1. Calibra - H - Store at 2-8 ºC.

Transcription

1 CALIBRA H Insert Ref.:80 Lot Expiration Calibrator Attention. It is suggested to verify carefully if the lot number printed in this insert corresponds to the lot on the bottle label. Intended use. is a multi-calibrator lyophilized, in human protein matrix, for calibration of clinical chemistry assays in automated systems and manual methods. Professional use [For in vitro diagnostic use.] 2020/05/05 Product description. is a preparation lyophilized in human protein matrix, containing several analytes which were adjusted by adding animal tissue extracts and other non-protein constituents such as purified chemical materials. Product characteristics. is appropriated for calibration in clinical chemistry assays, and may be applied on the transference of accuracy for automated systems of assays from a calibrator standard traceable to reference materials. Calibrator contain assigned for enzymes allowing its use on assays calibration for measuring the enzymatic activities, eliminating the observed difficulties when it is used factor in equipments with large band pass filter or procedures with bichromatic readings. may be also used successfully on the manual assays calibration. Traceability. The analytes concentrations present in are traceable to reference standard materials of the National Institute of Standards and Technology (NIST), International Federation of Clinical Chemistry (IFCC) and samples of agreed of the Proficiency Programs of College of American Pathologists (CAP). The reference materials developed by NIST have of analytes traceable to the results obtained with reference methods or definitive. These methods are part of CAP NIST Research Associate Program, where the relation between comparative methods and definitive methods is often confirmed in materials previously available in the CAP proficiency programs. The assigned for enzymes were calculated from the molar absorptivity of the products of the enzymatic activity whose measurement was performed in high resolution spectrophotometer. 1. Calibra - H - Store at 2-8 ºC. Reagent label bears expiration date. Lyophilized preparation containing several analytes in human protein matrix. See the concentration in Values. Precautions and warnings is prepared from human blood derivatives and was tested for the presence of HBsAg and antibodies anti-hcv and anti-hiv presenting negative results. Despite the use of validated and approved tests, none of them may assure that the derivatives products of human blood are free of infectious agents. Therefore, the usual security cares should be applied on the reagent handling. Disposal of all waste material should be in accordance with local guidelines. Preparation Hit carefully the bottle with the finger in order to loosen the lyophilized material from the bottle. Remove the plastic and rubber lids. Using a calibrated volumetric pipette, add to the bottle exactly 3.0 ml of deionized or distilled water, at ºC. Close the bottle with the rubber lid, hit carefully the botte wilh the finger, and let it rest for 10 minutes, homogenize gently by rotation for mixing. Intermittently for the next 10 minutes, invert the bottle gently until the complete dissolution of the material. Before use, homogenize gently, open the bottle and get the necessary amount for using. Close immediately and keep protected from light at 2-8ºC. Storage and stability. Unopened calibrators, when stored at indicated temperature, are stable up to expiration date shown on the label. Chemical or microbial contamination may occur during handling the product and decrease the stability. After the dissolution, the analytes of, except for bilirubin and alkaline phosphatase, are stable 7 days at 2-8 ºC in a tightly closed bottle and protected from light. Bilirubin and alkaline phosphatase are stable 2 days at 2-8 ºC in a tightly closed bottle. Some analytes of (bilirubin and creatine kinase) are sensitive to light therefore the light exposure should be avoided. All analytes, except for bilirubin and alkaline phosphatase, are stable for 15 days at -20 ºC in a hermetically closed container, protected from light. 01 English - Ref.: 80

2 In order to avoid repetitive freezing and melting, it is suggested to aliquot the calibrator in 0.5 ml to 1.0 ml before freezing. In order to avoid evaporation of the material, it is suggested to use appropriated tubes for freezing (cryotubes). The temperature of the freezer of a common refrigerator is around - 8 ºC. General instructions. dissolved is ready for using and must be processed exactly as proposed on the instructions of manual and automated applications. When stored in the refrigerator and mainly frozen, the calibrator must be homogenized before using. Do not mix strongly or use vortex. Be as fast as possible in order to not keep it out of the storage temperature or light exposed, and keep the calibrator bottle closed most of time. Limitations 1. Several factors alter the results obtained with. Among these factors are the errors of dissolution, homogenization, water or glasses contaminants, and inappropriate control of temperature or technical errors associated to equipment or the reagent systems. It is suggested to follow the Good Practices in Clinical Laboratories and the verification of the equipment and reagents instructions, related to the procedures limitations. 2. were established using Labtest Diagnostica procedures and reagents according to the described use instructions. Due the matrix effect, the calibration may be not appropriated if it is used reagents from other factory. Accuracy. The assigned of the analytes concentration presented in are traceable to NIST SRM 909, 916, 927, 965, 1951, IFCC ERM 470 and to agreed of the Proficiency Programs of College of America Pathologist (CAP). The chose procedure for calibration will have a high impact on the quality of the obtained results. Therefore, some aspects must be verified such as number of replicates, and the maximum acceptable differences on calibration that do not change the quality of the results. Reagent water quality. The deionized or distilled water in the laboratory to prepare reagents, use in the measurements and for final glass washing must have resistivity 1 megaohm.cm, or conductivity 1 microsiemens/cm and silicates concentration must be <0.1mg/L. References 1. Büttner J, Borth R, Boutwll JH, Broughton PMG. International Federation of Clinical Chemistry provisional recommendations on quality control in clinical chemistry. Part 3 Calibration and control materials. Clin Chim Acta 1977; 75:F11-F Eckfeldt JH, Copeland KR. College of American Pathologists Conference XXIII on matrix effects and accuracy assessment in clinical laboratories: Accuracy verification and identification of matrix effects. Arch Pathol Lab Med 1993; 117: Miller WG, Kaufman HW. College of American Pathologists Conference XXII on matrix effects and accuracy assessment in clinical laboratories: Introduction. Arch Pathol Lab Med 1993; 117: National Committee for Clinical Laboratory Standards. Evaluation of Matrix effects; proposed guideline. Document EP14-P. Presentation Product Reference Contents Customer information [Warranty conditions] CAL CAL 1 X 3 ml 6 X 3 ml Labtest Diagnóstica warrants the performance of this product under the specifications until the expiration date shown in the label since the application procedures and storage conditions, indicated on the label and in this insert, have been followed correctly. Labtest Diagnóstica S.A. CNPJ: / Av. Paulo Ferreira da Costa, Vista Alegre - CEP Lagoa Santa. Minas Gerais Brasil - Customer Service customerservice@labtest.com.br. The concentration are determined after statistical analysis of the results measured using Labtest reagents, and only refer to the specific lot of. The enzymatic measurements were performed at 37 ºC. Revision: April, 2014 Ref.: Copyright by Labtest Diagnóstica S.A. Reproduction under previous autorization 02 English - Ref.: 80

3 Attention. Make sure that the lot number labeled on the bottle of corresponds to the same lot on this insert. Systems with monochromatic readings Conventional s s IS 140* Uric acid Enzymatic 7.10 mg/dl 422 µmol/l 19 Albumin VBC 4.33 g/dl 627 µmol/l 108 ALT/GPT with Pyridoxal Phosphate IFCC UV 115 U/L 1921 nkat/l ALT/GPT without Pyridoxal Phosphate IFCC UV 112 U/L 1870 nkat/l 142 Amylase CNPG 466 U/L 7.78 µkat/l 109 AST/GOT with Pyridoxal Phosphate IFCC UV 102 U/L 1703 nkat/l AST/GOT without Pyridoxal Phosphate IFCC UV 108 U/L 1804 nkat/l 93 Direct bilirubin DCA 2.95 mg/dl 50 µmol/l 94 Total bilirubin DCA 4.57 mg/dl 78 µmol/l 31 Direct bilirubin Sims-Horn 3.60 mg/dl 62 µmol/l 31 Total bilirubin Sims-Horn 4.48 mg/dl 77 µmol/l 90 Cresolftalein mg/dl 2.94 mmol/l Calcium 95 Arsenaze III mg/dl 2.86 mmol/l 115 Chloride Thiocyanate 120 meq/l 120 mmol/l 76 Cholesterol Enzymatic 175 mg/dl 4.55 mmol/l 139 Cholinesterase Kinetic - DGKC 5594 U/L nkat/l 96 kinetic 4.14 mg/dl 366 µmol/l Creatinine 127 Enzymatic 3.94 mg/dl 348 µmol/l 86 Lactic Dehydrogenase Kinetic UV 899 U/L 15.0 µkat/l 79 Alkaline phosphatase PNPP 441 U/L 7.36 µkat/l 12 Phosphorus UV 7.43 mg/dl 2.40 mmol/l 105 Gamma GT Continuous kinetic 124 U/L 2071 nkat/l GOD-Trinder 230 mg/dl 12.8 mmol/l 133 GOD-Trinder*** 237 mg/dl 13.2 mmol/l Glucose 134 GOD-Trinder 234 mg/dl 13.0 mmol/l 137* Enzymatic HK 235 mg/dl 13.1 mmol/l 138 Lactate Enzymatic 40 mg/dl 4.44 mmol/l 107 Lipase Colorimetric enzymatic 144 U/L 2.40 µkat/l 50 Magnesium Magon/Xilidil blue 3.06 mg/dl 1.25 mmol/l 03 English - Ref.: 80

4 Systems with monochromatic readings Conventional s s IS 99 Total Proteins Biuret 7.52 g/dl 75 g/l 87 Triglycerides Enzymatic 160 mg/dl 1.81 mmol/l 104 Urea Enzymatic UV 110 mg/dl 18.3 mmol/l ***Value attributed to Labmax Plenno without sample blank. **Since most analyzers use the dot (.) as decimal separator, we apply the same procedure to avoid confusion when typing the value of the instrument. *Procedure without sample blank. 04 English - Ref.: 80

5 Systems with bichromatic readings Conventional s s IS 140 Uric acid Enzymatic 5.75 mg/dl 342 µmol/l 19 Albumin VBC 4.32 g/dl 626 µmol/l 108 ALT/GPT with Pyridoxal Phosphate IFCC UV 115 U/L 1921 nkat/l ALT/GPT without Pyridoxal Phosphate IFCC UV 112 U/L 1870 nkat/l 142 Amylase CNPG 466 U/L 7.78 µkat/l 109 AST/GOT with Pyridoxal Phosphate IFCC UV 102 U/L 1703 nkat/l AST/GOT without Pyridoxal Phosphate IFCC UV 108 U/L 1804 nkat/l 93 Direct Bilirubin DCA 2.86 mg/dl 49 µmol/l 94 Total Bilirubin DCA 4.57 mg/dl 78 µmol/l 31 Direct Bilirubin Sims-Horn 3.36 mg/dl 57 µmol/l 31 Total Bilirubin Sims-Horn 4.52 mg/dl 77 µmol/l 90 Cresolftalein mg/dl 2.94 mmol/l Calcium 95 Arsenaze III mg/dl 2.86 mmol/l 115 Chloride Thiocyanate 120 meq/l 120 mmol/l 76 Cholesterol Enzymatic 175 mg/dl 4.55 mmol/l 139 Cholinesterase Kinetic - DGKC 5594 U/L nkat/l 96 kinetic 4.19 mg/dl 370 µmol/l Creatinine 127 Enzymatic 3.94 mg/dl 348 µmol/l 86 Lactic Dehydrogenase Kinetic UV 899 U/L 15.0 µkat/l 79 Alkaline phosphatase PNPP 441 U/L 7.36 µkat/l 12 Phosphorus UV 7.07 mg/dl 2.28 mmol/l 105 Gamma GT Continuous kinetic 124 U/L 2071 nkat/l 133 GOD-Trinder 233 mg/dl 13.0 mmol/l 134 Glucose GOD-Trinder 234 mg/dl 13.0 mmol/l 137 Enzymatic HK 231 mg/dl 12.8 mmol/l 138 Lactate Enzymatic 40 mg/dl 4.44 mmol/l 107 Lipase Colorimetric enzymatic 144 U/L 2.40 µkat/l 50 Magnesium Magon/Xilidil blue 3.06 mg/dl 1.25 mmol/l 99 Total Proteins Biuret 6.87 g/dl 69 g/l 05 English - Ref.: 80

6 Systems with bichromatic readings Conventional s s IS 87 Triglycerides Enzymatic 160 mg/dl 1.81 mmol/l 104 Urea Enzymatic UV 110 mg/dl 18.3 mmol/l Attention. Make sure that the lot number labeled on the bottle of corresponds to the same lot on this insert. 06 English - Ref.: 80