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Immunoassay controls

Immunoassay controls2020-09-03T09:24:16+02:00

Immunoassay quality controls

BIOMED quality controls for immunoassays and monitoring of drug level settings are available in three different levels. They contain comprehensive target values and reference ranges for thyroid diagnostics, TDM (therapeutic drug monitoring) and toxicology, tumour markers for the diagnosis of different tumour entities, endocrine markers for the determination of hormone status, markers for reproductive medicine and other areas.

Parameters of thyroid diagnostics

Hyper- or hypo-function of the thyroid gland is indicated by changes in thyroid hormones. Therefore the determination of hormones in serum can be used for diagnosis, but also for monitoring the course of thyroid diseases.

The thyroid-stimulating hormone TSH (also: thyrotropin) is formed d in the pituitary gland. The hormone reaches the thyroid gland via the bloodstream, where it stimulates the production of thyroid hormones.

The thyroid gland produces and secretes the two hormones L-thyroxine (T4, free T4: FT4, total T4: TT4) and L-triionic dothyronine (T3, free T3: FT3, total T3: TT3). The active metabolic stimulating T3 is formed, if necessary, from its T4 storage form. With sufficient T3 and T4 concentration, the secretion of TSH is reduced.

The storage form of the thyroid hormone, the iodine glycoprotein thyroglobulin (TG, also thyroglobulin), is mainly used for the follow-up control of thyroid tumours.

With the help of the Thyroid Uptake (T-Uptake) the concentration of free thyroxine binding globulin (TBG) in the plasma can be determined. With lowered thyroid hormone levels, the unsaturated TBG increases.
Endocrine tests/Hormones

Endocrinology is the study of the morphology and function of glands with internal secretion (endocrine glands) of hormones and their disorders.

Adrenocorticotropin (also known as adrenocorticotropic hormone, or ACTH for short) is synthesised in the anterior pituitary gland and regulates adrenal cortex function. Thus it indirectly influences the production of cortisone and insulin. Various diseases and factors can cause altered ACTH production or release, e.g. cold, stress, inflammation of different aetiology, adrenal cortex insufficiency or tumours of the pituitary gland.
Cortisol (also: hydrocortisone) is a stress hormone that provides the body with energy-rich compounds by activating catabolic (=degrading) metabolic processes. It is the most important corticosteroid hormone for humans and influences among other things blood pressure and inhibits the immune system.
DHEA sulphate (dehydroepiandrosterone sulphate) is almost exclusively synthesised in the adrenal glands. It is a precursor of the female (estrogens) and male (androgens) sex hormones, but also shows hormone activity. Elevated values can, for example, indicate adrenal cortex tumours.

Parathyroid hormone (also: parathyrin, PTH) is produced in the main cells of the parathyroid glands. Its function is to increase calcium and decrease phosphate levels. The opponent of PTH is calcitonin, which has the opposite effect. The PTH level is determined when a disturbance of the calcium-phosphate balance is suspected, but it also indicates diseases of the adrenal gland. PTH is sensibly measured in combination with calcium and phosphate.

Procalcitonin (PCT), a precursor of the hormone calcitonin, is an inflammatory marker and is normally produced mainly in the thyroid gland. PCT levels specifically indicate bacterial, fungal or parasitic infection and are therefore measured in patients with sepsis (blood poisoning) and multiorgan failure and in newborns. No elevated value is found in cases of viral inflammation. Elevated values also occur with C-cell carcinoma of the thyroid gland and in stress conditions such as heat stroke.
Reproductive medicine/fertiliy

In the field of reproductive medicine, the basic principles of reproduction, the control of human fertility and disorders of fertility (sterility) are studied. Another area is the formation or disorders in the development of sexual characteristics.

17-OH-progesterone (also: 17-hydroxy-progesterone, 17-OHP) is a gestagen that is produced in the adrenal glands and gonads (testicles/testes or ovaries/ovaries). It is an intermediate product that occurs during the synthesis of various hormones (cortisol, testosterone and oestradiol). The determination of 17-OH-progesterone enables an early diagnosis of the adrenogenital syndrome (AGS).
CA 125 is a glycoprotein that can indicate gynaecological disorders such as pronounced endometriosis, acute inflammation of the adnexae and other benign diseases or ovarian cancer. Elevated levels may also be found in inflammations of different aetiology (pancreatitis, hepatitis, peritonitis) and in autoimmune diseases. The physiological blood concentration of CA-125 in women also varies depending on the phase of the menstrual cycle. As a non-specific marker of peritoneal inflammation, it is not recommended for tumour detection.
CA 15-3 is a glycoprotein. Its concentration increases in the 3rd trimester of pregnancy, as well as in infectious and inflammatory diseases, kidney failure or fibroadenoma. Certain types of cancer, especially breast cancer, but also ovarian cancer and tumours in the abdomen and lungs, are also associated with elevated levels.
Estradiol is the most effective physiological estrogen in humans. Together with progesterone, it is essentially involved in sex differentiation, regulation of the women cycle and the onset and maintenance of pregnancy. It is therefore an important factor in clarifying an unfulfilled desire to have a child.
The growth of follicles to a mature egg as well as ovulation are caused in the ovary by the glycoprotein follicle stimulating hormone (also: follitropin, Follicle Stimulating Hormone, FSH). Male spermatogenesis is also controlled by the FSH. An elevated FSH value can be an indication that the sex hormone producing glands (ovaries or testicles) are not functioning properly. Low FSH levels occur during pregnancy, but can also be an indication of hypothalamus or pituitary dysfunction.
Human chorionic gonadotropin (also: human chorionic gonadotropin, hCG) is a peptide hormone produced in the placenta during pregnancy. The detection of hCG in blood or urine is therefore an important sign of pregnancy.
Luteinizing hormone (LH, also lutropin) is formed in the pituitary gland (pituitary gland) and is involved in the maturation of the egg cells in the woman, initiating ovulation and causing formation of the corpus lutenum (yellow body). Reduced LH secretion prevents the development of a pregnancy. In men, LH increases the formation and secretion of testosterone in the Leydig cells of the testicle. The concentration of LH is determined in cases of abnormal puberty development, male infertility and unfulfilled desire for children.
The steroid hormone progesterone (also: progesterone) is an important representative of the gestagens (corpus luteum hormones). In women, it is mainly formed cycle-dependent by the corpus luteum and in much larger quantities during pregnancy by the placenta. Its function here is to prepare the mucosa for the implantation of the follicle. Mainly the Leydig cells in the testicles are responsible for the production of progesterone in men. Progesterone is determined in cases of unfulfilled desire to have children, irregular bleeding, suspected hormone-induced disease or to prove ovarian failure.
Prolactin (also prolactin, PRL) is produced in the lactidous cells of the hypohysema frontal lobe and is responsible for the growth and differentiation of the breast gland during pregnancy and lactation (milk secretion) during lactation. Female prolactin levels are determined in cases of unfulfilled desire for children, suspected ovarian dysfunction, virilisation (masculinisation), early puberty and irregular milk flow. In men, the prolactin level is determined if hypogonadism is suspected.
The androgen testosterone is responsible for the formation of the male phenotype. The hormone causes both sexes to increase muscle mass and strength as well as bone density. It also influences the fat and sugar metabolism. Increased testosterone levels in women can lead to increased body hair, acne, growth of the clitoris and deepening of the voice. In men, testosterone deficiency can cause reduced sperm count, shrinking testicles, osteoporosis, reduced libido and depressive moods.
Autoimmune diseases/autoimmune disorders

Autoimmune diseases can occur in all organs and tissues and are defined as diseases whose cause is a disturbed tolerance of the immune system to the body’s own substances. One consequence of the immune reaction is the formation of autoantibodies and immune complexes that trigger a symptomatic disease.

The plasma protein beta-2-microglobulin (β2-M) from the beta-globulin fraction is found in the membranes of most nucleated cells and is secreted into various body fluids. Increased plasma concentration of β2-M is associated with diseases that lead to increased cell turnover, such as infections, autoimmune diseases, hepatitis, some kidney diseases, but also malignant diseases such as carcinomas, lymphomas and leukaemias.
CA 19-9 is a glycoprotein whose value increases in inflammatory diseases of the digestive system, in many gastrointestinal carcinomas and in autoimmune diseases. The physiological expression of CA 19-9 depends, among other things, on a Lewis blood group.
Carcinoembryonic antigen (CEA) is a glycoprotein that is clearly associated with diseases of the digestive system. For example, CEA is elevated in inflammatory diseases such as liver cirrhosis, ventriculitis, ulcerative colitis, diverticulitis, pancreatitis, but also in colorectal, gastric, pancreatic and Crohn’s disease. Autoimmune diseases and special lifestyle habits such as abusus of nicotine and alcohol can also cause increased levels.
C-peptide, a part of proinsulin, is mainly analysed in the differential diagnosis of diabetes mellitus to assess the performance of pancreatic beta cells. The C-peptide concentration in the blood reflects the current insulin secretion of the pancreas better than the insulin itself and allows the differentiation between diabetes type 1 and type 2 and the detection of early insulin resistance while glucose tolerance is still slightly impaired.
Therapeutic drug monitoring (TDM) and toxicology

The term Therapeutic Drug Monitoring, TDM for short, refers to the measurement of systemic drug concentrations of drugs in the blood or blood compartments to monitor therapeutic drug administration. The Duotrol Immunoassay allows the monitoring of different drug groups.

– Amikacin: Aminoglycoside antibiotic, acts bactericidal against certain Gram-negative aerobic pathogens.

– Gentamicin: aminoglycoside antibiotic, used as an emergency drug for severe bacterial infections, especially nosocomial infections.

– Tobramycin: aminoglycoside antibiotic, used e.g. for severe pneumonia, complicated urinary tract infections, abdominal infections.

– Vancomycin: Glycopeptide antibiotic, used for the treatment of infections with Gram-positive bacteria, especially in the therapy of severe staphylococcal infections (MRSA) as a reserve antibiotic.

Acetaminophen (also: paracetamol): Non-opioid analgesic that relieves pain and reduces fever.

– Salicylates (e.g. aspirin): Drug against fever, pain, inflammatory diseases

– Benzodiazepines: Polycyclic organic compounds with anxiolytic (anxiety-relieving), sedative (calming), muscle-relaxing (muscle-relaxing) and hypnotic (sleep-inducing), sometimes also anticonvulsive (antispasmodic) effects.

– Carbamazepine: anticonvulsant (antiepileptic) from the class of dibenzazepines for the treatment of epilepsy, neuralgia, bipolar disorder and alcohol withdrawal.

– Phenobarbital: Barbiturate used in the treatment of epilepsy as well as in the preparation of anaesthesia. Can also be used as a sleeping pill.

– Phenytoin: anticonvulsant for the permanent treatment of epilepsy. Can also be used as an antiarrhythmic agent for the treatment of cardiac arrhythmia.

– Valproic acid (VPA): Used to treat epilepsy and seizures and to stabilize mood in bipolar disorders, mania and various types of psychosis or addiction.

An active ingredient from the group of cardiac glycosides for the treatment of heart failure and cardiac arrhythmia.
The antimantic agent from the group of antipsychotics is used in the form of its salts in bipolar disorder, mania or depression as a phase prophylactic and to increase the effectiveness of antidepressants.
Medicament for COPD, asthma bronchial and other respiratory diseases.
Analyzer for clinical chemistry in the laboratory
Other markers

Measurements regarding metabolic parameters of different metabolic areas as well as allergy markers can also be checked with the immunoassay quality control.

The cardiac marker homocysteine is an intermediate product of amino acid metabolism. Elevated homocysteine levels are a risk factor for atherosclerosis and venous thromboembolism. Elevated homocysteine levels are often due to factors that can be corrected, such as a lack of folic acid (vitamin B9) or vitamin B2, B6 or B12, the use of certain drugs and smoking. Genetic variants, chronic kidney failure and advanced age may also be involved in elevated levels. Another consequence of too much homocysteine can be neurodegenerative diseases such as dementia and cognitive disorders.
Ferritin (iron storage) and the two coenzymes folate (also: folic acid, vitamin B9) and vitamin B12 are important markers in anaemia/iron deficiency. Vitamins B9 and B12 are involved in regulating protein, fat and carbohydrate metabolism, play a role in cell division and are responsible for blood formation. A deficiency particularly affects erythrocytes and leukocytes, as these are cells with a high division rate.
Immunoglobulin E (also: Immunoglobulin E, IgE) is an important factor in allergy diagnostics.
25-OH vitamin D (also: 25-hydroxyvitamin D, calcidiol) is the precursor of biologically active vitamin D in the body and is used to determine the vitamin D status of a patient. Vitamin D plays an important role in the body’s mineral metabolism (calcium and phosphate) and in bone mineralisation. Another indication is the suspicion of increased bone resorption caused by bone metabolic disorders and rickets in infants and toddlers.
Procalcitonin (PCT), a precursor of the hormone calcitonin, is an inflammatory marker and is normally produced mainly in the thyroid gland. The PCT value specifically indicates a bacterial, fungal or parasitic infection and is therefore determined in patients with sepsis (blood poisoning) and multiple organ failure and in newborns. No increased value occurs in the case of viral inflammation.
Prostatic acid phosphatase (also known as prostate specific acid phosphatase, PAP) is a glycoprotein enzyme produced in the prostate. PAP serves as an organ-specific marker for the prostate. Prostatic Acid Phosphatase can show elevated levels in various benign prostate conditions, but it also serves as a progression control in prostate cancer. PSA levels can also be influenced by various “harmless” factors, including age, inflammation of the prostate or bladder, prostate hyperplasia, bladder voiding problems, mechanical pressure on the prostate or the use of certain medications.

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