CLINICAL CHEMISTRY REAGENTS. Product Profile

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1 Product Profile

2 Why Clinical Chemistry Reagents? Quantitative determination of specific analytes associated with various types of disease. Diagnosis Identifying a disease already present Prognosis Forecasting the possibility of getting a disease Screening - Mass testing Steps involved Assay procedure Data Interpretation Interpretation of test data Compare results with normal range Check the significant change from previous results α Amylase (LS) Methodology: kinetic method using α-napthylphosphate. Kit provided with Diluent (ACP), Diluent (Non prostatic ACP) and substrate. Sample volume : 0.1 ml semi automated and automated Stability of working Solution: 7-8 days at 2 8 ⁰ C Storage : 2-8 ⁰ C AC01 8 ml 8x1ml AC02 50 ml 10x5 ml ALBUMIN (LS) Determination of amylase activity in human serum or plasma. Methodology: kinetic method using Gal G 2 α CNP α - Amylase is a single reagent system. Sample volume : 0.05 ml semi automated and automated 8 ⁰ C Storage : 2 8 ⁰ C Reagent for determining Albumin in plasma or serum. Methodology: BCG method. Kit includes BCG Reagent & standard albumin-5gm/dl. Sample volume : 0.01 ml semi automated and Automated analyzer Stability of working Solution: Till Expiry at 2 Shelf life: 18 months Storage: 2 8 ⁰ C AM01 8 ml 8x1ml AM02 60 ml 2x30 ml ACID PHOSPHATASE Determination of acid phosphatase in human serum or plasma. AB01 50 ml 1x50 ml AB ml 2x50 ml AB ml 2x100 ml AB ml 5x50 ml AB ml 2x500 ml Product Profile Page 2

3 ALKALINE PHOSPHATASE BILIRUBIN DIRECT (LS) Reagent for determining alkaline phosphatase in Methodology: kinetic method using p-nitro phenyl phosphate (p-npp). Kit provided with a diluent solution and substrate p-npp tablet. Sample volume : 0.02 ml semi automated and Automated Stability of working Solution: 21 days at 2-8 Shelf life :18 months Storage : 2 8 ⁰ C Reagent for determining direct Bilirubin in Methodology: Jendrassik & Grof. Method using Diazotized sulphanilic acid Kit provided with Billirubin direct reagent (D1) and (D2) Sample volume : 0.05 ml Instrument: Colorimeter, spectrophotometer, discrete semi automated and automated Stability of working Solution: 2 days at 2-8 Storage 2-8 AP01 50 ml 5x10 ml AP ml 15x10 ml BILIRUBIN TOTAL (LS) Reagents for determination of total Bilirubin in plasma or serum Methodology: Jendrassik & Grof. Method using Diazotized sulphanilic acid with DMSO. Kit provided with Bilirubin total reagent (T1) and (T2) Ready to use Sample volume : 0.05 ml Stability of working Solution: 2 days at 2-8 Storage: 2-8 ⁰ C DB ml 2x100 ml DB ml 2x500 ml BILIRUBIN TOTAL & DIRECT (LS) Reagent for determining total and direct Bilirubin in Methodology: Jendrassik & Grof. Method using Diazotized sulphanilic acid with DMSO. Kit provided with Bilirubin Total Reagent (T 1) and (T 2), Bilirubin Direct Reagent (D1) and (D 2). Sample volume : 0.05 ml Stability of working Solution: 2 days at 2-8 Storage: 2 8 ⁰ C TB ml 2x100 ml TB ml 2x500 ml BI ml 2X50 ml BI ml 2x100 ml Product Profile Page 3

4 CALCIUM (LS) Reagent for determination of calcium in Methodology: O Cresolphthalein Complexone ( CPC) Kit provided with CPC reagent, diluent reagent and standard calcium (10mg/dl). Sample volume : 0.02 ml Stability of working Solution: 7 days at 2-8 Storage : 2-8 ⁰ C CA01 50 ml R 1 1x25 ml R 2 1x25 ml CA ml R 1 1x50 ml R 2 1x50 ml CA ml R 1 1x100 ml R 2 1x100 ml CALCIUM ARSINAZO (LS) Reagent for determination total calcium concentration in serum Methodology: Colorimetric method using Arsenazo III Calcium Arsinazo is ready to use, single liquid reagent system. Sample volume: Stability of working Solution: Till expiry at room temperature Storage: 2-8 ⁰ C AS01 50 ml 1x50 ml AS ml 2x50 ml CHLORIDE (LS) Reagent for determination of chloride in Methodology: Mercuric thiocynate method. Kit provided with chloride reagent, standard chloride (100mMol/L). Sample volume : 0.02 ml semi automated and Automated Storage : 2-8 ⁰ C CL01 50 ml 1x50 ml CL ml 2x50 ml CHOLESTEROL (LS) Reagent for determining total cholesterol in Methodology: Cholesterol oxidase (CHOD) Peroxidase (POD) Kit provided with Cholesterol enzyme reagent and standard cholesterol (200mg/dl). Discrete semi automated and automated Product Profile Page 4

5 CH01 50 ml 1x50 ml CH ml 5x25 ml CH ml 2x100 ml CH ml 5x50 ml CH ml 5x100 ml CH ml 2x500 ml CREATININE (LS) Reagent for determining creatinine in plasma or serum. Methodology: Jaffe(initial rate) using alkaline picrate. Kit provided with Picrate reagent, diluent reagent and standard Creatinine (2mg/dl). semi automated and Automated Stability of working Solution: 30 days at 2 8 CR01 50 ml R 1 1x25 ml R 2 1x25 ml CR ml R 1 1x50 ml R 2 1x50 ml CR ml R 1 1x100 ml R 2 1x100 ml CR ml R 1 1x500 ml R 2 1x500 ml Gamma (GT) Reagent for determining gamma glutamylrasferase (GGT) in Methodology: IFCC Method. Kit provided with reagent R 1 and R 2. semi automated and automated Stability of working Solution: 60 days at 2 8 Storage: 2 GA01 10 ml R 1 1x8 ml R 2 1x2 ml GA02 50 ml R 1 1x40 ml GA ml R 1 2x40 ml GA ml R 1 2x80 ml R 2 2x20 ml GLUCOSE (LS) Reagent for determining true glucose in Methodology: GOD POD Method. Kit provided with glucose enzyme reagent and standard Glucose (2g/ml). semi automated and Automated GU ml 5x100 ml GU ml 2x500 ml GU ml 4x500 ml HDL CHOLESTEROL (LS) Reagent for determining HDL Cholesterol in Methodology: Phosphotungstate / Mg 2+ Method. Product Profile Page 5

6 Kit provided with HDL Cholesterol precipitating reagent and standard HDL cholesterol (50mg/dl). semi automated and automated PH01 10 ml 1x10 ml PH02 25 ml 1x25 ml PH03 50 ml 1x50 ml PH ml 2x50 ml HEMOGLOBIN (LS) Reagent for determining hemoglobin in whole human blood. Methodology: Cyanmethemoglobin Kit provided with Hemoglobin reagent and standard Hemoglobin (60mg/dl). Sample Volume : 0.2ml Instrument: Colorimeter, Spectrophotometer, Discrete semi automated and automated Stability of working Solution: Till expiry at room temperature Storage: Hemoglobin Reagents (25-30) Hemoglobin Standard (2 8) HB ml 1x500 ml HB ml 2x500 ml HB ml 1x1000 ml HB ml 1x2000 ml HB ml 1x5000 ml LDH (Lactate Dehydrogenase) (LS) Determination of LDH activity in serum and plasma. Methodology: UV Kinetic Method (Pyruvate to Lactate). Kit provided with Reagent R 1 and R 2 Sample volume : 0.02ml semi automated and automated Stability of working Solution: 60 days at 2 8 LD01 10 ml R 1 1x8 ml R 2 1x2 ml LD02 50 ml R 1 1x40 ml LD ml R 1 2x40 ml LD ml R 1 2x80 ml R 2 2x20 ml PHOSPHORUS (LS) Reagent for determining phosphorus activity in Methodology: UV end point method using ammonium molybdate. Kit provided with single reagent R 1. semi automated and automated Product Profile Page 6

7 PP01 50 ml 1x50 ml PP02 50 ml 2x50 ml GOT/AST (LS) Reagent for determining GOT (AST) activity in Methodology: UV Kinetic Method. Kit provided with reagent R 1 and R 2. semi automated and Automated Stability of working Solution: 60 days at 2 8 PT01 25 ml R 1 1x20 ml R 2 1x5 ml PT02 50 ml R 1 1x40 ml PT ml R 1 2x40 ml PT ml R 1 2x80 ml R 2 2x20 ml PT ml R 1 4x50 ml R 2 2x25 ml PT ml R 1 4x100 ml R 2 2x50 ml TOTAL PROTEIN (LS) OT01 25 ml R 1 1x20 ml R 2 1x5 ml OT02 50 ml R 1 1x40 ml OT ml R 1 2x40 ml OT ml R 1 2x80 ml R 2 2x20 ml OT ml R 1 4x50 ml R 2 2x25 ml OT ml R 1 4x100 ml R 2 2x50 ml GPT/ALT (LS) Reagent for determining GPT (ALT) activity in Methodology: UV Kinetic Method. Kit provided with reagent R 1 and R 2. semi automated and Automated Stability of working Solution: 60 days at 2 8 Reagent for determining Total protein in Methodology: Biuret Method. Kit provided with Biuret reagent and standard Total protein (6mg/dl). TP01 50 ml 1x50 ml TP ml 2x50 ml TP ml 2x100 ml TP ml 5x50 ml TP ml 2x500 ml Product Profile Page 7

8 TRIGLYCERIDE (LS) Reagent for determining Triglycerides in Methodology: GOD POD Method. Kit provided with Triglyceride enzyme reagent and standard Triglycerides (200mg/dl). TG01 50 ml 1x50 ml TG ml 5x25 ml TG ml 2x100 ml TG ml 5x50 ml TG ml 5x100 ml TG ml 2x500 ml UREA Reagent for determining urea/blood urea nitrogen. Methodology: Modified Berthelot Method. Kit provided with Enzyme powder R 1, diluents solution R 2, chromogen solution R 3, Standard urea (40mg/dl). Stability of working Solution: 6 months at 2 8 UB ml R 1 Enz. Vial R 2 1x50 ml R 3 1x50 ml UB ml R 1 Enz. Vial R 2 1x100 ml R 3 1x100 ml UB ml R 1 Enz. Vial R 2 2x100 ml R 3 2x100 ml UB ml R 1 Enz. Vial R 2 3x100 ml R 3 3x100 ml UB ml R 1 Enz. Vial R 2 1x500 ml R 3 1x500 ml BUN UREA/GLDH (LS) Reagent for quantitative determination of Blood Urea Nitrogen (BUN)/Urea. Methodology: Enzymatic method using Urease enzyme and Glutamate dehydrogenase (GLDH) enzymes. Kit provided with Reagent R 1, Reagent R 2 and standard BUN (18.69 mg/dl), Urea (40 mg/dl). semi automated and Automated analyzer Stability of working Solution: 45 days at 2 8 UG01 50 ml R 1 1x40 ml UG ml R 1 2x40 ml UG ml R 1 4x50 ml R 2 1x50 ml UG ml R 1 4x100 ml R 2 1x100 ml Product Profile Page 8

9 URIC ACID (LS) Reagent for determining uric acid in plasma or serum. Methodology: Uricase POD Method Kit provided with Uric acid reagent and standard Uric acid (6mg/dl). Sample volume: 0.025ml Instrument: Spectrophotometer, Discrete semi automated and Automated analyzer Stability of working Solution: Till expiry at 2 Shelf life : 18 months Storage: 2 8 C UA01 50 ml 1x50 ml UA ml 5x25 ml UA ml 2x100 ml UA ml 5x50 ml UA ml 5x100 ml UA ml 2x500 ml Product Pro ile Page 9