Objective To develop an intelligent management system of documents and records that meets the requirements of ISO 15189 quality management system applied to regional medical laboratory center.Methods Based on the relevant terms of ISO 15189 document and record,an intelligent management system for laboratory documents and records with B/S architecture was established by the help of computer technology.Results The document and record management system stored the quality system documents required for ISO 15189 review as well as the external documents,such as laboratory-related laws and regulations,standard guidelines and expert consensus,which can be accessed by users through a computer or mobile phone.The multi-process control mode was adopted to author-ize the special personnel to complete the compiling,review,approval and,release of the files according to the type and attribute of the documents.The management system of records established 9 special records,319 form records and 20 process records to support the ef-fective operation of the quality system.Conclusion The established intelligent management system for documents and records has fully met the requirements of ISO 15189 on documents and records management,realized the sharing and interconnection of the documents in the given region.It is convenient for the employees to consult the documents and fill in the records in a timely and efficient manner.

Objective:To investigate the value of generative adversarial networks-based PET image reconstruction in improving the quality of low-dose 18F-FDG PET images and lesion detection in pediatric patients. Methods:Retrospective analysis of 61 PET images of children (38 males, 23 females, age (4.0±3.5) years) who underwent 18F-FDG total-body PET/CT imaging in Beijing Friendship Hospital, Capital Medical University from August 2021 to December 2021 was performed. The low-dose images (30 s, 20 s, 10 s) of all children extracted by list mode were input into the generative adversarial networks for deep learning (DL) reconstruction to obtain the corresponding simulated standard full-dose images (DL-30 s, DL-20 s, DL-10 s). The semi-quantitative parameters of the liver blood pool and primary lesion of standard full-dose 120 s, 30 s, 20 s, 10 s, DL-30 s, DL-20 s, and DL-10 s images were measured. The target-to-background ratio (TBR), contrast-to-noise ratio (CNR), and CV were calculated. The 5-point Likert scale was used for subjective scoring of image quality, and the detective abilities for positive lesions of each groups were compared. The sensitivities and positive predictive values of positive lesions detection were calculated. Mann-Whitney U test and Kruskal-Wallis rank sum test and χ2 test were used for data analyses. Results:CNR of the 30 s, 20 s, and 10 s groups were lower than those of DL-30 s, DL-20 s, and DL-10 s groups, respectively ( z values: -3.58, -3.20, -3.65, all P<0.05). Score of DL-10 s group was significantly lower than those of 120 s, DL-30 s and DL-20 s groups (4(3, 4), 5(4, 5), 4(4, 5), 4(4, 5); H=97.70, P<0.001). There were no significant differences in TBR, CNR, CV, SUV max and SUV mean of lesions and liver blood pool in 120 s, DL-30 s, DL-20 s, and DL-10 s groups ( H values: 0.00-6.76, all P>0.05). The sensitivities of positive lesion detection in DL-30 s, DL-20 s, and DL-10 s groups were 97.83%(225/230), 96.96%(223/230), 95.65%(220/230), respectively, and the positive predictive values were 96.57%(225/233), 93.70%(223/238), 84.94%(220/259), respectively. The positive predictive value in DL-10 s group was lower than those in DL-30 s and DL-20 s groups ( χ2=23.51, P<0.001). There were more false-positive and false-negative lesions detected by DL-10 s group than those of DL-30 s and DL-20 s groups in different sites. Conclusion:Based on the generative adversarial networks, the image quality of DL-20 s group is high and can meet the clinical diagnostic requirements.

Objective:To compare the consistency and detection capability of seven 2019-nCoV nucleic acid detection kits, and provide reference for detection method selection of clinical laboratory and diagnosis of new coronavirus pneumonia.Methods:Two batches of pharyngeal swab samples were collected from tenpatients with confirmed infection of 2019-nCoV and 10 suspected patients with negative 2019-nCoV test results during January 29 to February 5, 2020 in Shenzhen Luohu People′s Hospital. Seven kinds of kits were labeled as ato g and used for nucleic acid detection respectively to evaluate the consistency of the test results of the clinical samples. A 2019-nCoV positive specimen was selected and diluted to 5-concentration gradient plates (Level-1 to 5) with RNase-free water. The positive detection rate and intra-batch repeatability of different brands of kits were compared.Results:The negative and positive coincidence rates of twenty clinical samples tested by six kinds of kits were 100%, and the positive and negative coincidence rate was 8/10 and 10/10 for the other kit, respectively. The results of intra-batch repeatability showed the CVs of viral loads tested by these seven kits were all less than 5%. In the concentration range of Level-1 to 3, the detection capability for open reading frame (ORF)1ab gene of Kit b,d and f was lower than Kit a,c,e and g, and the detection capability of kit e and g was the highest (14/15). The detection capability for N gene of Kit a (15/15) was higher than the other 5 kits. The comprehensive analysis of the detection capability for ORF1ab and N gene showedthat Kit d had the lowest detection capability (ORF1ab:40%,N:53%), and there was no significant difference in the detection capability of Kit a, b, c, e, and f.Conclusions:There was no significant difference in the accuracy and repeatability of the seven kits for positive samples with high viral loads, and the detection performance was good; but some kits had poor detection capability for weak positive samples. It is suggested that the weak positive samples should be rechecked by at least two manufacturers′ kits to ensure the accuracy of the results.

Objective: To identify a α-globin gene mutation-IVS-Ⅱ-55 (T→A) and analyze hematological characteristics of IVS-Ⅱ-55 (T→G) carriers. Methods: The peripheral blood samples were collected from the members of five family and three sporadic IVS-Ⅱ-55(T→G) carriers for the analysis of RBC parameters and hemoglobin electrophoresis. Gap-PCR, PCR-RDB (reverse dot blot) and DNA sequencing were carried out for the identification of gene deletion and mutation of α-globin and β-globin. Results: The results of RBC parameters of five infant probands which presented with microcytic hypochromic anemia were below the normal reference interval. One of the adult carriers of IVS-Ⅱ-55 (T→G) heterozygote alone presented with microcytic hypochromic anemia, and the others showed normal RBC parameters. The hematological phenotype index (MCV, MCH and HbA 2 ) of one adult carrying a compound heterozygote for IVS-Ⅱ-55 (T→G) and βCD27-28M/N were 65.0 fL, 20.3 pg and 5.8% respectively. The hematological phenotype index (MCV, MCH, HbA 2 and HbF) of one adult carrying a compound heterozygote for IVS-Ⅱ-55 (T→G) and SEA-HPFH were 81.9 fL, 26.5 pg, 3.0% and 29.0% respectively. The HbA 2 levels of all carriers of IVS-Ⅱ-55 (T→G) heterozygote alone were in normal range. No abnormal hemoglobin band was detectable on hemoglobin electrophoresis for all the carries. Conclusion The carriers of IVS-Ⅱ-55(T→G) heterozygote alone were asymptomatic. The phenotype of compound heterozygote for β-thalassemia was similar to that of β-thalassemia alone.

Objective Non-muscle myosin heavy chain ⅡA (NMHC ⅡA ) plays a significant role in tumor progression and metastasis .Our prior study showed that the expression of NMHC ⅡA was much higher in human bladder cancer sample than that in adjacent tissue .The increased level of NM HC ⅡA expression was correlated with worse prognosis .However ,the role of NMHC ⅡA is unknown in the invasion and metastasis of bladder cancer .Methods RT-PCR and western blotting were used to examine NMHC ⅡA expression lev-els in normal bladder epithelial cells and bladder cancer cell lines .T he migration and invasion ability of cells was tested by wound healing assay and Transwell invasion assay ,respectively .Results Our study showed that knockdown of NMHC ⅡA inhibited migration and invasion in bladder cancer cell line .Conclusion The study indicated that NM HC ⅡA expression increased the invasion and metastasis ability of bladder cancer cell line in vitro .

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.

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.

Objective To explore the relationship between glucose-6-phosphate dehydrogenase deficiency and type 2 diabetes and to provide reference for clinical diagnosis,monitoring and treatment of Type 2 diabetes.Methods Subjects were selected from our hospital,including 173 cases of healthy volunteers assigned to the control group;1 95 cases with type 2 diabetes conforming to the diagnostic criteria of WHO were assigned to the diabetic group.97 cases were diagnosed with glucose-6-phosphate dehydrogenase deficiency in our hospital,of whom 82 cases were assigned to simple glucose-6-phosphate dehydrogenase deficiency group,and 1 7 cases were assigned to the diabetes with glucose-6-phosphate dehydrogenase deficiency group.The correlation of glucose-6-phos-phate dehydrogenase activity and diabetes was measured by each detected value.Results Compared with the control group,the glu-cose-6-phosphate dehydrogenase activity and RBC count in diabetic group were higher(P <0.05).Positive correlations between glu-cose-6-phosphate dehydrogenase activity and RBC count in the two groups were significant(P <0.05).HbA1c and FBG showed a significant positive correlation in the control group,diabetic group and diabeties with glucose-6-phosphate dehydrogenase deficiency group(P <0.05).But there was no significant correlation in the glucose-6-phosphate dehydrogenase deficiency group.The rate of screening for glucose-6-phosphate dehydrogenase deficiency in diabetes group was 3.6%,and the rate in the control group was 1. 1%.When HbAlc≥6.5%,the rate of screening for glucose-6-phosphate dehydrogenase deficiency in the diabetes group was signifi-cantly higher than that in the control group (χ2 =4.239,P =0.039).Conclusion The level of HbA1c is discordant with that of blood glucose in diabetic patients with glucose-6-phosphate dehydrogenase deficiency group.Diabetes leads to the increasement of the rate of glucose-6-phosphate dehydrogenase deficiency.The glucose-6-phosphate dehydrogenase activity of diabetic patients with non-glucose-6-phosphate dehydrogenase dificiency is higher than that of the normal group.It may be associated with the level of RBC or increase of compensatory.Further more,glucose-6-phosphate dehydrogenase activity may be a good indicator for controlling diabetes,which remains to be further studied.

Objective To investigate the interference of hyperlipidemia and hyperbilirubinaemia to HbA1c measurements by ion‐exchange high‐performance liquid chromatography(IE‐HPLC) method .Methods Fresh whole‐blood samples collected with EDTA‐K2 anticoagulant tubes were divided into four groups :control group(HbA1c<6 .2% ) ,diabetes group(HbA1c≥6 .2% ) ,hyperlipi‐demia group(TG 3 -20 mmol/L);hyperbilirubinaemis group (TBIL 21 -549 μmol/L) .HbA1c of these samples were measured with affinity chromatography(AC‐HPLC) and IE‐HPLC respectively .Results When HbA1c≤18 .7% ,r=0 .993 ;95% confidence interval(CI) of HbA1c results by using IE‐HPLC method was -0 .71 -0 .89 ;coefficient of variation was -5 .8% -6 .8% ;P=0 .198 and the difference was not statistically significant .When HbA1c< 16 .3% ,r= 0 .997;95% CI of HbA1c results with IE‐HPLC method is -0 .31-0 .67;coefficient of variation was -5 .8% -4 .3% .P=0 .000 and the difference was statistically signifi‐cant .No interference was detectded with the results ;When HbA1c was 16 .3% -18 .7% ,positive bias was observed with the re‐sults .When TG≤20 .78 mmol/L ,r=0 .995;95% CI of HbA1c results with IE‐HPLC method was -0 .26-0 .50 ;coefficient of var‐iation was -5 .5% -5 .8% .P=0 .000 and the difference was statistically significant .No interference was detectded with the re‐sults;When TBIL≤549 .3 μmol/L ,r=0 .990 ;95% CI of HbA1c results with IE‐HPLC method was -0 .08 -0 .63;coefficient of variation was -14% -4 .1% .P=0 .000 and the difference was statistically significant .When TBIL≤342 .1 μmol/L ,r= 0 .994 ;95% CI of HbA1c results with IE‐HPLC method was -0 .09-0 .50;coefficient of variation was -5 .5% -4 .1% .No interference was detectded with the results .When TBIL was 380 .7-549 .3 μmol/L ,negative bias was observed with the results .Conclusion Our data indicated that HbA1c measurement with IE‐HPLC method could resist the interference of hyperlipidemia;When TBIL≤380 .7 μmol/L and HbA1c<16 .3% ,the results could meet the needs of general clinical detection .Clinical staff should choose more specific HbA1c measurement method according to the patient's condition .

Homoacetogens are a group of microorganisms with application potential to produce chemicals and biofuels by the bioconversion of synthesis gas. In this study, we collected waste activated sludge samples to screen homoacetogens by Hungate anaerobic technique, and studied the effect of pH on acetate and alcohol production from H2/CO2 gas. The mixed culture contained Clostridium ljungdahlii, Lysinibacillus fusiformis and Bacillus cereus. Acetate concentration achieved 31.69 mmol/L when the initial pH was 7. The mixed culture containing homoacetogen could converting H2/CO2 to acetate, which provides an efficient microbial resource for the bioconversion of synthesis gas.
Acetates ; chemistry ; Bacteria ; classification ; Biofuels ; Carbon Dioxide ; Hydrogen ; Sewage ; microbiology