Problems and reflection on quality management of clinical molecular diagnosis / 中华检验医学杂志

ABSTRACT

Gene detection related to tumor targeted therapy, pharmacogenomics, birth defects area is now widely used in clinical laboratories with the introduction of"precision medicine"concept.As next-generation-sequencing and digital PCR technology get to clinical application quickly, clinical medical decision is highly dependent on molecular diagnosis test results, therefore, the requirements for tests accuracy is unprecedented.However,the continuous development and fast expansion of molecular diagnosis technology brings outstanding quality problems.Its quality management also faces new challenges, which deserve the attention of medical laboratories and regulation bureaus.