Clinical Diagnostics • Quality Control
Effectively Manage Risk with Bio-Rad's Independent Quality Controls
For Confidence in Your Patient Results
Before patient test results can be reported and used for diagnosis, prognosis or treatment planning, test systems should be assessed with quality controls.
Start the conversation ▸For decades, Bio-Rad Quality Controls experts have developed multi-analyte, independent controls for monitoring the precision of test systems and methods. With independent quality controls, you can count on consistent quality products that help assure the reliability of your patient results.
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The Case for Independent Quality Controls
Any patient result reported without monitoring quality control is at risk. The better way to monitor system performance is with independent controls from a third-party manufacturer.
ISO 15189
Laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples. Use of independent third-party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.
ISO 15189:2012. Medical laboratories – requirements for quality and competence. Clause 5.6.2.2 Quality Control Materials
Independent quality controls are an essential part of a quality control system.
- They provide an independent unbiased assessment of your lab's test system or method performance because they are manufactured independently of the instrument, reagents and calibrators
- They give you greater confidence in your results because they help detect errors that instrument manufacturer controls miss
Many instrument manufacturers provide calibrators and control materials for their own test systems.
Instrument controls are often designed and manufactured from the same materials as the calibrators. The controls may then mimic the calibrators and be less sensitive to changes in device performance.
Instrument controls may fail to detect:
- Calibration errors
- Procedural errors
- Errors due to faulty equipment
- Errors due to shifts in following maintenance
Failing to detect system and process errors can lead to accepting inaccurate patient results that can be medically important.
Bio-Rad experts can help you strategize and tailor the right quality control program for your lab.
Contact a Bio-Rad QC Expert today!
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For a truly independent assessment of the test system, it is very important to use controls that are not provided by the instrument manufacturer.
Carol Bartlett, QC Coordinator, USA
If you work with manufacturer controls, you will miss a lot of analytical problems that may have an impact on patient results. Moreover, testing independent controls is a requirement of ISO 15189:201
J. M. Gras, MD
Clinique Saint-Luc, Bouge, Belgium
Bio-Rad's independent controls with a longer shelf life enable you to use the same control lot over multiple batches of reagents and calibrators. This way you can detect shifts from lot-to-lot variation.
More laboratories trust Bio-Rad for quality control products than any other manufacturer. Count on Bio-Rad for consistent product quality and reliable patient results.
Bio-Rad's Independent Quality Controls
- Blood gas controls
- Cardiac assessment controls
- Chemistry controls & serum indices
- Coagulation controls
- Diabetes/hemoglobin controls
- Hematology controls
- Immunoassay controls
- Immunology/protein controls
- Infectious disease controls
- Molecular controls
- Premium controls
- QC products in Dimension Vista vials
- Therapeutic drug monitoring controls
- Toxicology: drugs-of-abuse controls
- Toxicology: specialty controls
- Urinalysis controls
Quality Control Solutions
Data Management Solutions
Bio-Rad's data management solutions including Connectivity, Unity Real-Time, Unity Interlaboratory Program and Bio-Rad Mission: Control.
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Education and Training
Online resources, virtual training and industry events to guide your quality control processes.
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Quality Control Support
Tools and support from our Quality Assurance experts to help answer your quality control questions.
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BRiCare Support and Monitoring
Bio-Rad's instrument monitoring application for remote service and support. BRiCare is available for all of Bio-Rad's diagnostic instruments for continuous monitoring and remote sessions with an instrument's computer.
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