Internal Quality Control (IQC) materials

What is IQC?

IQC is used to monitor analytical activities; ensuring that the laboratory observes and monitors an effective and sufficient control over instrument and reagent performance

It involves:

• In-house procedures for constant monitoring of the operation of instruments and reagents using IQC material
• Checking the produced data to ensure day to day consistency of IQC resultss
• Monitoring the bias of the IQC data
• Monitoring the accuracy and the precision of the complete analytical process
• Detection of system or reagent failure

How Does it Work?

A lab should define its quality goals and plan the processes involved with the utilisation of quality control samples. The laboratory should also, develop policies to create, implement and monitor the effectiveness an IQC system.

For planning:

• Identification of candidate IQC procedures and materials
• Predicting IQC performance
• Defining the quality requirement for the test and determine method precision and bias
• Setting goals for IQC performance

Normal

CEtrol Serum control is used as a quantitative and qualitative control for serum protein electrophoresis on the V8 Clinical Capillary Electrophoresis System.

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Abnormal

CEtrol Serum control is used as a quantitative and qualitative control for serum protein electrophoresis on the V8 Clinical Capillary Electrophoresis System.

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What regulations have to be followed?

• Each lab must design IQC systems which verify the success of the intended quality results (ISO 15189: 2007)
• The lab has to provide the levels of quality control materials run each day, the frequency of performing the quality control, the types of the QC materials and the QC acceptance criteria (ISO 15189: 2007)
• High importance should be given to the elimination of mistakes in the process of handling samples, requests, examinations and reports (ISO 15189:2007)
• The lab should use more than one level of IQC materials i.e. normal and a pathological/abnormal control
• For each IQC material each lab should establish its own Mean (CLSI C24-A3: 2006)
• Acceptable ranges (confidence limits) must be defined for IQC material (NATA, July 2009)
• The lab must use appropriate statistical QC rules to detect systematic and random errors e.g. Westgard rules(EQALM)
• Control materials should be different from the calibrator materials to ensure an independent assessment (CLSI C24-A3: 2006)
• Controls independent of the instrument/reagent supplier controls should also be used for the tests (NATA, July 2009)

Gel Electrophoresis Tests

Clinical Capillary Electrophoresis Tests

Clinical electrophoresis

• Gel
• Capillary
• Platinum 4V