Reagents

Albumin is the most important binding and transport protein of the organism. The multitude functions of albumin are: Major contribution to plasma colloidal osmotic pressure, binding and transport of proteins, metal ions, bilirubin, free fatty acids, hormones, drugs, serving as an amino acid pool for protein synthesis and major antioxidant in plasma. Albumin measurements are made for monitoring patients with acute liver diseases, for suspected liver cirrhosis and monitoring patients with this disease, diagnosis of edematous status, prognosis of elderly, hospitalized patients. Colorimetric test for the quantitative determination of albumin in human serum and plasma.

Alpha-amylase activity is measured for detection of acute pancreatitis, chronic (relapsing) pancreatitis, obstruction of the pancreatic duct, detection of pancreatic involvement in abdominal disorders, surgical procedures, anorexia, bulimia, and parotitis. There is also a detectable increase in amylase after an endoscopic retrograde cholangiopancreatography (ERCP) procedure. Enzymatic color test for the quantitative determination of alpha-amylase in human serum, heparinised plasma and urine.

Anti-streptolysin-O are specific antibodies to streptolysin O, formed by an extracellular enzyme of group A ß-hemolytic streptococci. Streptococci are responsible for a variety of infections, including acute pharyngitis and other manifestations as glomerulonephritis, rheumatic fever, bacterial endocarditis and scarlet fever. Antibodies against streptolysin O are detectable one week to one month after a streptococcal infection. Laboratory results should always be interpretated in conjunction with other clinical findings. Latex enhanced immunoturbidimetric test for the quantitative determination of anti-streptolysin-O in human serum.

The apolipoproteins A1 are the main protein components of high-density lipoproteins (HDL-c). APO A1 has a role in the removal of excess cholesterol from the tissues and reduced levels of APO A1 have been observed in patients with coronary vascular disease. APO A1 measurements are frequently used in characterizing patients with genetic disorders that lead to low HDL cholesterol concentrations. Over the past several decades, decreased serum levels of high-density lipoprotein (HDL) and increased levels of low-density lipoprotein (LDL) have been associated with increased risk of coronary vascular disease. Immunoturbidimetric test for the quantitative determination of apolipoprotein A1 in human serum.

The apolipoproteins B are the main protein components of low density lipoproteins (LDL-c). APO B is necessary for the reaction with LDL receptors in the liver and on cell membranes and is thus involved in transporting cholesterol from the liver to the vessel cells. Elevated levels of APO B are frequently found in atherosclerotic vascular changes and are a risk factor for atherosclerosis. Over the past several decades, decreased serum levels of high-density lipoprotein (HDL) and increased levels of low-density lipoprotein (LDL) have been associated with increased risk of coronary vascular disease. Immunoturbidimetric test for the quantitative determination of apolipoprotein B in human serum.

Bilirubin total is a laboratory test for the diagnosis, differential diagnosis and therapy control of jaundice, caused by liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. Colorimetric test for the quantitative determination of bilirubin total in human serum and plasma.

Direct bilirubin (DBIL) is a helpful marker for hepatic and post-hepatic jaundice, whereas pre-hepatic jaundice is primarily associated with an increase of indirect bilirubin. Increased direct bilirubin concentrations are found in acute and chronic viral hepatitis, liver cirrhosis, hepatocellular carcinoma, extrahepatic cholestasis, liver transplant rejection, and congential disorders like Dubin-Johnson and Rotor syndrome. Colorimetric test for the quantitative determination of bilirubin direct in human serum and plasma.

Cholinesterase activity measurements are used as a test of liver function in patients with acute and chronic hepatitis, liver sclerosis, as an indicator of insecticide poisoning and as a means to investigate atypical variants of the enzyme. A decreased level of enzyme activity is an indication of any of the above conditions. CHE is also used to identify patients with low enzyme activity before administration of muscle relaxants of the succinylcholine type. CHE activity is regarded as the most important indicator of degree of intoxication by organophosphorus pesticide. Enzymatic colorimetric test for the quantitative determination of Cholinesterase in human serum and plasma.

Creatine kinase activity and the activity of its isoenzymes is measured for diagnosis and therapy control of myocardial infarction, myocarditis, cerebrovascular accidents, skeletal muscular dystrophies, and cardiac and skeletal muscle diseases. Creatine kinase activity is also measured for monitoring the treatment of cancer patients. Enzymatic UV test for the quantitative determination of creatine kinase in human serum and plasma.

Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Colorimetric test for the quantitative determination of calcium total in human serum and heparinised plasma.

Total cholesterol (CHOL) measurements are used for diagnosis and therapy control of atherosclerotic coronary vascular disease and metabolic disorders such as dyslipidemia and liver diseases. The concentration of total cholesterol in serum or plasma is influenced by different factors like age, sex, diet and physical activity. Colorimetric enzymatic test for the quantitative determination of total cholesterol in human serum and plasma.

CK-MB is a rapidly appearing biomarker in case of a myocardial infarction. The rise in activity of CK-MB depends on the size of the cardiac muscle damage. Homogeneous test for the quantitative determination of CK-MB in human serum and plasma.

C-reactive protein (CRP) is an acute phase protein which is synthesised in the liver. Inflammatory processes, bacterial infections, polytrauma, myocardial infarction and certain other diseases (e.g. M. Bechterew, M. Crohn, rheumatoid arthritis) are accompanied by a significant increase of the CRP concentration. Following surgery the CRP concentration will also be elevated. It has been shown that persistently increased CRP levels may indicate a bad prognosis for the patients outcome. Therefore monitoring of the CRP concentration can be helpful to initiate necessary treatment in time. Immunoturbidimetric test for the quantitative determination of C-reactive protein in human serum and plasma.

Complement C3 (C3c) is the central point of the classic and alternative complement pathway. C3c is a constituent of C5 convertase. On activation split products of C3c have important biological functions. C3b is an opsonin and involved in immune adherence, C3a is an anaphylatoxin and a chemotoxin. C3c behaves also like an acute phase protein, therefore increased levels may be found in acute inflammatory reactions. Decreased levels are reported in complex diseases, recurrent immune infections with pyrogenic bacteria, various glomerulonephritides and in congenital deficiencies. Immunoturbidimetric test for the quantitative determination of complement C3 (C3c) in human serum.

Cystatin-C is as an excellent biomarker of the GFR and used for diagnosis and treatment of renal diseases. Cystatin-C is freely filtered through the glomerular membrane of the kidney and reabsorbed and degraded in the kidney cells. The concentration of Cystatin-C is only dependent on the glomerular filtration rate (GFR) itself. Latex enhanced immunoturbidimetric test for the quantitative determination of Cystatin-C in human serum.

Complement C4 (C4) is a constituent of C3 convertase and C5 convertase. Measurements of complement proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. Decreased levels are found in hereditary angioedema, immune complex diseases and congenital deficiencies. Immunoturbidimetric test for the quantitative determination of complement 4 (C4) in human serum.

Chloride is the most important anion of sodium. Chloride is co-responsible for the extracellular fluid volume and plasma osmolality. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, e.g. cystic fibrosis and diabetic ketoacidosis. Colorimetric test for the quantitative determination of chloride in human serum, urine and cerebrospinal fluid (CSF).

Ferritin is the main iron storage protein in the body. Ferritin is found at low concentrations in serum and is directly proportional to the body’s iron store. In general, variations in total body iron stores are reflected in the ferritin level in serum. Measurement of ferritin may aid in the diagnosis of iron deficiency anemia and hemochromatosis (iron overload). Latex enhanced immunoturbidimetric test for the quantitative determination of ferritin in human serum und plasma.

 

Aminotransferases measurements are basic investigations for the diagnosis and monitoring of liver and muscle damage. Aminotransferases are measured for diagnosis and differential diagnosis of hepatobiliary disease (GPT/ALAT), myocardial infarction (GOT/ASAT), skeletal muscle damage (GOT/ASAT), viral hepatitis (GPT/ALAT) and as a part of medical screening examinations. Enzymatic UV test for the quantitative determination of GOT/ASAT in human serum and plasma.

Gamma-GT activity measurements are used for diagnosis of suspected hepatobiliary disease, differential diagnosis and monitoring of hepatobiliary disease and monitoring of chronic alcoholism in combination with other laboratory tests. Enzymatic color test for the quantitative determination of gamma-GT in human serum and plasma.

Aminotransferases measurements are basic investigations for the diagnosis and monitoring of liver and muscle damage. Aminotransferases are measured for diagnosis and differential diagnosis of hepatobiliary disease (GPT/ALAT), myocardial infarction (GOT/ASAT), skeletal muscle damage (GOT/ASAT), viral hepatitis (GPT/ALAT) and as a part of medical screening examinations. Enzymatic UV test for the quantitative determination of GPT/ALAT in human serum and plasma.

Glucose (GLUC) measurements are used for diagnosis and therapy control of carbohydrate metabolism disorders. Elevated glucose values (hyperglycemia) are observed in the following discorders: diabetes mellitus, gestational diabetes and Addison’s disease. Decreased glucose values (hypoglycemia) are observed in neonatal hypoglycemia, congenital enzyme defects, Reye’s syndrome, hepatic dysfunction, insulinomas, insulin antibodies, alcohol ingestion, neoplasms, sepsis and chronic renal failure.

The determination of HbA1c is performed for the long term control in diabetes mellitus. HbA1c values provide an indication of the average glucose levels over the preceding 4-8 weeks. A high HbA1c value indicates poor glycemic control. Long term therapy of the disease requires control of blood glucose levels to prevent the acute complications of ketosis and hyperglycemia. In addition, preventing effective control of blood glucose levels can minimize long term complications such as retinopathy, neuropathy, and cardiovascular disease. Immunoassay for the direct photometric determination of HbA1c in whole blood with EDTA.

Homocysteine is an amino acid that is formed from the metabolism of dietary proteins. Elevated levels of homocysteine are associated with a significant higher risk of cardiovascular and peripheral arterial disease. The cause of elevated levels is related to the concentration of homocysteine measured in blood and is mostly associated with renal disease, low vitamin B and/or folat intake or inborn defects in the metabolism of the essential amino acid methionine (677C>T polymorphism of MTHFR gene). Enzymatic UV test for the quantitative determination of homocysteine in human serum and plasma.

HDL cholesterol (HDL-c) is regarded as a protecting lipid component against coronary vascular disease (CHD). Measurement of HDL-c cholesterol is used in the early recognition of ateriosclerotic risk and may also be used for therapy control during lipid lowering treatment. Together with LDL cholesterol it has a high diagnostic value to estimate the individual risk for CHD. Homogeneous enzymatic color assay for the quantitative determination of HDL cholesterol in human serum and plasma.

The measurement of hemoglobin concentration is important for the diagnosis of anemia. Colorimetric test for the quantitative determination of hemoglobin in capillary blood and whole blood with EDTA.

The iron and total iron binding capacity (TIBC) levels are influenced by changes in iron intake, absorption, storage, and release mechanisms. Such changes are indicative of a wide range of dysfunctions including anemias, nephrosis, cirrhosis and hepatitis. Iron measurements are interrelated parameters for the diagnosis of the iron status. Colorimetric test for the quantitative determination of iron in human serum and heparinised plasma.

Immunoglobulins are the most important part of the humoral immune system of the organism. Of clinical interest are immunoglobulin deficiencies and increased levels of the immunoglobulins. Changes in serum immunoglobulin concentrations can be classified as follows: Hypogammaglobulinemias: Individuals with secretory IgA deficiency are found to suffer more commonly from mucosal infections, atopy, and autoimmune diseases. Individuals with absent IgA have a higher than expected incidence of rheumatic disorders and lymphoma. Polyclonal gammopathies: Increased levels occur in chronic liver disease, chronic infections, especially of the gastrointestinal and respiratory tracts, neoplasia of the lower gastrointestinal tract, inflammatory bowel disease, some immunodeficiency states such as Wiskott-Aldrich syndrome and rheumatoid arthritis. Monoclonal gammopathies: IgA multiple myeloma Immunoturbidimetric test for the quantitative determination of immunoglobulin A (IgA) in human serum

IgG is particularly important in the body’s long-term defence against infection as it presents a slower but more sustained response than IgM to primary antigenic stimulus; however, the levels of IgG rise rapidly and early on re-exposure to the same antigenic stimulus. IgG promotes phagocytosis and activates complement. IgG is the only immunoglobulin that crosses the placenta and is therefore of special importance in the infant’s defence against infection. Changes in serum immunoglobulin concentrations can be classified as follows: Hypogammaglobulinemias: IgG deficiency may be genetic as in severe combined immunodeficiency or acquired as in AIDS. Definitive diagnosis requires extensive evaluation in the immune response. A decrease in IgG also occurs as a result of thermal burns, nephrotic syndrome, protein losing enteropathies and non-IgG myelomas. Polyclonal gammopathies: Increased levels of IgG in autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, Sjögren’s syndrome), sarcoidosis, chronic liver disease, some parasitic diseases and chronic or recurrent infections. Monoclonal gammopathies: e.g. in IgG type multiple myeloma, lymphomas, leukemia, and other malignancies. Immunoturbidimetric test for the quantitative determination of immunoglobulin G (IgG) in human serum.

Immunoglobulins are the most important part of the humoral immune system of the organism. The essential functions of IgM in the immune response are the agglutination of pathogens and the activation of the classical complement pathway. Elevated levels of IgM in cord serum or during the first four weeks of life may indicate intrauterine or neonatal infections such as rubella, cytomegalovirus, toxoplasmosis or syphilis. Changes in serum immunoglobulin concentrations can be classified as follows: Hypogammaglobulinemias: IgM deficiency is rare and is associated with recurrent pyrogenic infections. Polyclonal gammopathies: IgM levels are increased in primary biliary cirrhosis, haemoprotozoan infections such as malaria, viral or bacterial infections and rheumatoid arthritis. Monoclonal gammopathies, e.g. in Waldenström’s macroglobulinemia and malignant lymphoma. Immunoturbidimetric test for the quantitative determination of immunoglobulin M (IgM) in human serum.

Inorganic phosphorus (PHOS, PO3) is measured for diagnosis and therapy control of various disorders such as bone diseases, chronic kidney disease, dialysis patients, kidney stones, after thyroid surgery, diseases of the parathyroid gland, chronic alcoholism, in intensive care (parenteral nutrition, ventilated patients), suspected Vit D deficiency, muscle weakness and bone pain. UV test for quantitative determination of inorganic phosphate in human serum.

Lactate dehydrogenase measurements are used for diagnosis and therapy control of liver diseases such as acute viral hepatitis, cirrhosis, malignant liver diseases, myocardial infarction, tumors of the lung or kidneys, pulmonary embolism and hemolytic anemia. Enzymatic UV test for the quantitative determination of lactate dehydrogenase in human serum and plasma.

Lipase activity measurements are used primarily to investigate pancreatic disorders, usually pancreatitis. Indications for lipase measurements are detection and exclusion of acute pancreatitis (in acute upper quadrant abdominal pain), chronic (relapsing) pancreatitis, obstruction of the pancreatic duct and detection of pancreatic involvement in abdominal diseases. Enzymatic colorimetric test for the quantitative determination of lipase in human serum and plasma.

LDL cholesterol (LDL-c) is an independent risk factor for coronary vascular disease (CHD). Epidemiological studies have shown the importance of LDL-c levels for the identification of high risk patients. HDL cholesterol (HDL-c) is regarded a protecting lipid component against coronary vascular disease (CHD). Together with HDL cholesterol LDL cholesterol has a high diagnostic value to estimate the individual risk for CHD. Homogeneous enzymatic color assay for the quantitative determination of LDL cholesterol in human serum and plasma.

Lp(a) is a risk factor for coronary vascular disease that is independent of all other lipid parameters. The Lp(a) concentration in blood varies from almost undetectable levels to more than 100 mg/dl. Differences in Lp(a) levels are genetically determined and will not be much influenced by lifestyle. The presence of high Lp(a) levels in serum is a significant marker for an increased risk of atherosclerosis and coronary vascular disease, especially when Lp(a) and LDL-c concentrations are elevated simultaneously. Latex enhanced immunoturbidimetric test for the quantitative determination of lipoprotein (a) in human serum.

Lithium measurements are performed for monitoring the serum lithium concentration during the continous lithium therapy of bipolar disorders (manic depression).

 

Magnesium measurements are used in the diagnosis and treatment of hypo- and hypermagnesemia. When making clinical assessment of magnesium levels the calcium levels should also be considered. The best-defined manifestation of magnesium deficiency is impairment of neuromuscular function e.g. hyperirritability, tetany, convulsions, and electrocardiographic changes. Hypomagnesemia: Observed in diabetes, chronic alcoholism, forced diuresis, hyperthyroidism, hypoparathyroidism, hypocalcemia, malabsorption and acute pancreatitis. Hypermagnesemia: Increased serum magnesium levels have been found in cases of renal failure, dehydration, severe diabetic ketoacidosis and Addison’s disease. Colorimetric test for the quantitative determination of magnesium in human serum and plasma (no EDTA plasma).

Microalbuminuria is considered a clinically important indicator of deteriorating renal function in diabetic subjects and regular screening is valuable in monitoring these patients. Prospective studies have demonstrated that increased urinary albumin excretion precedes and is highly predictive of diabetic nephropathy, end stage renal disease, and proliferative retinopathy in type I diabetes. In patients with type II diabetes increased urinary albumin excretion is an independent predictor of progressive renal disease, atherosclerotic disease and cardiovascular mortality. Increased urinary albumin excretion, both independently and in conjunction with hyperinsulinemia, identifies a group of nondiabetic subjects at increased risk of coronary vascular disease. Immunoturbidimetric test for the quantitative determination of mircoalbumin in collected urine or random midstream urine.

Pancreatic amylase activity measurements in serum and urine are mainly applied for the diagnosis of pancreatic disorders as well as for detecting the development of complications. As pancreatic and salivary amylase show a structural homology of 97%, the only method to distinguish is to use an assay based on monoclonal antibodies to inhibit the salivary enzyme. The amylase in the blood is eliminated through the kidneys and excreted into the urine, therefore, elevated serum activity is reflected in the rise of urinary amylase activity. For confirmation of an acute pancreatitis an additional measurement of lipase is recommended. Enzymatic colorimetric test for the quantitative determination of pancreatic amylase in human serum, plasma and urine.

Potassium measurements are used in the diagnosis and treatment of hypokalemia (chronic ingestion of diuretics and laxatives, with/without disorders of the acid-base balance), hyperkalemia (overadministration of potassium, acidosis, or crush injuries), renal failure, Addison`s disease or other diseases involving electrolyte imbalance. Photometric tests for the quantitative determination of potassium in human serum and heparinised plasma.

Rheumatoid factors are autoantibodies (IgM, IgG) directed against the Fc-part of human IgGs. High titres of rheumatoid factors are found in different rheumatoid and non-rheumatoid diseases. Higher titres of rheumatoid factors are more common in patients with rapidly progressive joint destruction and in those with extraarticular manifestations such as subcutaneous rheumatic nodules. Positive rheumatoid factors are also seen in autoimmune rheumatic diseases and in non-rheumatic conditions with variable frequency e.g. SLE, Sjögren’s syndrome, subacute bacterial endocarditis and other bacterial infections, infectious hepatitis, chronic liver diseases, chronic active pulmonary diseases, parasitic infections and viral infections. Rheumatoid factors should not be the only criteria in the diagnosis of rheumatoid disease but be considered in conjunction with clinical symptoms. Immunoturbidimetric test for the quantitative determination of rheumatoid factors (IgM) in human serum.

Sodium measurements are used in the diagnosis and treatment of disturbances of fluid and electrolyte balance, e.g. due to a loss of water or salt, and other serum electrolytes deviating from their reference interval by polyuric-polydypsic syndromes and impaired thirst, renal diseases, hypertension, disorders of the acid-base balance, some endocrine diseases, edema, excessive sodium intake. Colorimetric tests for the quantitative determination of sodium in human serum and heparinized plasma.

Total protein (TP) is a major component of blood and the sum of all circulating proteins. Total protein is measured for diagnosis and therapy control of a variety of diseases involving liver, kidney or bone marrow as well as other metabolic and nutritional disorders. Hypoproteinemia may be caused by abnormal synthesis, protein malnutrition, protein malabsorption, protein loss and after infusions. Hyperproteinemia may be caused by monoclonal gammopathy, severe chronic inflammatory and autoimmune processes. Colorimetric test for the quantitative determination of total protein in human serum and plasma.

The measurement of triglycerides (TG) is used for diagnosis of primary and secondary hyperlipoproteinemias, primary and secondary prevention of coronary vascular disease (CHD), risk marker of metabolic syndrom, LDL-c calculation using the Friedewald formula as well as control of dietary and medical lipid lowering. Enzymatic colorimetric test for the quantitative determination of triglycerides in human serum and plasma.

Transferrin is the principle plasma protein for the transport of iron. Transferrin is a negative acute phase reactant and will decrease during any inflammatory state or malignancy. Increased levels of transferrin are found in iron deficiency, pregnancy, oestrogen administration and lipoidal nephrosis. Decreased levels may be encountered in hereditary deficiencies, testosterone administration, infection, acute inflammation, some forms of nephrosis, tumors, haemochromatosis, acute malaria and malnutrition. Immunoturbidimetric test for the quantitative determination of transferrin in human serum.

The iron and total iron binding capacity (TIBC) levels are influenced by changes in iron intake, absorption, storage, and release mechanisms. Such changes are indicative of a wide range of dysfunctions including anemias, nephrosis, cirrhosis and hepatitis. Iron and TIBC measurements are interrelated parameters for the diagnosis of the iron status. Saturation and absorbant reagents for sample preparation for the determination of total iron binding capacity (TIBC) in human serum or heparinised plasma.

Urea (UREA, BUN) measurements are used in the diagnosis, differential diagnosis, assessment and therapy control of certain renal and metabolic diseases such as acute renal failure, terminal renal disease, and metabolic status of intensive care and dialysis patients. Urea and creatinine determinations are frequently performed together in the differential diagnosis of kidney function. Conversion factor for UREA, BUN [mg/dl] Conc. (UREA) = 2.14 x conc. (BUN); conc. (BUN) = 0.47 x conc. (UREA) Enzymatic colorimetric test and fully enzymatic UV test for the quantitative determination of urea in human serum, plasma and urine.

Uric acid measurements are used in the diagnosis and therapy control of numerous renal and metabolic disorders, including chronic kidney disease, kidney stones, renal failure, gout, hyperlipidemia, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs or cyclosporine therapy in transplant recipients. Enzymatic colorimetric test with or without ascorbate oxidase for the quantitative determination of uric acid in human serum, plasma and urine.

The determination of total protein in urine supports the diagnosis and treatment of primary and secondary kidney disease and the diagnosis of diseases associated with cardiac and thyroid function. Increased total protein concentration in the urine (proteinuria) is a very common urinary finding and is one of the leading symptoms of kidney disease in addition to reduced eGFR. Increased total protein concentrations in cerebrospinal fluid (CSF) are observed in a variety of disease states of the central nervous system (CNS), e.g. cerebral haemorrhage, bacterial or viral meningitis, inflammatory CNS disorders and tumors. Colorimetric test for the quantitative determination of total protein in human urine and cerebrospinal fluid (CSF).