Current situation in laboratory developed tests supervision / 中华检验医学杂志

ABSTRACT

Laboratory developed tests ( LDT) are usually referred to the diagnostic methods for the medical laboratory , which can only be used in the medical laboratory and can not be sold to other medical laboratories , hospitals and individuals .The paper shows the draft guideline of LDT issued by Food and Drug Administration ( FDA) and the suggestions of clinical laboratory experts and relevant academic groups for different FDA monitoring models.