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  2. Reagents
  3. Clinical Chemistry Reagents

Clinical Chemistry Reagents Reagents

HUMAN‘s clinical chemistry reagents are characterized by a long shelf life, open vial stability and onboard stability. Liquid and ready-to-use reagents allow for a secure ease of use.

HUMAN's multipurpose reagents are designed for manual procedures in combination with photometric reading or automated processing on clinical chemistry analyzers. HUMAN's working reagent procedures enable a quick, simplified and reliable manual processing.

HUMAN's system reagents are ready to use and filled in barcoded reagent containers, which can be directly loaded on the system. To ensure a high quality of analysis, thoroughly validated assay settings are included in the respective system software. Monitoring of onboard and calibration stability as well as reagent inventory is done automatically saving time and reducing errors.

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  • Clinical Chemistry Reagents

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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Quantitative determination of IgM antibodies to rheumatoid factor.
Calibration: 12.5 / 25 / 50 / 100 / 200 U/ml Cut-off: 15 IU/ml
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.
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.
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.
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 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.
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.

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