A recent report published by Markets and Markets called “In Vitro Diagnostics (IVD) Quality Controls Market” has highlighted the significant growth within the Quality Control market, with further growth expected within the next 4 years, estimating that the IVD QC market will be worth $979 million. The report is crediting this growth to “the increasing number of accredited clinical laboratories and growing adoption of third-party quality controls”. It also indicates an anticipated growth of 4.7% CAGR between 2015 -2020 for third party quality controls. The adoption of third party controls is particularly interesting, as a survey conducted by Randox in 2015 found that only 35% of respondents felt that the most important feature when selecting quality controls for the laboratory was that they were third party, with stability being the top choice. This highlights the influence accreditation is having within the IVD market.

Why have these been influential?

Accreditation to ISO 15189:2012, and other similar standards, is becoming mandatory in many countries. Laboratories are becoming accredited to highlight the accuracy and reliability of the patient results they are releasing. Furthermore such accreditation standards and the industry regulatory bodies, like CAP, CLSI and so on, are recommending the use of third party controls. This is supported by ISO 15189:2012 which states, “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”. The report states that third party controls “offer various advantages over other types” of quality controls, this includes a longer shelf life and long term quality monitoring.

What can Randox Quality Control Offer?

The Acusera range of quality controls can be described as true third party or independent controls. Unlike first party controls or semi dependent controls they are manufactured independently of any instrument or reagent and thus are designed to deliver an unbiased assessment of analytical performance across all platforms while also meeting ISO 15189:2012 recommendations.  To assist with the other requirements of ISO 15189:2012 each control is 100% commutable, ensuring a matrix that will react to the test system in the same manner as a patient sample.  It should also be noted that the entire Acusera quality control range has been manufactured in line with clinically relevant decision levels. Employing controls that cover the entire clinical range will eliminate the need for separate low/high controls ultimately reducing costs while also ensuring accurate instrument performance. By employing any one of our Acusera Controls in your laboratory you could minimise costs & limit the time spent reassigning values after each lot change, highlighting just some of the additional benefits of employing a third party control.

To request a visit from a QC consultant contact us via acusera@randox.com

With more than 30 years’ experience developing pioneering high quality, cost effective Quality Control solutions for the IVD market Randox has designed their Acusera range of third party controls to simplify QC practice for labs of all sizes. The following outlines frequent complaints that arise in the lab & solutions we can offer to ensure you no longer quietly complain about your QC.

High volumes of controls needed to assess your test menu?

Acusera controls can contain a unique combination of up to 100 analytes in a single vial. This consolidation will permit you to reduce costs by removing the need to purchase extra controls to cover your complete test menu. As fewer controls are required the amount of time spent preparing controls is reduced, freeing staff to complete other tasks.

QC does not contain clinically relevant levels?

The analytes present in our Acusera controls have been included at clinical decision levels. The importance of employing controls that cover clinically relevant concentrations is highlighted by ISO 15189 & its significance is demonstrated in the following example. When measuring Troponin T the cut off value is 14 ng/l. Patients who present to the hospital with a concentration higher than 14 ng/l in their blood are said to have had a cardiac event. Test results lower than 14 ng/l would indicate that the patient is healthy or it is too early to tell if a cardiac event has occurred. As such it is imperative that analysers can accurately measure to this level and that performance at this level is assessed. QC material with similar cut off levels should therefore be used. Acusera meets these requirements, reducing the number of controls you need to cover both your complete test menu & the necessary clinical decision range for specific tests.

Frequent expensive lot changes?

With a shelf life of up to 2 years for liquid & 4 years for lyophilised controls, Acusera can help minimise costly lot changes. Furthermore each control has their own target values & extended open vial stability claims, which do not differ from lot to lot due to our unrivalled consistency. Both features will ultimately help reduce waste, minimise costs & limit the time spent reassigning values after each lot change.

Inconvenient shifts?

When using controls with non-human components you are likely to experience shifts in QC values when changing reagent batch. Our controls are 100% commutable, reacting to the test system in the same manner as a patient sample, helping you to not only meet ISO requirements but reduce costly QC shifts.

Need to improve confidence in QC results?

Acusera 24.7 is an interlaboratory data management designed for use with Randox true third party controls. The software has been created to help monitor and interpret QC data, providing access to; QC multi-rules, interactive charts, real-time peer group data and our unique dashboard interface for at-a-glance performance assessment.

With Acusera you will no longer quietly complain about your QC!

With features such as our test menu consolidation, clinically relevant levels, commutability & unrivalled stability, partnered with Acusera 24.7 can help you reduce waste and costs while improving performance in your lab. Simply contact us today for more information or request a consultation from one of our QC consultants via acusera@randox.com