Quality Control (QC) testing is undertaken in laboratories in order to ensure appropriate assay and test system performance. It is of critical importance to detect any changes, drift or inaccuracies of the test system which could lead to anomalous results, inaccurate or incorrect patient result reporting. As such, the use of quality controls is essential to prevent patient misdiagnosis.
Guidelines and Standards recommend the use of control and third-party control material to assess and monitor IVD assay and instrument performance:
“Laboratories should ensure that all commercial and in-house tests have been validated and shown to be fit for purpose. Laboratories should participate in external quality assessment schemes and undertake relevant internal quality control procedures.”
European Directive on In Vitro Diagnostic Medical Devices (98/79/EC)
“…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 in its entirety, including the procedure for calibration of the measurement.”
CLSI C24-A3, Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition, 6.2.1 Relation to Calibrators
“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.”
Medical Laboratories — Requirements for quality and competence (ISO 15189:2012).
“Collect at least 20 measurements over at least 2 weeks or 10 working days, and preferably over at least 4 weeks or 20 working days. You do this by including control materials as part of your daily work for a long enough period to observe the variation expected in your laboratory.
“Too short a period leads to too small an estimate of the standard deviation. Longer estimates will include pre and post maintenance performance, changes in reagent lot numbers, sample probes or pipettes, etc.,.”
James O. Westgard, P. (2015). QC - The Calculations - Westgard. See online article.
“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.”
“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, Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition CLSI C24-A3: 2006)
“Controls independent of the instrument/reagent supplier controls should also be used for the tests.”
(NATA, July 2009)
“Third-party” controls are those which are manufactured without the intention of being used on a particular instrument/reagent combination in order to give a completely unbiased performance assessment of the test system as a whole. Helena Biosciences’ third-party controls are manufactured independently of the test system reagents and associated control material allowing complete impartial assay verification.
Helena Biosciences offer extensive batch sizes with a long shelf life allowing use of the same lot number over multiple changes in reagents and calibrators. This enables each laboratory to detect shifts or a drift in results which may occur within the test system. The controls are manufactured using human plasma, resulting in control material similar in composition to patient samples. Multiple levels of control within the normal reference interval, as well as close to the medical decision limit, ensures complete monitoring of the assay throughout the analytical range.
Using independent control material offers wide ranging benefits including:
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