Standatrol S-E. 2 niveles. Lyophilized serum for precision control in clinical chemistry
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1 Lot: Level 1: Level 2: C Standatrol S-E 2 niveles Lyophilized serum for precision control in clinical chemistry USES Standatrol S-E 2 niveles is adaptable to different uses: - intralaboratory precision studies in which a stable, reproducible in time control specimen is required.. It can be used in the reproducibility daily control and in the preparation of control charts following usual methods; - as unknown sample in interlaboratory precision surveys, based on its constant dosage and high stability. PRINCIPLE Standatrol S-E 2 niveles contains the compounds usually determined in clinical chemistry laboratories. It must be noted that the assigned values for the different constituents of the control sera have been obtained with Wiener lab. s methods and reagents, thus, the obtained results will only be comparable to the list if the corresponding methods and reagents have been used. PROVIDED S Control Level 1: 5 ml-vials of homogenized and lyophilized serum with normal concentrations or normal/pathological threshold of metabolites and enzymes. Control Level 2: 5 ml-vials of homogenized and lyophilized serum with pathological concentrations or normal/pathological threshold of metabolites and enzymes. NON-PROVIDED S Bidistilled or deionized water. INSTRUCTIONS FOR USE - Open the vial, slowly pulling out the rubber stopper to avoid any loss of the lyophilized material. - Add exactly 5.00 ml bidistilled or deionized water (using appropriate volumetric device). - Cap and mix by gentle inversion, avoiding the formation of foam. Do not shake. - Let dissolve for 20 minutes at room temperature, occasionally mixing by inversion. - Mix by inversion immediately before use. WARNINGS Reagents are for in vitro diagnostic use. These control sera have been prepared from non-reactive material to HBsAg, HCV and HIV. However, the controls and blood samples should be handled as if it were infectious material. Use the reagents according to the working procedures for clinical laboratories. The reagents and samples should be discarded according to the local regulations in force. STABILITY AND STORAGE INSTRUCTIONS Standatrol S-E 2 niveles: is stable in refrigerator (2-10 o C) until the expiration date shown on the box. Once reconstituted the controls, most of their constituents are stable for 10 days refrigerated (2-10 o C), with the exception of alkaline phosphatase whose activity may increase with time, and bilirubin that is stable for 12 hours at 4 o C and protected from light. For each particular component, the stability is similar to that in the native serum and may be consulted in the corresponding package insert. To improve its performance, it is recommended to freeze (-20 o C) the reconstituted control serum, divided in fractions in airtight containers (e.g. 1.5 ml microcentrifuge tubes). They should only be thawed one time at room temperature, homogenizing the serum before use. INSTABILITY OR DETERIORATION OF S Any variation of the organoleptic features of the control sera (such as unusual coloration, humid appearance of lyophilized reagent, incomplete dissolution with abundant flocculation or lump formation) may be a sign of its deterioration. PROCEDURE Reconstituted controls should be used in the same manner as an unknown sample, following the package insert of the reagent kit in use. Note: the enzymes assigned values were obtained using techniques at 37 o C in the different automated analyzers. PROCEDURE LIMITATIONS Mistakes in the reconstitution or conservation may cause erroneous results. See PROCEDURE LIMITATIONS on the package insert of the kit in use. WIENER LAB. PROVIDES 6 x 5 ml vials (Cat ). REFERENCES - International Federation of Clinical Chemistry - Clin. Chem. 23/9:1784, Tonks, D.B. - Can. J. Med. Tech. 30:38, / 17 p. 1/20
2 MANUAL TECHNIQUE - METABOLITES METABOLITE Uric acid Albumin Direct bilirubin (mg/l) Total bilirubin (mg/l) Calcium Cholesterol (g/l) Creatinine (mg/l) Inorganic phosphorus Glucose Iron Magnesium Total proteins Triglycerides (g/l) UIBC VALUE ACCEPTABLE VALUE ACCEPTABLE Uricostat enzimático Uricostat enzimático AA Uricostat enzimático AA líquida Proti-2 (BCF Reag.) Albúmina AA Bilirrubina Bilirrubina Directa AA Bilirrubina Directa AA líquida Bilirrubina Bilirrubina Total AA Bilirrubina Total AA líquida Ca-Color Ca-Color AA Ca-Color Arsenazo III AA Colestat enzimático Colestat enzimático AA Colestat enzimático AA líquida Creatinina cinética AA líquida Creatinina directa Kinetic technique Endpoint technique Creatinina Fosfatemia Fosfatemia UV AA Glicemia enzimática Glicemia enzimática AA Glicemia enzimática AA líquida Fer-color Fer-color AA Fer-color AA líquida Mg-color AA Proti-2 (EDTA/Cu Reag.) Proteínas Totales AA TG Color GPO/PAP AA TG Color GPO/PAP AA líquida UIBC/TIBC AA líquida (-) Non-assigned / 17 p. 2/20
3 MANUAL TECHNIQUE - METABOLITES METABOLITE Urea (g/l) VALUE ACCEPTABLE VALUE ACCEPTABLE Urea color 2R Uremia Urea UV cinética AA Urea UV cinética AA líquida / 17 p. 3/20
4 MANUAL TECHNIQUE - ENZYMES ENZYME Alanine aminotransferase (GPT/ALT) Amylase Aspartate aminotransferase (GOT/AST) Cholinesterase Creatine Kinase Alkaline phosphatase g-glutamyl transferase Lactate dehydrogenase ) VALUE ACCEPTABLE VALUE ACCEPTABLE GPT (ALT) UV unitest GPT (ALT) UV AA GPT (ALT) UV AA líquida Amilasa 405 cinética Amilasa 405 AA líquida GOT (AST) UV unitest GOT (AST) UV AA GOT (AST) UV AA líquida Colinesterasa (30ºC) Colinesterasa AA (30ºC) CK NAV UV unitest CK NAC UV AA CK NAC UV AA líquida ALP 405 cinética optimizada ALP 405 AA líquida Fosfatasas Alcalina optim g-g-test cinética AA g-g-test cinética AA líquida LDH-P UV unitest LDH-P UV AA LDH-P UV AA líquida / 17 p. 4/20
5 TARGA BT METABOLITES METABOLITE Uric acid Albumin Direct bilirubin Total bilirubin Calcium Chloride Cholesterol Creatinine Inorganic phosphorus Glucose HDL Cholesterol Iron Lactate LDL Cholesterol Magnesium Potassium Total Proteins Sodium Triglycerides Uricostat enzimático AA Uricostat enz. AA líquida Albúmina AA Bilirrubina Bilirrubina Directa AA Bilirrubina Directa AA líquida Bilirrubina Bilirrubina Total AA Bilirrubina Total AA líquida Ca-Color AA Ca-Color Arsenazo III AA Colestat enzimático AA Colestat enz. AA líquida Creatinina cinética AA líquida Creatinina enzim. AA líquida Fosfatemia UV AA Glicemia enzimática AA Glicemia enz. AA líquida HDL Colesterol monofase AA plus Fer-color AA Fer-color AA líquida Lactate LDL Colesterol monofase AA Mg-color AA Proteínas Totales AA TG Color GPO/PAP AA TG Color GPO/PAP AA líquida / 17 p. 5/20
6 TARGA BT METABOLITES METABOLITE UIBC Urea UIBC/TIBC AA líquida Urea UV cinética AA Urea UV cin.aa líquida (-) Non-assigned / 17 p. 6/20
7 TARGA BT ENZYMES ENZIMA Alanine aminotransferase (GPT/ALT) Amylase Aspartate aminotransferase (GOT/AST) Cholinesterase Creatine kinase Alkaline Phosphatase g-glutamyl transferase Lactate deshidrogenase Lipase GPT (ALT) UV AA GPT (ALT) UV AA líquida Amilasa 405 cinética AA Amilasa 405 AA líquida GOT (AST) UV AA GOT (AST) UV AA líquida Colinesterasa AA Cholinesterase CK-NAC UV AA CK-NAC UV AA líquida ALP 405 AA líquida g-g-test cinética AA g-g-test cinética AA líquida LDH-P UV AA LDH-P UV AA líquida LDH-L Lipasa AA líquida / 17 p. 7/20
8 KONELAB SERIES / WIENER LAB. CT SERIES - METABOLITES METABOLITE Uric acid Albumin Direct bilirubin Total bilirubin Calcium Ionized calcium (Ca i ) (mmol/l) Chloride Cholesterol Creatinine Inorganic phosphorus Glucose HDL Cholesterol Iron Lactate LDL Cholesterol Lithium (mmol/l) Magnesium Uricostat enzimático AA Uricostat enz. AA líquida Albúmina AA Bilirrubina Bilirrubina Directa AA Bilirrubina Directa AA líquida Bilirrubina Bilirrubina Total AA Bilirrubina Total AA líquida Ca-Color AA Ca-Color Arsenazo III AA Colestat enzimático AA Colestat enz. AA líquida Creatinina cinética AA líquida Creatinina cinética AA líquida (compensated) Creatinina enzim. AA líquida Fosfatemia UV AA Glicemia enzimática AA Glicemia enz. AA líquida Glucose HK HDL Colesterol monofase AA plus HDL Cholesterol fast Fer-color AA Fer-color AA líquida Lactate LDL Colesterol monofase AA Mg-color AA Magnesium CPZ / 17 p. 8/20
9 KONELAB SERIES / WIENER LAB. CT SERIES - METABOLITES METABOLITE Potassium Total proteins Sodium Triglycerides UIBC Urea Proteínas Totales AA Total Protein TG Color GPO/PAP AA TG Color GPO/PAP AA líquida UIBC/TIBC AA líquida Urea UV cinética AA Urea UV cin.aa líquida (-) Non-assigned / 17 p. 9/20
10 KONELAB SERIES / WIENER LAB. CT SERIES - ENZYMES ENZYME Alanine aminotransferase (GPT/ALT) Amylase Aspartate aminotransferase (GOT/AST) Cholinesterase Creatine kinase Non-prostatic acid phosphatase Total acid phosphatase Alkaline phosphatase g-glutamyl transferase Lactate dehydrogenase Lipase GPT (ALT) UV AA GPT (ALT) UV AA líquida Amilasa 405 cinética AA Amilasa 405 AA líquida GOT (AST) UV AA GOT (AST) UV AA líquida Colinesterasa AA Cholinesterase CK-NAC UV AA CK-NAC UV AA líquida Fosfatasa Acida Total y Prostática cinética Fosfatasa Acida Total y Prostática cinética ALP 405 AA líquida g-g-test cinética AA g-g-test cinética AA líquida LDH-P UV AA LDH-P UV AA líquida LDH-L Lipasa AA líquida / 17 p. 10/20
11 BT 3000 PLUS / WIENER LAB. CB SERIES - METABOLITES METABOLITE Uric acid Albumin Direct bilirubin Total bilirubin Calcium Chloride Cholesterol Creatinine Inorganic phosphorus Glucose HDL Cholesterol Iron Lactate LDL Cholesterol Magnesium Potassium Total proteins Uricostat enzimático AA Uricostat enz. AA líquida Albúmina AA Bilirrubina Bilirrubina Directa AA Bilirrubina Directa AA líquida Bilirrubina Bilirrubina Total AA Bilirrubina Total AA líquida Ca-Color AA Ca-Color Arsenazo III AA Colestat enzimático AA Colestat enz. AA líquida Creatinina cinética AA líquida Creatinina cinética AA líquida (compensated) Creatinina enzim. AA líquida Fosfatemia UV AA Glicemia enzimática AA Glicemia enz. AA líquida Glucose HK HDL Colesterol monofase AA plus HDL Cholesterol fast Fer-color AA Fer-color AA líquida Lactate LDL Colesterol monofase AA Mg-color AA Magnesium CPZ Proteínas Totales AA Total Protein / 17 p. 11/20
12 BT 3000 PLUS / WIENER LAB. CB SERIES - METABOLITES METABOLITE Sodium Triglycerides UIBC Urea TG Color GPO/PAP AA TG Color GPO/PAP AA líquida UIBC/TIBC AA líquida Urea UV cinética AA Urea UV cin.aa líquida (-) Non-assigned / 17 p. 12/20
13 BT 3000 PLUS / WIENER LAB. CB SERIES - ENZYMES ENZYME Alanine aminotransferase (GPT/ALT) Amylase Aspartate aminotransferase (GOT/AST) Cholinesterase Creatine kinase Non-prostatic acid phosphatase Total acid phosphatase GPT (ALT) UV AA GPT (ALT) UV AA líquida Amilasa 405 cinética AA Amilasa 405 AA líquida GOT (AST) UV AA GOT (AST) UV AA líquida Colinesterasa AA Cholinesterase CK-NAC UV AA CK-NAC UV AA líquida Fosfatasa Acida Total y Prostática cinética Fosfatasa Acida Total y Prostática cinética Alkaline phosphatase ALP 405 AA líquida g-glutamyl transferase Lactate dehydrogenase Lipase g-g-test cinética AA g-g-test cinética AA líquida LDH-P UV AA LDH-P UV AA líquida LDH-L Lipasa AA líquida / 17 p. 13/20
14 METROLAB 2300 PLUS / WIENER LAB. CM SERIES - METABOLITES METABOLITE Uric acid Albumin Direct bilirubin Total bilirubin Calcium Cholesterol Creatinine Inorganic phosphorus Glucose HDL Cholesterol Iron Lactate LDL Cholesterol Magnesium Total proteins Triglycerides UIBC (-) Non-assigned / 17 p. 14/20 Uricostat enzimático AA Uricostat enz. AA líquida Albúmina AA Bilirrubina Bilirrubina Directa AA Bilirrubina Directa AA líquida Bilirrubina Bilirrubina Total AA Bilirrubina Total AA líquida Ca-Color AA Ca-Color Arsenazo III AA Colestat enzimático AA Colestat enz. AA líquida Creatinina cinética AA líquida Creatinina cinética AA líquida (compensated) Creatinina enzim. AA líquida Fosfatemia UV AA Glicemia enzimática AA Glicemia enz. AA líquida HDL Colesterol monofase AA plus HDL Cholesterol fast Fer-color AA Fer-color AA líquida Lactate LDL Colesterol monofase AA Mg-color AA Magnesium CPZ Proteínas Totales AA Total Protein TG Color GPO/PAP AA TG Color GPO/PAP AA líquida UIBC/TIBC AA líquida
15 METROLAB 2300 PLUS / WIENER LAB. CM SERIES - METABOLITES METABOLITE Urea Urea UV cinética AA Urea UV cin.aa líquida / 17 p. 15/20
16 METROLAB 2300 PLUS / WIENER LAB. CM SERIES - ENZYMES ENZYME Alanine aminotransferase (GPT/ALT) Amylase Aspartate aminotransferase (GOT/AST) Cholinesterase Creatine kinase Non-prostatic acid phosphatase Total acid phosphatase Alkaline phosphatase g-glutamyl transferase Lactate dehydrogenase Lipase GPT (ALT) UV AA GPT (ALT) UV AA líquida Amilasa 405 cinética AA Amilasa 405 AA líquida GOT (AST) UV AA GOT (AST) UV AA líquida Colinesterasa AA Cholinesterase CK-NAC UV AA CK-NAC UV AA líquida Fosfatasa Acida Total y Prostática cinética Fosfatasa Acida Total y Prostática cinética ALP 405 AA líquida g-g-test cinética AA g-g-test cinética AA líquida LDH-P UV AA LDH-P UV AA líquida LDH-L Lipasa AA líquida / 17 p. 16/20
17 METABOLITE WIENER LAB. CMD 800 SERIES - METABOLITES / 17 p. 17/20 Uric acid Uricostat enz. AA líquida Albumin Direct bilirubin Total bilirubin Calcium Chloride Albúmina AA Bilirrubina Directa AA líquida Bilirrubina Total AA líquida Ca-Color Arsenazo III AA Cholesterol Colestat enz. AA líquida Creatinine Creatinina cinética AA líquida (compensated) Creatinina enzim. AA líquida Inorganic phosphorous Fosfatemia UV AA Glucose HDL Cholesterol Iron Lactate LDL Cholesterol Glicemia enz. AA líquida Glucose HK HDL Colesterol monofase AA plus HDL Cholesterol fast Fer-color AA líquida Lactate LDL Colesterol monofase AA Lithium (mmol/l) Lithium enzymatic Magnesium Magnesium CPZ Potassium Total Protein Sodium Triglycerides UIBC Urea Proteínas Totales AA Total Protein TG Color GPO/PAP AA líquida UIBC/TIBC AA líquida Urea UV cinética AA líquida (-) Non-assigned
18 ENZYME WIENER LAB. CMD 800 SERIES - ENZYMES Alanine aminotransferase (GPT/ALT) GPT (ALT) UV AA líquida Amilase Amilasa 405 AA líquida Aspartate aminotransferase (GOT/AST) GOT (AST) UV AA líquida Cholinesterase Creatine kinase Non-prostatic acid phosphatase Total acid phosphatase Alkaline phosphatase g-glutamyl transferase Lactato dehydrogenase Lipase Cholinesterase CK-NAC UV AA líquida Fosfatasa Acida Total y Prostática cinética Fosfatasa Acida Total y Prostática cinética ALP 405 AA líquida g-g-test cinética AA líquida LDH-P UV AA líquida LDH-L Lipasa AA líquida / 17 p. 18/20
19 WIENER LAB. IC SERIES - IONS Potassium Sodium Chloride Ionic calcium - Ca n (mmol/l) Ionic calcium - Ca i (mmol/l) ION / 17 p. 19/20
20 Symbols The following symbols are used in the packaging for Wiener lab. diagnostic reagent kits. C This product fulfills the requirements of the European Directive 98/79 EC for "in vitro" diagnostic medical devices P Authorized representative in the European Community V X H l F Cont. "In vitro" diagnostic medical device Contains sufficient for <n> tests Use by Temperature limitation (store at) Do not freeze Biological risks Volume after reconstitution Contents M i Calibr. Calibrator b Control Manufactured by: Harmful Corrosive / Caustic Irritant Consult instructions for use b Positive Control c Negative Control g Batch code h Catalog number M Wiener Laboratorios S.A.I.C. Riobamba Rosario - Argentina Tech.Dir.: Viviana E. Cétola Biochemist A.N.M.A.T. Registered product Disp. Nº: 1435/ /08 Wiener lab Rosario - Argentina / 17 p. 20/20 UR171227
Standatrol S-E. 2 niveles. Lyophilized serum for precision control in clinical chemistry
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s vary between populations and age groups and it is important to always check the reference Haematology: Haemoglobin Male 130 175 g/l 0 6 days 145-220 g/l Female 115 165 g/l 7 days 140-186 g/l 8 days 3
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ATRYP Antitrypsin alpha 1 ERM-DA470k/IFCC 9 136 1.36 1.84 0.0184 GPROT Acid glycoprotein alpha 1 CRM 470 2 90.1 0.901 0.890 0.00890 ACP Acid phosphatase total 1-naphthyl phosphate 0.720 43.1 0.00703 0.421
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