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