Complement C4 – Biomarker for Systemic Lupus Erythematosus (SLE)
Complement C4 – Biomarker for Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus (SLE) is an autoimmune disorder associated with a deficiency in complement C4. Complement C4 is one of nine components of the complement system which is an integral part of the immune system that enhances (complements) the ability of antibodies and phagocytic cells to clear microbes and damaged cells from the host, promote inflammation, and attack the cell membrane of pathogens.
Complement C4 is a vital component of two immunology pathways: Classical pathway and Mannrose Binding Lectin (MBL) pathway.
The classical pathway is triggered by antibody-antigen complexes which induces a conformational change in the C1 complex. The activated C1 complex cleaves the C4 component, resulting in a reactive C4b which covalently binds to proteins or polysaccharides at the surface in close proximity of the C1 component. The bound C4b complexes binds to the C2 component rendering C2 for proteolysis by C1.
The MBL pathway is activated through the binding of MBL to mannose residues on the pathogen surface. This in turn activates the MBL-associated serine proteases, MASP-1 and MASP-2, which activates the C4 and C2 components, to form the C3 convertase, C4b2a. The C4b2a complex splits C3 into two fragments which causes the release of vasoactive mediators such as histamine.
Complement C4 deficiency is commonly associated with systemic lupus erythematosus (SLE).
According to lupus.org, 16,000 new cases of lupus are reported each year. Approximately 1 in 250 people may end up developing SLE at some point with 90% of SLE patients being female aged between 15-44 years. The causes of SLE are unknown, but are believed to be linked to environmental, genetic, and hormonal factors. 1.5 million Americans are living with diagnosed lupus.
There are four forms of lupus:
- Systemic – accounts for approximately 70% of all lupus cases. In half of these cases, a major organ or tissue in the body, such as the heart, lungs, kidneys, or brain will be affected.
- Cutaneous lupus – accounts for approximately 10% of all lupus cases and only affects the skin.
- Drug-induced lupus accounts for approximately 10% of all lupus cases and is caused by high doses of certain medications.
- Neonatal lupus is a rare condition in which the mother’s antibodies affect the fetus. At birth, the baby may have a skin rash, liver problems, or low blood cell counts, but these symptoms typically disappear completely after six months with no lasting effects.
The Randox Complement C4 assay
The Randox Complement C4 assay is used for the quantitative in vitro determination of complement C4 concentration in serum. The Randox Complement C4 assay can be used as a biomarker in the diagnosis and monitoring of SLE. It is the cell-bound levels of processed complement activation products, especially E-C4d (erythrocyte-bound C4) that makes the complement C4 assay a biomarker for SLE.
Key Features of the Randox Complement C4 assay
Liquid ready-to-use reagents – The Randox reagent comes in a convenient liquid format requiring minimal preparation thus reducing the risk of errors.
Exceptional correlation with standard methods – The Randox methodology was compared against other commercially available methods and the Randox Complement C4 assay showed a correlation coefficient of r=0.98.
Wide measuring range – The healthy range for Complement C4 is 7 -49 mg/dl. The Randox Complement C4 assay can comfortably detect levels outside of the healthy range measuring between 2.90 – 152 mg/dl.
Excellent stability – Stable until expiry date when stored at +2 to +8°C.
For health professionals
If you are a clinician or laboratory who are interested in running specific protein assays, Randox offer a wide range of high-quality routine and niche assays including: Cystatin C, Complement C3, CRP, Lipoprotein (a), Apolipoprotein C-II, Apolipoprotein C-III and Apolipoprotein E. These can be run on most automated biochemistry analysers.
Instrument Specific Application (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
For more information, download our Specific Proteins Brochure email reagents@randox.com
Looking after your kidney health during your pregnancy
With this year’s World Kidney Day theme focusing on women’s health and in particular, their kidney health, the campaign is drawing attention to the need for a higher awareness, timely diagnosis and proper follow-up of kidney issues amongst women.
One key area being highlighted by the campaign is the close links between pregnancy and kidney health problems. The two are intrinsically connected – with CKD considered a high-risk factor for problematic pregnancies and reduced fertility, and in turn, pregnancy-related complications, including preeclampsia, can increase the risk of kidney disease.
Although not commonly known, women who have Chronic Kidney Disease are at increased risk of hypertensive disorders and premature births – which can be devastating for all involved.
Women with Chronic Kidney Disease who become pregnant also usually have mild kidney dysfunction, the severity of which will depend on the stage the CKD is at.
It is clear therefore that there is a need for increased awareness of Chronic Kidney Disease in pregnancy, to timely identify its existence before conception, and to monitor its progress before, during and after birth.
With a comprehensive panel of kidney health tests, Randox are working to ensure timely diagnosis of kidney function problems, to ensure that necessary treatment is administered at the earliest possible stage, when it is most likely to be successful.
Pregnant women, or women hoping to get pregnant in the future, can therefore determine their kidney health and be empowered to embark upon the necessary lifestyle changes or treatment required to ensure a safe and healthy pregnancy.
For example, the Randox test for albumin, low concentrations of which are the earliest marker of kidney damage, can identify individuals with diabetic nephropathy (damage to the kidneys caused by diabetes) around 10 years earlier than standard protein tests. The Randox albumin test can therefore enable preventative measures to be taken to reduce your risk of developing kidney disease.
In addition to albumin, there are a number of other highly specific and sensitive tests for kidney health, which are available as part of a Randox Health Check at our Randox Health Clinics. These include;
- Estimated Glomerular Filtration Rate, which is an equation that considers age, gender, blood and protein levels to determine how well the kidneys are functioning.
- Creatinine, which is a waste product produced by muscle tissue, and removed by the kidneys. When kidney function is diminished, creatinine levels increase.
- Other proteins within the body which should be filtered by the kidneys, and are therefore measured to determine kidney function, include;
– Cystatin C
– Beta-2-Microglobulin
– Microalbumin, which is not usually found in urine, but can appear when normal kidney function is impaired.
- Minerals processed by the kidneys and analysed by Randox Health include;
– Magnesium
– Calcium
– Phosphate
– Potassium
– Sodium
Both World Kidney Day and Randox are working towards improving healthcare worldwide. With access to these high-performance kidney health tests, expectant mothers with kidney problems can be diagnosed early, before the condition develops into something more serious – keeping both you, and your baby healthy.
With early diagnosis we can improve patient treatment outcomes and reduce the number of people across the world suffering with kidney health problems.
If you are a clinician or lab interested in running renal function assays, download our Reagents Brochure or email reagents@randox.com
If you want to find out the status of your own Kidney Health, book a health check with Randox Health today. Speak to our team by phoning 0800 2545 130.
Rare inherited diseases of copper metabolism
This year, Randox Reagents are supporting Rare Disease Day on 28th February. Randox offer a test that aids in the diagnosis and monitoring of Wilson Disease and Menkes Disease which are rare inherited disorders of copper metabolism.
What is a rare disease?
According to the European Union, a rare disease is defined as a disease that affects less than 5 in 10,000 of the general population. 7% of the population will be affected by a rare disease at some point in their life. This equates to 30 million people in Europe.
Wilson Disease
Wilson Disease is a rare inherited autosomal recessive disorder of copper metabolism, characterised by excessive deposition of copper in various bodily tissues, particularly the liver, brain, and corneas of the eyes. This is due to mutations of the ATP7B gene which is responsible for encoding specific proteins that are responsible for the transportation of copper from the liver around the body, which is prohibited due to the mutations. If left untreated, Wilson Disease can cause hepatic disease, central nervous system dysfunction, or death. Approximately 1 in 30,000 people are affected by Wilson Disease worldwide (WDA, 2018). The first sign of Wilson Disease is liver dysfunction in more than half of patients, beginning at six years of age, however, it usually presents clinically in teenage years or early twenties manifesting as acute hepatitis. Some individuals with Wilson Disease have been thought to have infectious hepatitis or infectious mononucleosis and so it is vital that those with unexplained, abnormal liver tests are tested for Wilson Disease.
Menkes Disease
Menkes Disease is more likely to affect premature babies and is a rare inherited x-link recessive disorder of copper metabolism, characterised by sparse, kinky hair; failure to gain weight and grow at the expected rate (failure to thrive); and deterioration of the nervous system. This is due to mutations of the ATP7A gene which is responsible for the absorption of copper from food in the small intestines and supplying copper to certain enzymes that are critical for the structure of bone, skin, hair, blood vessels, and the nervous system. Approximately 1 in 100,000 people are affected by Menkes disease worldwide (USA National Library of Medicine, 2018). The first sign of Menkes Disease develops at 2-3 months of age and includes curly, sparse, coarse, dull, and discoloured haired.
As there are no cures for Wilson Disease or Menkes Disease, treatment aids to reduce/replace copper within the body. The Randox Copper assay can comfortably detect copper levels outside of the healthy range to aid in the diagnosis and monitoring of treatment of Wilson Disease and Menkes Disease.
Randox Copper Assay
The Randox Copper assay is used to measure the amount of copper in the blood; to help with the diagnosis and monitoring of rare inherited diseases related to copper toxicity (Wilson Disease) and copper deficiency (Menkes Disease). Copper deficiency is less likely because a normal diet contains plenty of copper including organ meats, beans, and wholegrains, however, copper deficiency is more likely to occur in those who are malnourished, more likely children.
For more information visit: https://www.randox.com/copper
To request an application for your specific analyser, contact reagents@randox.com
Alprazolam and Prescription Drug Abuse
Alprazolam, also known as the trade name Xanax, is a widely prescribed anxiety drug in the US. Alprazolam is a minor tranquilliser which can cause sedation, short term memory loss and depress the nervous system, slowing down the brain and body. Recommended for short term use, the drug can be highly addictive and only be obtained on private prescription in the UK.
People have been known to crush or melt the dangerous tranquilliser that comes in a tablet form, to inject the substance. Extremely dangerous and fatal, the chalk in the tablets can cause collapsed veins and lead to an abscess and infection.
A recent article by BBC News uncovered that Alprazolam is being purchased online and abused by children as young as 13. The news comes after reports of social media sites being used to buy dangerous substances and locate drug dealers. In 2017, up to 20 teenagers from Wiltshire needed treatment after using Alprazolam. This year in Sussex alone, several young people have been admitted to hospital after taking the prescription drug.
A spokesperson from Pfizer, a Xanax manufacturer, expressed concerns over the alarming rise of counterfeit Xanax drugs and the growing availability on the dark web. Discussing the issue, they mentioned that ingredients such as boric acid, heavy metals and floor polish have been found in counterfeit Xanax medications. Defined as “part of our youth culture” Nick Hickmott from Addaction states, it is currently debatable how many people are currently using Alprazolam. London’s MP Bambos Charalambous has called for awareness campaigns and further research to be conducted in order to support services.
Alprazolam is not the only widely abused prescription drug, as criminal gangs were reported smuggling tens of millions of prescription drugs out of the UK’s protected supply chain. Northern Ireland have also expressed concerns over the rise of pregabalin, with BBC spotlight revealing a 46% rise from a data base of 20 million prescription records written by GPs across the country in the past four years. However, the biggest killer in Northern Ireland is tramadol, a prescription painkiller taken by thousands daily.
Randox Toxicology offer the most comprehensive drugs of abuse test menu across multiple forensic matrices. Our level of expertise in toxicology has enabled us to provide the DoA ULTRA panel, which can screen for a wide range of prescription drugs of abuse, including Alprazolam and Tramadol. Using our revolutionary Biochip Array Technology, Randox Toxicology provide a complete immunoassay profile in the initial screening phase.
For more information about our DoA ULTRA panel and how Randox Toxicology are fighting drugs of abuse, email us at info@randoxtoxicology.com
For further information, please contact the Randox PR team via email: randoxpr@randox.com or phone 028 9442 2413
Acetaminophen-Induced Acute Kidney Failure
Acetaminophen is a commonly used medicine for pain-relief. During cold and flu season, it is common to resort to pain-relief medicines to relieve headaches, and ache and pain symptoms associated with a cold or flu as there is no cure. However, the therapeutic range for acetaminophen is 10-30 mg/l, which is small and very easy to go over. During cold and flu season, it is important to monitor the amount of paracetamol entering your body as acetaminophen is more dangerous than suspected. At therapeutic levels, acetaminophen does not produce any adverse effects, however, long-term treatment, prolonged use, and taking a few more than the recommended dose can be severely damaging and fatal. Accidental acetaminophen overdose took the lives of 1,500 people in the U.S between 2001 and 2010. The Randox Acetaminophen assay is used to determine the concentration levels of acetaminophen in the blood to determine if an overdose has taken place.
It is commonly recognised that acetaminophen overdose causes hepatotoxicity, but it is less commonly recognised that it can also cause nephrotoxicity in less than 2% of patients. Nephrotoxicity is toxicity of the kidneys and is often associated with a reduced amount of glutathione which is important for normal cellular metabolism in the kidneys. The Randox Glutathione Reductase assay is required for the regeneration of reduced glutathione. Glutathione is often discussed in association with the Randox Glutathione Peroxidase, which requires reduced glutathione for activation. Both Glutathione reagents are unique to Randox.
Acute renal failure due to acetaminophen manifests as acute tubular necrosis, which can occur alone or in combination with hepatic necrosis. Nephrotoxicity can also occur when the therapeutic levels of acetaminophen are not exceeded. This most commonly occurs when acetaminophen is taken in combination with alcohol. Upon testing acetaminophen levels and the results fall within the therapeutic range, the Randox Ethanol assay can test alcohol levels to determine if a combination of alcohol and acetaminophen caused nephrotoxicity. Renal impairment may be more common than previously suspected as acute renal failure occurs in 10-40% of patients with severe hepatic necrosis. Upon testing acetaminophen to determine toxicity, Randox also offer the following renal tests to test for nephrotoxicity:
- Creatinine (Enzymatic and JAFFE)
- Cystatin C
- IgG
For more information visit: https://www.randox.com/acetaminophen
To request an application for your specific analyser, contact reagents@randox.com
Drug and Alcohol Testing in the Medico-legal Market
Medico-legal testing for drugs and alcohol may be required by various professional bodies involved in child custody cases, care proceedings or child protection cases. In cases regarding divorce and children, a dispute may arise during the process of discussions involving the custody of children. In these cases drug and alcohol testing may be sought if there has been a substance abuse claim against a parent fighting for custody or visitation. In cases relating to child protection, social services may seek drug and alcohol testing if child welfare claims have been made regarding suspected substance misuse.
Normally in medico-legal cases a hair sample would be tested as it provides the longest detection window.
Why is Drug and Alcohol Testing in Medico-legal Cases Important?
Drug and alcohol testing is important to ensure child protection from the detrimental effects of parental substance misuse and to ensure they have a quality of life they deserve. In addition it is also important to enable parents the opportunity to get the help and support they need and begin rehabilitation treatment.
Doing the right thing by the child is the main priority, and where possible parent and child relationships are sought to be maintained. Drug and alcohol testing assists in these efforts and in such cases abstinence monitoring testing may be required to assess a parentās recovery e.g. if a visitation case is being reassessed.
Our Expertise
At Randox Testing Services we provide drug and alcohol testing to all professionals within the family law and medico-legal sector. Our hair drug testing service utilises accredited testing methods and is made more cost-effective through utilising patented testing methods developed by Randox.
We understand the impact a positive result can have on a parent, child, and extended family and ensure results of the highest precision and accuracy. With over 35 yearsā experience in the diagnostic industry we have gained reputation as a trusted provider.
Our drug and alcohol testing solutions are flexible and can be tailored to our customer needs with a choice of testing methods. We offer a comprehensive drugs of abuse test menu and our service also includes expert witness reporting where applicable.
Contact Us
To speak to one of our experts about hair drug testing contact enquiries@randoxtesting.com or call +44 (0) 161 741 2760. We work with companies within the medico-legal sector along with a wide range of workplaces and also private individuals.
For further information on RTS, or to arrange interviews, please contact the Randox PR team via email: randoxpr@randox.com or phone 028 9442 2413
Liver Cirrhosis is a Global Health Burden
#LoveYourLiver this January. This month, we are taking a closer look at Liver Cirrhosis.
Liver cirrhosis occurs when the healthy tissue of the liver is replaced with scar tissue (fibrosis) due to long-term liver damage. Liver cirrhosis can result in liver failure which can be fatal.
Liver complications such as liver disease and cirrhosis can be detrimental if it is not treated or monitored. Liver disease is the only major cause of death still increasing year-on-year. Globally, deaths due to liver cirrhosis have increased from 676,000 in 1980 to over 1 million in 2010 (NCBI, 2014). Cirrhosis and other chronic liver diseases have increased by 12.4% from 2006-2016 and was the cause of 1,256,900 deaths in 2016 (Global Burden of Disease, 2016).
There are a few factors that increase the risk of liver cirrhosis. The three main factors are heavy alcohol consumption, an undiagnosed hepatitis infection, particularly hepatitis C, and non-alcoholic steatohepatitis (a more severe form of non-alcoholic fatty liver disease) due to obesity.
There are numerous symptoms associated with liver cirrhosis. Some of the more severe symptoms include:
- Jaundice – yellowing of the skin and whites of the eyes
- Personality changes, confusion, difficulty concentrating, memory loss, or hallucinations
- A tendency to bleed or bruise easily
- In women, abnormal periods
- In men, enlarged breasts, a swollen scrotum (the loose sac of skin that contains the testicles) or shrunken testicles
- Vomiting
- Diarrhea
- Stomach pain – swollen or bloated stomach
Liver cirrhosis cannot be cured, but the aim of treatment is to manage the symptoms and complications, and to stop the condition getting worse.
#LoveYourLiver and prevent or reduce the symptoms of liver cirrhosis through: moderating alcohol consumption, not sharing needles to inject drugs, using a condom during sex, taking medications as prescribed, and maintaining a healthy weight.
The early stages of liver cirrhosis usually does not present any symptoms and is often first detected using routine blood tests. Liver cirrhosis can be diagnosed and monitored through the following routine blood tests:
Alanine Aminotransferase (ALT)
ALT is one of the enzymes within the aminotransferases group and are among the most sensitive liver enzymes. The normal concentration levels of ALT in the blood are low, however, when the liver is damaged, such as liver cirrhosis, the levels of ALT increase. During the diagnosis of liver cirrhosis, the root cause of the damage can be established, such as disease, drug or injury. ALT is commonly measured alongside AST as part of the hepatic panel.
Aspartate Aminotransferase (AST)
AST is an enzyme found throughout the body. Elevated concentration levels of AST in the blood is directly correlated to the severity of the tissue damage. AST also allows for the root cause of the damage to be diagnosed. Excessive levels are indicative of damage due to acetaminophen overdose or acute viral hepatitis. Moderately high levels are indicative of alcohol abuse. Slightly high levels are indicative of cirrhosis.
AST is commonly measured alongside ALT as part of the hepatic panel, although ALT levels are higher in most types of liver damage.
Albumin
Albumin is a special protein made in the liver and provides the body with the proteins it requires to grow and repair tissue. The body requires a proper balance of albumin to prevent fluid from seeping out of blood vessels. Decreased concentrations levels of this protein in the blood is an indicator of liver cirrhosis.
Randox supply a range of third party clinical diagnostic hepatic reagents to aid in the diagnosis and managing the complications of liver cirrhosis. All reagents are available for use on a range of third party biochemistry analysers. Randox offer the following hepatic reagents to diagnose liver cirrhosis:
Alanine Aminotransferase (ALT)
Aspartate Aminotransferase (AST)
Randox also offer the following high performance and unique tests to diagnose liver cirrhosis:
Why choose Randox reagents?
- Randox offers the largest range of chemistries
- Liquid ready-to-use reagents available
- Automated applications for a wide range of clinical analysers
- Excellent correlation to reference methods
- Wide measuring ranges
- Flexible pack sizes
- Official accreditation to national and international standards including UKAS, ISO 13485:2003, and FDA.
- Easy fit reagents
- Easy read reagents
To request an application for your specific analyser, contact reagents@randox.com
For more information on liver function or to view our hepatic panel, visit https://www.randox.com/liverfunction/
GPs are told to stop prescribing antibiotics for sore throats
Today, the National Institute for Health and Care Excellence has published guidelines that state doctors should not prescribe precious antibiotics for most people with sore throats and should instead recommend drugs like paracetamol.
The guidelines from NICE and Public Health England, which aim to limit the use of antibiotics, said doctors should only be prescribing the medicines for more severe cases that are most likely to have been caused by a bacterial infection.
This is despite recent research that suggests antibiotics are prescribed in 60% of sore throat cases, for which doctors are unable to tell if the infection is viral or bacterial.
The National Institute for Health and Care Excellence said most sore throats were caused by viral infections, which cannot be treated by antibiotics.
At Randox, our pioneering R&D teams have developed a revolutionary swab test for respiratory infections which indicates the cause of the infection and whether a patient needs antibiotics or not. This helps to limit the number of patients who are prescribed antibiotics unnecessarily.
The Randox test, which can rapidly detect and identify the cause of 21 respiratory infections in just 5 hours, assists the clinician in prescribing the appropriate antibiotic.
John Lamont, Lead Scientist at Randox Laboratories, said;
“Current diagnostic testing for respiratory infections takes at least 36 hours to confirm the nature of an infection, and they cannot name and categorise infections as bacterial or viral in the way our new respiratory test can.”
This test, if widely adopted, could allow medical practitioners to make the correct treatment choice on the same day as examination and before patients have already begun a precautionary course of inefficient antibiotics. It would also have additional efficiency savings for the NHS, by eliminating the need for lengthy microbiology lab tests and unnecessarily prescribing drugs which are not needed.
This new rapid and accurate test will give clinicians confidence in their diagnosis of respiratory infections and will allow for quicker treatment if necessary, which benefits patient outcomes.
The test is also available as a Randox Health Cough, Cold & Flu offering, and can be carried out by booking an appointment with Randox Health at our clinics in Crumlin, Holywood or London, or by arranging the mobile clinic to visit you at your home or place of work.
Find out more about the Cough, Cold & Flu Respiratory test here.
Book an appointment with one of our clinics, or arrange the mobile clinic, by phoning 0800 2545 130 or by clicking here.
For further information please contact the Randox PR team by email: randoxpr@randox.com or phone 028 9442 2413
The Effect of Drug Deliveries and MDMA
A recent report by the Independent discussed how buying drugs has become as easy as buying ice cream. The report comes after experts named London as a city where cocaine is now delivered faster than pizza. According to the NHS, in the UK 2.7 million people between the ages of 16 and 59 took an illicit drug in 2015 and 2016 (roughly one in 12 adults). As a result, the Global Drug Survey are now looking at the impact of encrypted mobile phone messaging services and other methods that have enabled quick drug deliveries.
However, the drug problem is worldwide. In the US, life expectancy has fallen for the second consecutive year amid concerns of increased drug related deaths, the first multi-year drop since 1962 and 1963 according to the US National Centre for Health Statistics (NCHS). The NCHS documented that more than 63,600 US deaths in 2016 were due to drug related overdoses, a number that continues to increase.
MDMA has continued to appear in the news, after the deadly substance was responsible for the recent deaths of multiple teenagers in the UK. Also known as Ecstasy, MDMA is often described as the original designer drug due to its link with the dance culture in the late 80s and early 90s. Randox Toxicology’s DoA II panel tests for common drugs of abuse, including MDMA and generic opioids.
With the use of Biochip Array Technology, we have made multiplex testing capabilities possible. Our level of expertise in toxicology research and development allows us to adapt quickly to the ever-changing drug market influences and develop assays for current and novel drug trends.
| Analyte | Compound | Cross Reactivity % |
| MDMA | MDMA | 100 |
| MDEA | 321.7 | |
| PMMA | 23.75 | |
| MDA | 5.5 | |
| d,I,BDB | 4.8 |
Purity is a concern with MDMA, which is regularly sold containing other fatal drugs. Newshub released information from Wendy Allison at KnowYourStuffNZ, who stated that only 20 percent of the drugs they tested in New Zealand contained MDMA. KnowYourStuffNZ’s website advises people to avoid certain pressed pills containing large amounts of MDMA. Theses pills include “Green Guccis”, a rectangular green pill with the Gucci logo and “Yellow Rolexes”, a yellow pill shaped like the Rolex crown logo. The comedown of Ecstasy can cause users to feel depression, whilst long term users can suffer from memory problems and anxiety. The use of the Class A drug has also been linked to liver, kidney and heart problems.
For further information on our DoA II panel and how Randox Toxicology are advancing the future of toxicology, email info@randoxtoxicology.com
Reconstituting Lyophilised Controls
What is Lyophilisation?
Lyophilisation or ‘freeze drying’ is the process by which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate processes:
- Freezing
- Primary Drying (Sublimation)
- Secondary Drying (Desorption)
There are many benefits to using a lyophilised control including; improved product shelf-life and enhanced stability of volatile analytes. For example, many lyophilised controls have a shelf life of up to four years from the date of manufacture resulting in a reduction of costly new lot validation studies. Furthermore, lyophilised controls can be aliquoted and refrozen to extend the working stability of the product.
Reconstituting Lyophilised QC Material
The process of reconstitution involves adding a specified volume of distilled water to lyophilised QC material. The water should completely dissolve the lyophilised contents, giving a liquid solution, which is ready for analysis.
Reconstitution is a straightforward process, but requires a high level of precision. Small errors can have serious implications to the reconstituted material:
- If too much water is pipetted during reconstitution, the material will be heavily diluted and results will be lower than expected
- If too little water is pipetted during reconstitution, the material will not be sufficiently diluted, and results will be higher than expected
- If the correct volume of water is pipetted, but a small amount of water gets stuck in the pipette tip due to poor pipetting technique, results will be higher than expected
If a lyophilised control has been reconstituted incorrectly the contents of the vial will be wasted. It is therefore vitally important that controls are reconstituted with care.
Materials and Methods Required
The list of requirements for an accurate and consistent reconstitution technique is not extensive, but each requirement is vital. Labs should have:
- Calibrated volumetric pipettes
- Sterile, appropriately sized pipette tips
- Distilled water, or other reconstitution fluid as specified
- Technician with good pipetting technique
- Lyophilised QC stored according to manufacturer’s specifications
How to Reconstitute Lyophilised QC Material
Each different lyophilised control may require slightly different preparation, always refer to the instructions for use before reconstituting control material. The below guide provides a general overview of the reconstitution process, using the Randox Human Assayed Chemistry Premium Plus control (HN1530) as an example
- Place the vial of lyophilised QC on a flat surface, carefully remove the lid and the rubber stopper making sure not to spill any material
- Using a calibrated pipette and sterilised pipette tip, add exactly 5ml of distilled water directly into the QC vial, ensuring no water is left in the pipette tip, or on the rim/side of the vial
- Place the rubber stopper and lid firmly back onto the QC vial, and leave to stand for 30 minutes
- After 30 minutes, gently invert the QC vial 10-15 times to ensure the contents is completely dissolved, making sure to avoid the formation of foam. It is important that you DO NOT SHAKE the vial. Alternatively place the vial on a roller for 30 minutes to ensure the contents is thoroughly mixed
- Once satisfied all material has been completely dissolved, proceed to use the QC product in accordance with the ‘Control’ section of the individual analyser application
- Once finished, refrigerate any unused material. It is good practice to label the vial with the date of reconstitution to prevent the use of material outside of the recommended stability period
- Prior to reusing lyophilised material, mix the contents thoroughly by gentle inversion, as highlighted in Step 4
Additional Considerations
It is important to remember that there may be slightly different reconstitution requirements for different QC material. For this reason, it is vital that the instructions provided on the QC Kit Inserts are closely followed.
Reconstituting lyophilised QC can be time-consuming. Therefore, Randox Acusera offer convenient 5ml distilled water serum diluent to assist laboratories with reconstitution of lyophilised controls. These user-friendly pour over vials streamline the reconstitution process and eliminate the risk of pipetting errors.
If you have any further questions regarding lyophilised controls or would like to contact us, please do so by emailing us at acusera@randox.com or use the contact us button provided.
