Product Spotlight: Respiratory Controls – Molecular Infectious Disease Testing
Product Spotlight
Molecular Controls for Respiratory Infection Testing
Flu is a contagious respiratory illness cause by influenza viruses that infect the throat, nose, and sometimes lungs. It can cause illness and sometimes death. Getting vaccinated is the best way to prevent catching flu [1].
There are four types of seasonal flu, A, B, C, and D. Types A and B cause seasonal epidemics of disease. Illnesses range from severe to mild and can even result in death in high risk groups. High risk groups include, pregnant women, children under 5 years of age, the elderly, and people with chronic or immunosuppressive medical conditions [2].
Flu season begins as early as October, reaches its peak in February, and ends in March. In the southern hemisphere, flu season falls between June and September. Wherever it’s cold, it’s flu season.
Diagnosing Flu
A test to detect Influenza viruses can be used to determine whether a patient has the flu. A swab is taken from either the nose or back of the throat and sent for testing. Molecular assays can be used to detect genetic material of the virus [3]. Molecular methods play an important role in the diagnosis and surveillance of influenza viruses. Molecular diagnostics allow timely and accurate detection of influenza and are already implemented in many laboratories. The combination of automated purification of nucleic acids with real-time PCR should enable even more rapid identification of viral pathogens such as influenza viruses in clinical material [4].
The Qnostics range of complete molecular controls for infectious disease testing can be used in the daily monitoring of assay performance, linearity assessment, assay evaluation, validation/verification of new assays and staff training. As whole pathogen controls, the range is designed to mimic the performance of patient samples and can be used to effectively monitor the entire testing process including extraction, amplification and detection.
Qnostics offers a range of solutions for molecular respiratory testing:
Q Controls
Independently manufactured, these positive and externally run controls are designed to be treated as a patient sample within an assay run. Helping to support a laboratory’s accreditation requirements in line with ISO 15189:2012, Q Controls are supplied in an unassayed, liquid frozen format delivering accurate and reliable test results.
Analytical Q Panels
Each Analytical Q Panel consists of five or more individual samples including a negative and is designed to cover the dynamic range of individual infectious disease assays, in a linear progression. Analytical Q Panels are intended for use in the validation and verification of new assays with the main purpose of helping to ensure assays are linear throughout the dynamic range. In addition, Analytical Q Panels will support a laboratory’s accreditation requirements, in line with ISO 15189:2012.
Evaluation Panels
Evaluation Panels may be used to evaluate assay characteristics, confirm performance claims and ultimately ensure the assay is fit for purpose. Evaluation Panels may also be used in the validation of clinical assays and the development of diagnostic tests.
Flu Season
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References
[1] “Key Facts About Influenza (Flu) | Seasonal Influenza (Flu) | CDC”, Cdc.gov, 2018. [Online]. Available: https://www.cdc.gov/flu/keyfacts.htm. [Accessed: 25- Sep- 2018].
[2] “Influenza (Seasonal)”, World Health Organization, 2018. [Online]. Available: http://www.who.int/en/news-room/fact-sheets/detail/influenza-(seasonal). [Accessed: 27- Sep- 2018].
[3] “Diagnosing Flu | Seasonal Influenza (Flu) | CDC”, Cdc.gov, 2018. [Online]. Available: https://www.cdc.gov/flu/about/qa/testing.htm. [Accessed: 25- Sep- 2018].
[4] J. Ellis and M. Zambon, “Molecular diagnosis of influenza”, Reviews in Medical Virology, vol. 12, no. 6, pp. 375-389, 2002.
Infection: Making Sure You Get the Right Treatment
When you have an infection, it’s important to receive the correct diagnosis in order to access appropriate treatments. Misdiagnosis can not only lead to the prolonging of the infection, but could also prove detrimental to your long-term health, such as if you become resistant to certain anti-biotic strains through mistaken prescription.
Throughout this month, we’ve been highlighting how the Randox clinical product range can assess the impact of infection. The RX series’ dedicated testing panel comprises of IgA, hsCRP and ASO which are also available for third-party use. The extensive QC range caters for assessment of infectious disease testing in both liquid and lyophilised formats.
Reagents
The Randox range of third-party reagents enables the clinical analysis of 113 different analytes with comprehensive range measurements and excellent correlations to reference methods.
IgG (the most abundant antibody) and IgM (the first antibody made in response to infection) can be used in the diagnosis of Dengue Fever. This is significant as more than 40 % of the global population, in more than 100 countries, are at risk of the Dengue Virus.
IgA is an antibody that lines the mucous membranes lining the mouth, airways and digestive tract. A deficiency in IgA is common in patients with bronchitis, conjunctivitis and otitis media.
Other Randox assays that may be used to detect differing infections include: albumin, ferritin, alpha-1-antitrypsin (AAT), complement C3, complement C4, haptoglobin, CRP, alpha-1-acid glycoprotein (AGP) and anti-streptolysin (ASO).
RX series
The RX series range offers the most comprehensive testing profile for assessing infectious diseases within an individual. The RX series test menu possesses the most extensive infectious disease testing panel available to give an expansive picture of an individual’s health. The RX series zinc test will assess the levels of zinc in an individual, Zinc plays a significant role in an individual’s health s it’s functions include cell and enzyme production as well as wound healing.
To view the full RX series test menu click here.
Internal Quality Control
Randox has partnered with Qnostics to provide a wide range of molecular controls for infectious disease testing. Designed to meet the demand of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics Molecular Infectious Disease range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseases, Respiratory Infections, Blood Borne Viruses, Sexually Transmitted Infections, Gastrointestinal Diseases and Central Nervous System Diseases.
External Quality Control
Randox have also partnered up with QCMD to offer a vast array of molecular EQA programmes for infectious disease testing. With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.
Frequent challenges, comprehensive reports and international accreditation ensures the best assessment of test system performance.
For more information on how Randox is helping to diagnose infection accurately and effectively, visit www.randox.com.
Product Spotlight: Acusera Cardiac Quality Control
For this month’s product spotlight, we have chosen our whole range of cardiac quality control solutions. Randox offers options for both Internal Quality Control (IQC) and External Quality Assessment (EQA).
29th September is World Heart Day. World Heart Day is a global campaign during which individuals, families, communities and governments around the world participate in activities to take charge of their heart health and that of others.
Cardiovascular disease (CVD) is a term to describe conditions that affect the heart and blood vessels. It is normally associated with a build up of fatty deposits in the arteries and an increased risk of blood clots. CVD is the leading casues of death globally, representing around 30% of all deaths. A healthy lifestyle can help prevent CVD; however, increasingly busy lifestyles mean that it is difficult to avoid CVD. This means it is vitally important that individuals are tested for CVD and to ensure that diagnoses are acurate.
The accurate diagnosis of a potentially life threatening cardiac event is essential in order to avoid misdiagnosis and/or incorrect treatment. The Acusera Cardiac Quality Controls have been designed to cover a wide range of cardiac markers at clinical decision levels eliminating the need for additional low level controls at extra expense. Available in a choice of both liquid ready-to-use and lyophilised formats, they are ideal for use at the point-of-care and in the laboratory. Manufactured from 100% human serum a matrix similar to that of the patient is guaranteed.
Liquid Controls
Liquid Cardiac Control
Liquid, Assayed, 100% Human serum
8 AnalytesBNP Control
Liquid, Assayed, 100% Human serum
1 AnalyteLyophilised Controls
Cardiac Control
Lyophilised, Assayed, 100% Human serum
7 AnalytesCK-MB Control
Lyophilised, Assayed, 100% Human serum
2 AnalytesH-FABP Control
Lyophilised, Assayed, 100% Human serum
1 AnalytehsTnT Control
Lyophilised, Assayed, 100% Human serum
1 Analyte
The RIQAS Cardiac EQA programme is designed to monitor the performance of up to 7 clinically significant cardiac markers. Two flexible reporting options are available to suit the needs of all laboratory sizes.
Accredited to ISO/IEC 17043
• 100% human serum
• Bi-weekly reporting
• Submit results and view reports online via RIQAS.Net
• Register up to five instruments at no extra cost
Parameters
CK, Total | CK-MB activity units | CK-MB mass units | Homocysteine | Myoglobin | Troponin I | Troponin T
Cardiac Controls
Cardiac EQA
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September focus: Infection
Throughout the month of September, we will be highlighting on our social media channels how the Randox clinical range can help combat infections and infectious diseases through accurate and swift diagnosis, allowing the necessary steps to be taken in order to improve individual health.
What is infection?
Infection is the infiltration of an organism’s body tissues by disease-causing agents, their multiplication, and the reaction of host tissues to the infectious agents and toxins they produce. Infectious disease can also be known as communicable disease and transmissible disease.
How is the Randox helping to diagnose infection?
The Randox portfolio comprises of a wide range of products to combat infections including the RX series’ dedicated infectious disease testing panel, diagnostic reagents such as copper, potassium and sTfR and an extensive QC range catering for infectious disease testing in both liquid and lyophilised formats.
How can I limit my risk of contracting infection?
- The most important way to reduce the spread of infection is to wash your hands regularly with soap and water
- If you have an infection, get the appropriate vaccine and do not take antibiotics when they are not needed. This will only increase antibiotic-resistance
- Stay at home if you are sick to limit the spread of infection
- Use single-use tissues and dispose of them immediately after use
- Do not share cups, glasses or cutlery
- Do not touch your eyes, nose or mouth as viruses can transfer from your hands and in to the body
How can my workplace limit the spread of infection?
- Have an infection control plan
- Provide clean hand washing facilities
- Offer alcohol-based hand sanitisers when regular facilities are not available
- Provide boxes of single-use tissues and encourage their use
- Remind staff not to share cups, glasses or cutlery
- Remove newspapers and magazines from waiting areas
- Encourage staff to regularly disinfect their workspaces
- Make sure ventilation systems are working properly
For more information on how Randox is helping to diagnose infection, visit www.randox.com/infections.
Molecular QC and EQA for Infectious Disease Testing
Earlier this year, Randox entered into a strategic partnership, bringing on-board Qnostics Molecular Controls and QCMD Molecular EQA which comprises hundreds of controls and EQA programmes for molecular infectious disease testing.
The Global Molecular Diagnostics market is estimated to be worth 6.54 billion USD. This market is classified into infectious diseases, oncology, genetic tests and blood screening. Infectious diseases account for the largest share of the global market.
According to the World Health Organisation (WHO), Infectious Diseases are caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi. These diseases can be spread – directly or indirectly – from one person to another.
Designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseased, Respiratory Diseases, Blood Borne Viruses, Sexually Transmitted Infections, Gastro-Intestinal Diseases and Central Nervous System Diseases.
Qnostics products can be used in the daily monitoring of assay performance, linearity assessment, assay evaluation, validation/verification of new assays and staff training.
There are five main product areas for Qnostics:
Product Groups (click to expand)
Q Controls
Independently manufactured, this range of positive run, whole pathogen, third party controls are designed to monitor the daily performance of a wide of range molecular assays used in the detection of infectious diseases. These controls help in supporting a laboratory’s accreditation requirements, in line with ISO 15189:2012.Analytical Q Panels
Designed to cover the dynamic range of an assay, Analytical Q Panels allow assessment of an assays linearity, LOD and LOQ. Each panel contains a minimum of five samples, including a negative that spans the dynamic range of the assay in a linear progression.Molecular Q Panels
Consisting of three levels (high, medium and low), Molecular Q Panels are intended to evaluate an assays analytical measuring range. Molecular Q Panels can also be used to support training of laboratory staff and in the development of molecular diagnostic assays.Evaluation Panels
Evaluation Panels cover a range of genotypes and may be used to evaluate assay characteristics, confirm performance claims and ultimately ensure the assay is fit for purpose. Evaluation Panels may also be used in the validation of molecular assays and development of new molecular diagnostic assays.QCMD Past Panels
Available for use in assay evaluation and staff training, EQA samples are available from past QCMD challenges.Custom ManufactureQnostics are specialists in the custom manufacture of quality control materials for use in the detection of infectious diseases using molecular based methods. Qnostics will work with you to develop a bespoke solution designed specifically to meet the individual and unique requirements of your lab.
- Choose from hundreds of molecular characterised targets
- Targets can be custom made into numerous different formats
- The whole pathogen format accurately mimics clinical samples
- All materials can be provided in a “ready-to-use” or liquid frozen format
Qnostics custom made Molecular Infectious Disease Controls are designed to fit all stages of your assays product life cycle from product development to launch.
QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.
With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of infectious disease testing.
EQA participants receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.
Features & Benefits (click to expand)
Frequency
A variety of programme options are available. Choose the number of challenges that best suit your laboratory’s requirements.
Online EQA Management System
ITEMS provides an online tool to easily manage all EQA activities from programme registration to submission of results and provision of EQA reports. Different levels of user access are available so data can be accessed by whoever needs it.
High level of participation
Over 2000 participants in more than 100 countries ensuring peer group numbers are maximised.
Comprehensive reports
Receive individual reports for each challenge and a final supplementary report at the end of the cycle visual assessment of performance.
International accreditation
Programmes are accredited to ISO 17043.
Qnostics
QCMD
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Product Spotlight: Acusera Immunoassay Premium Plus Control
The Randox Acusera Immunoassay Premium Plus quality control covers an impressive 54 analytes with assayed instrument specific target values and ranges provided for up to 51 analytes. The unique combination of routine tumour markers, therapeutic drugs and Vitamin D allows laboratories to dramatically reduce the number of controls required while ultimately keeping costs to a minimum. Three levels of control are available with analytes present at clinically significant levels.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Assayed, instrument specific target values provided for up to 51 parameters
- Ferritin and Vitamin B12 levels suitable for anaemia monitoring
- Ultra low TSH levels in the level 1 control
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of 7 days at 2°C – 8°C or 4 weeks at -20°C
- Contains routinely run tumour markers: AFP/CA15-3/CA19-9/CA-125/CEA/PSA/Free-PSA
Flexible options are available with a low, normal and high level, as well as a combined tri-level.
Description |
Size |
Analytes |
Cat No. |
| Immunoassay Premium Plus Level 1 | 12 x 5 ml | 54 | IA3109 |
| Immunoassay Premium Plus Level 2 | 12 x 5 ml | 54 | IA3110 |
| Immunoassay Premium Plus Level 3 | 12 x 5 ml | 54 | IA3111 |
| Immunoassay Premium Plus Tri-Level | 4 x 3 x 5 ml | 54 | IA3112 |
The clinical significance of some selected analytes.
Androstenedione
Androstenedione is an androgen, which are hormones responsible for the induction of sexual differentiation and produce secondary male physical characteristics such as a deep voice and facial hair. Another example is testosterone. They are also present in females as precursors to female hormones (such as estrogen).
This test measures the amount of androstenedione in the blood. Because AD has its origins in the adrenal glands, it is useful as a marker of adrenal gland function, of the function of the ovaries or testicles, and androgen production.
An androstenedione level may be used to [1]:
• Evaluate adrenal gland function and distinguish between androgen-secreting conditions that are caused by the adrenal glands from those that originate in the ovaries or testicles, if results of DHEAS and testosterone testing are abnormal • Help diagnose tumours in the outer layer (cortex) of the adrenal gland or tumours outside of the adrenal gland that secrete ACTH (ectopic) and separate these conditions from ovarian or testicular tumours and cancers • Diagnose congenital adrenal hyperplasia (CAH) and monitor CAH treatment, in addition to tests for testosterone and 17-hydroxyprogesterone • Help diagnose polycystic ovarian syndrome (PCOS) and help rule out other causes of infertility, no monthly menstrual periods (amenorrhea), and excess body and facial hair (hirsutism) in women who have abnormal results on tests for DHEAS, testosterone, and other hormones such as FSH, LH, prolactin, and estrogen • Help determine the cause of delayed puberty and investigate suspected ovarian or testicular failure • Investigate and diagnose the cause of male physical characteristics (virilisation) in young girls and early (precocious) puberty in young boys Digoxin
Digoxin is a therapeutic drug used to treat abnormal heart rhythms and failure. Heart failure causes the heart to become less effective at circulating blood, resulting in blood backing up in the hands, legs, liver, and lungs, causing swelling.
This test measures the level of digoxin in the blood. Digoxin is prescribed to patients to alleviate symptoms of heart failure by strengthening contractions, helping the heart pump blood more effectively. Digoxin can also be used to treat arrhythmias. It cannot be used to cure heart failure or arrhythmias but can help to manage the symptoms along with other medication, exercise and diet.
Digoxin levels are monitored due to the drug’s narrow safety range. If the level is too high, toxicity may occur, if too low, symptoms may recur.
• Monitor the concentration of the drug in the patient's blood • Determine if a patient's symptoms are due to insufficient levels of Digoxin or due to digoxin toxicity • Increase the strength and efficiency of heart contractions, helping control the rate and rhythm of the heart • Slows electrical conduction between the atria and the ventricles, which is useful in treating abnormally rapid atrial rhythms that can cause heart attacks Luteinizing Hormone (LH)
Luteinizing Hormone (LH) is associated with the reproductive cycle and the release of an egg from the ovary in women and testosterone production in men. LH production is a complex system controlled by the hypothalamus in the brain, hormones produced in the testes and ovaries, and the pituitary gland.
This test measures the amount of luteinizing hormone in the blood or urine. It is used alongside other tests such as FSH, estradiol, progesterone, and testosterone to investigate reproductive irregularities.
A luteinizing hormone level may be used [4]:
In both men and women:
• In the workup of infertility • To aid in the diagnosis of pituitary disorders that can affect LH production • To help diagnose conditions associated with dysfunction of the ovaries or testicles In women:
• In the investigation of menstrual irregularities • To detect a surge in LH levels during the menstrual cycle, helping determine when a woman is likely to be the most fertile In children:
• To diagnose delayed and precocious (early) puberty. Irregular timing of puberty may be an indication of a more serious problem involving the hypothalamus, the pituitary gland, the ovaries or testicles, or other systems Insulin
Insulin is a hormone produced and stored in the beta cells of the pancreas. It is secreted as a response to an elevated glucose level following a meal and is vital in the transportation and storage of glucose, the body’s primary source of energy. Insulin regulates blood glucose by helping transport it from blood to cells.
This test measures the amount of insulin in the blood. After a meal, carbohydrates are broken down into glucose, this is then absorbed into the blood causing the blood glucose level to rise, this then falls as it moves into cells. If an individual cannot produce enough insulin, or if they are insulin resistant (cells are resistant to insulin’s effects), glucose does not reach the body’s cells and they starve. The blood glucose level will rise to an unhealthy level, which can cause various complications, including Diabetes.
An insulin level may be used to [5]:
• Diagnose an insulinoma, verify that removal of the tumor has been successful, and/or to monitor for recurrence • Diagnose the cause of hypoglycemia in an individual with signs and symptoms • Identify insulin resistance • Monitor the amount of insulin produced by the beta cells in the pancreas (endogenous); in this case, a C-peptide test may also be done. Insulin and C-peptide are produced by the body at the same rate as part of the conversion of proinsulin to insulin in the pancreas • Determine when a type 2 diabetic might need to start taking insulin to supplement oral medications • Determine and monitor the success of an islet cell transplant intended to restore the ability to make insulin, by measuring the insulin-producing capacity of the transplant What test results mean [5]:
DisorderFasting Insulin LevelFasting Glucose LevelInsulin resistance High Normal or somewhat elevated Not enough insulin produced in beta cells (diabetes, pancreatitis) Low High Hypoglycemia due to excess insulin (insulinomas, cushing syndrome) Normal or High Low
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References
[1] “Androstenedione”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/androstenedione. [Accessed: 07- Aug- 2018].
[2] “Digoxin”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/digoxin. [Accessed: 08- Aug- 2018].
[3] O. Ogbru and J. Marks, “digoxin, Lanoxin: Drug Facts, Side Effects and Dosing”, MedicineNet. [Online]. Available: https://www.medicinenet.com/digoxin/article.htm#which_drugs_or_supplements_interact_with_digoxin?. [Accessed: 08- Aug- 2018].
[4] “Luteinizing Hormone (LH)”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/luteinizing-hormone-lh. [Accessed: 08- Aug- 2018].
[5] “Insulin”, Labtestsonline.org, 2017. [Online]. Available: https://labtestsonline.org/tests/insulin. [Accessed: 08- Aug- 2018].
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Product Spotlight: Acusera Immunoassay Speciality 2 Control
The Randox Acusera Immunoassay Speciality II quality control is designed to complement our Immunoassay Premium and Premium Plus controls. Assayed, instrument specific target values and ranges are provided for 4 complex immunoassay parameters.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human serum
- Assayed target values provided for 4 parameters
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of up to 5 days at 2°C – 8°C and 4 weeks at -20°C
Procalcitonin
Procalcitonin (PCT), a protein that consists of 116 amino acids, is the peptide precursor of calcitonin, a hormone that is synthesized by the parafollicular C cells of the thyroid and involved in calcium homeostasis.
Procalcitonin is also produced by the neuroendocrine cells of the lung and intestine and is released as an acute-phase reactant in response to inflammatory stimuli, especially those of bacterial origin. This raised procalcitonin level during inflammation is associated with bacterial endotoxin and inflammatory cytokines.
Procalcitonin (PCT) versus C-reactive protein (CRP)
CRP is the most common laboratory marker used in the clinical setting to evaluate systemic inflammatory response to an infectious agent.
Procalcitonin is a more useful diagnostic inflammation parameter than CRP in patients with pediatric neutropenic fever, both in estimating the severity of infection and the duration and origin of the fever. Procalcitonin is also a more reliable parameter in the diagnosis of bacterial sepsis, allowing better differentiation among sepsis-related fatalities.[2]
Calcitonin
A calcitonin assay is helpful in identifying patients with nodular thyroid disease. It is often performed in the hope of identifying early MTC. Successful treatment of MTC depends on early detection; late detection confers a poor prognosis. In addition, calcitonin levels are reported to be increased in other malignancies, such as carcinoid tumors, lung carcinoma, melanoma, pancreatic and breast carcinoma, and pheochromocytoma.
Calcitonin is produced and released by parafollicular cells of the thyroid. Calcitonin is derived from larger precursors. Precalcitonin is cleaved to procalcitonin, which is further cleaved to immature calcitonin and then to mature calcitonin, a monomer of a 3.5-kd peptide composed of 32 amino acids, which is the only biologically active form.
Calcitonin’s precise physiologic role in humans remains to fully understood. It is known to act on the bones, kidneys, and gastrointestinal tract, binding directly to osteoclasts, thereby directly inhibiting osteoclastic bone resorption. Although this inhibition may be important in short-term control of calcium loads, it is short-lived and likely plays an insignificant role in overall calcium homeostasis. Calcitonin also inhibits the action of parathyroid hormone and vitamin D. [1]
Gastrin
Gastrin testing is employed in the diagnosis of gastrinoma, either with or without Zollinger-Ellison syndrome, and in the investigation of pernicious anemia and achlorhydria.
In patients who have undergone antrectomy with vagotomy, gastrin levels are reduced. In contrast, gastrin levels are increased in Zollinger-Ellison syndrome.[3]
Renin
Renin, also known as Angiotensinogenase, is an enzyme involved in the renin–angiotensin aldosterone system (RAAS), which regulates the body’s water balance and blood pressure level. The system regulates the extracellular volume in the blood plasma, lymph and interstitial fluid, as well as controlling constriction of the arteries and blood vessels.[5] It is secreted by the kidney from specialized cells called granular cells and has a fundamental role in hypertension development. Over activation of this system contributes to hypertension and associated end-organ damage.[4]
The secretion of renin is stimulated by the following three factors:
-
- When a fall in arterial blood pressure is detected by pressure sensitive receptors (baroreceptors) in the arterial vessels.
- When a decrease in sodium chloride (salt) is detected in the kidney by the macula densa in the juxtaglomerular apparatus.
- When sympathetic nervous system activity is detected through beta1 adrenergic receptors.[4]
-
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References
[1]A. Sofronescu and E. Staros, “Calcitonin”, Emedicine.medscape.com, 2015. [Online]. Available: https://emedicine.medscape.com/article/2087580-overview#a4. [Accessed: 16- Jul- 2018].
[2]J. Lin, S. Yap and E. Staros, “Procalcitonin”, Emedicine.medscape.com, 2015. [Online]. Available: https://emedicine.medscape.com/article/2096589-overview#a4. [Accessed: 16- Jul- 2018].
[3]B. Devkota and E. Staros, “Gastrin”, Emedicine.medscape.com, 2014. [Online]. Available: https://emedicine.medscape.com/article/2089092-overview#a4. [Accessed: 16- Jul- 2018].
[4]T. Meštrović, “Renin Clinical Applications”, News-Medical.net, 2015. [Online]. Available: https://www.news-medical.net/health/Renin-Clinical-Applications.aspx. [Accessed: 16- Jul- 2018].
[5]D. Mandal, “Renin (Angiotensinogenase)”, News-Medical.net, 2014. [Online]. Available: https://www.news-medical.net/health/Renin-Angiotensinogenase.aspx. [Accessed: 16- Jul- 2018].
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Product Spotlight: Molecular QC and EQA for Infectious Disease Testing
Earlier in the year, Randox entered into a strategic partnership, bringing on-board Qnostics Molecular Controls and QCMD Molecular EQA which comprises hundreds of controls and EQA programmes for molecular infectious disease testing.
The Global Molecular Diagnostics market is estimated to be worth 6.54 billion USD. This market is classified into infectious diseases, oncology, genetic tests and blood screening. Infectious diseases account for the largest share of the global market.
According to the World Health Organisation (WHO), Infectious Diseases are caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi. These diseases can be spread – directly or indirectly – from one person to another.
Designed to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseased, Respiratory Diseases, Blood Borne Viruses, Sexually Transmitted Infections, Gastro-Intestinal Diseases and Central Nervous System Diseases.
Qnostics products can be used in the daily monitoring of assay performance, linearity assessment, assay evaluation, validation/verification of new assays and staff training.
There are five main product areas for Qnostics:
Product Groups (click to expand)
Q Controls
Independently manufactured, this range of positive run, whole pathogen, third party controls are designed to monitor the daily performance of a wide of range molecular assays used in the detection of infectious diseases. These controls help in supporting a laboratory’s accreditation requirements, in line with ISO 15189:2012.Analytical Q Panels
Designed to cover the dynamic range of an assay, Analytical Q Panels allow assessment of an assays linearity, LOD and LOQ. Each panel contains a minimum of five samples, including a negative that spans the dynamic range of the assay in a linear progression.Molecular Q Panels
Consisting of three levels (high, medium and low), Molecular Q Panels are intended to evaluate an assays analytical measuring range. Molecular Q Panels can also be used to support training of laboratory staff and in the development of molecular diagnostic assays.Evaluation Panels
Evaluation Panels cover a range of genotypes and may be used to evaluate assay characteristics, confirm performance claims and ultimately ensure the assay is fit for purpose. Evaluation Panels may also be used in the validation of molecular assays and development of new molecular diagnostic assays.QCMD Past Panels
Available for use in assay evaluation and staff training, EQA samples are available from past QCMD challenges.Custom ManufactureQnostics are specialists in the custom manufacture of quality control materials for use in the detection of infectious diseases using molecular based methods. Qnostics will work with you to develop a bespoke solution designed specifically to meet the individual and unique requirements of your lab.
- Choose from hundreds of molecular characterised targets
- Targets can be custom made into numerous different formats
- The whole pathogen format accurately mimics clinical samples
- All materials can be provided in a “ready-to-use” or liquid frozen format
Qnostics custom made Molecular Infectious Disease Controls are designed to fit all stages of your assays product life cycle from product development to launch.
QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.
With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of infectious disease testing.
EQA participants receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.
Features & Benefits (click to expand)
Frequency
A variety of programme options are available. Choose the number of challenges that best suit your laboratory’s requirements.
Online EQA Management System
ITEMS provides an online tool to easily manage all EQA activities from programme registration to submission of results and provision of EQA reports. Different levels of user access are available so data can be accessed by whoever needs it.
High level of participation
Over 2000 participants in more than 100 countries ensuring peer group numbers are maximised.
Comprehensive reports
Receive individual reports for each challenge and a final supplementary report at the end of the cycle visual assessment of performance.
International accreditation
Programmes are accredited to ISO 17043.
Qnostics
QCMD
Contact Us
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Complete QC Solutions for Results you can Trust
Randox is one of the largest manufacturers of true third party quality control solutions. With over 35 years’ experience delivering reliable, high quality products designed to effectively challenge instrument performance you can be confident in the accuracy of patient test results, whilst reducing time and costs. With more than 390 analytes available across the Acusera range and a wide range of formats providing flexibility & choice, we have a solution to suit you.
Our diverse range of multi-analyte, third party controls offer industry leading opportunities for consolidation, ultimately delivering cost savings, reduced preparation time and increased efficiency all without compromising on quality. Manufactured using the highest quality raw materials, lot to lot consistency and unrivalled commutability is guaranteed, ensuring performance mirrors that of the patient sample and costly shifts in QC results are reduced.
Benefits
Consolidation
Specialising in consolidation, the Acusera range of multi-analyte controls is designed to reduce the number of individual controls required to cover your test menu, ultimately reducing costs, preparation time and storage space.Commutability
All Acusera controls are designed to react to the test system in the same manner as the patient sample, helping to meet ISO 15189:2012 requirements whilst reducing inconvenient and costly shifts in QC results when reagent batch is changed.Clinically Relevant Levels
The presence of analytes at key decision levels not only helps to ensure accurate instrument performance but maximises laboratory efficiency by eliminating the need for additional low/high level controls at extra expense.Reduced Waste
The unrivalled working stability of the Acusera control range helps to keep waste and costs to a minimum.Flexibility
With an extensive range of assayed/unassayed, liquid/lyophilised and single/multi-analyte controls, the Acusera portfolio has a solution to suit all laboratory preferences.True Third Party Controls
Manufactured independently, the Acusera range delivers unbiased performance assessment with any instrument or method, helping to meet ISO 15189:2012 requirements whilst simultaneously eliminating the need for multiple instrument dedicated controls.
Choose below to find a control that suits you.
Complementing our Internal Quality Control range is Acusera 24•7, a powerful data management tool designed to help even the most demanding laboratories manage their daily QC activities. Delivering unique access to real-time peer group statistics, a variety of fully interactive charts and automatic calculation of performance metrics such as Measurement Uncertainty, Acusera 24•7 will speed up data review and troubleshooting.
Acusera Third Party Controls
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RX series (Concept 3)
The RX series range of clinical chemistry analysers includes both semi-automated and fully automated testing for a range of clinical settings. With a world leading test menu comprising of routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing, the RX series offers laboratories the complete clinical chemistry package and results you can trust. The RX series was built with three core values in mind – Reliability, Accuracy and Precision.
Consolidation of Routine & Specialised Testing on One Single Platform
With an extensive product portfolio covering over 100 disease markers within routine and nice testing, the RX series removes the need for a separate nephelometry system for specific proteins and allows laboratories to bring all testing in-house; thus ensuring minimal downtime and providing real cost savings through consolidation.
Low Reagents & Sample Volumes
Built with excellence in mind, the RX series range of analsyers require a low sample volume to deliver consistent high quality results which is beneficial when working with paediatric patients and animals. Combined with our high quality reagents, the RX series reduce the possibility of misdiagnoses, offering accurate, reliable and precise results each time, every time.
Unrivalled Customer Support
Our team of trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument. We know time is critical in any laboratory and our global network means we are uniquely positioned to meet your needs with local service and support whenever you need it.
