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Special Quality Controls

Special Quality Controls2020-05-20T18:39:06+02:00

Special Quality Controls

BIOMED’s special quality controls include accuracy control sera for quality control in the analysis of blood concentrations of alcohol, ammonia, cystatin C, bilirubin and various heart markers.

Alcohol-Ammonia Controls

The stable, human serum matrix based liquid control Duotrol®Alcohol/Ammonia Combi is designed to monitor quantitative analytical conditions for the determination of alcohol and ammonia in human serum and plasma samples in clinical laboratories.

Acute alcohol consumption can be detected by the direct detection of alcohol (ethanol) in the blood (serum or plasma). The measured blood alcohol level can be used to draw relatively reliable conclusions about alcohol levels over a few hours. Alcohol is broken down in the liver by alcohol dehydrogenase (ADH) via acetaldehyde to acetic acid. The rate of degradation varies from individual to individual, with women degrading on average 15 % more slowly than men. Endogenous alcohol does not exceed 0.012 ‰ (per thousand) and therefore need not be taken into account in measurements.

The concentration of ammonia (NH3) in the blood should be determined in cases of changes in consciousness or coma with unclear findings, as well as in infants who vomit constantly or are unusually lethargic. Ammonia is produced in the intestine with the help of bacteria by splitting proteins into amino acids and ammonia. Via the portal vein the ammonia is transported to the liver where it is broken down to urea and glutamine. The urea is then transported to the kidneys and excreted with urine. If this process does not function sufficiently, ammonia accumulates in the blood and can enter the brain, resulting in hepatic encephalopathy (liver-brain disorder). This is a functional disorder of the brain, which can lead to mental and neurological changes with deterioration of cognitive and motor skills up to epileptic seizures, loss of consciousness and coma. Causes of increased ammonia levels can be defects in the urea cycle, severe liver disease, reduced blood flow to the liver, Reye’s syndrome, kidney failure or hereditary hyperammonemia (hereditary ammonia excess).
Bilirubin Controls

Duotrol®Bilirubin Paediatric is a stable bovine serum-based liquid control for the quantitative determination of bilirubin in the high, abnormal range and is used to monitor assay conditions in clinical laboratory testing of serum and plasma samples. The analyte concentrations are achieved with bilirubin extracts and synthetic derivatives.

Bilirubin in serum is composed of unconjugated, conjugated and δ bilirubin. Endogenously, 80 – 85 % bilirubin is produced daily. Elevated bilirubin levels are associated with Meulengracht’s disease, hepatitis, fatty liver or liver cirrhosis, bile congestion and hemolysis.

Cystatin C-controls

Duotrol® Cystatin C is a liquid correctness control serum of human origin with target values in the normal and pathological range.

Cystatin-C is produced endogenously at a constant rate by almost all nuclear cells in the human body. The serum concentration depends on the glomerular filtration capacity of the kidney. With a reduced GFR the concentration of cystatin C increases. Cystatin C concentration is not influenced by age, sex, muscle mass, nutrition and inflammatory processes (except immune diseases). Cystatin C is elevated in renal insufficiency and autoimmune diseases.

Cardio control sera clinical chemistry
Cardio quality controls

The ready-to-use liquid control serum Duotrol® Cardio is a trueness control derived from human serum for monitoring the quantitative analysis conditions of cardiology markers in laboratory diagnostics. Symptoms of heart disease such as myocardial infarction are often non-specific, such as shortness of breath, exhaustion or edema: they may or may not be caused by heart failure. In addition, heart problems often start insidiously and are therefore not recognized at first. In order to detect cardiac insufficiencies and exclude other diseases, certain heart-specific biomarkers in the blood are examined.

The biologically inactive signal peptide NT-Pro-BNP (N-terminal pro-BNP, N-terminal pro-B-type natriuretic peptide) and the natriuretic peptide BNP are formed by cleavage of proBNP, the synthesis of which is stimulated in the heart muscle cells by wall tension (increased pressure in the heart) and neurohumoral stimulation noradrenalin, angiotensin). Elevated values of BNP and NT-Pro-BNT are therefore an indication of acute heart failure. NT-Pro-BNP is stable for longer in the blood and in the samples and is therefore well suited for diagnosis.

CK-MB (creatine kinase of myocardial type = heart muscle type) is the isoenzyme of creatine kinase, which is mainly found in the heart muscle. Damage to the heart muscle, for example cell necrosis of cardiomyocytes, can cause increased CK-MB to enter the blood. When measuring CK-MB, the enzyme activity in the blood is determined. A heart attack, also called myocardial infarction, can be detected by determining the CK-MB.

The acute-phase protein CRP (C-reactive protein) is a marker of cardiovascular risk to detect unstable phases in atherosclerosis.

Inflammatory reactions are involved in the formation, spread and instability of atherosclerotic plaques.

Digitoxin, a naturally occurring active substance for the treatment of cardiac arrhythmia and heart failure, from the group of cardiac glycosides, slows down the beat rate and increases inotropy (contractility of the heart muscles) by inhibiting sodium-potassium ATPase in the heart muscle cells and affecting the vagus nuclei.

The dosage of digitoxin should be monitored to prevent intoxication.

Myoglobin (Mb) is a muscle protein that is released quickly after cell damage (myoglobinemia). It is used in the laboratory diagnosis of myocardial infarction as a sensitive early marker. If no increase in myoglobin is detectable, a myocardial infarction is very unlikely.

A protein complex found in the muscle cells of the heart muscle is cardiac troponin (cTn), in particular the two subunits troponin I (cTnI, inhibitory subunit) and troponin T (cTnT, tropomyosin-binding subunit). Damage to the heart muscle (e.g. after a myocardial infarction) causes increased transfer of these proteins into the blood so that they can be measured there. The determination of cardinal troponins can be used not only to diagnose a heart attack, but also to monitor its progress or the success of therapy, after a heart attack, but also to detect minor damage to the heart muscle.

Homocysteine, an intermediate product of amino acid metabolism, is needed for the formation of new proteins and nucleic acids, among other things. Even slightly elevated levels of homocysteine represent a risk factor for atherosclerosis, venous thromboembolism, coronary heart disease or strokes. An elevated homocysteine value can, under certain circumstances, already be reduced by the administration of folic acid and vitamin B6.

Duotrol® Quality Controls

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