1.Performance verification of precision, trueness, and accuracy of self-developed detection system in ;clinical chemistry
Xiuming ZHANG ; Yongli FAN ; Dongmei WEN ; Jingli XIAO ; Lijuan KAN
Chinese Journal of Laboratory Medicine 2016;39(9):715-719
Objective To investigate the precision, trueness, and accuracy of self-developed detection system in clinical chemistry.Methods This was a methodological evaluation.Take serum creatine kinase( CK) for instance, 6 serum sampleswith different leves ( on the upper or lower limit of the reference range or close to the medicine decide levels ( MDLs) , were collected for within-run precision( repeatability) and within-laboratory precision ( intermediate precision ) experiments.5 proficiency testing ( PT ) samples, 5 samples assigned value by reference method, and 40 fresh-frozen serums were measured and compared with reference method for trueness verification.Drawing method evaluation decision chart, calculating total errors and sigma level evaluation experiment based on the CV, bias, and allowed total errors(TEa)were used to evaluate the accuracy performance.The precision, trueness, and accuracy were compared with the quality indicators.Results The within-run precision and within-laboratory precision were less than the highest requirement of Chinese industrial standard.The mean bias was -8.96%, didn′t reachthe required standard (5.5%).After taking corrective actions, all samples but one ( -5.8%) met the required standard. Compared with the reference method, the mean bias on the MDLs was less than TEa.The performance points of the method evaluation decision chart indicated excellence performance.The total errors on MDLs were 14.2%, 10.4% and 7.6%, less than 15%.The sigma levels on MDLs were 5.9, 7.5 and 15, also achieved excellent level. Conclusions The precision, trueness, and accuracy performance of CK measured by self-developed detection system achieved excellent level of the Chinese industry standard, and the same results were found from different evaluation methods.
2.Performance verification of laboratory-developed clinical chemistry system-Analytical measurement range and clinical reportable range
Xiuming ZHANG ; Yongli FAN ; Dongmei WEN ; Lijuan KAN ; Jingli XIAO ; Kang CHEN
Chinese Journal of Laboratory Medicine 2016;39(12):946-952
Objective To estimate the methodology for evaluating the analytical measurement range ( AMR) and the clinically reportable range ( CRR) in lab-developed system in clinical chemistry .Methods Method evaluation .Take serum CK for instance , a series of samples were prepared from both a specimen with a high concentration of the analyte of interest and a specimen with a low concentration for the following assays.Average slope method , linear dilution recovery method and the method recommended by Clinical and Laboratory Standards Institute ( CLSI ) EP6-A were used to established AMR in the lab-developed clinical chemistry system.Based on the maximum valid dilution of the specimen and the results of AMR , CRR were determined.One-half of the total error allowance ( TEa) of Chinese health standard was set up as allowance error (7.5%).Results X-Y scatter plot was made by assigning sample numbers to the horizontal axis and actual measured values to the vertical axis , which determined the upper limit of AMR was approximate 1 651 U/L.The results analyzed by average slope method indicated that the linear correlation between expected values and actual measured values was determined , the correlation (r), the intercept (a) and the slope (b) met the linear standard, and AMR was 5-1 699 U/L.The results analyzed by EP6-A indicated that the best fitting curve was obtained by using cubic polynomial method , and the linearity deviation of the minimum concentration was -77.1%, which exceeded one-half of TEa.Followed by the deletion of the maximum concentration , the resumed experiment was done .The results showed that the nonlinear coefficient c of quadratic polynomial and the nonlinear coefficient c and d of cubic polynomial have no significant difference to 0, and AMR was 7.5-1 458.0 U/L.By linear dilution recovery method , the linear correlation between expected values and actual measured values was determined , the correlation ( r) , the intercept ( a) and the slope ( b) met the linear standard , the recovery rates was between 100.0%and 104.8%, and AMR is 5 -1 699 U/L.The CRR was determined to be 5 -33 880 U/L, which met the standard of TEa . Conclusions Average slope method, linear dilution recovery method and EP 6-A method were all used to established AMR in lab-developed clinical chemistry system .Without complicated statistical analysis , linear dilution recovery method was suitable for clinical use .The linearity deviation of the minimum concentration analyzed by EP6-A did not meet the standard of the quality objective system , suggesting defects in the statistical analysis of the results .CRR was feasibly determined by using linear dilution recovery method align with AMR.
3.Expression of vascular endothelial growth factor,S100A4 and survivin in thyroid carcinoma and their clinical significance
Lixia GUO ; Jingli LAN ; Zhaopeng HU ; Xiangping XU ; Na XIAO ; Jun RONG
Chinese Journal of Primary Medicine and Pharmacy 2016;23(10):1479-1482
Xu XP,Xiao N);Department ofGeneral Surgery,Pingxiang People's Hospital,Pingxiang,Jiangxi 337000,China(Rong J) Objective To study the expression of vascular endothelial growth factor(VEGF),S100A4 and survivin in thyroid carcinoma and their clinical significance.Methods The expression of VEGF,S100A4 and survivin in normal thyroid tissues from 28 people and thyroid cancer tissues obtained from 73 patients were detect by immuno-histochemistry method.Results The positive rates of VEGF,S100A4 and survivin in thyroid cancer were 84.93%, 86.30% and 79.45%,which in the normal thyroid tissues were 3.57%,7.14% and 14.29%,respectively.There were significant differences between every two groups,thyroid cancer and the normal thyroid tissues,statistically(χ2 =57.08,55.28,36.26,all P =0.000).VEGF,S100A4 and survivin in the positive expression of capsular infiltration carcinoma group were 97.37%,97.74%,97.74%,which in lymph node metastasis positive group cancer rates were 97.30%,94.60%,97.30% were significantly increased compared with no capsular infiltration group (71.43%, 77.14%,62.86%,respectively)and lymph node metastasis group(72.22%,77.78%,61.11%),the differences were statistically significant(χ2 =8.96,4.37,14.63,9.58,4.77,11.34,all P <0.05);the positive expression rate of three with thyroid cancer histological grade increased.Conclusion VEGF,S100A4 and survivin are closely related to the aggressive and metastatic character of thyroid cancer.A combination of VEGF,S100A4 and survivin may be of grate significance for predicting high aggressive and metastatic character in thyroid carcinoma.
4.Curcumin ameliorates insulin resistance via enhancing GLUT4 translocation in skeletal muscle in streptozocin-induced diabetic rats
Yanjuan ZHU ; Jingli CHENG ; Zhongai GAO ; Xiao CUI ; Xiaochen LI ; Baocheng CHANG
Chinese Journal of Endocrinology and Metabolism 2021;37(2):143-148
Objective:To investigate the effects and mechanisms of curcumin on insulin resistance in streptozocin-induced diabetic rats.Methods:Diabetic rats were induced by intraperitoneal injection of STZ, then all the rats were randomly divided into diabetes (DM), diabetes+ curcumin (DM+ Cur), and diabetes + buffer control (DM+ NC) groups. Normal SD rats were used as control group (NC). The DM+ Cur group was treated with curcumin, while the DM+ NC group was treated with equal-volume buffer. The test lasted 12 weeks. The blood glucose was detected, and hyperinsulinemic-euglycemic clamp test was performed to estimate peripheral insulin resistance. At the end of the experiments, rats were killed and the total protein and cell membrane protein were extracted from skeletal muscle. The levels of phosphorylated PI3K, phosphorylated AKT, total PI3K, and total AKT were measured by Western blot. The levels of total GLUT4 and GLUT4 of cell membrane were also detected by Western blot, GLUT4 levels in skeletal muscle cell membranes were detected by immunofluorescence.Results:Blood glucose levels of DM+ Cur group were lower than those of DM group [(18.67±1.99 vs 24.38±2.88) mmol/L, P<0.05], and insulin resistance was also improved[the average GIR(14.69±0.29 vs 10.25±0.30) mg·kg -1·min -1, P<0.01]. The phosphorylation levels of PI3K and AKT were increased, and GLUT4 translocation to the cell membrane was increased. Conclusion:By activating the PI3K/AKT pathway, curcumin promotes GLUT4 translocation, increases skeletal muscle glucose uptake, and finally improves insulin resistance.
5.Analysis of genetic variant in a patient with juvenile meterochromic leukodystrophy.
Xiao ZHANG ; Miaomiao LI ; Jianhua MA ; Yucui ZANG ; Jingli WANG ; Yinglei XU ; Lu SHEN ; Shiguo LIU
Chinese Journal of Medical Genetics 2022;39(10):1093-1098
OBJECTIVE:
To explore the genetic basis for a child with metachromatic leukodystrophy (MLD).
METHODS:
Clinical data of the patient was collected. Genomic DNA was extracted from peripheral blood samples of the child and his family members. Potential variant was screened by whole exome sequencing (WES), and candidate variant was verified by Sanger sequencing. The pathogenicity the variant was analyzed by multiple sequence alignment of the amino acid sequence and three-dimensional model prediction of its protein product.
RESULTS:
The child was found to harbor compound heterozygous variants c.257G>A (p.R86Q) and c.467del (p.G156Afs*6) of the ARSA gene, among which the c.467del (p.G156Afs*6) frameshift variation was unreported previously. Multiple sequence alignment showed that the site of the c.257G>A (p.R86Q) missense variant is highly conserved. Three-dimensional structure modeling analysis showed that the partial deletion due to the p.G156Afs*6 variant may cause significant alteration of the structure of ARSA protein.
CONCLUSION
The discovery of novel variant in ARSA has enriched the mutational spectrum of MLD and may facilitate the understanding of the genotype-phenotype correlation of MLD.
Cerebroside-Sulfatase/genetics*
;
DNA
;
Genetic Association Studies
;
Humans
;
Leukodystrophy, Metachromatic/genetics*
;
Mutation
6.Distant Metastasis and Survival Outcomes after Computed Tomography-guided Needle Biopsy in Stage -Ⅱ Non-small Cell Lung Cancer
FAN JINGLI ; ZHAI KEKE ; REN TINGTING ; FENG XIAO ; SUI LIN ; HU JING ; MENG QINGWEI
Chinese Journal of Lung Cancer 2017;20(3):187-191
Background and objectiveComputed tomography-guided needle biopsy (CTNB) is a well-established and commonly used technique for diagnosing pulmonary nodules with high accuracy and safety. Needle-tract implantation after CTNB has been reported in various reports. The aim of this study is to evaluate whether preoperative CTNB affected the distant metastasis and overall survival in pathological stage I-II lung cancer patients.Methods A total of 1,234 patients with pathological stage I-II non-small cell lung cancer were collected. 113 patients received preoperative CTNB, and 1,121 patients did not receive any biopsy before surgical resection. Propensity score-matching method was adopted to balance observed co-variates between two groups, 113 pairs were matched.Cox regression analysis andKaplan-Meier estimates were used to process survival analysis.Results Distant metastasis free survival (DMFS) was significantly poorer in the preoperative CTNB group than in the non-biopsy group (P=0.032). But there was no difference in the overall survival between the two groups (P=0.086). Conclusion CTNB increased the risk of distant metastasis, not increasing the risk of mortality.