2016年 · 第39卷第07期

This recommendation describes the critical value reporting system related terms and definitions, documents and some references, and gives recommendations on critical value item selection procedures, critical value reporting limit determination procedures, critical value identification and confirmation procedures, critical value reporting path selection procedures, critical value review procedures, critical value confirmation/reading/recording procedures, and critical value reporting system evaluation procedures.

Due to the different types and concentrations of buffer and sample/reagent volume ratio selected by each reagent manufacturer, coupled with the difference of optical path precision of cuvette and constant temperature performance of reaction tank of different biochemical analyzer, the results of routine serum enzyme detection systems are different. Different preparation of calibrators by different reagent manufacturers and different assignment processes of calibrators increase the differences between test results. In order to make the results of quantitative determination of serum enzymes comparable, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has studied and established a number of reference methods for enzymatic detection, and has studied and developed reference substances, etc. However, while everyone blindly emphasizes such standardization, they ignore the interchangeability of calibrators. Miller, a well-known standardization expert, and Zegers, who was involved in the preparation of ERM470 reference materials, both raised the importance of calibrator interchangeability and the problems that still exist^[1,2]。

Mild cognitive impairment (MCI) is a transitional state between normal aging and Alzheimer's disease (AD)^[1]。 Study suggests that 50% of MCI patients progress to AD within 4 years^[2,3]Therefore, MCI is considered to be the precursor state of AD. At present, the early diagnosis of MCI mainly relies on the examination of neuropsychology, neuroimaging, genetic material and neurochemical substances, such as cerebrospinal fluid detection, etc. There are problems such as subjectivity, invasiveness and inconvenience of operation^[4,5]。 Therefore, it is necessary to find biomarkers that can be detected rapidly, with accuracy, specificity and non-invasiveness for the early diagnosis of MCI. As a diagnostic marker, serum MicroRNA (miRNA) has the characteristics of good clinical stability, high specificity and sensitivity, easy detection, less invasive and easy promotion, and has shown unique value in the diagnosis and prognosis of many diseases^[6]。 Previous studies of our research group used gene chip technology to screen a series of differentially expressed miRNAs including miR-206 and miR-132 in SAMP8 hippocampus of rapidly aging mice, which may be involved in the pathogenesis of AD^[7]。 This study investigated the value of serum miR-206 and miR-132 in the diagnosis of MCI by detecting the expression levels of miR-206 and miR-132 in serum of patients with MCI and those with normal cognitive function.