Liquid Bilirubin Control
Liquid Bilirubin Control
Providing a true third party solution for the measurement of Bilirubin, the Acusera Liquid Bilirubin Control is designed to deliver an unbiased, independent assessment of analytical performance helping to ensure accurate and reliable patient testing.
Covering the required clinically relevant decision levels for neonatal testing of Direct and Total Bilirubin, with a 7 day open vial stability and 2 year shelf life the Acusera Liquid Bilirubin Control will reduce waste, whilst remaining easy and convenient to use.
Features & Benefits
- Liquid frozen
- 100% human serum
- 2 year shelf life from date of manufacture
- Clinically relevant decision levels, recommended by ISO15189
- Open vial stability of 7 days at 2°C – 8°C
- Assayed Control
- CE Marked
| Description | Size | Analytes | Cat No. | |
|---|---|---|---|---|
| Liquid Bilirubin Control | 3x3mL | Direct Bilirubin Total Bilirubin | BR10443 | |
Analytes
- Direct Bilirubin
- Total Bilirubin
Related Products
Troponin T Quality Control
Intended for use with the Roche system, this control is manufactured using only the highest quality material and offers an unrivalled 7-day thawed stability at +2ºC to +8ºC.
Features & Benefits
- Liquid frozen for enhanced stability
- Aqueous based material
- Ultra low levels of Troponin T
- Stable to expiry date at -18-24ºC storage
- Thawed stability of 7 days at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Troponin T Control | 6 x 3 ml | 1 | CQ10450 | |
Analytes
- Ultra low Troponin T
Molecular Testing on the Evidence Investigator
The Evidence Investigator is a compact, semi-automated benchtop analyser which is renowned for its versatility, robustness and effective reporting methods. The Evidence Investigator has offered efficient and comprehensive testing in a wide range of laboratory settings for many years including, clinical diagnostics, molecular, research, toxicology and food diagnostics.
The Evidence Investigator is the perfect fit for medium throughput laboratories seeking maximum use of bench space and can process up to 44 results from a single sample, with a maximum throughput of up to 2376 tests per hour.
It is extremely well equipped to provide reliable and accurate results because results are generated using Charge Coupled Device (CCD) camera, which quantifies chemiluminescent light. The light then measures the degree of binding between the sample and specific biochip bound ligands. The Evidence Investigator image processing software translates light signal generated from chemiluminescent reactions into analyte concentrations which removes the need for any manual processing of data.
Our molecular product range offers diagnostic, prognostic and predictive solutions across a variety of disease areas including sexually transmitted infection (STI), respiratory tract infection, colorectal cancer, familial hypercholesterolemia (FH) and cardiovascular disease (CVD). Additionally, we can provide a wide range of assay formats including single nucleotide polymorphisms (SNP) genotyping, pathogen detection and mutation detection. The technology allows simultaneous detection of multiple analytes from a single sample for efficient and cost-effective testing.
Pathogen Detection
STI and Respiratory Arrays
Sexually transmitted infections (STIs) affect more than 1 million people every day and each year 500 million new cases of STIs occur.1 Therefore, it is vital for early and accurate detection. Randox’s Sexually Transmitted Infections Multiplex Array simultaneously detects 10 bacterial, viral and protozoan including primary, secondary and asymptomatic co-infection for a complete infection profile. The assay is based on a combination of multiplex PCR and biochip array hybridisation. Innovative PCR priming technology permits high discrimination between multiple targets.
Respiratory tract infections are caused by many viral and bacterial pathogens and are the second most common cause of morbidity and mortality worldwide.2 The Respiratory Multiplex Array is the most comprehensive screening test for infections of both the upper and lower respiratory tracts, simultaneously detecting 22 bacterial and viral pathogens from a single sputum lavage or nasopharyngeal sample.
Both arrays detect the most common and frequently requested infections in sexual and respiratory health. These comprehensive, highly sensitive and specific tests enable identification of co-infections simultaneously, often in asymptomatic patients and enable antibiotic stewardship.
Mutation Detection
KRAS, BRAF, PIK3CA Array and Familial Hypercholesterolemia Arrays I & II
The colorectal cancer (CRC) is the third most common cancer worldwide. Overall, the lifetime risk of developing colorectal cancer is: about 1 in 22 (4.49%) for men and 1 in 24 (4.15%) for women.3 The KRAS, BRAF, PIK3CA Array simultaneously detects 20 point mutations within the KRAS, BRAF and PIK3CA genes. The assay is validated for use with the DNA extracted from fresh/frozen and formalin fixed paraffin embedded tissue. The array is CE marked for routine clinical use.
Familial Hypercholesterolemia (FH) is a genetic disorder of lipoprotein metabolism. 4It is the most common autosomal dominant, or inherited disease and affects the plasma clearance of LDL-cholesterol, resulting in premature onset of cardiovascular disease and higher mortality risk.5 Early diagnosis is crucial as by the time the FH sufferer enters early adulthood they will have accumulated >20 years of continuous exposure to build up of fatty or lipid masses in the arterial walls and are at the hundred-fold greater risk of a heart attack than other young people. The Familial Hypercholesterolemia (FH) Arrays I & II are rapid, simple and accurate detection of 40 FH-causing mutations within the LDLR ApoB and PCSK9 genes.
These unique biochip assays permit high discrimination between multiple targets in several genes with a rapid turnaround time (3 hours). The arrays enable detection of the most frequently occurring mutations known to cause disease (FH) and adversely affect patient treatment (KRAS, BRAF, PIK3CA). A unique primer set is designed for each target which will hybridise to a complimentary oligo-nucleotide probe spotted on a biochip discrete test region (DTR).
SNP Genotyping
Cardiovascular Risk Prediction Array
Coronary Heart Disease is the leading cause of death in the developed world and its prevention is a core activity for public health systems worldwide.6 Randox have the Cardiac Risk Prediction Array which will allow for 19 SNPs to be genotyped simultaneously, which incorporate a test to identify patients predisposed to statin-induced myopathy.
This array identifies individuals with a genetic predisposition to coronary heart disease (CHD). The innovative multiplex primers are designed to discriminate DNA sequences which differ only at one base.
For more information on our Evidence Series or Molecular range of Assays, contact us at info@biosciencesrandox.com
- https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)
- https://www.ncbi.nlm.nih.gov/pubmed/25189349
- https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4472364/
- https://www.ncbi.nlm.nih.gov/books/NBK395572/
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2864143/
Randox Biosciences Launch New Website
Randox Biosciences is delighted to officially announce the launch of our new website which offers a sleek, simple yet informative platform to further your knowledge of our product range and how we can assist you.
After six months of hard work and dedication the website has a fresh look. The interactive aspect of the website provides an easy way for our visitors to learn about Randox Biosciences products and services.
The improved interactive navigation ensures the user enjoys a seamless transition through Randox Biosciences extensive range of products and services with a better experience for both mobile and desktop versions. Potential customers will be able to identify with ease which client segment they fit into – whether it be Academic Research, Biopharma or Clinical Laboratory, enjoying a fully responsive experience.
During the redesign of the Randox Biosciences website we ensured that the brand identity remained consistent throughout, incorporating the brand colours across the site. We in cooperated GIFS (Graphics Interchange Format or moving images) on the top of the homepage as the main header of the website to automatically attract visitors with a moving graphic.
The GIF represents the Biochip Array Technology and the two different diagnostics testing we offer at Randox Biosciences. The GIFs images were continued throughout the website to highlight the three industries we cater for. Brochure downloads are also available on the new website for customers to enhance their knowledge with more in-depth information of Randox’s products and services.
The incorporation of an overview video on the homepage enables website users to gain a snapshot view of Randox Biosciences products and services. The idea of presenting the video first is to allow the visitor to understand our company from a visual method rather than processing a lot of written information.
73% of consumers worldwide would prefer seeing a video than text because they are more “entertaining”.1 The video itself, captures exactly what Randox Biosciences is and what we do. A short yet effective video clearly illustrates the science behind of Randox Biosciences and how this reaches the patient through drug discovery and development.
Julie-Ann O’Hare, Director of Randox Biosciences, commented:
“I am thrilled with the final product of the website, which I hope our current and potential customers will utilise it with ease. The website is another aspect of aligning our marketing strategy and branding to ensure our messaging is clear, concise and consistent across the board. We look forward to the continuation of promoting Randox Biosciences in the digital landscape throughout 2019.”
An e-commerce section of the website is under construction for the sale of our BioReagent products, which they are very excited to launch upon completion in Q3.
Check out our new and improved website for yourself. It is available at: https://www.randoxbiosciences.com/. Also, to find out more email us at info@randoxbiosciences.com
- http://rocketium.com/academy/6-reasons-why-customers-prefer-video-ads-to-the-text-ones
sTfR Quality Control
Providing a true third party solution for the measurement of Soluble Transferrin Receptor (sTfR), the Acusera sTfR Control will deliver an unbiased, independent assessment of analytical performance.
Designed for use with sTfR assays, this handy single analyte control saves money on wasted material.
Features & Benefits
- Lyophilised control
- Human based material
- Assayed target values available
- Stable to expiry date at 2°C to 8°C
- Reconstituted stability of 30 days at 2°C to 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| sTfR Control (Bi-level) | 3 x 2 x 1 ml | 1 | TF10162 | |
| sTfR Calibrator | 6 x 1 ml | 1 | TF10161 | |
Analytes
- Soluble Transferrin Receptor (sTfR)
Related Products
Metabolic Syndrome Array II Quality Control
A multi-analyte quality control with target values and ranges provided for 3 parameters associated with metabolic syndrome.
Features & Benefits
- Lyophilised for enhanced stability
- 100% human material
- Stable to expiry date at 2oC – 8oC
- Reconstituted stability of 72 hours at 2oC – 8oC and 7 days at -20°C
- Assayed values available for Randox Biochip systems
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Metabolic Syndrome Array II Control | 3 x 3 x 1ml | 3 | EV3761 | |
| Metabolic Syndrome Array II Calibrator | 9 x 1 ml | 3 | EV3760 |
Analytes
- Adiponectin
- CRP
- Cystatin C
RTS: Back-to-Lab Testing
Randox Testing Services offers high quality drug testing with use of our revolutionary Biochip Array Technology specifically optimised for drugs of abuse testing. This technology allows multiplex back-to-lab testing of different drugs from one sample and offers test consolidation for comprehensive testing at an affordable price.
With a comprehensive drugs of abuse test menu we are able to test for a range of different drugs. Drug testing packages can be customised to include multiple different drugs to test per sample.
Our drug testing methods ensure fast and simple sample collection. We have a variety of non-invasive methods for patient comfort including use of a urine sample, hair strand or oral fluid sample to test for specified drugs. Utilisation of different testing methods also ensures flexibility of drug abuse profiling with the ability to offer short-term drug abuse profiling via oral fluid and urine testing, long-term drug abuse profiling via hair testing or a combination of both.
Oral Fluid Testing
An oral fluid test can detect drugs for up to 48 hours after consumption. Providing analysis of short-term drug abuse, an oral fluid drug test is used by employers conducting for-cause and post-incident testing, as well as medico-legal solicitors who may require testing for abstinence of drugs.
An oral fluid test consists of obtaining a saliva sample from between the cheek and gums to analyse traces of drugs. This sample method is reliable due to the high concentrations of drug components which remain in the oral cavity for a period of time after drug consumption. Sample collection is taken quickly, easily and is non-invasive. The sample collection is also observed which ensures samples are not tampered with.
Urine Testing
A urine test offers short-term detection of substance abuse. Alcohol is detectable in urine for less than 12 hours, and a urine drug test can detect traces of drugs from between 4 hours and up to 8 days (this may be extended for regular cannabis users to around 30 days). It is often used in a combination with hair testing to provide an enhanced time-line for drug and alcohol detection; therefore allowing analysis of chronic substance abuse.
As a simple and practical method it is used as the most common sample type for workplace drug and alcohol testing. It is also utilised when conducting family law testing to ensure no alcohol intake by someone who has been forbidden to consume alcohol by a court of law or someone who is on a drugs or alcohol rehabilitation program.
A urine test consists of gaining a urine sample from the individual securely. Due to the nature of the urine sample being deposited privately by the sample donor, measures need to be taken to ensure the sample is not tampered with. At Randox Testing Services samples are collected under strict chain of custody protocols to guarantee sample integrity for legally defensible testing. We also increase accuracy of results by testing for creatinine which is a simple method of testing the authenticity of the sample given and reduces false-negative results giving you confidence in these testing methods.
Hair Testing
Hair testing is a long-term substance abuse profiling with a detection window of 90+ days. It is commonly used by recruiters and employers conducting pre-employment screening and is the most common sample type used for substance abuse assessment in child protection and medico-legal cases.
Hair testing involves taking a hair stand sample from an individual to detect if and approximately when someone has consumed drugs or alcohol. A 3cm sample is generally used to obtain a longer analysis of substance abuse.
When a drug is taken it is absorbed into the blood stream and circulated around the body. As a result it is incorporated into the hair follicle meaning that as the hair grows, drugs are transferred into the hair strand. It can take up to 2 weeks for drug components to enter the hair and therefore analysis of a 3cm sample is recommended.
Analysis of the hair strand allows traces of drugs to be detected to provide an overall picture of drug abuse or a month by month analysis. Segmentation of the hair sample to provide a detailed month-on-month view is advantageous as it can highlight trends of drug use and identify periods of abstinence or high level use. Body hair can be used in special circumstances however segmentation into a month by month analysis is not possible.
Randox Testing Services
Through utilising innovative multiplex drug and alcohol screening methods as well as LC/GC mass spectrometry confirmatory analysis our complete service guarantees reliable and accurate results.
For more information on our back-to-lab testing services contact us at testingservices@randox.com to speak with one of our experts.
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.
This Christmas, treat your laboratory to the “gift” of Randox Quality Control
At Christmas time all around the globe, people search for the best gift for their loved ones, something they will really like. At Randox Quality Control, we understand you care for your patients, and your laboratory. This year, show how much you care by treating your lab to a Randox Quality Control.
With over 35 years’ experience in the market, Quality Control is our passion and streamlining QC practice is our forte! Our extensive product offering comprises true third party controls, interlaboratory data management, external quality assessment and calibration verification.
Last year we looked in depth at Acusera – our range of true third party controls. This year, lets add another product to the Christmas wish list in the form of RIQAS, the world’s largest EQA scheme. Don’t wait until Christmas to wake up to a RIQAS programme under your tree – enrol in one of our comprehensive programmes today.
With over 45,000 laboratory participants across 133 countries, our RIQAS portfolio spans 32 comprehensive programmes ranging from Chemistry to Immunoassay, Lipids to Cardiac, Drugs to Serology and much more!
User-friendly, one page per parameter reports are available within 72 hours of the submission deadline. These reports enable at-a-glance performance assessment, ultimately allowing your laboratory to save valuable time. You will also gain access to complimentary multi-instrument and inter-laboratory reports as well as an end-of-cycle report summarising laboratory performance for each cycle and helping to identify progress over time.
Consolidation is key – and with an extensive parameter index available (up to 360 parameters) RIQAS will help you to significantly reduce costs, time and the number of individual programmes required to cover your test menu.
All RIQAS samples are free from interfering preservatives ensuring a commutable matrix that reacts to the test system in the same manner as a patient sample.
Additionally, enrolling in RIQAS isn’t just enrolling in an EQA scheme. Our programmes are accepted by National and International accreditation bodies worldwide and at the end of each cycle, participation in the scheme results in a certificate that can be used to decorate your laboratory all year around – not just at Christmas!
So this Christmas don’t give your laboratory second best, choose RIQAS, and reap the rewards.
To find out more on any of our RIQAS programmes visit our website – http://www.randox.com/riqas-external-quality-assessment/ or email us at acusera@randox.com
Randox Quality Control wish you all Season’s Greetings & a Prosperous New Year!
Mythbusting: āUsing IQC and EQA From the Same Provider Leads to QC Bias’
Some laboratory professionals believe that using Internal Quality Control (IQC) and External Quality Assurance (EQA, also known as Proficiency Testing) material from the same provider can lead to increased levels of qc bias, or that their test system will not be appropriately challenged. It is important to address these concerns, because some labs may in fact be hindering their own performance by using IQC and EQA material from different sources.
It is important to first understand how IQC and EQA work together to help form a complete Laboratory Quality Management System.
IQC and EQA in Laboratory Quality Management
IQC is a means of monitoring test system precision on a daily basis. IQC effectively evaluates test system performance over time, so that any sudden or gradual shifts in performance can be detected. However, while IQC is an effective performance monitor, it cannot detect more intricate problems like calibration errors or wide acceptable limits provided by some QC manufacturers.
EQA is essential for challenging test system accuracy, and is carried out less frequently than IQC testing. EQA samples are tested ‘blind’ and the results are returned to the scheme organiser. As EQA testing compares an individual lab’s performance to other labs using the same method and instrument, it is a very effective tool for identification of potential issues.
Is there any disadvantage to using IQC and EQA material from the same provider?
The answer to this question depends primarily on the source material of the IQC and EQA. If an IQC provider manufactures their material using artificial additives or components of animal origin, then it will not be suitable to use EQA material from the same provider. Westgard (2011) maintains that using non-commutable IQC or EQA material can lead to results becoming compromised due to matrix effects – something which would not happen using commutable controls.
For example, with Immunoassay testing, non-human components of IQC material interact with antibodies in the reagent in a different way to fully human patient samples – ultimately giving unpredictable shifts, and not adhering to the ISO 15189 requirement to: “use quality control materials that react to the examining system in a manner as close as possible to patient samples”.
However, if the IQC and EQA material is manufactured using a source material which is similar in composition to patient samples (100% human), this commutable control will adequately mimic patient sample performance; meaning labs can use EQA and IQC material from the same provider with confidence that the integrity of their results is maintained.
Conclusion
ISO 15189 also states: “Use of independent third party control materials should be considered…”. In this instance, ‘Independent’ does not mean from a separate provider. It means that the QC material should not be optimized for use on one specific instrument (i.e. not dependent on a single instrument/method type).
No regulatory body states a requirement to use different providers for IQC and EQA material. Indeed, using IQC from one provider and EQA from another provider could increase the risk of labs using non-commutable material.
Labs should use commutable IQC and EQA material for a true assessment of their test system. Randox QC and RIQAS EQA are specifically designed with commutability in mind, giving labs a control which reflects patient sample performance and ensures excellent performance.
How can we help?
To learn how Randox can offer a complete solution for your laboratory, follow the links below or submit a question using the form above.
References
Westgard, S. (2011). Is QC Quality Compromised?. Available: https://www.westgard.com/qc-quality-compromised.htm. Last accessed 31st October 2017.
