Tender For Procurement Of Kits, Chemicals & Reagents For Two Years From The Date Of Award Of Contract (Aoc) And Its Extension, If Required 1 Acetone A02/KCR Bottle of 500 ml 5000 2 Albumin - Test Kit A06/KCR 1 ml 100000 3 Alkaline Phosphatase - Test Kit A07/KCR 1 ml 82000 4 Ammoniam Oxalate A10/KCR Bottle of 500 gms 100 5 Amylase - Test Kit A16/KCR 1 ml 38000 6 Antiseptic Lotion 15% Cetrimide w/v + Chlorhexidine Gluconate Soln. I.P. 7.5% v/v(Container of 5 litres) A29/KCR Cont. of 5 Litres 25000 7 ASO LATEX AGGLUTINATION KIT A31/KCR 100 Test 1000 8 Benedict Solution B14/KCR Bottle of 500 ml 700 9 Bile salt B06/KCR Bottle of 250 gm 200 10 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 B07/KCR Box of 10 RDT Kits with diluents 600000 detect P. Falcciparaum Histidine –Rich Protein – 2 (HRP2) and P. Vivax Lactate Dehyydrogenase (pLDH) and not aldolase. RDT Performance 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. B. Content of Kit and Packaging: Each kit should be hermetically sealed in nonpermeable 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, 350 C and 450 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 FIND report 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, expected arrival 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 close to 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. 11 Brain Heart Infusin Agar B11/KCR Bottle of 500 gms 200 12 Brain Heart Infusin Broth B12/KCR Bottle of 500 gms 100 13 Calcium Reagent Test Kit C01/KCR Test Per ml 3000 14 Cedarwood Oil C05/KCR Bottle of 30 ml 450 15 Cholesterol - Test Kit C31/KCR 1 ml 192000 16 Citric Acid C33/KCR Bottle of 500 ml 150 17 Conc. Hydrochloric Acid C39/KCR Bottle of 500 ml 1500 18 CPK (MB) Test Kit C44/KCR 1 ml 5000 19 C-Reactive Protein (Immunoterbedimetric) - Test Kit C46/KCR 1 ml 80000 20 Creatinine -Test Kit C47/KCR 1 ml 320000 21 Cresol with Soap Solution 50% I.P. C48/KCR Container of 5 litres 30000 22 Dengue IgM capture ELISA kit Technical Specification: 1) The ELISA kit should be designed for qualitative D03/KCR 96 Wells 4000 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. 23 Dengue NS1 Antigen detection kit (Elisa) D04/KCR 96 Test / Kit 8000 24 Disinfectant Fluids (Black), Phenolic Type, Grade 3 (RW coeff 5-7) IS 1061:1997 D06/KCR Cont. of 5 Litres 66000 25 Esbachs Reagent E02/KCR Bottle of 500 ml 200 26 Formalin Solution 40% F04/KCR Bottle of 500 ml 60000 27 Giemsa Stain 25 gm. G02/KCR Container of 25gm. 5000 28 Glucose-6-Phosphate Dehydrogenase - Test Kit G05/KCR 1 ml 7000 29 Glutaraldehyde Solution 2% for instrument sterilization G06/KCR Container of 5 litres 30000 30 Hand Disinfactant : Each 100 gm Soln. contains : 2- Propanol- 45g, 1-Propanol- 30g, Ethyl-Hexadecyl- Dimethyl - Ammonium Ethyl Sulphate - 0.2 g - 100 ml Bot. H04/KCR Bottle of 100 ml 100000 31 Hand Rub Soln.: 0.5% W/V Chlorhexidine Gluconate & 70 % Ethanol H05/KCR Bottle of 500 ml 60000 32 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, H08/KCR Per Test 1300000 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. 33 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 H10/KCR Per Test 1600000 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 prequalified 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. 34 HDL Cholesterol - D (Immunoterbedimetric) Test Kit H11/KCR 1 ml 9000 35 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 H15/KCR Per Test 520000 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 prequalified 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. 36 Hydrogen Peroxide with Silver Nitrate Solution for Hospital use. H17/KCR Jar of 1 litre 48000 37 Immension Oil 30 ml. I02/KCR Bottle of 30 ml 4000 38 Isoprophyl Alcohol IP 70% v/v I05/KCR Bottle of 500 ml 80000 39 KIT FOR EARLY DIAGNOSIS OF PREGNANCY BY IMMUNOLOGICAL METHOD (HCG) K02/KCR Per Kit 175000 40 LDL Direct Diagnostic Kit. L03/KCR 1 ml 5000 41 Leishman Stain Soln. L04/KCR Bottle of 500 ml 10000 42 Lipase Test Kit L09/KCR 1 ml 4000 43 Mac Conkey Agar M01/KCR Bottle of 500 gms 200 44 Micro Protein Test Kit M10/KCR 1 ml 4500 45 Mueller Hintone Agar M13/KCR Bottle of 500 gms 200 46 Oxalic Acid O03/KCR Bottle of 500 gms 2000 47 Paraffin Wax 58 c to 60 c P01/KCR Bottle of 500 gms 4000 48 Paraffin Wax 60 c X 62 c P02/KCR Bottle of 500 gms 2000 49 Peptone P04/KCR Bottle of 500 gms 100 50 pH paper range 1 to 14 P05/KCR 50 Strips 200 51 Potassium Iodide P09/KCR Bottle of 500 gms 100 52 Puriffied Water I.P. P19/KCR Jar of 5 liter 70000 53 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 R05/KCR Per Test 1200000 antibodies in serum or 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 by WHO. 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 Kit in the light of BTS TRG recommendation dated 12th January 2015. 54 SGOT Test Kit S03/KCR 1 ml 175000 55 SGPT Test Kit S04/KCR 1 ml 165000 56 Simmons Citrate Agar S05/KCR Bottle of 100 gm 100 57 Sodium Hypochlorite – 500 ml Bot. S06/KCR Bottle of 500 ml 1500000 58 Sodium Hypochlorite 5% Solution S06.1/KCR Jar of 5 liter 250000 59 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 S10/KCR Bottle of 500 ml 40000 60 TCBS Agar T02/KCR Bottle of 500 gms 100 61 Toludine Blue T07/KCR Bottle of 25 gms 100 62 Total Protein Test Kit T08/KCR 1 ml 115000 63 Triglyceride Test Kit T12/KCR 1 ml 160000 64 TSH - Elisa T14/KCR 96 Wells 1500 65 TSI Agar T15/KCR Bottle of 100 gm 200 66 Typhoid IgM Test Kit T16/KCR 30 Test/Kit 1800 67 Urea - (GLDH) Reagent Kit U01/KCR 1 ml 10000 68 Urea -(Berthelot) Reagent Kit U02/KCR 1 ml 460000 69 Urea Agar Base U03/KCR Bottle of 100 gm 100 70 Uric Acid Test Kit U05/KCR 1 ml 170000 71 Uristix (10 Parameters) U06/KCR 100 Test 40000 72 VDRL Kit - latex kit V02/KCR 100 test per kit 4750 73 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 W04/KCR 50 TESTS KIT with 20 ml Buffer solution and 50 lan 70000 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 74 Widal Antigen Test Kit W03/KCR 1 ml 100000 75 XLD Agar X01/KCR Bottle of 500 gms 100 76 Xylene X02/KCR Bottle of 500 ml 9000
