Infectious Disease Controls for Serology Testing

A responsible laboratory understands the critical nature of infectious disease testing

The role of the laboratory in providing accurate test results is a key component in controlling the spread of infection. The implications of reporting a false positive result are obvious, but the consequences of reporting a false negative can be just as devastating in terms of necessary treatment and personal life style changes for the patient. Using Bio-Rad infectious disease controls as an independent assessment of your testing systems helps to provide additional confidence in your test results.

Multi-analyte Quality Controls you can depend on

Bio-Rad Laboratories offers a comprehensive line of infectious disease quality controls. Choose from over 25 infectious disease control products that cover a wide-range of testing, including hepatitis and retrovirus, sexually transmitted diseases, congenital diseases, pediatric diseases and other specialty testing. Establishing an internal QC system that incorporates independent controls and comprehensive QC data management will help you assure the quality and reliability of your infectious disease testing.

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Why Choose Infectious Disease Quality Controls from Bio-Rad?

We speak from more than 30 years of experience in clinical diagnostics

Choose from over 25 infectious disease control products that cover a wide-range of testing, including hepatitis and retrovirus, sexually transmitted diseases, congenital diseases and other specialty testing. Our infectious disease controls are used on a wide-range of test systems and methods, which include automated immunoassay systems, EIA processors and manual EIA methods.

    Where can our controls be used?
  • Blood Banks
  • Public Health, Virology & Reference Laboratories
  • Microbiology, Serology & Immunology Departments
    How do our controls stand out?
  • Unbiased independent assessment
  • Worldwide peer group comparisons
  • Liquid stable, ready-to-use, multi-analyte
  • QC data management

*Available outside the U.S. only Refer to the package insert of currently available lots for specific analyte and stability claims.
Content is provided as a guide and for informational purposes only. Results and specific performance characteristics may vary with different manufacturers' test kits and assay procedures, different lots of the same test kit, and different lots of the control material. Please note that not all products may be available in all countries. Refer to the product insert for current product claims.

Important Differences Between Independent and In-kit Controls

Assuring Quality in the Laboratory

Regulations often provide plenty of general information on quality control, but may not always offer specific information regarding quality control especially for infectious disease testing. Without this specific direction, laboratories may unknowingly perform the minimum amount of quality control, or use only the manufacturer provided (in-kit) controls.

    In-kit Controls
  • May be same material as calibrators
  • Specific to each kit/reagent lot
  • May not identify shifts between reagent lots
  • Can be used to calculate assay cut-off
  • Levels may be well above or below assay cut-off
  • Frequent lot changes don’t allow for long-term monitoring
  • May not be similar to patient sample(s)
    Independent Controls
  • Different from kit calibrators
  • Independent of kit/reagent lot
  • Identify shifts between reagent lots
  • Designed to monitor the precision of the test system
  • Levels are typically targeted to be reactive within a relevant range
  • Same control lot can be used across multiple reagent lots allowing long-term monitoring of assay performance
  • Control may be treated the same as a patient sample
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Controls should always be run with new reagent lots. However, it’s important to be aware that in-kit controls are typically used as part of the process to determine assay cut-off, and are specific to each new lot of reagents. Independent controls are independent of reagent lots, and therefore, may detect shifts or changes that may not be identified by the in-kit controls. In the illustration above, the in-kit controls matched to Reagent Lot 2, did not identify a change in sensitivity that resulted in a shift in patient sample results and the independent controls. Without independent controls, a situation like this could potentially result in reporting incorrect results.

Frequently Asked Questions

What is an independent quality control? Independent quality controls provide an unbiased, independent assessment of a test system or method performance because they are manufactured independently of the instrument, reagents and calibrators.
 

Are there risks associated with only using manufacturer or in-kit controls? Instrument manufacturer or in-kit controls are designed only for use on specific test systems for which they are made. They are often manufactured from the same materials as their calibrators, making them less sensitive to changes in device performance. This can lead to acceptance of patient test results with analytical errors that could be medically important.

Why should I use an independent quality control? Many instrument manufacturers provide both calibrators and control materials for their own systems. These controls are designed for use only on their own test systems, but more importantly, they are often 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 acceptance of patient test results with analytical error that could be medically important.

Conversely, independent quality controls which are more like patient samples, may be better able to detect performance shifts. This can increase confidence in reported patient results.

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