Compliance of test systems for in vitro diagnostics with the European requirements to safety and efficiency – the key to reliable results (Ovcharenko O.M.)

The need for reliable and accurate laboratory diagnosis led to the creation of a multi-level system of quality control of laboratory tests.
Quality assurance at the level of the public health system: European Economic Area – CE marking, the United States – FDA approval, Ukraine – national mark of conformity assessment.
Quality assurance at the company-manufacturer level includes analytical characteristics, technical files, repeatability and reproducibility, evaluation of the effect of sample storage conditions, “the limit of a negative value,” “limit of detection” and “limit of quantification”, cross-reactivity and interference, linearity range, compliance with the standards, and the cut-off level.
Quality assurance at the level of individual diagnostic laboratory.

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