Most regulatory organizations recognize that independent quality controls are an important part of an effective lab QC system. There’s a good reason these guidelines call for independent controls: instrument manufacturer controls are less sensitive to changes in device performance, and analytical errors could affect patient test results. Our unbiased quality controls are not optimized to work with any specific test system and are manufactured independently of instrument, reagents, and calibrators—allowing your lab to manage risk more effectively.
Manufactured independently of instrument, reagents, and calibrators
Independent assessment and more sensitive to changes in device performance
Consist of human-based matrix
Similar to patient samples
Offer long shelf lives and lot-to-lot consistency
Long-term QC monitoring and detect shifts that may occur with new reagents and calibrators
Because the manufacturer control was designed to work specifically with the instrument, a lab did not realize that their calibrator material had degraded and patient results were compromised.
During APTT testing, a lab compared results from in-kit controls, which were in range, to an independent Bio-Rad control, which were out of range. This alerted the lab to a missed procedure change.
After preventative instrument maintenance, the manufacturer controls were within the acceptable range. However, there was a shift for an independent Bio-Rad control. Concern over this shift resulted in the slide reading station needing adjustment.
Results for the instrument manufacturer’s intact PTH control were within acceptable limits. However, an independent Bio-Rad control provided values that were higher than expected. After replacing the luminometer, the Bio-Rad control fell within the acceptable range.
By partnering with Bio-Rad, your lab can access the powerful Unity QC data management system, which provides access to the world’s largest peer group through our interlaboratory program. Assessment tools and reports can help your lab meet regulatory and compliance requirements, streamline your QC workflow, create standards for testing and benchmarking lab performance, and report results with confidence.
Bio-Rad can support your lab with more than our leading independent quality controls. We provide QC technical support, program support for both Unity and the QCNet portal, software and connectivity support, and specialized technical proficiency in the form of trained specialists.
The term “independent" control is used to describe a control material that:
Many instrument manufacturers provide both calibrators and control materials for use specifically with their own systems. These controls are often designed and manufactured from the same materials as the calibrators. Consequently, the control may mimic the calibrator, making it less sensitive to changes in device performance. This can lead to patient test results with analytical error that could be medically important.
Often, a laboratory using an instrument manufacturer or in-kit control may receive a different control lot with each new reagent lot. This does not provide the laboratory with the benefits of long-term QC monitoring. Independent controls with a longer shelf life allow use of the same control lot over multiple batches of reagents and calibrators, giving the laboratory the ability to detect shifts that may occur with new lot of reagents or calibrators.
A control with a long shelf life allows for long-term QC monitoring across different reagent lots and saves time and money due to fewer lot crossovers. See chart to help provide further explanation.
Yes. There are several professional organizations that specifically recommend using independent controls.
Calibrators and controls are not the same. They are designed to be used for two completely different purposes.
No. If a calibrator is also used as a control, then the control will closely mimic the calibrator. In this situation, the control may not be able to detect shifts in values that could be caused by a degrading calibrator.
Yes. Bio-Rad is the worldwide leader in quality controls for the clinical laboratory. Bio-Rad also provides a wide range of instruments and assay methods. Bio-Rad quality controls meet all the criteria for an independent control. The controls are manufactured independently of the calibrators and reagents and are not optimized to work with any specific instrument or method. Bio-Rad controls provide an unbiased, independent assessment of performance, regardless of the instrument or reagent manufacturer.
“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.”
ISO15189: 2012, Subclause 5.6.2.2
International Organization for Standardization (ISO)
"In general, calibrators should not be used as QC materials."
Chemistry and Toxicology Checklist, CHM.14150 CAP Accreditation Program
College of American Pathologists (CAP)
"...quality control materials should be different from the calibrator materials to ensure that the QC procedure provides an independent assessment of the measurement procedure’s performance..."
CLSI C24 4th ed., 5.2.5 Relation to Calibrators
Clinical and Laboratory Standards Institute (CLSI)
“For a truly independent assessment of the test system, it is very important to use controls that are not provided by the instrument manufacturer.”
"I trust Bio-Rad controls because they have not been formulated for only one specific test system."
"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 15189:2012."
A webinar with Abobaker Mohamed Yagoot, MT (ASCP), MLT (CMLTO) This webinar discusses the benefits of independent QC.
Bio-Rad independent QC helps increase consistency of your system, reducing risk of erroneous test results.
In this tutorial, we cover the basics of third-party quality controls, including choosing the right products.
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