Protected: QCMD – Molecular External Quality Control (NEW)
Protected: QCMD – Molecular External Quality Control (NEW)
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.
Fully Automated
Test Menu
Semi-Automated
Test Menu
Niche
Test Menu
QCMD – Molecular External Quality Control
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 molecular diagnostics.
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.
- Blood Borne Viruses
- Central Nervous System Diseases
- Drug Resistance
- Exotic / Emerging Diseases
- Gastrointestinal Diseases
- Immunocompromised Associated Diseases
- Multiple Pathogen / Syndromic Infections
- Respiratory Diseases
- Serology
- Sexually Transmitted Infections
- Transplant Associated diseases
- Typing
- New Pilot Studies
After the close of the results return phase, EQA participants will 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.
Contact Us
QCMD Website
RIQAS EQA
*Randox are authorised by QCMD to provide the QCMD EQA schemes under a strategic global partnership. The EQA design, composition, data analysis & reporting remain the responsibility of QCMD. Please refer to specific geographical regions for further details on availability.
Protected: RX series (Concept)
Get your teeth into a Randox commutable control this Halloween
Get your teeth into a Randox commutable control this Halloween
It is that time of year again – when people dress up, children trick-or-treat and many a scary story is told in households around the world. An age-old tradition celebrated globally by millions of people – it can only be Halloween.
Last year Randox QC brought you the truly scary story about a laboratory who chose not to use a third party control, but eventually “treated their laboratory to a true third party control”. This year, we have another scary story for you about a lab manager in Transylvania, Dr. Acula.
It was a normal, busy day in the lab for Dr. Acula. That was until it was time to change reagent batch, after changing batch of reagent Dr. Acula was shocked to find his QC results had shifted by over 20%. This left Dr. Acula very frustrated, having to spend precious time troubleshooting and reassigning QC targets. After troubleshooting showed no apparent root cause, Dr. Acula searched the internet for an answer finally stumbling upon an educational guide from Randox Quality Control on commutability and its many benefits to the lab.
Grinning from ear-to-ear with excitement, Dr. Acula began to read the guide in the hope of finding a solution to his problem – and solutions he found. While reading the guide, Dr. Acula came across a quote from ISO 15189:2012. It read that laboratories “must use quality control materials that react to the examining system in a manner as close as possible to the patient sample”.
Dr. Acula made a decision to look for a commutable control material that met all of his requirements and he didn’t have to search very far. Randox Quality Control were able to supply Dr. Acula and his laboratory with a QC material to meet all his needs – true third party, excellent stability, consistency and consolidation but most importantly of all commutable controls. The fact all Randox immunoassay and immunology controls are manufactured from 100% human material appealed to Dr. Acula a lot. After trialing the Randox control material alongside patient samples and comparing results between reagent batches, Dr. Acula was thrilled with the results.
Labs rely heavily on quality control to detect errors in their test system and to ultimately make critical decisions regarding the accuracy and reliability of patient test results, the use of a control that reacts to the test system in the same manner as a patient sample is therefore essential.
At Randox Quality Control we take quality seriously. All our QC products are manufactured to the highest possible standard ensuring controls of unrivalled quality time and time again. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories meet ISO 15189:2012 requirements.
Just ask Dr. Acula, who likes our 100% human controls so much he has started to drink them himself!
QC Material Stability – Dig a Little Deeper
QC Material Stability
Stability has a number of different definitions, however, the most relevant to clinical diagnostics, and indeed quality control sera, is the “resistance to chemical change or physical disintegration”. Much like a chain, your quality control system is only as strong as its weakest link, or in this case analyte.
Whilst we appear to be stating the obvious here, this might not be as straightforward as it first appears. The product literature you peruse will help you decide what control best suits your needs, whilst many companies will state their control stability in the literature there are some instances where all may not be as it first appears. It is also important to note that some manufacturers may not make stability claims for some of the analytes listed in their control material. In such instances, you are required to validate these in-house, taking up precious time and resources.
Dig a Little Deeper
Whilst we understand that some analytes do have limitations due to their inherent nature, misleading analyte claims can cost the laboratory both time and money. In a recent survey conducted by Randox, 65.5% of respondents indicated that they felt stability was a ‘Very Important’ QC feature. As such it’s important that you look beyond the sales literature when it comes to control stability. Look out for exceptions in the small print of the control kit inserts. For example, if a control has a stability claim of 7 days at 2-8oC and a routine analyte like Cholesterol has a stability claim of just 2 days at 2-8oC then the true stability of the control is only 2 days. In such instances, there is a lot of potential for waste, as laboratories will be required to prepare a new vial of QC material every 2 days leading to increased costs and time. However, if you dig a little deeper into the controls and always read the small print, you could avoid such issues.
How can Randox Acusera benefit you?
For more than 30 years Randox has been shaping the future of clinical diagnostics with our pioneering high quality, cost effective laboratory solutions. Quality Control is our passion, we believe in producing high-quality material that can help streamline procedures, whilst saving money for laboratories of all sizes and budgets. We pride ourselves in not misleading our customers with false stability claims for our controls. With controls such as our Liquid Cardiac and Specific Proteins Controls, you could benefit from a 30-day open vial stability for all analytes, without exception.
By employing our Randox Acusera quality control materials you could benefit from;
Commutable controls, ensuring a matrix that reacts to the test system in the same manner as a patient sample, enabling an accurate and reliable assessment of instrument performance.
Accurate target values that won’t shift throughout the shelf life of the controls, eliminating the need to spend valuable time and money assigning values in-house.
Consolidation of test menu with controls comprising up to 100 analytes, reducing preparation time and storage space required.
Analytes present at clinically relevant levels ensuring accurate test system performance across the clinical range, maximising laboratory efficiency by eliminating the need to purchase additional high or low-level controls at extra expense.
True third party controls designed to provide an unbiased assessment of performance, our Acusera controls have not been manufactured in line with or optimised for use with any particular reagent, method or instrument.
For more information on any of our products, or to request a consultation from one of our QC Consultants, contact us via acusera@randox.com.
Take steps to prevent incorrect patient results by making one simple change
According to the NHS Litigation Authority; in 2015 within the UK alone, £193,680,744.30 was spent on ‘wrong diagnosis’ or ‘failed/delayed diagnosis’ causing huge financial strain and impact on labs.
With approximately 75% of clinical decisions and diagnosis based on laboratory test results. The only way to guarantee a high degree of accuracy is to implement a good Quality Control plan. The importance of this is recognised globally, several bodies exist internationally including ISO (International organisation for standardisation) who have developed a set of guidelines and quality systems to ensure the reliability of laboratory test results.
So what can you do to improve accuracy and reliability?
Choose a third party QC
ISO 151589:2012 Section 5.6.2.2 states that “the use of third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”.
First Party Controls are those manufactured by the instrument/reagent manufacturer. These controls are optimised specifically for use with the manufacturers test system and therefore will mask a multitude of weaknesses. First Party Controls tend to result in perceived accuracy and a biased assessment of performance.
Third Party Controls on the other hand are designed to be completely independent and are not optimised for use with a specific test or system. Leading manufacturers of third party controls will assign target values based on data collected from thousands of independent laboratories, ensuring the availability of statistically robust multi-method, multi-analyser data. Therefore laboratories using Third Party Controls can be assured of unbiased error detection across multiple platforms.
Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any laboratory-regardless of size or budget.
Look out for QC samples with clinically relevant concentrations
ISO 15189:2012 states that ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.
It is important to assess the full clinical range of an assay i.e. the range between the lowest and highest results which can be reliably reported. In order to make sure a laboratory instrument is performing accurately across the full clinical range and in particular at the medical decision level, QC materials that cover low, normal and elevated concentrations should be used.
Due to the superior manufacturing process used by Randox, QC target values consistently cover the MDL of tests. By ensuring the controls in use cover clinical decision levels laboratories can be confident of the reliability and accuracy of the patient results they release.
Opt for a commutable control material
A good QC material has many essential properties but above all, controls must perform consistently and reflect the performance of patient samples – if a control meets these requirements then we can say it is commutable. Having a commutable control would aid in the prevention of incorrect patient results because they replicate the performance of a patient sample and react to the test system in a similar manner. Use of a commutable control will also reduce costly shifts in QC target values when reagent batch is changed.
At Randox we take quality seriously, that’s why all QC products are manufactured to the highest possible standard, delivering controls of unrivalled quality. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories to meet ISO 15189:2012 requirements. A good QC process will include the use of Third Party Controls, Clinically Relevant Concentrations and controls which can be described as commutable. By employing Quality Control’s that encompass these traits, a laboratory professional can be certain that they have taken the necessary steps to decrease incorrect results and therefore potential misdiagnosis.
Liquid HbA1c Quality Control
Conveniently supplied liquid ready-to-use the Liquid HbA1c control is ideally suited to both clinical laboratories and POCT helping to significantly reduce preparation time. With a stability of 30 days waste and costs are also kept to a minimum.
Features & Benefits
- Liquid ready-to-use
- Human based whole blood
- Assayed target values
- Convenient bi-level pack covering clinically relevant decision levels
- Stable to expiry date at 2°C – 8°C
- Open vial stability of 30 days at 2°C – 8°C
Description Size Analytes Cat No
Liquid HbA1c Control 2 x 2 x 0.5 ml 1 HA10155
Liquid HbA1c Control Level 1 6 x 1 ml 1 HA10224
Liquid HbA1c Control Level 2 6 x 1 ml 1 HA10225
Analytes
HbA1c (Haemoglobin A1c)
Microalbumin Calibrator
Dedicated Microalbumin calibrator designed for use with Microalbumin assays on a wide range of clinical analysers. 6 levels are provided in a liquid ready-to-use format making it both easy and convenient to use.
Features & Benefits
- Liquid ready-to-use
- 100% human serum
- Stable to expiry date at 2oC – 8oC
- Once opened stable to expiry date at 2oC – 8oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Microalbumin Calibrator Series | 6 x 2ml | 1 | MA1567 | |
Analytes
- Microalbumin
Toxicology Control Calibrators
Analytes
- Oxazepam
Drugs of Abuse Array I Plus Calibrator
Multi-analyte calibrator designed for use with the Drugs of Abuse Array I Plus.
Features & Benefits
- Lyophilised for enhanced stability
- Stable to expiry date at 2oC – 8oC
- Urine- Reconstituted stability of 14 days at 2oC – 8oC
- Whole Blood – Reconstituted stability of 7 days at 2oC – 8oC or 14 days at -20oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Drugs of Abuse Assay I Plus (Urine) Calibrators | 9 x 1ml | 14 | EV3744 | |
Analytes
- Amphetamine
- Barbiturates
- Benzodiazepine 1
- Benzodiazepine 2
- Buprenorphine
- Cannabinoids
- Cocaine Metabolite
- MDMA
- Methadone
- Methamphetamine
- Opiates
- Phencyclidine
- Tricyclic Antidepressants
- Creatinine
Drugs of Abuse Array II Calibrators
Dedicated calibrator designed for use the Drugs of Abuse Array II control.
Features & Benefits
- Lyophilised for enhanced stability
- Stable to expiry at 2oC – 8oC
- Urine- Reconstituted stability of 7 days at 2oC – 8oC or 28 days at -20oC
- Whole Blood – Reconstituted stability of 7 days at 2oC – 8oC or 28 days at -20oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Drugs of Abuse Array II (Whole Blood) Calibrator Series | 9 x 1ml | 11 | EV3687 | |
Analytes
- 3,4 Methylenedioxymethamphetamine (MDMA)
- Ketamine
- Lysergic Acid Diethylamide (LSD)
- Methaqualone
- Buprenorphine
- Fentanyl
- Generic Opioids
- Oxycodone I
- Oxycodone II
- Propoxyphene
- Creatinine
Drugs of Abuse Array III Calibrators
Multi-analyte calibrator designed for use with the Drugs of Abuse Array III control.
Features & Benefits
- Lyophilised for enhanced stability/li>
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of 7 days at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Drugs of Abuse Array III (Urine) Calibrator Series | 9 x 1ml | 11 | EV3829 | |
| Drugs of Abuse Array III (Whole Blood) Calibrator Series | 9 x 1ml | 11 | EV3797 | |
Analytes
- Chloral Hydrate Metabolite
- Ethyl Glucuronide
- Fentanyl
- Ketamine Metabolite
- Meperidine
- Meprobamate
- Zaleplon
- Zolpidem
- Zopiclone
- 7-amino Flunitrazepam
- Creatinine
Drugs of Abuse Array IV Calibrator
Multi-analyte calibrator designed for use with the Drugs of Abuse Array IV control.
Features & Benefits
- Lyophilised for enhanced stability
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of 7 days at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Drugs of Abuse Array IV (Whole Blood) Calibrator | 9 x 1ml | 14 | EV3808 | |
Analytes
- Acetaminophen
- Dextromethorphan
- Escitalopram
- Fluoxetine
- Haloperidol
- Ibuprofen
- Methylphenidate
- Salicylate
- Salicyluric Acid
- Sertraline
- Tramadol
- Trazodone
- Tricyclic Antidepressants
- Creatinine
Drugs of Abuse Array V Calibrators
Multi-analyte calibrator designed for use with the Drugs of Abuse Array V control.
Features & Benefits
- Lyophilised for enhanced stability
- Stable to expiry date at 2°C – 8°C
- Reconstituted stability of 7 days at 2°C – 8°C
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Drugs of Abuse Array V (Urine) Calibrator Series | 9 x 1ml | 10 | EV3815 | |
| Drugs of Abuse Array V (Whole Blood) Calibrator Series | 9 x 1ml | 10 | EV3847 | |
Analytes
- Bath Salts 1 (Methcathinone and Mephedrone)
- Bath Salts 2 (MDPV)
- Benzylpiperazines
- Mescaline
- Phenylpiperazines
- Salvinorin
- Synthetic Cannabinoids 1
- Synthetic Cannabinoids 2
- Synthetic Cannabinoids 3
- Synthetic Cannabinoids 4