Since 2008, we have reliably been supplying hospital, pathology and research laboratories with Hyphen-BioMed products for testing and diagnostic purposes. Our industry-standard supply chain ensures that we meet TGA requirements. We are happy to provide technical advice and answer your enquiries pertaining to the applications of Hyphen-BioMed products.
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Third-party calibrators and controls give labs an independent, objective measure of test system performance. They reduce risk, increase confidence in results, support regulatory compliance, and improve patient safety.
“. . . 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
“Controls independent of those produced by the manufacturer of the test or analyzer should be used.”
NATA (National Association of Testing Authorities) AS 4633 (ISO 15189), Australia, 5.6.1 Internal Quality Control
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