Following recommendations from recognized institutions such as ISO and CLIA, more laboratories are using third party controls than ever before. However, great care should be taken when choosing which third party control to use. A number of factors should be considered, and primarily among these is whether the control challenges the complete Clinical Range and the Medical Decision Levels. 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’.
Measuring the Complete Clinical Range
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 working across the full clinical range, a QC which covers low, normal and elevated concentrations must be used.
Question: “If the full clinical range isn’t covered by QC, how will we know whether patient results which fall outside the range of quality controls are accurately reported?”
What are Medical Decision Levels?
Medical Decision Levels (MDL) are the analyte values at which medical professionals can determine whether a patient may be suffering from a certain condition. The MDL is determined by a consensus of medical professionals and clinical research. Patients’ test results are compared to the MDL and appropriate diagnoses or medical interventions can be made.
For example, the MDL of Glucose can indicate a certain diabetic status:
|Analyte||Medical Decision Level||Diagnostic Status|
|Glucose (fasting)||<100 mg/dL||Non-Diabetic|
Many QC manufacturers ‘cut corners’ in an attempt to keep costs down, which often results in the sale of controls which do not cover the complete clinical range or vital medical decision levels. Below is an example of the Glucose concentrations present in a competitor control:
Competitor Chemistry Control Level 1 – 68 mg/dL
Competitor Chemistry Control Level 2 – 134 mg/dL
Competitor Chemistry Control Level 3 – 386 mg/dL
In the examples above, the competitor’s level 1 control covers the non-diabetic MDL, but the level 2 control is not within the ‘Pre-Diabetic’ decision range. The level 3 control is also much higher than can be expected for an elevated diabetic patient result (200 mg/dL or more).
Due to the superior manufacturing process used by Randox, QC target values are consistently within the MDL of tests. For example, the Glucose concentrations present in our Liquid Assayed Chemistry Premium Plus control are:
Level 1 – 57 mg/dL
Level 2 – 114 mg/dL
Level 3 – 236 mg/dL
The MDL for Glucose is covered by the Randox control, meaning laboratory professionals can be confident that patient results will be accurately interpreted.
Immunoassay Medical Decision Levels
Controls which cover the MDL can reduce the number of Quality Controls required by laboratories. For example, Randox Acusera Lyophilised Immunoassay Controls contain particularly low levels of TSH, Ferritin and Vitamin B12 in the Level 1 control, eliminating the need for an additional control at extra expense:
|Analyte||Medical Decision Level||Randox Level 1 IA Control||Competitor Level 1 IA Control|
|TSH||0.1 or 0.27 uU/mL||0.15uU/mL||0.37 uU/mL|
|Vitamin B12||190 pmol/L||174 pmol/L||327 pmol/L|
|Ferritin||12 ng/mL||11.1 ng/mL||49.6 ng/mL|
In this example the competitor offers an anaemia control with lower levels of TSH, Vitamin B12 and Ferritin at an additional cost. With Randox Acusera QC, only one control is required for anemia monitoring and detection.
Are you thinking of working at Randox? Great! Whether you’re from a science background, business, or art, Randox embrace multiple disciplines and we, at Randox Careers, are here to give you 5 reasons why you’ll love working with us!
1. Company Culture
Randox have built a team of the most passionate, inspiring and motivated individuals in the industry. Employees of Randox aren’t just a team, but they’re family!
Randox Laboratories likes to celebrate talent, and encourages people to work to their strengths, as recently demonstrated in the largely successful Future in the Making event, which was held to gather and thank Randox employees worldwide for the success of the growth of the company. Randox encouraged employees to share their experiences through the hashtag #WeAreRandox. Check it out, here!
2. Learning Opportunities are Endless!
Due to the size of Randox, and the vast specialties in the health sector, Randox Laboratories has a lot to offer in teaching new, innovative techniques in business, science, design, technology, engineering, and many more!
Randox is a great place to be given the opportunity to get creative in your industry! Work is always fast-paced, forward-thinking and open to fresh, innovative ideas! Peter FitzGerald (Randox Founder & MD) stated “We never stand still here! Our mission is to transform healthcare by continuously improving diagnostic solutions, which, for us, ultimately means saving lives.”
Randox Laboratories is not only a great place to grow, develop and climb the career-ladder whilst in full-time work, but it encourages growth in students, too! Renowned for their highly active Placement programs for 1st and 2nd year students, Randox offers 50+ positions each year for every sector. We hold a special awards ceremony for our highest achieving students at the end of the year, commending them for their outstanding work at Randox! You can read about the Pinnacle Placement Awards and see this year’s winners here.
3. Randox is a Globally Respected Brand
Working for a company like Randox will prove your ambition to individuals in every industry globally. We understand your CV is very important to you, and having worked for a well-respected brand like Randox, you’re sure to stand out from the crowd!
4. Be a Jet-setter!
Randox has a large global presence. With offices in over 145 countries, we are frequently attending high profile events in such places as Dubai, Thailand, London, USA, and Paris! (You can check out some of our upcoming events, here.)
You can have the opportunity to experience these beautiful countries with Randox!
5. Let Your Work Change The World
Randox is an influential company and a global leader in the Healthcare and Diagnostics industry, responsible for diagnosing 5% of the population’s conditions. We are dedicated to improving the healthcare industry, and saving lives with our hard work. Randox’s success means better quality of life for the global population, as we discover how to diagnose as early as possible.
Do you want to change the world with us? Join the team, check out our opportunities!