EURO DIAGNOSTICA PRODUCT CATALOG RADIOIMMUNOASSAY (RIA)

Transcription

1 EURO DIAGNOSTICA PRODUCT CATALOG RADIOIMMUNOASSAY (RIA)

2 Radioimmunoassay Catalog Euro Diagnostica We are proud to introduce the 2013/2014 RIA Catalog Euro Diagnostica is an international diagnostic solutions provider in autoimmunity testing with a long history and commitment to quality. The company celebrates 20 years this year and was created following a merger between Ferring Diagnostica, Balticor Diagnostica, Euro Diagnostics and Medscand Diagnostics (MILAB). In 2004, Euro Diagnostica expanded its services by acquiring Wieslab AB, Sweden, a leading autoimmunity testing laboratory. From its facilities in Malmö, Sweden, Euro Diagnostica develops, manufactures and markets an extensive product range of the highest possible quality in over 100 countries. Our complete diagnostic kits and reagents are used daily in medical assessments both manually and on the majority of instrument platforms available worldwide. Our tests are developed for clinical auto immunology, microbiology and immunochemistry. Thanks to the long experience and continuous development of our personnel and production processes, Euro Diagnostica offers top quality cost-effective customized coating services. Our Laboratory Testing Unit, Wieslab, offers clinical testing and disease assessment within autoimmunity by qualified diagnostic specialists every day of the year. Wieslab Laboratory Services offers a comprehensive range of individual and panel tests, and ensures accurate and fast results. Testing is available for most autoimmune diseases. In this catalog our radioimmunoassay (RIA) kits are presented. For a complete overview of our product portfolio please visit our website ( Euro Diagnostica RIA kits Name Background RIA - Radioimmunoassay 4 Principle of the RIA technology 5 Angiotensin II EURIA 6 ANP EURIA 6 CCK EURIA 7 Chromogranin A EURIA 8 Chromogranin B EURIA 8 Beta-Endorphin EURIA 9 Endothelin EURIA 9 Gastrin EURIA 10 Glucagon EURIA 10 Alpha-MSH EURIA 11 NPY EURIA 11 PP EURIA 12 Somatostatin EURIA 12 Vasopressin EURIA 13 VIP EURIA 13 Availability and product claims may differ from country to country based on regulations and product approvals. Please contact your local representative for further details. Page Copyright: 2013, Euro Diagnostica AB Version: Graphic design: Oddville AB Printed by: Bildcenter i Lund AB RIA CATALOG I 3

3 Technology Technology Background RIA - Radioimmunoassay Principle of the RIA-technology The radioimmunoassay (RIA) technology was developed during the late 1950s by Berson and Yalow. Their work resulted in the classical paper on measurement of insulin concentrations in human plasma 1. For this work on insulin, Rosalyn Yalow received the 1977 Nobel Prize in Medicine. The development of the RIA technique eventually revolutionized research and clinical practice in many areas, in particular endocrinology. Due to the superior sensitivity of RIA, the technique continues to be widely used for accurate determination of biological components in low concentrations such as hormones. The high sensitivity allows for accurate determinations in the pmol/l range. Zero-standard Start No Ag added After mixing and incubation Bound* = 6 Free *= I-(Labeled antigen) 125 I-Ag (Fixed concentration) Antigen Ag (Unknown concentration in test sample) Antibody (Fixed amount) * 125 I-Ag Technology The rationale behind the RIA technology is fascinating in its simplicity and elegance, and based on the principle illustrated in figure 1. An unknown quantity of antigen in the test sample competes with a fixed concentration of radio labeled antigen in binding to a fixed amount of specific antibody. Known concentrations of unlabeled antigen are included in the assay to construct a calibration curve from which the concentration of unknown antigen in the test samples can be calculated. Euro Diagnostica RIA Portfolio Euro Diagnostica offers a portfolio of in-house developed RIA kits presented on the following pages. All kits are manufactured in our own production facilities. Focus areas of our RIA products are: Tumor markers Endocrine markers Metabolic markers Vasoregulation Low concentration of unknown antigen High concentration of unknown antigen Ag=6 Ag=12 Bound* = 3 Free *= 3 Bound* = 2 Free *= 4 Figure 1a. RIA is a competitive assay where a fixed and known amount of 125I-labeled antigen is used to calculate the unknown levels of antigen (unlabeled) in the test sample. The labeled and unlabeled antigens will compete in binding to fixed amount of antibodies to form antigenantibody complexes. These can then be separated from the unbound antigens and the radioactivity is measured. Higher levels of antigen in the test sample will result in lower signal as the unlabeled antigens will outcompete the labeled. Our RIA portfolio was introduced more than 20 years ago and has continuously been expanded and improved since then. Over the years the products have been appreciated by customers, not only for their simplicity and excellent performance, but also for practical characteristics as up to 4 years shelf life for some non-radioactive key components. This in turn results in stable and repeatable assays. The specification of several of our RIA kits regarding cross-reactivity and sensitivity are superior to other technologies, allowing for accurate and specific determination of some peptide hormones present at very low concentrations. Peptides labeling services In addition to RIA kits Euro Diagnostica also offers peptide labeling services. During the years of development and manufacturing of RIA kits, Euro Diagnostica has optimized the production processes resulting in an efficient and flexible production fulfilling all applicable quality standards. % binding ratio in unknown Unlabeled antigen (conc.) antigen in unknown Figure 1b. Schematic graph of a RIA standard curve. This is prepared from known levels of antigen and used to calculate the amount of antigen in test samples. Please contact us for prices and further discussions. Yalow, RS, Berson, SA (1960). Immunoassay of endogenous plasma insulin in man. J Clin Invest 39 (7): I RIA catalog RIA CATALOG I 5

4 Products Angiotensin II EURIA Angiotensin II is a biologically active key compound of the reninangiotensin system. The octapeptide angiotensin II is the strongest physiological vasoconstrictor known. Euro Diagnostica angiotensin II kit contains reagents and instructions for measuring angiotensin II in plasma. After the plasma samples, angiotensin II is assayed by a competitive radioimmunoassay. The assay is specific and the cross-reactivity with Angiotensin I is very low (<0.1%). Sensitivity determined as 3 standard deviations change from zero calibrator is 2.0 pmol/l. RB EURIA Angiotensin II RIA (100 tubes) RB RUO EURIA Angiotensin II RIA (100 tubes) ANP EURIA It has been shown that alpha-anp causes diuretic and natriuretic activities and relaxes smooth muscle. These effects are thought to be mediated by circulation in peripheral blood. EURIA-ANP is a simple, sensitive and reliable radioimmunoassay for ANP in human plasma. Euro Diagnostica ANP kit contains reagents and instructions for quantitative measurement in plasma samples. After extraction, concentrations are measured by non-equilibrium radioimmunoassay with delayed addition of the iodinated tracer. The determined concentration of ANP is expressed in picograms/ml (pg/ml). The sensitivity of the assay, judged as 3 SD change from zero calibrator is 3.5 pg/ml. CCK EURIA Cholecystokinin (CCK) is one of the classical gut hormones. It is believed to be a major regulator of gall bladder contraction and pancreatic enzyme secretion. CCK occurs in many different molecular forms. The intended use of these reagents is for determination of CCK in plasma. CCK is extracted from plasma. The C-terminal sulphation and the C-terminal amidation are important for the biological activity of CCK. CCK shares an identical sequence with gastrin in the five C-terminal amino acids, which requires an antiserum with very low cross-reactivity to gastrin. Plasma concentrations of CCK are very low, which makes it necessary to have a highly sensitive assay system. EURIA CCK radioimmunoassay is based on an antiserum specific for the sulphated form of CCK, with very low cross-reactivity to gastrin-17, sulphated gastrin. The assay system has been optimized to a very high sensitivity of 0.3 pmol/l. RB EURIA CCK RIA (100 tubes) RB 302 RUO 2 EURIA CCK RIA (100 tubes) Specificity The following cross-reactions have been found: Peptide Cholecystokinin 26-33, sulphate 100.0% Cholecystokinin-33, sulphate 134.0% Cross-reaction Cholecystokinin 26-33, non-sulphated < 0.01% Cholecystokinin < 0.01% Gastrin-17, sulphate 0.5% Gastrin-17, non-sulphated < 0.01% BANI RUO 1 EURIA ANP RIA (100 tubes) Please contact 6 I RIA catalog RIA CATALOG I 7

5 Products Chromogranin A EURIA Tumours of neuroendocrine origin such as carcinoids usually present with increased levels of chromogranin A in serum and plasma. Neuroendocrine tumours are derived from the neuroendocrine cells and typically include carcinoid tumours, pheochromocytomas, neuroblastomas, small cell lung cancers, hyperparathyroid adenomas, pituitary tumours, prostate cancers and pancreatic islet tumours, including MEN1 and MEN2 syndromes. The present chromogranin A RIA is a competitive method based on polyclonal rabbit antibodies. The antibodies were raised against a purified fragment containing amino acid sequence of the chromogranin A molecule. The sensitivity of the assay, judged as 2 SD change from zero calibrator, is nmol/l. The assay kit includes two controls (high and low). RB EURIA Chromogranin A RIA (100 tubes) RB 321 RUO 2 EURIA Chromogranin A RIA (100 tubes) Chromogranin B EURIA Chromogranins are soluble secretory proteins which are stored in the majority of different neuroendocrine cells. Increased levels in the circulation are often seen in conjunction with various neuroendocrine tumours. However, chromogranin A levels are often elevated in response to decreased renal function, atrophic gastritis and treatment with proton pump inhibitors. Chromogranin B levels are not affected by either proton pump inhibitor treatment or decreased renal function and have been shown to have similar use as chromogranin A. With its lower sensitivity but very high specificity, chromgranin B measurements can serve as a valuable complement to chromogranin A. EURIA Chromogranin B kit is a competitive radioimunoassay (RIA) for determination of chromogranin B in human plasma and serum. The antibodies were raised against a synthetic peptide containing amino acid sequence in the chromogranin B molecule. Beta-Endorphin EURIA ß-endorphin is found in neurons of the hypothalamus, as well as the pituitary gland. The behavioural effects of ß-endorphin are exerted by its actions in the brain and spinal cord, and it is presumed that the hypothalamic neurons are the major source of ß-endorphin at these sites. In situations where the level of ACTH is increased (e.g., Cushing s Syndrome), the level of endorphins also increases. ß-endorphin in sample (plasma, cerebrospinal fluid or tissue) is extracted. The extracts are analysed by a competitive radioimmunoassay using antibodies against synthetic human ß-endorphin. Sensitivity calculated from a decrease in binding of 2 SD in the zero standard is 3 pmol/l. RB 301 RUO 1 EURIA Beta-Endorphin RIA (100 tubes) Please contact Endothelin EURIA Endothelin is synthetized in and released from endothelial cells. Endothelin occurs in three different molecular forms: Endothelin 1, 2 and 3. Endothelin 1 is a potent vasoconstrictor peptide. Endothelin occurs in the circulation in very low concentrations and may be an important factor in the regulation of local blood circulation, blood pressure and contractility of the heart. Endothelin is extracted from plasma. The extracts are assayed by a competitive radioimmunoassay using a rabbit antiserum raised against an endothelin-1 albumin con jugate. The antiserum used in this assay crossreacts with endothelin-1 (100%), endothelin-2 (48%) and endothelin-3 (109%). The lowest de tectable concentration is 4 pmol/l corresponding to 0.4 pmol/l in the sample. RB 304 RUO 1 EURIA Endothelin RIA (100 tubes) Please contact The sensitivity of the assay, judged as 2 SD change from zero calibrator, is 0.19 nmol/l. RB EURIA Chromogranin B RIA (100 tubes) RB 322 RUO 2 EURIA Chromogranin B RIA (100 tubes) 8 I RIA catalog RIA CATALOG I 9

6 Products Gastrin EURIA Gastrin is involved in a number of physiological processes in the GI tract such as stimulating secretion of gastric acid (HCl) by the parietal cells of the stomach and inducing pancreatic secretions and gallbladder emptying. Determining gastrin is useful when diagnosing gastrin-producing tumours and achylia with or without pernicious anemia. In Zollinger- Ellison syndrome, gastrin is produced at excessive levels, often by a gastrinoma. Treatment with powerful anti-secretagogues may cause a rise in the serum gastrin concentration, and measurement of serum gastrin can thus be used to monitor the treatment efficacy. Gastrin occurs in the circulation in several different forms, among those gastrin-34 and gastrin-17, sulphated and non-sulphated. The five C-terminal amino acids of gastrin and cholecystokinin are identical, which explains their overlapping biological effects. The antiserum used in this assay completely cross-reacts with gastrin-34 and the sulphated forms of gastrin-17 and gastrin-34, but much less with CCK-8. MD EURIA Gastrin RIA (100 tubes) MD 302 RUO 2 EURIA Gastrin RIA (100 tubes) CE marked for IVD use. Available in the US. 2) Please contact your local representative for availability in your country. Glucagon EURIA Glucagon is involved in carbohydrate, fat and protein metabolism. Basal amounts of glucagon are essential for the maintenance of normoglycemia and one physiological role for glucagon is to prevent hypoglycemia. Since glucagon in diabetics has been found elevated absolutely or relatively to insulin, it has been proposed that glucagon contributes essentially to the development of the hyperglycemia and keto acidosis found in diabetes. Elevated levels of glucagon in plasma are found in patients with A-cell tumors. (Glucagon is a 29-amino acid straight-chain peptide produced in the pancreatic alpha cells.) EURIA radioimmuno assay is specific for pancreatic glucagon with no cross-reactivity with gut GLI (Glucagon-Like-Immunoreactivity). The sensitivity of the assay, judged as 2 SD change from zero calibrator, is 3 pmol/l. EURIA Glucagon correlates with WHO 69/164 standard. Specificity The following cross-reactions have been found: Compound Gastrin % Gastrin-17, sulphated 83% Gastrin-34 61% CCK-8 36% Gastrin 1-14 < 0.1% Peptide Glucagon, pancreatic, human 100.0% Gut GLI < 0.1% Cross-reaction Gastric releasing peptide < 0.01% Vascoactive intestinal peptide < 0.01% Motilin < 0.01% Glucagon < 0.01% Somatostatin 14 < 0.01% C-peptide < 0.01% Specificity The following cross-reactions have been found: Cross-reaction Secretin < 0.02% Cholecystokinin -39 < 0.02% Vasoactive intestinal peptide < 0.02% Gastric inhibitory peptide < 0.02% Alpha-MSH EURIA Alpha-Melanocyte Stimulating Hormone (Alpha-MSH) is a potent modulator of fever and inflammation. The average plasma Alpha- MSH level has been found higher in subjects with AIDS than in control subjects. Alpha-MSH is derived from pro-opiomelanocortin, a precursor protein that contains, within its structure, the sequences of other melanotropic peptides. Alpha-MSH is a 13-amino acid peptide with identical sequence to adrenocorticotropic hormone (ACTH 1-13). The intended use of the EURIA radioimmuno assay kit is the determination of Alpha-MSH in human plasma or cerebrospinal fluid. The antiserum used in this kit is directed to the amidated C-terminal part of the Alpha-MSH molecule and shows no cross-reactivity to ACTH (Adreno-Corticotropic-Hormone). Sensitivity calculated from a decrease in binding of 2 SD in the zero standard is 3 pmol/l. RB 303 RUO 1 EURIA Alpha-MSH RIA (100 tubes) Please contact NPY EURIA Neuropeptide Y (NPY) is a 36-amino acid peptide hormone found in the brain and autonomic nervous system. The hormone has been shown to be involved in several physiological/clinical processes including food intake, obesity, and anorexia nervosa. Increased serum/plasma concentrations of NPY have been found in patients with neuroblastoma and phaeochromocytoma. Increased serum/ plasma concentrations of NPY have also been found in pediatric B-cell precursor leukemia. The intended use of this EURIA kit is determination of NPY in human serum/plasma by direct assay without extraction. The antiserum used is very specific for NPY with no cross-reactivity with either pancreatic polypeptide (PP) or peptide YY (PYY). Sensitivity calculated from a decrease in binding of 2 SD in the zero standard is 3 pmol/l. RB EURIA NPY RIA (100 tubes) RB 317 RUO 2 EURIA NPY RIA (100 tubes) RB EURIA Glucagon RIA (100 tubes) RB 310 RUO 2 EURIA Glucagon RIA (100 tubes) CE marked for IVD use. Available in the Us and Japan. 2) Please contact 10 I RIA catalog RIA CATALOG I 11

7 Products PP EURIA Pancreatic polypeptide (PP) is secreted by the F-cells of the islets of Langerhans in the pancreas. PP is localized almost entirely in the pancreas, although detectable levels throughout gastrointestinal tract have been reported. The secretion of PP is stimulated by intake of food, especially protein and fat. Its function is to self-regulate pancreatic secretion activities. PP also effects hepatic glycogen levels and gastrointestinal secretions. It is also produced by endocrine-active tumours in the pancreas and the gastrointestinal tract. These tumours often produce several peptide hormones in the combinations PP-VIP, PP-glucagon or PP-gastrin. Tumours with only PP-secretion have been reported. These tumours may occur at the WDHA or Verner- Morrison syndrome. EURIA PP kit is intended for determining PP in human serum. Serum PP is assayed without extraction by a competitive radio immunoassay using a rabbit antiserum raised against bovine PP. The assay is specific for PP with very low cross-reactivity to a number of other functionally-related peptide hormones. Sensitivity calculated from a decrease in binding of 2 SD in the zero standard is 3 pmol/l. RB EURIA PP RIA (100 tubes) RB 316 RUO 2 EURIA PP RIA (100 tubes) Somatostatin EURIA Somatostatin is a cyclic peptide hormone secreted in several locations of the digestive system such as the stomach, intestine and delta cells of the pancreas. It is also secreted in the brain (e.g. hypothalamus). Functionally, somatostatin is an inhibitor hormone, inhibiting release of other hormones such as growth hormone, TSH, glucagon and gastrin. Somatostatin in plasma is extracted. The extracts are analysed by a competitive radioimmunoassay using an antiserum to synthetic cyclic somatostatin 14. The sensitivity calculated from a decrease in binding of 2 SD in the zero standard is 6 pmol/l. RB 306 RUO 2 EURIA Somatostatin RIA (100 tubes) Please contact Vasopressin EURIA One of the most important roles of vasopressin or antidiuretic hormone (ADH) is to regulate the body s retention of water. In addition, vasopressin has been implicated in a variety of physiological functions and has clinical applications in diabetes, hyponatraemia, and hypertension studies. Vasopressin, or Antidiuretic Hormone (ADH), is a cyclic nanopeptide with a structure very similar to that of oxytocin, differing in only two amino acids. Euro Diagnostica vasopressin kit contains reagents and instructions for the quantitative measurement of vasopressin in plasma or urine. After solid-phase extraction (SPE) or ethanol extraction, plasma vasopressin concentrations are measured by radioimmunoassay (RIA). Urine vasopressin concentrations can be measured directly. The assay is specific for vasopressin with no cross-reactivity to oxytocin. It has been calibrated against WHO standard 77/501. Sensitivity calculated from a decrease in binding of 3 SD in the zero standard is 0.5 pmol/l RB EURIA Vasopressin RIA (100 tubes) RB 319 RUO 1 EURIA Vasopressin RIA (100 tubes) VIP EURIA Vasoactive intestinal peptide (VIP) is produced in many tissues including the gut, pancreas and hypothalamus. It is a linear polypeptide structurally related to secretin and other members of the secretin family. VIP is believed to play crucial roles in the regulation of intestinal motility and intestinal epithelial ion and water transport. Increased plasma immunoreactive VIP concentrations have been reported in patients with WDHA syndrome (water, diarrhea, hypokalemia and achlor hydria). Increased plasma levels have also been reported in patients with cirrhosis. EURIA VIP kit is used to determine VIP in human plasma by a competitive radioimmunoassay without extraction. The assay is specific for VIP with very low cross-reactivity to other members of the secretin family. Its sensitivity calculated from a decrease in binding of 2 SD in the zero standard is 3 pmol/l. RB EURIA VIP RIA (100 tubes) RB 311 RUO 2 EURIA VIP RIA (100 tubes) Specificity The following cross-reactions have been found: Parameter VIP 1-28 (whole sequence) 100% VIP 1-6 < 2.5% VIP 1-18 < 2.5% VIP 1-22 < 2.5% VIP % VIP % VIP % Cross-reaction Secretin, porcine < 0.01% Gastric inhibitory peptide, porcine < 0.01% Pancreatic gluacon, porcine < 0.01% Enteroglucagon, porcine < 0.01% Pancreatic polypeptide, human < 0.01% Substance P < 0.01% Somatostatine, ovine < 0.01% 12 I RIA catalog RIA CATALOG I 13

8 TECHNICAL / PRODUCT OVERVIEW Product overview Alphabetical order Technical / Product overview EURIA Product Product code Antigen(s)/Material Market Authorization Standards, Controls Specimen, Sample volume Incubation times (min) Angiotensin II RB 320 Synthetic peptide, polyclonal antiserum IVD use in Europe (EEA) 7, low C, high C Plasma, extraction 24 h Angiotensin II RB 320 RUO Synthetic peptide, polyclonal antiserum RUO, worldwide 7, low C, high C Plasma, extraction 24 h ANP BANI RUO Synthetic peptide, polyclonal antiserum RUO, worldwide 9, low C, high C Plasma, extraction 48 h CCK RB 302 Synthetic sulphated peptide (CCK-8), polyclonal antiserum IVD use in Europe (EEA) High C, low C Plasma, extraction 6 days CCK RB 302 RUO Synthetic sulphated peptide (CCK-8), polyclonal antiserum RUO, worldwide High C, low C Plasma, extraction 6 days Chromogranin A RB 321 Purified human chromogranin A fragment IVD use in Europe (EEA) 7, low C, high C Serum, plasma 100 µl 24 h Chromogranin A RB 321 RUO Purified human chromogranin A fragment RUO, worldwide 7, low C, high C Serum, plasma 100 µl 24 h Chromogranin B RB 322 Synthetic peptide IVD use in Europe (EEA) 7, low C, high C Serum, plasma 100 µl 24 h Chromogranin B RB 322 RUO Synthetic peptide RUO, worldwide 7, low C, high C Serum, plasma 100 µl 24 h Beta-Endorphin RB 301 RUO Synthetic peptide, polyclonal antiserum RUO, worldwide 7, low C, high C Plasma, extraction 48 h Endothelin RB 304 RUO Synthetic peptide, polyclonal antiserum RUO, worldwide 7, low C, high C Plasma, extraction 48 h Gastrin MD 302 Synthetic sulphated peptide, polyclonal antiserum IVD use in Europe (EEA) and US 7, low C, high C Serum, 100 µl 2 h Gastrin MD 302 RUO Synthetic sulphated peptide, polyclonal antiserum RUO, worldwide 7, low C, high C Serum, 100 µl 2 h Glucagon RB 310 Synthetic peptide, polyclonal antiserum IVD use in Europe, US and Japan 7, low C, high C Plasma 48 h Glucagon RB 310 RUO Synthetic peptide, polyclonal antiserum RUO, worldwide 7, low C, high C Plasma 48 h Alpha-MSH RB 303 RUO Synthetic peptide, polyclonal antiserum RUO, worldwide 7, low C, high C Plasma, Liqvor, 100 µl 48 h NPY (neuropeptide Y) RB 317 Synthetic peptide, polyclonal antiserum IVD use in Europe (EEA) 7, low C, high C Serum, 200 µl 48 h NPY (neuropeptide Y) RB 317 RUO Synthetic peptide, polyclonal antiserum RUO, worldwide 7, low C, high C Serum, 200 µl 48 h PP (pancreatic polypeptide) RB 316 Synthetic peptide, polyclonal antiserum IVD use in Europe (EEA) 7, low C, high C Serum, 100 µl 48 h PP (pancreatic polypeptide) RB 316 RUO Synthetic peptide, polyclonal antiserum RUO, worldwide 7, low C, high C Serum, 100 µl 48 h Somatostatin RB 306 RUO Synthetic peptide, polyclonal antiserum RUO, worldwide 7, low C, high C Plasma, extraction 48 h Vasopressin RB 319 Synthetic peptide, polyclonal antiserum IVD use in Europe (EEA) 7, low C, high C Plasma extraction, urine 48 h Vasopressin RB 319 RUO Synthetic peptide, polyclonal antiserum RUO, worldwide 7, low C, high C Plasma extraction, urine 48 h VIP (vasointestinal peptide) RB 311 Synthetic peptide, polyclonal antiserum IVD use in Europe (EEA) 7, low C, high C Plasma, 200 µl 48 h VIP (vasointestinal peptide) RB 311 RUO Synthetic peptide, polyclonal antiserum RUO, worldwide 7, low C, high C Plasma, 200 µl 48 h 14 I RIA catalog RIA CATALOG I 15

9 Diagnostic solutions leader in autoimmunity testing We thank you for your interest in our products and we commit ourselves to continually developing and providing you with the highest quality innovative clinical solutions. Euro Diagnostica AB Mail address: P.O. Box SE Malmö Sweden Visiting address: Lundavägen 151 Malmö Sweden T F E W info@eurodiagnostica.com Doc No: E-083-GB00, October 2013