The FDA has cleared Randox’s Acusera Liquid Assayed Chemistry Premium Plus control for use in US laboratories. A multi-analyte control, it contains 100 of the most commonly used analytes in routine medical testing.

Randox believes the ‘super-control’ will revolutionize quality control in laboratories, saving time and money whilst ensuring highly accurate results and patient diagnosis.

Where laboratories previously may have had to use as many as 30 controls to cover the full clinical range, the launch of this new control means labs can now run QC for 100 analytes all within one control, whilst ensuring accuracy and high performance.

Randox’s Acusera Liquid Assayed Chemistry Premium Plus control is the most comprehensive multi-analyte control on the world market to date, containing a unique combination of protein, lipids, immunoassays, cardiac markers, blood markers, therapeutic drugs and routine chemistry analytes. It offers the following features:

• A true third party control, in liquid format for ease of use
• Assayed, with clinically significant values provided for a wide range of analysers at key decision points
• Available in 3 concentrations, covering the full clinical range
• Highly stable, with open vial stability of 7 days at +2-8°c
• Human-based, ensuring performance that closely mirrors patient samples
• High levels of CRP and other key proteins

John Schaefering, US Director, Randox Quality Control said:

“Randox are pushing the boundaries of quality control, helping laboratories improve their performance and productivity while ensuring highly accurate results. As laboratory budgets come under increasing pressure, consolidated QC products offer major savings to labs in both time and money.  Randox shows the labs they understand the need for efficiency in today’s healthcare market by offering this type of multi-constituent control.”

Global clinical diagnostics firm Randox Laboratories has launched a new ‘Advisor’ application to complement its interlaboratory data management software Acusera 24•7 Live Online.

Acusera Advisor is an optional tool designed to help laboratories select an optimum QC strategy for each individual test in use. It will recommend and automatically apply QC multi-rules per parameter, as well as advising how frequently a laboratory should run IQC.

By automatically recommending optimised QC multi-rules, this lowers the Probability for False Rejection (Pfr) whilst maintaining high Probability for Error Detection (Ped). It helps labs reduce time spent troubleshooting anomalies, helping avoid unnecessary and costly QC repeats without affecting error detection.

Based on the performance limits selected by the customer Acusera Advisor will calculate the laboratory’s allowable imprecision (%CV) and allowable inaccuracy (%bias). These figures are then plotted on an Operating Specifications Chat (OPSpecs Chart) against the line equations for each strategy and from this the optimal QC multi-rules and frequency are selected.

The QC multi-rules and frequency are recommended based on the level of quality that the laboratory wishes to achieve. Before any recommendations can be made for any particular method, users must enter a minimum of 20 results for at least two levels of controls and set user defined performance limits.

A web-based system, Acusera 24•7 offers an easy-to-use and intuitive interface, direct connectivity to the laboratory’s LIS and the ability to produce fully interactive charts and comprehensive reports to meet individual laboratory requirements. Peer group data is updated every 24 hours, giving laboratories access to the most up to date information available. Statistics for Acusera 24•7 are generated from a peer data group of over 28,000 laboratory participants, the largest available in the market. This ensures a large database of results and analytical methods, therefore increasing statistical validity.

For more information visit www.randoxqc.com.

Randox Laboratories has launched a third party multi-analyte haematology control; the most comprehensive haematology quality control (QC) solution on the market to date. 

Recently CE marked, Randox’s Acusera Haematology control contains 45 parameters – more than any other haematology control on the market – enabling labs to completely cover the commonly tested full blood profile in a single control. It provides a true third party QC solution for Sysmex haematology analysers, with clinically relevant target values provided for instruments with 5-part differential technology guaranteeing an unbiased, independent assessment of analytical performance.

The new control is liquid ready-to-use for added convenience, with open vial stability for 14 days for all analytes when stored at +2 to +8°c. The tri-level controls have barcoded labels enabling quick and easy sample recognition and increased productivity.

Steven Jordan, Global Business Manager, Randox Quality Control said:

“This new control from Randox effectively trebles laboratory efficiency in blood testing by streamlining the quality controls process, helping laboratories to drastically cut the number of costly and time-consuming single controls they need to use to cover the full blood profile.”

Randox today announced that the Food and Drug Administration has cleared the company’s HbA1c quality control, a product used to ensure accuracy in diagnosis and the ongoing monitoring of diabetes.

Randox’s Acusera HbA1c is a lyophilized control, enhancing stability and longevity, with assayed values provided for HPLC and a wide range of clinical chemistry analyzers. It is a 100% human whole blood control, which helps minimize matrix effects reducing lot-to-lot variations between batches. When reconstituted the control remains stable for 4 weeks at +2 – 8°C. The control is available in levels 1 and 2, and a calibrator is also available.

The FDA has also cleared for use two Randox clinical chemistry controls, namely Aldolase calibrator and controls, and Ammonia Ethanol control.

Acusera Aldolase calibrator and controls can be used when testing for liver damage as well as skeletal muscle diseases such as muscular dystrophy. Randox Aldolase control is available in levels 2 and 3 and is lyophilized, with a reconstituted stability of 5 days at +2 – 8°C.

Randox Ammonia Ethanol control is liquid ready to use, with an open vial stability of 30 days at +2 – 8°C, and comes in levels 1, 2 and 3.

Randox has also received FDA clearance for its Immunology CSF control. This is a multi-analyte cerebrospinal fluid control, which is suitable for use on most clinical analyzers providing method specific target values and ranges for 11 analytes, as follows:

• Albumin
• Alpha Globulin
• Alpha Globulin
• Beta Globulin Gamma-Globulin
• Chloride
• Glucose
• Immunoglobulin G Lactate
• Protein (Total)
• Sodium

Randox’s US Director of Sales QC, John Schaefering said: “We are delighted to receive FDA clearance. It gives US laboratories more choice in the marketplace and will allow our US customers to benefit from improved accuracy in patient testing.”

All Randox controls are true third party controls, manufactured independently meaning they have not been optimized for use with any reagent, method or instrument. All assigned targets and ranges have been assigned using data from totally independent laboratories, resulting in genuinely independent, multi-method and multi-analyzer data.

For enhanced laboratory performance, all of Randox QC products can be used in conjunction with Acusera 24·7 Live Online, an interlaboratory data management and peer group reporting package designed to help monitor analytical performance, interpret QC results and, ultimately, to improve patient diagnosis through accurate and reliable patient test results.

For more information email: acusera@randox.com.