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Why Independent
QC Matters?

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.

Independent controls are...

Unbiased icon
Unbiased icon

Manufactured independently of instrument, reagents, and calibrators

Risk icon
Risk icon

Independent assessment and more sensitive to changes in device performance

Human matrix incon
Human matrix icon

Consist of human-based matrix

Patient test icon
Patient test icon

Similar to patient samples

Lot consistency icon
Lot consistency icon

Offer long shelf lives and lot-to-lot consistency

UI icon
UI icon

Long-term QC monitoring and detect shifts that may occur with new reagents and calibrators

Minimize medically important errors

Detect crucial calibration errors

Scenario

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.

Why use independent QC?

  • Bio-Rad's Liquichek Cardiac Markers Plus Control LT is manufactured independently and therefore more closely mimics patient samples.
  • Using this control would have detected a shift in degradation to avoid erroneous patient results.

Detect important procedural errors

Scenario

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.

Why use independent QC?

  • Bio-Rad's Lyphochek Coagulation Control more closely mimics patient samples.
  • Using this control allowed the lab to detect a procedural error that potentially could have affected patient results.

Detect shifts after instrument maintenance

Scenario

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.

Why use independent QC?

  • Bio-Rad's Lyphochek Assayed Chemistry Control found an undetected shift in the recoveries for triglycerides and cholesterol.
  • This shift could have affected patient results.

Detect faulty equipment

Scenario

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.

Why use independent QC?

  • Bio-Rad's Liquichek Specialty Immunoassay Control identified a problem with the luminometer.
  • If it had gone undetected, patient results could have been affected.

Experience the Bio-Rad advantage

Integrated Unity software solutions

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.

Learn more about Unity software solutions right arrow icon

Highest level of customer service, partnership, and technical support

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.

Learn more about our software, QC program, and technical support right arrow icon

Frequently asked questions

Laboratory standards

“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)

Customer testimonials

“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

"I trust Bio-Rad controls because they have not been formulated for only one specific test system."

Lab Manager, France

"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."

J. M. Gras, MD, Clinique Saint-Luc, Bouge, Belgium

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