of The Kit Must Be Provided To The Tender Committee For Precise Verification Of The Size, Shape, Measurement And Other Specifications. 13. Other Requirement ( If Approved And Order Is Placed For Purchase ) :-Each Supply Lot / Batch Has To Be Provided With Certificate Of Analysis ( Quality Assurance Certificate ) Otherwise The Kit Will Not Be Accepted. 14. Should Have Icmed 13485 Certification By Qci Or Is / Iso 13485 Certification Or Ce Certificate Or Us Fda Approval Certificate. , Co-Trimoxazole Antibiotic Disc , Cpk ( Mb ) Test Kit , Cpk Test Kit , C-Reactive Protein ( Immunoterbedimetric ) - Test Kit , Creatinine -Test Kit , Cresol With Soap Solution 50% I.P. , De Ionized Water , Dengue Detection Kit ( Igg Antibody ) -Elisa , Dengue Igm Capture Elisa Kit Technical Specification: 1 ) The Elisa Kit Should Be Designed For Qualitative Detection Of Dengue Igm Antibodies Of All 4 Dengue Serotypes In Human Serum. 2 ) The Kit Should Be Provided With The Following Materials And Reagents: A. Anti-Human Igm Coatedbreak-Apart Microwells ( 12*8=96 Wells ) . Desiccant Should Be Provided For Storing The Unused Microwells Which Are To Be Resealed Immediately. B. Horseradish Peroxidase Conjugated Monoclonal Antibody Tracer With Preservatives. C. Chromogenic Substrate In Buffer. D. Positive Control In The Form Of Positive Human Serum With Preservatives And Antibiotics. E. Negative Control In The Form Of Confirmed Negative Human Serum With Preservatives And Antibiotics. F. Calibrators. G. Sample Diluents. H. Wash Buffer. I. Stop Solution. 3 ) The Time Required For Performing The Test For Detection Of Dengue Igm, Should Range Between 2-4 Hours. 4 ) The Elisa Kit For Detection Of Dengue Igm Should Have A Sensitivity Of >95% And A Specificity Of >98%. 5 ) The Kit Should Be Such That, One Well Is To Be Consumed For Evaluation Of Each Sample ( Barring The Wells Used For Control ) . 6 ) Test Elisa Kit Should Distinguish Between Dengue And Other Diseases With Similar Clinical Presentation. 7 ) The Kit Should Have A Shelf-Life Of At Least One Year When Stored At An Ambient Temperature Of 2ºc - 8ºc. 8 ) Transportation Should Be Under Cold Chain 9 ) Test Kit Should Fit In All The Commonly Available Brand / Make Of Elisa Reader & Washer Machine. 10 ) The Volume Of Each And Every Reagents Or Consumables Supplied In A Pack ( For 96 Wells ) Should Be Such That, Tests Can Be Run At Least In Twelve Occasions By Using The 96 Wells. 11 ) User Certificates From The Reputed Institution. , Dengue Ns1 Antigen Detection Kit ( Elisa ) , Developer ( X-Ray Film ) , Disinfectant Fluids ( Black ) , Phenolic Type, Grade 3 ( Rw Coeff 5-7 ) Is 1061:1997 , Doxycyclin Antibiotic Disc , Drabkin’S Solution , Durham’S Tube , E.D.T.A. Powder , Esbachs Reagent , Estradiol Elisa Kit , Ethanol 95% V / V ( Rectified Spirit ) - 100 Ml , Ethanol 95% V / V ( Rectified Spirit ) , Ether Solvent , Ferritin- Elisa , Fixer ( X-Ray Film ) , Formaldehyde Tablet , Formalin Solution 40% , Fpsa - Elisa , French Chalk , Fsh - Elisa , Ft3- Elisa , Ft4- Elisa , Furazolidone Antibiotic Disc , Gamma Benzene Hexachloride 1% W / V + Cetrimide 0.1% W / V , Gentamicin Antibiotic Disc , Giemsa Stain 25 Mg. , Glacial Acetic Acid , Glucose Test Kit , Glucose-6-Phosphate Dehydrogenase- Test Kit , Glucostix [ One Glucometer Must Be Supplied Free Of Cost Per 500 Strips Of Glucostix ] , Gluteraldehyde Solution 2% For Instrument Sterilisation , Glycerin I.P. , Glycin Irrigation Fluid , Gram Stain Kit , H2s Strip Kit , Haemodialysis Fluid With Bi-Carb , Hamatoxyllin Eosin Stain Powder , Hand Disinfactant : Each 100 Gm Soln.Contains : 2- Propanol- 45G, 1-Propanol- 30G, Ethyl-Hexadecyl- Dimethyl - Ammonium Ethyl Sulphate - 0.2 G , Hand Rub Soln.: 0.5% W / V Chlorhexidine Gluconate & 70 % V / V Ethanol , Hba1ctest Kit , Hbsag ( Elisa ) Kit Specification: 1. Microplate Elisa 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 Have Been Registered And Licensed In India By Dcg ( I ) . 6. 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 ) . 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 Assay Component Should Include Reactive And Non-Reactive Controls. 9. The Assay Should Have Sensitivity Of More Than Or Equal To 99% And Specificity Of More Than Or Equal To 98% 10. The Assay Should Have Analytical Sensitivity Of Detecting Less Than Or Equal To 0.5Ng / Ml. 11. 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. 12. The Kit Size Should Be 96 Tests / Kit. 13. The Item Should Be Up Graded From Iii Generation To Iv Generation Test Kitin The Light Of Bts Trg Recommendation Dated 12Th January 2015. , 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 Kitin The Light Of Bts Trg Recommendation Dated 12Th January 2015. , Hcv ( Elisa ) Kit Specification: 1. Microplate Elisa Coated With Recombinant / Synthetic Peptide Antigens For Core, Ns3, Ns4 And Ns5. 2. Adequated 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. 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 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 ) . 6.The Kits Should Have Minimum Shelf-Life Of 60% Or 12 Months ( Whichever Is More ) At The Port Of Discharge Of Consignees. 7. The Assay Component Should Include Reactive And Non-Reactive Controls. 8.The Assay Should Have A Sensitivity More Than Or Equal To 99% And Specificity Of More Than Or Equal To 98%. 9.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. 10. The Kit Size Should Be 96 Test / .Kit. 11. The Item Should Be Up Graded From Iii Generation To Iv Generation Test Kitin 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 50Tests. 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 Kitin The Light Of Bts Trg Recommendations Dated 12Th January 2015. , Hdl Cholesterol - D ( Immunoterbedimetric ) Test Kit , Hepatitis A Test Kit , Hepatitis Etest Kit , Hiv ( Elisa ) Kit Specification: 1. Should Be Solid Phase Microplate Coatedhivi & Ii Recombinant And / Or Synthetic Peptide Antigens. 2. The Assay Should Detected Hiv 1 And Ii Antibodies. 3. Adequate Documents Detailing The Principal, Components, Details Of Antigen For Antibody Detection Of Hiv 1And 2, Bio-Safety, Methodologies, Validity Criteria, Interpretation Of Results, Performance Characteristics, Storage Condition, Limitation Of Assays, Manufacturing & Expiry Dates Should Be Provide With Each Kit. 4.The Kit 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 Should Be Licensed Issued By The Competent Authority Defined Under Drugs And Cosmetics Act, 1940 & Also Be Evaluated By The Centers Approved By Dcg ( I ) 7.The Kitshould Have Minimum Shelf-Life Of 60% Or 12 Months ( Whichever Is More ) At The Port Of Discharge Of Consignees . 8.The Assay Component Should Includ Reactive And Non-Reactive Controls With Each Kit. 9.The Assay Should Have Sensitivity Level Of More Than Or Equal To 99.5% And Specificity Level Of More Than Or Equal To 98%. 10.The Manufacture / Authorized Agent Should Ensure Maintenance Of Cold Chain During Storage And 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 Be 96 Tests / Kit. 12.The Item Should Be Up Graded From Iii Generation To Iv Generation Test Kitin The Light Of Bts Trg Recommendation 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 Ofindigenous 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 Kitin The Light Of Bts Trg Recommendation Dated 12Th January 2015. , Hscrp Test Kit , Hydrogen Peroxide 11% W / V +Diluted Silver Nitrate 0.01% W / V , Hydrogen Peroxide Soln. ( 20Vol ) I.P. , Imipenem / Cilastatin Antibiotic Disc , Immersion Oil , Indole Strip , Iodine Crystal , A.R. , Isoprophyl Alcohol Ip 70% V / V , Kanamycin Antibiotic Disc , Kit For Early Diagnosis Of Pregnancy By Immunological Method ( Hcg ) , Koh Solution 10% L , Lactate Test Kit , Ldh , Ldl Direct Diagnostic Kit , Leishman Stain Soln. , Levofloxacin Antibiotic Disc , Lh Kit - Elisa , Lincomycin Antibiotic Disc , Lineazolid Antibiotic Disc , Lipase Test Kit , Liquid Paraffin I.P. ( Heavy ) , Liquified Phenol I.P. ( Carbolic Acid ) , Lomefloxacin Antibiotic Disc , Mac Conkey Agar , Magnesium Sulphate I.P. , Malachite Green , Mb / Bact Antibiotic Suppliment Kit , Meropenem Antibiotic Disc , Methyl Alcohol , Methyl Violet , Methylene Blue Liquid , Methylene Blue Powder , Micro Protein Test Kit , Minocyclin Antibiotic Disc , Moxifloxacin Antibiotic Disc , Mueller Hintone Agar , Multistrips- 8 Parameter ( Alb, Glucose, Ph, Ketone, Blood, Bilirubin, Urobilinogen & Nitrite ) , Muritic Acid , Nalidixic Antibiotic Disc , Netilmycin Antibiotic Disc , Nitric Acid , Nitrofurantoin Antibiotic Disc , Norfloxacin Antibiotic Disc , O.T.Sterilization Solution For Fumigation / Mopping, In Powder Form, Composition :-Potassium Mono Per Sulphate ( Triple Salt ) - 40% To 50 %, Sodium C 10-13 Alkyl Benzene Sulphate - 10% To 20% And Sodium Chloride - 1% To 5%. , Ofloxacin Antibiotic Disc , Paraffin Wax 58 C To 60 C , Paraffin Wax 60 C X 62 C , Penicillin Antibiotic Disc , Peptone , Ph Paper Range 1 To 14 , Piperacillin Antibiotic Disc , Pipercillin-Tazobactam Antibiotic Disc , Poly Sodium Citrate , Potassium Iodide , Potassium Permanganate I.P. , Ppa Media , Primary Antibody Er , Primary Antibody Her , Primary Antibody Pr , Progesterone Elisa Kit , Prolactin - Elisa , Providone Iodine Cleansing Solution 7.5% W / V Surgical Scrub , Pt Reagent , Purified Water I.P. , Pyr Reagent , Pyr Strip , Rapid Diagnostic Kit For Kala-Azar ( Rk-39 ) , Rheumatoid Factor ( Immunoterbedimetric ) Test Kit , Rifampicin Antibiotic Disc , Roxithromycin Antibiotic Disc , Rpr ( Rapid Plasma Reagin ) Kit Specification: 1. The Indigenous Rpr ( Rapid Plasma Reagin ) Kits Should Have Been Manufactured Under Manufacturing License Issued By The State Licensing Authority Under The Drugs And Cosmetics Act. The Imported Kits Should Have Been Imported Under Import License Issued By The Dcg ( I ) Under Drugs And Cosmetics Act. 2. The Assay Should Allow For Qualitative And Semi Quantitative Determination Of Reagin Antibodies In Serumor Plasma For Sero-Diagnosis Of Syphilis Based On Flocculation Principle Using Non Treponemal Antigens. 3.The Assay Should Be Suitable To Perform With Either Serum Or Plasma 4.The Assay Should Have Sensitivity Of 85% Or More In Primary Syphilis And A Specificity Of 93% Or More. 5.The Assay Should Be Calibrated To Who Reference Serum And The Same Should Be Supported By Statements In Kit Insert And Certificate From Manufacturer. 6.The Test Should Be Able To Yield Results Within 20 Minutes. 7.The Pack Size Of Rpr Test Kit Should Be Less Than Or Equal To 50 Tests Per Kit. 8.The Assay Components Should Include Positive And Negative Serum Control Sufficient For Conducting 20% Of The Tests ( 10% Negative And 10% Positive Controls ) . 9. The Kit Should Have All Essential Accessories Required For The Test Such As Cards, Droppers, Applicator Etc. In Adequate Quantities For The Number Of Tests To Be Performed. 10.The Kit Should Have Minimum Shelf-Life Of 60% Or 12 Months ( Whichever Is More ) At The Port Of Discharge Of Consignees. 11. The Cumulative Time Temperature Indicator Technology Used Should Be Pre-Qualified Bywho. 12. Literature, Detailing The Components, Methodologies, Validity Criteria, Performance Characteristics, Storage Conditions, Manufacturing And Expiry Dates Should Be Provided With Each Kit. 13. The Item Should Be Up Graded From Iii Generation To Iv Generation Test Kitin The Light Of Bts Trg Recommendation Dated 12Th January 2015. , Sabouraud Dextrose Agar ( Sda ) With Cc , Serum Billirubin Test Kit , Sgot Test Kit , Sgpt Test Kit , Simmons Citrate Agar , Sodium Hypochloride – 500 Ml Bot. , Solution For Instrumental Sterilization In Powder Form, Composition : Sodium Perborate Monohydrate 50% W / W ( 0.26% Per Acetic Acid ) , Sparfloxacin Antibiotic Disc , Streptomycin Antibiotic Disc , Surface Disinfactant Soln ( Each 100 Gm Contains: 1, 6 Di-Hydroxy 2, 5 Di-Oxyhexane ( Chemically Bound Formaldehyde ) - 11.2 Gms , Glutaraldehide 5 Gm , Benzalkonium Chloride 5 Gm, Alkyl Urea Derivatives 3 Gms , T4 - Elisa , Tcbs Agar , Teicoplanin Antibiotic Disc , Tetracyclin Antibiotic Disc , Ticarcillin / Clavulanic Acid Antibiotic Disc , Tobramycin Antibiotic Disc , Toludine Blue , Total Protein Test Kit

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INR 10000.0 /-

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Name of Work: E-TENDER FOR EMPANELMENT OF NABL LABORATORY FOR TESTING OF DRUGS, KIT,CHEMICALS & REAGENTS AND CONSUMABLES FORTWO YEARS FROM THE DATE OF A.O.C. (2021-2023)BY THE DEPUTY DIRECTOR OF HEALTH SERVICES (E&S), CENTRAL MEDICAL STORES.

Sl. No.	Item Description
1	Barium Chloride Powder
2	Barium Sulphate Powder(175gm)
3	Basic Fuchsin
4	Benedict Solution
5	Bile Esculin Disc
6	Bile salt
7	BIVALENT ANTIGEN-DETECTING RAPID DIAGNOSTIC TESTS (RDTs) FOR P. FALCIPARUM AND P. VIVAX MALARIA UNDR NVBDCP TECHNICAL SPECIFICATIONS: - A. Description of the Test Kit: The Bivalent Rapid Diagnostic Test (RDT) for Malaria should comprise of test card (cassette) and reagents including buffer solution in a dropping bottle. The test kit should be able to rapidly diagnose both P. Falciparum and P. Vivax. The test should be based on the principle of capture of parasite antigen from blood using monoclonal antibodies specific for antigen targets. Each test kit should contain all the materials required for performing the test including individually packed sterile lancets for pricking, heparinised capillary tubes (diameter-1mm) with relevant markings and reaction tubes with stand /wells as required. The manufacturer should have specified International Organisation for Standardization (ISO) certification. One should be able to perform the test with the blood taken by finger prick of the patient. Temperature stability data: information on thermal stability data for the lab product should be available. TYPE OF RDT- The RDT should be able to detect P. Falcciparaum Histidine –Rich Protein – 2 (HRP2) and P. Vivax Lactate Dehyydrogenase (pLDH) and not aldolase. RDTPerformance Criteria :- The products should conform to the following set of criteria (A-D), based on the results of the evaluation of the WHO Malaria RDT Product Testing. A. For the detection of Plasmodium falciparum (Pf) in all transmission settings the panel detection score (PDS) against Pf samples should be at least 75% at 200 parasites/uL. B. For the detection of Plasmodium Vivax (Pv) in all transmission settings the panel detection score (PDS) against Pv samples should be at least 75% at 200 parasites /uL. C. The false positive rate should be less than 10% . D. The invalid rate should be less than 5%. Each lot of RDT should be tested at a designed lot testing laboratory by using WHO protocol at the time of delivery. Only those lots with PASS report will be accepted for delivery. Content of Kit and Packaging: Each kit should be hermetically sealed in non-permeable pouch and should have moisture absorbent material. 10 such test cards (cassette), or lesser quantity as required by the programme should be packed in a box containing the reagents and the test plates. Adequate literature detailing the test kit components, principle , methodologies and validity criteria as specified under ‘RDT performance criteria’ should be provided in the kit inserts with the test kits. Storage conditions, expiry dates and limitations of test should be provided. The small box should be packed in bigger cardboard carton containing 5 such small boxes. The carton should be sealed with a sealing tape. C. Shelf Life : Shelf life from manufacturing date to expiry date should be at least 2 years and the RDTs should not have lost more than 1/6th of their effective life from the date at the time the material is offered for inspection .Losses due to premature deterioration as a result of biological and other activities during the life of potency of the Rapid Diagnostic Tests will be made good by the firm at its own cost. D. Stability requirements at temperatures of intended storage, transport and use : RDTs should have high thermal stability for use in areas with very high ambient temperatures as per the evaluation by WHO Malaria RDT Product Testing against a single cultured P. falciparum isolate at 200 parasites /uL at based line and after 60 days of incubation at room temperature, 35°C and 45° C. E. Quality Assurance :- The product should comply with ISO 13485. F. Marking /Labelling: i. Each card (cassette) should have space for recording particulars of patients, time and date of the test. ii. The large carton (containing 10 small boxes) and small box (containing 10 tests) should have the following markings: a. Name of the Test b. Lot number c. Manufacturing and expiry date d. Name of the manufacturer with address e. Details of the contents f. Storage conditions. g. Handling procedures h. Disposal instruction for the box and its contents i. GOI,NVBDCP Supply –NOT FOR SALE G. Details regarding approval of license: i. Manufacturing and Marketing License for manufacturing of Rapid Malaria Diagnostic Tests should have been obtained from the concerned Regulatory authority in the country by the manufacturer. ii. The Bidders must submit scientific study report in support of their claim of performance criteria of the offered product, i.e. WHO FINDreport mentioning the Panel detection score, false positivity rate, invalid rate, ease of use ,thermal stability data etc. Claim should be supported by reports of actual shelf life studies. iii. Reports of proven performance of the offered product in conditions similar to Indian field conditions (room temperature up to 40° C) with certification of no adverse report for the offered product from the end users during the last five years must be submitted with the bid. iv. The Bidders must submit a sample of their product (for example as two kits to procurement Agent for assessment of user friendliness by the Procurement Agent. v. Recommended conditions for storage (e.g. room temperature) and shelf life should clearly be mentioned on the label of RDT. H. Shipping from manufacturer : Before shipping : The manufacturer should provide to the consignees the details of airway bill numbers, airline carrier, flight number, numbers of containers, expectedarrival tiem . These details should be sent by email and flowed up by fax. The shipper (air carrier) should be notified of temperature storage requirements by the manufacturer in writing and by clear markings on cartons and related documents.(Stowage of the shipment closeto the skin of some aircraft may result in freezing.) The manufacturer should initiate shipment only when the consignee has confirmed the receipt of shipping notification. Manufacturer should ensure/arrange to have customs agents or other personnel on site to receive materials. Shipments should be moved immediately to moderate temperature storage places (less than 30° C ) .Leaving materials on airport tarmacs, in customs sheds , or in vehicles should be avoided. I. Ground Transportation : Ground transportation should be carried out during any stage of delivery without delay, maintaining temperature requirements while the vehicle is moving and is parked. Avoid leaving RDTs in vehicles parked in the sun.
8	Bleaching Powder - IS1065 /1989 [Containing not less than 30% w/w of available chlorine & Stability (max.) = 1 / 15 ]
9	Boric Acid IP.
10	Bovine Albumin I.P.(10 ml Vial)
11	Brain Heart Infusion Agar
12	Brain Heart Infusion Broth
13	Calcium Reagent Test Kit
14	Canada Balsam
15	CEA ELISA KIT
16	CedarwoodOil 25 gms.
17	Cedarwood Oil 30 ml
18	Cefaclor Antibiotic Disc
19	Cefadroxyl Antibiotic Disc
20	Cefazolin Antibiotic Disc
21	Cefdinir Antibiotic Disc
22	Cefepime Antibiotic Disc
23	Cefixime Antibiotic Disc
24	Cefoperazone Antibiotic Disc
25	Cefoperazone/ Salbactam Antibiotic Disc
26	Cefotaxime Antibiotic Disc
27	Cefpirome Antibiotic Disc
28	Cefpodoxime Antibiotic Disc
29	Cefprozil Antibiotic Disc
30	Ceftazidime Antibiotic Disc
31	Ceftizoxime Antibiotic Disc
32	Ceftriaxone /Salbactum Antibiotic Disc
33	Ceftriaxone Antibiotic Disc
34	Cefuroxime Antibiotic Disc
35	Cefuroxime Sodium Antibiotic Disc
36	Cephalexin Antibiotic Disc
37	Cephaloridine Antibiotic Disc
38	Cephalothin Antibiotic Disc
39	Chloramphenicol Antibiotic Disc
40	Chlorhexidine Gluconate 4% w/v for Surgical Scrubbing
41	Chloroform A.G.
42	Chlorohexidine Gluconate3%(w/v) and Strong Cetrimide 6%Solution
43	Cholesterol - Test Kit
44	Ciprofloxacin Antibiotic Disc
45	Citric Acid
46	Citrosteril Disinfectant Chemical Lotion
47	Clarithromycin Antibiotic Disc
48	Clindamycin Antibiotic Disc
49	Cloxacillin Antibiotic Disc
50	Collodian
51	Conc. Hydrochloric Acid
52	Conc. Sulphuric Acid
53	Coombs Diluents (Gel System)
54	Cord Blood Processing Kit (CBP Kit) for the Cord Blood Bank 1. The CBP Kit must consist of three bags integrally connected by tubing, two of which are PVC bags-one larger bag & one smaller bag and a third smallest bag which is the Cryo bag / freezing bag. 2. The larger bag should have a fill volume of 200ml with an attached spike for transferring content from a different collection bag. It must have one leak proof access port for injecting chemicals inside or taking out sample. One additional entry port to this bag is preferred for injecting chemicals only through the nozzle of the syringe without using needle with very narrow calibre connecting tubing for administration of Cryoprotectant(s). 3. Other smaller bag should have a fill volume of 150ml. It must have one leak proof access port for injecting chemicals inside or taking samples from the bag. 4. The third integrally attached bag (Cryo bag / Freezing bag) consists of EVA material or approved material for storing stem cells at ultra low temperature (minus 196°C) of liquid nitrogen. It must be a 3D bag (3 dimensional) with two compartments of 20ml & 5ml capacity with intercommunication. 5. Length of this Cryo bag/Freezing bag is 85-87mm & width 63-65mm (However the total width is 71-73mm including the height of the two ports (for connecting spike for transplant) of the bag one connected with the 20ml part and other connected with the 5ml part. This Cryo bag/Freezing bag along with at least 90mm integral tube segment should fit inside the metal cassette with dimension 91-92mm (Length) X 84-85mm (Width) X 8-9mm (thickness) for preservation. 6. Temperature range of storage should be minus 196°C plus 40°C. 7. Easily manipulative clamp must be present on every connecting tubing from bag to bag and from bag to spike and bag to entry or exit ports. 8. The kit should have an expiry of at least 2 years from the date of manufacture. 9. The kit manufacturing process should follow the national and or international standards like ISO etc. so that the bags are pyrogen free, sterilised, animal pathogenicity test passed, can withstand the shearing force during centrifugation etc. 10. Should provide copy of the supply order to other national or international cord blood banks. 11. Should provide customer satisfaction certificate for the product. 12. Specimen of the kit must be provided to the tender committee for precise verification of the size, shape, measurement and other specifications. 13. Other requirement (if approved and order is placed for purchase):-Each supply lot/batch has to be provided with Certificate of Analysis (quality assurance certificate) otherwise the kit will not be accepted. 14. Should have ICMED 13485 Certification by QCI or IS / ISO 13485 Certification or CE Certificate or US FDA approval Certificate.
55	Co-trimoxazole Antibiotic Disc
56	CPK (MB) Test Kit
57	CPK Test Kit
58	C-Reactive Protein (Immunoterbedimetric) - Test Kit
59	Creatinine -Test Kit
60	Cresol with Soap Solution 50% I.P.
61	De Ionized Water
62	Dengue Detection Kit (IgG Antibody) -Elisa
63	Dengue IgM capture ELISA kit Technical Specification: 1) The ELISA kit should be designed for qualitative detection of dengue IgM antibodies of all 4 dengue serotypes in human serum. 2) The kit should be provided with the following materials and reagents: a. Anti-Human IgM coatedBreak-apart Microwells (12*8=96 wells). Desiccant should be provided for storing the unused Microwells which are to be resealed immediately. b. Horseradish peroxidase conjugated monoclonal antibody tracer with preservatives. c. Chromogenic substrate in buffer. d. Positive Control in the form of positive human serum with preservatives and antibiotics. e. Negative control in the form of confirmed negative human serum with preservatives and antibiotics. f. Calibrators. g. Sample diluents. h. Wash buffer. i. Stop solution. 3) The time required for performing the test for detection of dengue IgM,should range between 2-4 hours. 4) The ELISA kit for detection of dengue IgM should have a sensitivity of >95% and a specificity of >98%. 5) The kit should be such that, one well is to be consumed for evaluation of each sample (barring the wells used for control). 6) Test ELISA kit should distinguish between Dengue and other diseases with similar clinical presentation. 7) The kit should have a shelf-life of at least one year when stored at an ambient temperature of 2ºC - 8ºC. 8) Transportation should be under cold chain 9) Test kit should fit in all the commonly available Brand/Make of ELISA reader & washer machine. 10) The volume of each and every reagents or consumables supplied in a pack (for 96 wells) should be such that, tests can be run at least in twelve occasions by using the 96 wells. 11) User certificates from the reputed institution.
64	Dengue NS1 Antigen detection kit (Elisa)
65	Developer (X-Ray film)
66	Disinfectant Fluids (Black), Phenolic Type, Grade 3 (RW coeff 5-7) IS 1061:1997
67	Doxycyclin Antibiotic Disc
68	Drabkin’s Solution
69	Durham’s Tube
70	E.D.T.A. Powder
71	Esbachs Reagent
72	Estradiol Elisa Kit
73	Ethanol 95% v/v (Rectified Spirit) - 100 ml
74	Ethanol 95% v/v(Rectified Spirit)
75	Ether Solvent
76	FERRITIN- Elisa
77	Fixer (X-Ray film)
78	Formaldehyde Tablet
79	Formalin Solution 40%
80	fPSA - Elisa
81	French Chalk
82	FSH - Elisa
83	FT3- Elisa
84	FT4- Elisa
85	Furazolidone Antibiotic Disc
86	Gamma Benzene Hexachloride 1% w/v + Cetrimide 0.1% w/v
87	Gentamicin Antibiotic Disc
88	Giemsa Stain 25 mg.
89	Glacial Acetic Acid
90	Glucose Test Kit
91	Glucose-6-Phosphate Dehydrogenase- Test Kit
92	Glucostix [One Glucometer must be supplied free of cost per 500 strips of Glucostix]
93	Gluteraldehyde Solution 2% for Instrument Sterilisation
94	Glycerin I.P.
95	Glycin Irrigation Fluid
96	Gram Stain Kit
97	H2S Strip Kit
98	Haemodialysis Fluid with Bi-Carb
99	Hamatoxyllin Eosin Stain Powder
100	Hand Disinfactant : Each 100 gm Soln.contains : 2- Propanol- 45g, 1-Propanol- 30g, Ethyl-Hexadecyl- Dimethyl - Ammonium Ethyl Sulphate - 0.2 g
101	Hand Rub Soln.: 0.5% W/V Chlorhexidine Gluconate & 70 % v/v Ethanol
102	HbA1CTest kit
103	HbsAg (Elisa) Kit Specification: 1. Microplate ELISA 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 have been registered and licensed in India by DCG(I) . 6. 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). 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 assay component should include reactive and non-reactive controls. 9. The assay should have sensitivity of more than or equal to 99% and specificity of more than or equal to 98% 10. The assay should have analytical sensitivity of detecting less than or equal to 0.5ng/ml. 11. 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. 12. The Kit size should be 96 tests /kit. 13. The item should be Up graded from III Generation to IV Generation Test Kitin the light of BTS TRG recommendation dated 12th January 2015.
104	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 Kitin the light of BTS TRG recommendation dated 12th January 2015.
105	HCV (Elisa) Kit Specification: 1. Microplate ELISA Coated with recombinant / synthetic peptide antigens for core, NS3, NS4 and NS5. 2. Adequated 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. 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 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). 6.The kits should have minimum shelf-life of 60% or 12 months (whichever is more) at the port of discharge of consignees. 7. The assay component should include reactive and non-reactive controls. 8.The assay should have a sensitivity more than or equal to 99% and specificity of more than or equal to 98%. 9.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. 10. The kit size should be 96 test/.kit. 11. The item should be Up graded from III Generation to IV Generation Test Kitin the light of BTS TRG recommendation dated 12th January 2015.
106	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 50tests. 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 Kitin the light of BTS TRG recommendations dated 12th January 2015.
107	HDL Cholesterol - D (Immunoterbedimetric) Test Kit
108	Hepatitis A test Kit
109	Hepatitis Etest Kit
110	HIV (Elisa) Kit Specification: 1. Should be solid phase microplate CoatedHIVI & II Recombinant and/or synthetic peptide antigens. 2. The assay should detected HIV 1 and II antibodies. 3. Adequate documents detailing the principal, components, details of antigen for antibody detection of HIV 1and 2, bio-safety, methodologies, validity criteria, interpretation of results, performance characteristics, storage condition, limitation of assays, manufacturing & expiry dates should be provide with each kit. 4.The kit 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 should be licensed issued by the competent authority defined under Drugs and Cosmetics Act, 1940 & also be evaluated by the centers approved by DCG(I) 7.The kitshould have minimum shelf-life of 60% or 12 months (whichever is more) at the port of discharge of consignees . 8.The assay component should includ reactive and non-reactive controls with each kit. 9.The assay should have sensitivity level of more than or equal to 99.5% and specificity level of more than or equal to 98%. 10.The manufacture / authorized agent should ensure maintenance of cold chain during storage and 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 be 96 tests/kit. 12.The item should be Up graded from III Generation to IV Generation Test Kitin the light of BTS TRG recommendation dated 12th January 2015.
111	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 ofindigenous 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 Kitin the light of BTS TRG recommendation dated 12th January 2015.
112	HsCRP Test Kit
113	Hydrogen Peroxide 11% w/v +diluted Silver Nitrate 0.01% w/v
114	Hydrogen Peroxide Soln. (20Vol) I.P.
115	Imipenem/Cilastatin Antibiotic Disc
116	Immersion Oil
117	Indole strip
118	Iodine Crystal , A.R.
119	Isoprophyl Alcohol IP 70% v/v
120	Kanamycin Antibiotic Disc
121	KIT FOR EARLY DIAGNOSIS OF PREGNANCY BY IMMUNOLOGICAL METHOD (HCG)
122	KOH Solution 10% L
123	Lactate Test Kit
124	LDH
125	LDL Direct Diagnostic Kit
126	Leishman Stain Soln.
127	Levofloxacin Antibiotic Disc
128	LH kit - Elisa
129	Lincomycin Antibiotic Disc
130	Lineazolid Antibiotic Disc
131	Lipase Test Kit
132	Liquid Paraffin I.P. (Heavy)
133	Liquified Phenol I.P. (Carbolic Acid)
134	Lomefloxacin Antibiotic Disc
135	Mac Conkey Agar
136	Magnesium Sulphate I.P.
137	Malachite Green
138	MB/BACT Antibiotic Suppliment Kit
139	Meropenem Antibiotic Disc
140	Methyl Alcohol
141	Methyl Violet
142	METHYLENE BLUE Liquid
143	METHYLENE BLUE Powder
144	Micro Protein Test Kit
145	Minocyclin Antibiotic Disc
146	Moxifloxacin Antibiotic Disc
147	Mueller Hintone Agar
148	Multistrips- 8 Parameter (Alb,Glucose, pH, Ketone, Blood, Bilirubin, Urobilinogen & Nitrite)
149	Muritic Acid
150	Nalidixic Antibiotic Disc
151	Netilmycin Antibiotic Disc
152	Nitric Acid
153	Nitrofurantoin Antibiotic Disc
154	Norfloxacin Antibiotic Disc
155	O.T.sterilization solution for fumigation/mopping, in powder form, Composition :-Potassium Mono per Sulphate (Triple Salt )- 40% to 50 %, Sodium C 10-13 Alkyl benzene Sulphate - 10% to 20% and Sodium Chloride - 1% to 5%.
156	Ofloxacin Antibiotic Disc
157	Paraffin Wax 58 c to 60 c
158	Paraffin Wax 60 c X 62 c
159	Penicillin Antibiotic Disc
160	Peptone
161	pH paper range 1 to 14
162	Piperacillin Antibiotic Disc
163	Pipercillin-Tazobactam Antibiotic Disc
164	Poly Sodium Citrate
165	Potassium Iodide
166	Potassium Permanganate I.P.
167	PPA Media
168	Primary Antibody ER
169	Primary Antibody HER
170	Primary Antibody PR
171	Progesterone Elisa Kit
172	PROLACTIN - Elisa
173	Providone Iodine cleansing solution 7.5% w/v surgical scrub
174	PT Reagent
175	Purified Water I.P.
176	PYR Reagent
177	PYR strip
178	Rapid diagnostic kit for Kala-azar (RK-39)
179	Rheumatoid Factor (Immunoterbedimetric) Test Kit
180	Rifampicin Antibiotic Disc
181	Roxithromycin Antibiotic Disc
182	RPR (Rapid Plasma Reagin) Kit Specification: 1. The indigenous RPR (Rapid Plasma Reagin) kits should have been manufactured under manufacturing license issued by the State Licensing Authority under the Drugs and Cosmetics Act. The imported kits should have been imported under import License issued by the DCG(I) under Drugs and Cosmetics Act. 2. The assay should allow for qualitative and semi quantitative determination of Reagin antibodies in serumor plasma for sero-diagnosis of syphilis based on flocculation principle using non treponemal antigens. 3.The assay should be suitable to perform with either serum or plasma 4.The assay should have sensitivity of 85% or more in primary syphilis and a specificity of 93% or more. 5.The assay should be calibrated to WHO reference serum and the same should be supported by statements in kit insert and certificate from manufacturer. 6.The test should be able to yield results within 20 minutes. 7.The pack size of RPR test kit should be less than or equal to 50 tests per kit. 8.The assay components should include positive and negative serum control sufficient for conducting 20% of the tests (10% negative and 10% positive controls). 9. The kit should have all essential accessories required for the test such as cards, droppers, applicator etc. in adequate quantities for the number of tests to be performed. 10.The kit should have minimum shelf-life of 60% or 12 months (whichever is more) at the port of discharge of consignees. 11. The cumulative time temperature indicator technology used should be pre-qualified byWHO. 12. Literature, detailing the components, methodologies, validity criteria, performance characteristics, storage conditions, manufacturing and expiry dates should be provided with each kit. 13. The item should be Up graded from III Generation to IV Generation Test Kitin the light of BTS TRG recommendation dated 12th January 2015.
183	Sabouraud Dextrose Agar (SDA) with CC
184	Serum Billirubin Test kit
185	SGOT Test Kit
186	SGPT Test Kit
187	Simmons Citrate Agar
188	Sodium Hypochloride – 500 ml Bot.
189	Solution for instrumental sterilization in powder form, Composition : Sodium Perborate Monohydrate 50% w/w (0.26% per acetic acid)
190	Sparfloxacin Antibiotic Disc
191	Streptomycin Antibiotic Disc
192	Surface Disinfactant Soln (Each 100 gm Contains: 1,6 Di-Hydroxy 2,5 Di-Oxyhexane (Chemically Bound Formaldehyde ) - 11.2 gms , Glutaraldehide 5 gm , Benzalkonium Chloride 5 gm, Alkyl Urea Derivatives 3 gms
193	T4 - Elisa
194	TCBS Agar
195	Teicoplanin Antibiotic Disc
196	Tetracyclin Antibiotic Disc
197	Ticarcillin/Clavulanic Acid Antibiotic Disc
198	Tobramycin Antibiotic Disc
199	Toludine Blue
200	Total Protein Test Kit