Meet the challenge of ISO 15189:2012
Third-party controls provide an essential yet impartial quality assessment of your laboratory’s test systems. Confident monitoring of inter-batch variation can be ensured with third-party control shelf life far exceeding primary reagent longevity.
Helena Biosciences’ extensive range of controls are manufactured independently of your existing system, offering complete impartial assay validation as recommended by the ISO 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.”
Medical Laboratories — Requirements for quality and competence (ISO 15189:2012).
“…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
“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)
“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.
James O. Westgard, P. (2015). QC - The Calculations - Westgard. See online article.
Helena Biosciences offer a portfolio of clinically normal and abnormal third party controls that are independently manufactured using human donors therefore ensuring analytical accuracy. Controls are manufactured to give results at multiple levels, offering a number of advantages:
With vast experience in multi-origin raw material handling and control manufacture, partnered with exceptional skills in leading analyte detection methods, make Helena Biosciences your first choice for independent Quality Control assessment across all disciplines: