Randox Laboratories
Established in 1982, Randox is dedicated to improving healthcare worldwide with the use of innovative diagnostic technologies.
As the heartbeat of the UK’s National COVID Testing Programme, we have completed more than 26 million gold-standard PCR tests.
A world leader in healthcare, our product portfolio aims to improve the speed & accuracy of diagnostics with clinical chemistry analysers & reagents, quality control, molecular diagnostics, toxicology and more.
Press Releases
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For over 40 years Randox has been shaping the future of clinical diagnostics. Quality Control is our passion, and we believe in producing high quality material that can help streamline procedures, whilst saving time and money for laboratories of all sizes and budgets.
With an already extensive offering of third party quality controls, we are excited to introduce the latest addition to our portfolio: the Acusera Smart Controls. This range consists of Smartscan and Smartload products which have been designed to fit directly onto a wide range of test systems. This range further streamlines the QC process, without the need to aliquot material minimising human error and optimising workflows.
The control range consists of: PTH, Liquid Cardiac, Clinical Chemistry and Immunoassay. With a specific protein and urine chemistry control coming soon.
How It Works:
Our two product categories have slightly different systems in place, designed to suit multiple laboratories.
SMARTSCAN QC;
- The Smartscan QC is directly loaded onto the analyser.
- The analyser scans the barcode.
- The operator can log on to access the relevant target value file and upload as instructed
SMARTLOAD QC;
- The Smartload QC is directly loaded onto the analyser
- Operator follows relevant instructions to upload values.
PTH Control
The Acusera Smart PTH Control is intended for use with in vitro diagnostic assays for the quantitative determination of Parathyroid Hormone in human serum and plasma. This notoriously unstable marker is available with an impressive 30 day open vial stability, reducing waste while remaining easy-to-use. Available in our Smartload format, benefits include:
Liquid Cardiac Control
The Acusera Smart Liquid Cardiac Control is designed to cover a range of cardiac markers at clinical decision levels, eliminating the need for additional low-level controls at extra expenses. It is intended for use with in vitro diagnostic assays for the quantitative determination of 7 cardiac markers. This control also has an impressive 14 day open vial stability for Troponin I, and 30 days for other analytes. It is designed for use in the routine monitoring of both accuracy and precision. Available in our Smartload and Smartscan format, benefits include:
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- Liquid frozen for ease of use
- Human serum based ensuring a commutable sample matrix
- Open vial stability of 30 days at 2-8ºC for most analytes (excluding Troponin I)
- Consolidates 7 key cardiac markers
- Cut off levels for Troponin I in line with internationally recommended levels
Clinical Chemistry Control
The Acusera Smart Liquid Chemistry Control is intended for in vitro diagnostic use, in the quality control of diagnostic assays. Three clinically significant levels are available. Covering 98 analytes, the control enables effective consolidation and cost saving. Available in our Smartload and Smartscan format, benefits include:
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- Liquid frozen for ease of use
- Human serum based ensuring a commutable sample matrix
- Open vial stability of 7 days at 2-8ºC for most analytes
- Consolidates 98 analytes
- High levels of CRP and other proteins eliminate the need for multiple controls
Immunoassay Control
The Acusera Smart Liquid Immunoassay Control is intended for in vitro diagnostic use to cover immunoassay testing in a single tube. The three clinically significant levels provided will not only ensure accurate performance at key decision levels, but will also elimate the need for additonal controls, enabling greater conslidation and cost savings. Available in our Smartload and Smartscan format, benefits include:
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- Liquid frozen for ease of use
- 100% human serum ensuring a commutable sample matrix
- Stable for 7 days at 2ºC to 8ºC for most analytes
- Consolidates routinely run tumour markers, cardiac markers, therapeutic drugs and hormones
In addition to these controls, we have a further Specific Protein and Urine Chemistry options coming soon.
Discover the full range by visiting: https://www.randox.com/acusera-smart-controls/
Contacts us to learn more: qualitycontrol@randox.com
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Pre-Analytical errors caused by Hemolysis, Icterus and Lipemia are responsible for more rejected results and incorrect diagnosis than any other pre-analytical factor. It is therefore of the upmost importance to accurately capture the presence of interfering substances in samples before quantitative analysis is carried out.
The Serum Indices Control is designed to monitor an instrument’s response to, and ability to detect Hemolyzed, Icteric or Lipemic (HIL) samples. Providing a full range of clinically relevant testing levels, including a negative (-) and three positives (+, ++ & +++), all HIL interferents are provided in one control pack, supporting laboratories in consolidating their testing and removing the need to purchase multiple kits.
The Control displays an impressive 14-day reconstituted stability, minimizing waste material, as well as a superior manufacturing method using human serum, increasing commutability and reacting to the test system in the same manner as that of a patient sample.
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Randox Acusera 24·7 can provide your laboratory with one location for all your statistical analysis and the management of daily QC activities.
Compatible for use with the Acusera and Qnostics range of third-party controls, the Acusera 24·7 software provides a tool to track QC results and manage daily QC activities from all laboratory analyzers on one centralized platform. With access to an impressive range of features which includes interactive charts, advanced statistical analysis and comprehensive reports, Acusera 24·7 is the most comprehensive package available on the market.
Interactive Levey-Jennings Charts - Identify trends, bias and precision problems at a glance.
With Acusera 24·7, Levey-Jennings charts are easily generated, providing an instant, visual indication of test system performance over time. The ability to conveniently combine multiple instruments, analytes and QC lots on a single chart allows for comparative performance assessment and immediate visualization of any ongoing or emerging trends.
Uncertainty of Measurement Report - Automatic Uncertainty of Measurement (UM) calculation
The unique Uncertainty of Measurement report displays the UM of all QC tests currently in use, helping you to meet accreditation requirements.
Interactive Histogram Charts - Rapidly identify test system bias.
Generated at the touch of a button, the Histogram allows rapid identification of a test system bias for a given time period. Designed to be completely interactive, multiple instruments, analytes and QC lots can be added to a single chart. Delivering comparative performance assessment, easy identification of trends and faster troubleshooting capabilities.
Exception Report - View assays which show a higher error rate.
Designed to quickly and easily identify assays with a high percentage of errors, the exception report provides an on-screen summary of the number of QC results for each individual assay and control lot that fall within the following categories: <2SD, 2-3SD and >3SD. Reports are instantly generated for a user-defined date range and may be exported to Excel or PDF format.
Learn more about how Acusera 24·7 can assist in the management of your daily QC activities by visiting: https://www.randox.com/acusera-247-interlaboratory-data-management-software-3/
Or contact us at: quality.control@randox.com
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For over 40 years Randox has been shaping the future of clinical diagnostics. Quality Control is our passion, and we believe in producing high quality material that can help streamline procedures, whilst saving time and money for laboratories of all sizes and budgets.
The Acusera Cystatin C Control is a true third-party quality control, covering clinically relevant levels including a suitably high level for assessment of kidney function in pediatric patients. Additionally, our level 3 control provides suitably high levels for measuring Glomular Filtration Rate (GFR) in pediatrics.
| Description |
Size |
Cat. Code |
Concentration Range |
| Cystatin C Control Level 2 |
3 x 2 ml |
CYS5019 |
0.900 – 1.10 mg/l |
| Cystatin C Control Level 3 |
3 x 2 ml |
CYS5020 |
2.90 – 3.54 mg/l |
| Cystatin C Calibrator |
5 x 2 ml |
CYS2699 |
0.62 mg/l - 9.90 mg/l |
Control Features & Benefits:
- Liquid ready-to-use with minimal preparation required.
- 100% human serum ensuring a commutable sample matrix.
- Two clinically relevant levels available including suitably high levels available for paediatric testing.
- Open vial stability of 30 days when stored at 2˚C - 8˚C, helping to minimize waste.
Clinical Significance Of Cystatin C In Pediatric Patients
In Adults, the normal range for Cystatin C is 0.62-1.15mg/l or 0.50-1.27mg/l. Whereas children under the age of 1- the normal range is 0.59-1.97mg/l and due to immaturity of kidney function, Cystatin C levels are higher in neonates less than three months of age. Studies have shown Cystatin C is a promising marker for early diagnosis of Acute Kidney Injury (AKI). AKI has been associated with high morbidity and mortality rates among critically ill children. High levels of Cystatin C in the first year of life reflect the low glomerular filtration rate of neonates and infants.
Reference ranges for plasma Cystatin C
| Premature Infants |
0.43 – 2.77 mg/l (Mean 1.56) |
| >1 year |
0.59 – 1.97 mg/l (Mean 1.20) |
| 1-17 years |
0.50 – 1.27 mg/l (Mean 0.82) |
A high level quality control is required for pediatric samples to help make critical decisions for AKI / CKD / renal functions. If you would like to learn more about the Randox Cystatin C control visit: https://www.randox.com/cystatin-c-quality-control/
Or contact us at: qualitycontrol@randox.com
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Randox Toxicology have always been committed to the Research and Development of new products, and the last couple of years have been no exception. In 2023, we added the world’s first Xylazine ELISA to our highly accurate drug screening solutions, which is now also available on the Evidence MultiSTAT. Xylazine is an analgesic drug primarily used within the veterinary industry as a tranquilizer. Although it has not been approved for human use, studies continue to show the drug used as an additive in heroin and illicit fentanyl.
The opioid epidemic in the USA shows little sign of slowing down, with an estimated 82,339 people losing their lives in the 12-month period ending May 2023 (CDC). Helping to battle the opioid epidemic, the Evidence MultiSTAT has been introduced in Medical Examiner and Coroner Offices across the country to assist communities and public health efforts in rapidly detecting areas that experience drug overdoses.
With the world’s largest toxicology test menu, screening for over 600 drugs and drug metabolites, our range of versatile analyzers offers toxicology solutions for both high and low-throughput laboratories.
Evidence MultiSTAT
Fully automated drug screening immunoassay analyzer
The Evidence MultiSTAT delivers simultaneous, semi-quantitative detection of up to 29 classical, prescription, and synthetic drugs and drug metabolites from a single sample. Designed to work across a variety of matrices, our patented Biochip Array Technology provides a complete immunoassay profile. The MultiSTAT offers a fully automated 3-step process:
- Apply the sample
- Load it into the machine
- Press start
With a throughput of up to 116 tests per hour, the MultiSTAT offers rapid and highly accurate results. Our easy-to-use software is controlled via a 15.6” touchscreen, where results are displayed and can be printed or exported to LIMS.
DOA ToxPlex
Available on the MultiSTAT, DOA ToxPlex delivers:
- Fast Analysis: Receive up to 58 results in under 30 minutes.
- User-Defined Cut-Offs: With a range of cut-offs, you can select the cut-off that is suitable for you.
- Semi-Quantitative: Results from the ToxPlex Array are semi-quantitative on our new Evidence MultiSTAT software update.
- Dual Sample Input: Our first Evidence MultiSTAT panel that can run two samples simultaneously side by side.
DOA Urine MultiPlex
DOA Urine Multiplex provides promising development for the MultiSTAT, with newly approved clinical applications:
- FDA Approval for In Vitro Diagnostic Use.
- Qualitative determination of up to 9 drugs and drug metabolites in urine samples.
- Valuable results help clinicians make informed decisions.
To find out more about our range of toxicology screening products, email us at info@randoxtoxicology.com