bilirubin direct - Diatek：直接胆红素- diatek

bilirubin direct - Diatek：直接胆红素- diatek Bilirubin Direct DA Diagnostic reagent for quantitative in vitro determination of direct bilirubin in serum or plasma on photometric systems Order Information Waste Management Catalog,No,Kit,size,R1,R2,Please refer to local legal requirements. D1B20,–,125,5,x,25,ml,5,x,20,ml,1,x,25,ml,Reagent Preparation D1B20,–,250,10,x,25,ml,10,x,20,ml,2,x,25,ml,The reagents are ready-to-use. D1B20,–,500,5,x,100,ml,5,x,80,ml,1,x,100,ml,D1B20,–,LT1,800R1/200R2,800,ml,200,ml,Materials required but not provided NaCl solution 9 g/l. Summary [1,2] General laboratory equipment. Bilirubin is a breakdown product of hemoglobin. Free, unconjugated bilirubin is extremely apolar and nearly Specimen insoluble in water, thus forming a complex with albumin Serum, heparin plasma or EDTA plasma. for the transport in the blood from the spleen to the liver. It is very important to store the sample protected from In the liver, bilirubin is conjugated with glucoronic acid light! and the resulting water-soluble bilirubin glucoronic acid is Stability: 2 days at 15 - 25 ?C excreted via the bile ducts. 7 days at 2 - 8 ?C Hyperbilirubinemia can be caused by increased bilirubin 3 months at - 20 ?C production due to hemolysis (pre-hepatic jaundice), by In case of immediate freezing. parenchymal damages of the liver (intra-hepatic jaundice) Freeze only once! or by occlusion of bile ducts (post-hepatic jaundice). A Discard contaminated specimens. chronic congenital (predominantly unconjugated) hyperbilirubinemia called Gilbert’s syndrome is quite Assay Procedure frequent in the population. High levels of total bilirubin are Application sheets for automated systems are observed in 60-70% of neonates due to an increased available on request. postpartal breakdown of erythrocytes and because of delayed function of enzymes for bilirubin degradation. Wavelength 546 nm, (540 - 560 nm) Common bilirubin methods detect either total bilirubin or Optical path 1 cm direct bilirubin. Determinations of direct bilirubin measure Temperature 20 – 25 ?C / 37 ?C mainly conjugated, water soluble bilirubin . Unconjugated Measurement Against reagent blank bilirubin can therefor be estimated as the difference between total bilirubin and direct bilirubin. Blank Sample or standard Sample or standard - 100 µl Method Dist. Water 100 µl - Photometric test using 2,4-dichloroaniline (DCA) Reagent 1 1000 µl 1000 µl Mix, incubate for 3 – 5 min. at 20 – 25?C / 37?C, Principle read absorbance A1, then add: Direct bilirubin in presence of diazotized 2,4-dichloro-Reagent 2 250 µl 250 µl aniline forms a red colored azocompound in acidic solution. Mix, incubate for exactly 5 min. at 37?C, or 10 min. at 20 – 25?C, then read absorbance A2. Reagents ,A = [(A2 – A1) sample or standard] - [(A2 – A1) blank] Components and Concentrations Calculation N.B. Concentrations are those in the final test mixture. With calibrator. R1: 0.07 mmol/l EDTA-Na 2,ASample NaCl 6.6 g/l Bilirubin[mg/dl],，Conc.Cal[mg/dl] ,ACal Sulfamic acid 70 mmol/l R2: 2,4-Dichlorophenyl-diazonium salt 0.09 mmol/l Conversion factor HCl 130 mmol/l Bilirubin [mg/dl] x 17.1 = Bilirubin [µmol/l] 0.02 mmol/l EDTA-Na 2 Calibrators and Controls Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated For the calibration of automated photometric systems the Diasis TruCal U calibrator is recommended. For internal month of expiry, if stored at 2 – 8 ?C and contamination is avoided. Do not freeze the reagents! quality control Diasis TruLab N and P controls should be assayed with each batch of samples. Reagent 2 must be protected from light. Cat. No. Kit size Warning and Precautions DDS Calibrator D1C15-060 20 x 3 ml Take the necessary precautions for the use of laboratory D1C15-009 3 x 3 ml reagents. Control N D1C70-100 20 x 5 ml D1C70-025 5 x 5 ml Control A D1C75-100 20 x 5 ml D1C75-025 5 x 5 ml 2004/05 Rev : 00 Bilirubin Auto Direct – Page 1 Performance Characteristics Reference Range [1] Adults and children , 0.2 mg/dl (, 3.4 µmol/l) Measuring range The test has been developed to determine bilirubin Literature concentrations within a measuring range from 0.1 – st1. Thomas L ed. Clinical Laboratory Diagnostics. 1 ed. 10 mg/dl. When values exceed this range samples should Frankfurt: TH-Books Verlagsgesellschaft, 1998:192-be diluted 1 + 1 with NaCl solution (9 g/l) and the result 202. multiplied by 2. 2. Tolman KG, Rej R. Liver function. In: Burtis CA, Specificity / Interferences Ashwood ER, editors. Tietz Textbook of Clinical rdChemistry. 3 ed. Philadelphia: W.B Saunders No interference was observed by ascorbic acid up to Company; 1999. p. 1125-77. 30 mg/dl and lipemia up to 1000 mg/dl triglycerides. 3. Rand RN, di Pasqua A. A new diazo method for the Interference by hemoglobin occurs starting at hemoglobin determination of bilirubin. Clin Chem 1962;6:570-8. concentrations of 50 mg/dl. Sensitivity / Limit of Detection Manufacturer The lower limit of detection is 0.1 mg/dl. Diasis Diagnostik Sistemler Tic. Ve San. A.?. Merkez Mah.Burcu Sk. Precision (at 37?C) No:6/4 Mart Plaza 34406 Intra-assay precision Mean SD CV Kagithane – Istanbul n = 20 [mg/dl] [mg/dl] [%] TURKEY Sample 1 0.36 0.01 3.12 Tel :+90(212) 294 20 00 Sample 2 0.76 0.01 1.46 Fax:+90(212) 294 20 20 Sample 3 2.07 0.03 1.30 Inter-assay precision Mean SD CV n = 20 [mg/dl] [mg/dl] [%] Sample 1 0.35 0.01 3.34 Sample 2 0.75 0.01 1.00 Sample 3 2.13 0.02 0.71 Method Comparison A comparison between Diasis Bilirubin auto direct (y) and a commercially available test (x) using 85 samples gave following results: y = 0.95 x + 0.04 mg/dl; r= 0.995. 2004/05 Rev : 00 Bilirubin Auto Direct – Page 2