GB/T 43279.3-2023

This standard specifies the pre-examination processes for isolating circulating cell-free DNA (cfDNA) from plasma derived from venous whole blood, ensuring sample quality and integrity for downstream molecular in vitro diagnostic testing. It is applied in clinical laboratories and healthcare settings for non-invasive prenatal testing, oncology liquid biopsies, and other diagnostic applications requiring cfDNA analysis. The standard covers critical steps such as blood collection, transport, plasma separation, and cfDNA extraction to minimize pre-analytical variability and ensure reliable test results.