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| 1 | Required items |
| 2 | Multi-assay Human Sera based Chemistry Control - Level1(Low range) / All Stable Lyophilized pre assayed materials of Levels 1 (Low) Chemistry Controls.It should be Multi-assay human sera-based Chemistry Controls in 3- 5 ml volume.The analytes should include all routinely measured parameters and common hormones including Albumin, Alkaline Phosphatase ,ALT, AST, Amylase ,Bilirubin (Total),Bilirubin (Direct), Calcium, Chloride, Cholesterol (Total), Cholesterol (HDL), Creatine Kinase, Creatinine ,Urea ,Urea nitrogen, Uric acid Glucose, Iron, Iron (TIBC), Iron (UIBC), Lactate Dehydrogenase, Lipase, Magnesium, Phosphorus, Potassium, Total Protein, Sodium, Triglycerides,Minimum Stability after reconstitution should be 7 days at 2-8°C and 1 month at -20°CTotal one year requirement should be of same lot. |
| 3 | Multi-assay Human Sera based Chemistry Control – Level 2 (Normal range) Stable Lyophilized pre assayed materials of Levels 2 (Normal) Chemistry Controls.It should be Multi-assay human sera-based Chemistry Controls in 3- 5 ml volume.The analytes should include all routinely measured parameters and common hormones including Albumin, Alkaline Phosphatase ,ALT, AST, Amylase ,Bilirubin (Total),Bilirubin (Direct), Calcium, Chloride, Cholesterol (Total), Cholesterol (HDL), Creatine Kinase, Creatinine ,Urea ,Urea nitrogen, Uric acid Glucose, Iron, Iron (TIBC), Iron (UIBC), Lactate Dehydrogenase, Lipase, Magnesium, Phosphorus, Potassium, Total Protein, Sodium, Triglycerides,Minimum Stability after reconstitution should be 7 days at 2-8°C and 1 month at -20°CTotal one year requirement should be of same lot. |
| 4 | Multi-assay Human Sera based Chemistry Control - Level-3 (Pathological range) Stable Lyophilized pre-assayed materials of Levels 3 (Pathological) Chemistry Controls.It should be Multi-assay human sera-based Chemistry Controls in 3- 5 ml volume.The analytes should include all routinely measured parameters and common hormones including Albumin, Alkaline Phosphatase ,ALT, AST, Amylase ,Bilirubin (Total),Bilirubin (Direct), Calcium, Chloride, Cholesterol (Total), Cholesterol (HDL), Creatine Kinase, Creatinine ,Urea ,Urea nitrogen, Uric acid Glucose, Iron, Iron (TIBC), Iron (UIBC), Lactate Dehydrogenase, Lipase, Magnesium, Phosphorus, Potassium, Total Protein, Sodium, Triglycerides,Minimum Stability after reconstitution should be 7 days at 2-8°C and 1 month at -20°C Total one year requirement should be of same lot. |
| 5 | Human Sera based Immunoassay controls- Low range alone or as trilevel Levels (Normal, Low and High, covering full clinically significant range) for immunoassay controls .Stable Lyophilized pre-assayed materialsIt should be human sera based and include at least following parameters: 25-Hydroxy Vitamin D, Alpha-fetoprotein (AFP), Anti-Thyroglobulinin (Anti-Tg),Anti-Thyroid peroxidase (Anti-TPO), C-Peptide, Calcitonin, CEA, Cortisol, Cyclosporine, Dehydroepiandrosterone (DHEA), Estriol Free & Total Estrogen (Total), Ferritin, Folate, FSH, Glucagon, hCG, hCG-β Subunit, hGH , Immunoglobulin A (IgA), E (IgE), G (IgG), M (IgM), Insulin, LH, Progesterone, Prolactin, PSA, PSA (Free), PTH (Intact), Salicylate, T3 (Free), T3 (Total), T4 (Free), T4 (Total), TBG, Testosterone, Testosterone (Free), Thyroglobulin (Tg),TSH, Vitamin B12Minimum Stability after reconstitution should be 7 days at 2-8 °C and 1 month at -20 °C Total one year requirement should be of same lot. |
| 6 | Human Sera based Immunoassay controls- Normal range alone or as trilevel Levels (Normal, Low and High, covering full clinically significant range) for immunoassay controls Stable Lyophilized pre-assayed materialsIt should be human sera based and include at least following parameters: 25-Hydroxy Vitamin D, Alpha-fetoprotein (AFP), Anti-Thyroglobulinin (Anti-Tg),Anti-Thyroid peroxidase (Anti-TPO), C-Peptide, Calcitonin, CEA, Cortisol, Cyclosporine, Dehydroepiandrosterone (DHEA), Estriol Free & Total Estrogen (Total), Ferritin, Folate, FSH, Glucagon, hCG, hCG-β Subunit, hGH , Immunoglobulin A (IgA), E (IgE), G (IgG), M (IgM), Insulin, LH, Progesterone, Prolactin, PSA, PSA (Free), PTH (Intact), Salicylate, T3 (Free), T3 (Total), T4 (Free), T4 (Total), TBG, Testosterone, Testosterone (Free), Thyroglobulin (Tg),TSH, Vitamin B12Minimum Stability after reconstitution should be 7 days at 2-8 °C and 1 month at -20 °C Total one year requirement should be of same lot. |
| 7 | Human Sera based Immunoassay controls- Pathological range alone or as trilevel Levels (Normal, Low and High, covering full clinically significant range) for immunoassay controls Stable Lyophilized pre-assayed materials It should be human sera based and include at least following parameters: 25-Hydroxy Vitamin D, Alpha-fetoprotein (AFP), Anti-Thyroglobulinin (Anti-Tg),Anti-Thyroid peroxidase (Anti-TPO), C-Peptide, Calcitonin, CEA,Cortisol, Cyclosporine, Dehydroepiandrosterone (DHEA), Estriol Free & Total Estrogen (Total), Ferritin, Folate, FSH, Glucagon, hCG, hCG-β Subunit, hGH , Immunoglobulin A (IgA), E (IgE), G (IgG), M (IgM), Insulin, LH, Progesterone, Prolactin, PSA, PSA (Free), PTH (Intact), Salicylate, T3 (Free), T3 (Total), T4 (Free), T4 (Total), TBG, Testosterone, Testosterone (Free), Thyroglobulin (Tg),TSH, Vitamin B12Minimum Stability after reconstitution should be 7 days at 2-8 °C and 1 month at -20 °C Total one year requirement should be of same lot. |
| 8 | Human Sera based Tumor markers controls Low range alone or as trilevel Levels (Normal, Low and High, covering full clinically significant range) for tumor markers. Stable Lyophilized pre-assayed materials ofIt should be Human sera based and should include at least following parameters- Alpha- lipoprotein (AFP), CA 15-3, CA 19-9, CA125, Carcinoembryonic antigen (CEA), Ferritin, beta hCG, HE4, Prolactin, PSA, PSA (free), Thyroglobulin.Minimum Stability after reconstitution should be 7 days at 2-8°C and 1 month at -20°C Total one year requirement should be of same lot. |
| 9 | Human Sera based Tumor markers controls Normal range alone or as trilevel Levels (Normal, Low and High, covering full clinically significant range) for tumor markers. Stable Lyophilized pre-assayed materialsIt should be Human sera based and should include at least following parameters- Alpha- lipoprotein (AFP), CA 15-3, CA 19-9, CA125, Carcinoembryonic antigen (CEA), Ferritin, beta hCG, HE4, Prolactin, PSA, PSA (free), Thyroglobulin.Minimum Stability after reconstitution should be 7 days at 2-8°C and 1 month at -20°C Total one year requirement should be of same lot. |
| 10 | Human Sera based Tumor markers controls Pathological range alone or as trilevel Levels (Normal, Low and High, covering full clinically significant range) for tumor markers. Stable Lyophilized pre-assayed materialsIt should be Human sera based and should include at least following parameters- Alpha- lipoprotein (AFP), CA 15-3, CA 19-9, CA125, Carcinoembryonic antigen (CEA), Ferritin, beta hCG, HE4, Prolactin, PSA, PSA (free), Thyroglobulin.Minimum Stability after reconstitution should be 7 days at 2-8°C and 1 month at -20°C Total one year requirement should be of same lot. |
| 11 | Blood Gas Controls Low range alone or as trilevel Levels ,liquid stable controls in individual vials of 1.5-2 ml each for pH, pCO2 & PO2. Aqueous based matrixAssigned Values for common blood gas analysers & POCT devices should be provided Minimum Stability for 2 years at ambient temperature. |
| 12 | Blood Gas Controls Normal range alone or as trilevel Levels, liquid stable controls in individual vials of 1.5-2 ml each for pH, pCO2 & PO2. Aqueous based matrixAssigned Values for common blood gas analysers & POCT devices should be provided Minimum Stability for 2 years at ambient temperature. |
| 13 | Blood Gas Controls Pathological range alone or as trilevel Levels, liquid stable controls in individual vials of 1.5-2 ml each for pH, pCO2 & PO2. Aqueous based matrixAssigned Values for common blood gas analysers & POCT devices should be provided Minimum Stability for 2 years at ambient temperature. |
| 14 | Blood gas controls with electrolytes Low range alone or as trilevel Levels ,liquid stable controls in individual vials of 1.5-2 ml each for pH, pCO2 & PO2.Aqueous based matrixAssigned Values for common blood gas analysers & POCT devices should be provided Minimum Stability for 2 years at ambient temperature. |
| 15 | Blood gas controls with electrolytes Normal range alone or as trilevel Levels, liquid stable controls in individual vials of 1.5-2 ml each for pH, pCO2 & PO2.Aqueous based matrixAssigned Values for common blood gas analysers & POCT devices should be provided Minimum Stability for 2 years at ambient temperature. |
| 16 | Blood gas controls with electrolytes Pathological range alone or as trilevel Levels, liquid stable controls in individual vials of 1.5-2 ml each for pH, pCO2 & PO2.Aqueous based matrixAssigned Values for common blood gas analysers & POCT devices should be provided Minimum Stability for 2 years at ambient temperature. |
| 17 | Cardiac Marker Liquid stable, pre-assayed, human sera-based Low range controls. Analytes present must include:CK (Total), CK-MB Isoenzyme, Homocysteine, Myoglobin, NT-proBNP, Troponin I, Troponin TIf analytes are not available as combo, individual may be quoted20 day open-vial stability at 2-8°C. |
| 18 | Cardiac Marker Liquid stable, pre-assayed, human sera-based Normal range controls. Analytes present must include:CK (Total), CK-MB Isoenzyme, Homocysteine, Myoglobin, NT-proBNP, Troponin I, Troponin TIf analytes are not available as combo, individual may be quoted.20 day open-vial stability at 2-8°C. |
| 19 | Cardiac Marker Liquid stable, pre-assayed, human sera-based Pathological range controls. Analytes present must include:CK (Total), CK-MB Isoenzyme, Homocysteine, Myoglobin, NT-proBNP, Troponin I, Troponin TIf analytes are not available as combo, individual may be quoted20 day open-vial stability at 2-8°C. |
| 20 | Diabetes Hemoglobin control Should be lyophilized control available in Low rangeIt Should include parameters:Hemoglobin (Total Glycated), Hemoglobin (Total), Hemoglobin A1, Hemoglobin A1CHemoglobin FIf analytes are not available as combo, individual may be quotedHuman whole blood-based control3-year shelf life at 2-8°C7-day reconstituted stability at 2-8°C |
| 21 | Diabetes Hemoglobin control Should be lyophilized control available in Normal rangeIt Should include parameters:Hemoglobin (Total Glycated), Hemoglobin (Total), Hemoglobin A1, Hemoglobin A1CHemoglobin FHuman whole blood-based controlIf analytes are not available as combo, individual may be quoted3-year shelf life at 2-8°C7-day reconstituted stability at 2-8°C |
| 22 | Diabetes Hemoglobin control It Should be lyophilized control available in Pathological rangeIt Should include parameters:Hemoglobin (Total Glycated), Hemoglobin (Total), Hemoglobin A1, Hemoglobin A1CHemoglobin FHuman whole blood-based controlIf analytes are not available as combo, individual may be quoted3-year shelf life at 2-8°C7-day reconstituted stability at 2-8°C |
| 23 | Urine Chemistry controls Low range controls liquid human urine based / lyophilized, pre-assayed controls.Should include parameters, Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Osmolarity, pH, Phosphorus, Potassium, Protein (Total), Sodium, Specific gravity, Urea, Uric acidOpen-vial stability at 2-8°C should be at least 30 days |
| 24 | Urine Chemistry controls Normal range controls liquid human urine based / lyophilized, pre-assayed controls.Should include parameters, Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Osmolarity, pH, Phosphorus, Potassium, Protein (Total), Sodium, Specific gravity, Urea, Uric acidOpen-vial stability at 2-8°C should be at least 30 days |
| 25 | Urine Chemistry controls Pathological range controls liquid human urine based / lyophilized, pre-assayed controls.Should include parameters, Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Osmolarity, pH, Phosphorus, Potassium, Protein (Total), Sodium, Specific gravity, Urea, Uric acidOpen-vial stability at 2-8°C should be at least 30 days |
| 26 | CRP controls with or without RFLiquid, human serum based, Low range pre-assayed controls. (Target values should be provided)30 day open-vial stability at 2-8°C |
| 27 | CRP controls with or without RFLiquid, human serum based, Normal range pre-assayed controls. (Target values should be provided)30 day open-vial stability at 2-8°C |
| 28 | CRP controls with or without RFLiquid, human serum based, Pathological range pre-assayed controls. (Target values should be provided)30 day open-vial stability at 2-8°C |
| 29 | Protein analytes including Rheumatoid Factor Control Liquid, human serum based, Low range controls for Rheumatoid factor testing.30 day open-vial stability at 2-8°C |
| 30 | Protein analytes including Rheumatoid Factor Control Liquid, human serum based, Normal range controls for Rheumatoid factor testing.30 day open-vial stability at 2-8°C |
| 31 | Protein analytes including Rheumatoid Factor Control Liquid, human serum based, Pathological range controls for Rheumatoid factor testing.30 day open-vial stability at 2-8°C |
| 32 | Ammonia Low range controls for quantitative estimation of ammonia in blood.Open-vial stability at 2-8°C should be at least 20 days |
| 33 | Ammonia Normal range controls for quantitative estimation of ammonia in blood.Open-vial stability at 2-8°C should be at least 20 days |
| 34 | Ammonia Pathological range controls for quantitative estimation of ammonia in blood.Open-vial stability at 2-8°C should be at least 20 days |
| 35 | Maternal Serum 1st Trimester Control - Low range alone or as trilevel combo, liquid, human serum-based controls designed to monitor the precision of tests immunoassay test methods used during maternal serum first trimester screeningIt Should include clinically relevant levels of Free beta hCG and PAPP-AOpen vial stability should be at least 15 days at 2-8°C |
| 36 | Maternal Serum 1st Trimester Control - Normal range , or as trilevel combo ,liquid, human serum-based controls designed to monitor the precision of tests immunoassay test methods used during maternal serum first trimester screeningIt Should include clinically relevant levels of Free beta hCG and PAPP-AOpen vial stability should be at least 15 days at 2-8°C |
| 37 | Maternal Serum 1st Trimester Control - Pathological range, or as trilevel combo, liquid, human serum-based controls designed to monitor the precision of tests immunoassay test methods used during maternal serum first trimester screeningIt Should include clinically relevant levels of Free beta hCG and PAPP-AOpen vial stability should be at least 15 days at 2-8°C |
| 38 | Maternal Serum 2nd Trimester Control (Quadruple test)Low range, or as trilevel combo, liquid, human serum-based controls designed to monitor the precision of immunoassay Quadruple test used duringmaternal serum second trimester screeningIt Should include clinically relevant levels of AFP, hCG, Free Estriol and Inhibin-AOpen vial stability should be at least 15 days at 2-8°C |
| 39 | Maternal Serum 2nd Trimester Control (Quadruple test)Normal range, or as trilevel combo, liquid, human serum-based controls designed to monitor the precision of immunoassay Quadruple test used duringmaternal serum second trimester screeningIt Should include clinically relevant levels of AFP, hCG, Free Estriol and Inhibin-AOpen vial stability should be at least 15 days at 2-8°C |
| 40 | Maternal Serum 2nd Trimester Control (Quadruple test)Pathological range or as trilevel combo ,liquid, human serum-based controls designed to monitor the precision of immunoassay Quadruple test used duringmaternal serum second trimester screeningIt Should include clinically relevant levels of AFP, hCG, Free Estriol and Inhibin-AOpen vial stability should be at least 15 days at 2-8°C |