Tender Document For Laboratory Equipments Micro-Biology Year, 2023-24 ( Part 3 ) ; 701 Kit - Anti Hev Igg -Elisa 96 Well Elisa • Once Opened, Reagents Should Be Stable For Minimum 6 Months At 2-8º C. • Positive And Negative Control Should Be Minimum 1.0 Ml Quantity. • All Reagents Required For Testing Should Be Supplied With The Kit. • Serum Can Be Used As Sample. • Both Sensitivity & Specificity Should Be More Than 99 %. • Documented Study Should Be Provided Along With Tender For Sensitivity & Specificity Claims. • Should Have Shelf Life Of 1 – 2 Years. • Should Be Stored At Room Temperature Or In Refrigerator ( 2 – 8 C ) . • Company Should Provide Good Manufacturing Product ( Gmp ) / Who Certificate & Iso 13485 Certificate / Fda Approved Along With Tender. • Kit Should Provide All Accessories & Control. • For Elisa Kit, 12 Strips Of 8 Wells Should Be Supplied • Expiry Should Be 1 – 2 Year From Date Of Manufacturing. • It Is Preferable, If Kit Has Good Rapport In Commercial Market Since Last 3 Years. • Detailed Literature Regarding Kit Should Be Provided Along With Tender. • Authority Letter From Manufacturer Is Mandatory. • For Imported Item, Ce Certificate Is Must. Rate Per Test 702 Kit - Anti Hev Igm -Elisa 96 Well Elisa • Can Be Stored At Room Temperature Or In Refrigerator ( 2 – 8 C ) . • Once Opened, Reagents Should Be Stable For Minimum 6 Months At 2-8º C. • Positive And Negative Control Should Be Minimum 1.0 Ml Quantity. • All Reagents Required For Testing Should Be Supplied With The Kit. • Both Sensitivity & Specificity Should Be More Than 99 %. • Documented Study Should Be Provided Along With Tender For Sensitivity & Specificity Claims. • Company Should Provide Good Manufacturing Product ( Gmp ) / Who Certificate & Iso 13485 Certificate / Fda Approved Along With Tender. • Kit Should Provide All Accessories & Control. • For Elisa Kit, 12 Strips Of 8 Wells Should Be Supplied • Expiry Should Be Minimum 1 Year From Date Of Manufacturing • Detailed Literature Regarding Kit Should Be Provided Along With Tender. • Authority Letter From Manufacturer Is Mandatory. • For Imported Item, Ce Certificate Is Must. • Globe / Dia-Sorin / Dia-Pro / Bio-Rad / Dsi / Dia-Sys / Biomerieux / Mp Diagnosis / Adaltis Rate Per Test 703 Kit - Anti Hev Igm -Rapid Immunochromatography, Rapid Test - Test To Be Finished Within 15-20 Min, With All Accessories Rate Per Test 704 Kit - Anti Hiv 1 & 2 Antibody Comb Test, Rapid Test 45 Minutes, Qualitative L Detection Of Igg Antibodies To Hiv 1 & 2 In Human Sera / Plasma, Use Of Synthetic Peptide As Antigens, Sensitivity 100%, Specificity 99.4%, Evaluated By Who, Pack Size= 24-36 Tests Rate Per Test 705 Kit - Anti Hiv 1 & 2 Antibody Comb Test, 90 Minutes, Differntial Detection - Reactivity For Antibodies To Hiv Type 1 Or 2, Use Of Synthetic Antigens Like P24, P31, Gp120, Gp41, Gp36 For Rapid Serological Determination Of Hiv Antibody, Sensitivity & Specificity Should Be Comparable To Western Blots, Sensitivity >99 To 100 %, Specificity > 99 To 100 % ; 706 Kit - Anti Hiv 1 & 2 Antibody & P24 Ag Detection Kit 96 Well Elisa - 4Th Generation • Can Be Stored At Room Temperature Or In Refrigerator ( 2 – 8 C ) . • Elisa Reader Based Test • Must Detect Both Hiv 1 And 2 Antibody & P24 Antigen • Negative Predictive Value 0.01 % • Kit Must Be As Per Naco Guidelines • Both Sensitivity & Specificity Should Be More Than 99 %. • Company Should Provide Good Manufacturing Product ( Gmp ) / Who Certificate & Iso 13485 Certificate / Fda Approved Along With Tender. • Kit Should Provide All Accessories & Control. • For Elisa Kit, 12 Strips Of 8 Wells Should Be Supplied • Expiry Should Be Minimum 1 Year From Date Of Manufacturing • Detailed Literature Regarding Kit Should Be Provided Along With Tender. • Authority Letter From Manufacturer Is Mandatory. • For Imported Item, Ce Certificate Is Must. Rate Per Test 707 Kit - Anti Hiv 1 & 2 Antibody Detection Kit 96 Well Elisa - 3Rd Generation • Can Be Stored At Room Temperature Or In Refrigerator ( 2 – 8 C ) . • Elisa Reader Based Test • Must Detect Both Hiv 1 And 2 Antibody • Negative Predictive Value 0.01 % • Kit Must Be As Per Naco Guidelines • Both Sensitivity & Specificity Should Be More Than 99 %. • Company Should Provide Good Manufacturing Product ( Gmp ) / Who Certificate & Iso 13485 Certificate / Fda Approved Along With Tender. • Kit Should Provide All Accessories & Control. • For Elisa Kit, 12 Strips Of 8 Wells Should Be Supplied • Expiry Should Be 1 – 2 Year From Date Of Manufacturing. • Detailed Literature Regarding Kit Should Be Provided Along With Tender. • Authority Letter From Manufacturer Is Mandatory. • For Imported Item, Ce Certificate Is Must. Rate Per Test 708 Kit - Anti Hiv 1 & 2 Antibody -Rapid Rapid Test - Test To Be Finished Within 20 Min • Must Differntiate Hiv 1 And 2 Antibody • Negative Predictive Value 0.01 % • Kit Must Be As Per Naco Guidelines • Suitable For Processing Even Single Sample • Pack =25 / 50 / 100 Tests Rate Per Test 709 Kit - Anti Leishmania Antibodies Rapid Test, 15-20 Minutes, Flexible Sample Usage I.E. Serum , Plasma, With All Accessories, Pack = 10 / 30 / 50 Tests Rate Per Test 710 Kit - Anti Leptospira Igg / Igm Antibodies Rapid Test, 15-20 Minutes, Flexible Sample Usage I.E. Serum , Plasma Or Whole Blood, With All Accessories, Pack = 10 / 30 / 50 Tests Rate Per Test 711 Kit - Anti Leptospira Igm Antibodies 96 Well Elisa • Serum Can Be Used As Sample. • Both Sensitivity & Specificity Should Be More Than 99 %. • Documented Study Should Be Provided Along With Tender For Sensitivity & Specificity Claims. • Should Have Shelf Life Of 1 – 2 Years. • Should Be Stored At Room Temperature Or In Refrigerator ( 2 – 8 C ) . • Company Should Provide Good Manufacturing Product ( Gmp ) / Who Certificate & Iso 13485 Certificate / Fda Approved Along With Tender. • Kit Should Provide All Accessories & Control. • For Elisa Kit, 12 Strips Of 8 Wells Should Be Supplied • Expiry Should Be 1 – 2 Year From Date Of Manufacturing. • It Is Preferable, If Kit Has Good Rapport In Commercial Market Since Last 3 Years. • Detailed Literature Regarding Kit Should Be Provided Along With Tender. • Authority Letter From Manufacturer Is Mandatory. • For Imported Item, Ce Certificate Is Must.
