1.Evaluation of Coefficients of Variation for Clinical Chemistry Tests Based on Internal Quality Control Data Across 5,425 Laboratories in China From 2013 to 2022
Wei WANG ; Zhixin ZHANG ; Chuanbao ZHANG ; Haijian ZHAO ; Shuai YUAN ; Jiali LIU ; Na DONG ; Zhiguo WANG ; Fengfeng KANG
Annals of Laboratory Medicine 2024;44(3):245-252
Background:
Clinical chemistry tests are most widely used in clinical laboratories, and diverse measurement systems for these analyses are available in China. We evaluated the imprecision of clinical chemistry measurement systems based on internal QC (IQC) data.
Methods:
IQC data for 27 general chemistry analytes were collected in February each year from 2013 to 2022. Four performance specifications were used to calculate pass rates for CVs of IQC data in 2022. Boxplots were drawn to analyze trends of CVs, and differences in CVs among different groups were assessed using the Mann–Whitney U-test or Kruskal– Wallis test.
Results:
The number of participating laboratories increased significantly from 1,777 in 2013 to 5,425 in 2022. CVs significantly decreased for all 27 analytes, except creatine kinase and lipase. Triglycerides, total bilirubin, direct bilirubin, iron, and γ-glutamyl transferase achieved pass rates > 80% for all goals. Nine analytes with pass rates < 80% based on 1/3 allowable total error were further analyzed; the results indicated that closed systems exhibited lower CVs than open systems for all analytes, except total protein. For all nine analytes, differences were significant between tertiary hospitals and non-tertiary hospitals and between accredited and non-accredited laboratories.
Conclusions
The CVs of IQC data for clinical chemistry have seen a continuous overall improvement in China. However, there is ample room for imprecision improvement for several analytes, with stricter performance specifications.
2.Analysis on the performance of aldosterone testing and the results of EQA in China
Weiyan ZHOU ; Wenbo LUO ; Qingxiang LIU ; Jiangtao ZHANG ; Rong MA ; Cuihua HU ; Haijian ZHAO ; Chuanbao ZHANG
Chinese Journal of Laboratory Medicine 2020;43(3):267-273
Objective:To evaluate the performance of aldosterone testing in China through the External Quality Assessment (EQA) and improve the testing quality of aldosterone.Methods:Two kinds of EQA program for aldosterone were carried out in China, one of which is Routine EQA and the other is Trueness verification scheme. Lyophilized sera with 5 concentration levels were used as quality control of Routine EQA. The results were grouped according to the instrument. Target values and the coefficient of variation ( CV) were calculated in each group. Trueness verification scheme was verified by using frozen human sera of 3 concentration levels determined by the reference method, and the bias of each instrument group from the target value was calculated. Results:272 laboratories submitted the testing results, and 91.6% of laboratories used chemiluminescence method. The maximum CV was obtained by radioimmunoassay and liquid chromatography mass spectrometry, and the robust CVs were 14.6%-33.4% and 43.5%-53.9%, respectively. For chemiluminescence methods, the robust group CV was less than 10%. The results of the Trueness verification scheme showed that liquid chromatography mass spectrometry method was the most accurate method, with biases of -7.9%, 8.9% and -0.7% for the three quality controls. Diasorin system had the more accurate results deviated from the target by 58.7%, 7.9% and -2.1%, respectively. The results of other chemiluminescence methods were negatively correlated with the sample concentration, and one of them with a bias of 479%. Conclusions:The accuracy and comparability of aldosterone among laboratories in China are not satisfactory. Reagent manufacturers and laboratories should pay more attention to EQA, with the aldosterone results traceable to SI unit, and improve the test quality of aldosterone.
3.Exploration and Validation of the Performance of Hemoglobin A1c in Detecting Diabetes in CommunityDwellers With Hypertension
Shanhu QIU ; Ziwei DU ; Wei LI ; Juan CHEN ; Hang WU ; Jingbao LIU ; Min CAI ; Bei WANG ; Haijian GUO ; Zilin SUN
Annals of Laboratory Medicine 2020;40(6):457-465
Background:
Diabetes can complicate hypertension management by increasing the risk of cardiovascular disease (CVD) and all-cause mortality. Studies targeting diabetes detection in hypertensive individuals demonstrating an increased risk of diabetes are lacking.We aimed to assess the performance of hemoglobin A1c (HbA1c) and its cut-off point in detecting diabetes in the abovementioned population.
Methods:
Data from 4,096 community-dwellers with hypertension but without known diabetes were obtained from the Study on Evaluation of iNnovated Screening tools and determInation of optimal diagnostic cut-off points for type 2 diaBetes in Chinese muLti-Ethnic (SENSIBLE) study; these data were randomly split into exploration (70% of the sample) and internal validation (the remaining 30%) datasets. The optimal HbA1c cut-off point was derived from the exploration dataset and externally validated using another dataset from 2,431 hypertensive individuals. The oral glucose tolerance test was considered the goldstandard for confirming diabetes.
Results:
The areas under the ROC curves for HbA1c to detect diabetes were 0.842, 0.832, and 0.829 for the exploration, internal validation, and external validation datasets, respectively. An optimal HbA1c cut-off point of 5.8% (40 mmol/mol) yielded a sensitivity of 76.2% and a specificity of 74.5%. Individuals who were not diagnosed as having diabetes by HbA1c at 5.8% (40 mmol/mol) had a lower 10-year CVD risk score than those diagnosed as having diabetes (P = 0.01). HbA1c ≤ 5.1% (32 mmol/mol) and ≥ 6.4% (46 mmol/mol) could indicate the absence and presence of diabetes, respectively.
Conclusions
HbA1c could detect diabetes effectively in community-dwellers with hypertension.
4. Research progress on internal statistical quality control procedures for quantitative tests in clinical laboratories
Huizhen SUN ; Wei WANG ; Haijian ZHAO ; Yuxuan DU ; Jiali LIU ; Zhiguo WANG
Chinese Journal of Laboratory Medicine 2019;42(10):879-883
The laboratory medicine is aimed to support clinical decisions and patient health by providing accurate results. The internal statistical quality control (SQC) can help laboratories detecting the instability of the analytical system and preventing laboratories from reporting the patient results with medically important errors, so it is essential to ensure the quality of testing results and patient safety. The traditional methods of designing SQC strategy are based on the probability of error detection (Ped) and the probability of false rejection (Pfr). With the introduction of risk management concepts, the design of SQC strategy began to be based on the patient risk parameter [MaxE(Nuf)] proposed by Parvin, which means the maximum increase in the number of unacceptable patient results reported compared to the in-control condition during the existence of an undetected out-of control error condition. MaxE(Nuf) is related to the SQC frequency and patient risk, which is very essential for optimizing the SQC frequency and designing a risk-based SQC strategy.
5.Myxoid synovial sarcoma: a report of 2 cases and literature review
Qiuyue LIU ; Rongjun ZHANG ; Haijian HUANG ; Qiuju JIANG
Chinese Journal of Clinical and Experimental Pathology 2017;33(2):183-185,189
Purpose To investigate the clinicopathological features,diagnosis and differential diagnosis of myxoid synovial sarcoma (MSS).Methods Clinicopathological changes and immunophenotype were retrospectively evaluated in two MSS cases collected from Fujian Provincial Hospital,conbined with genetic mutation analysis.The relevant literatures were reviewed to explore its clinical and pathological features of this tumor.Restilts The two cases,one man and one woman,aged 71 and 15years,respectively.Tumor was located in the left down abdomen in case 1,and left frontal temporal lobe in case 2.Histopathologically,at low magnification in case 1,the tumor was nodular,which was made up of areas of hypercellularity and hypocellularity.In some areas of hypocellularity,the tumor cells were arranged in fascicular,story-form,sheet arrangements with mucoid degeneration.In hypercellularity area,the tumor cells were arranged in fascicular,fish bone-liked arrangenents.At low magnification in case 2,the tumor was nodular,which was made up of areas of hypercellularity and hypocellularity.In hypocellularity area,the tumor cells were arranged in net-like,sheet arrangements,and fascicular,sheet arrangements in case 2.In some area,the tumor cells were epithelioid with cluster distribution,without infringing brain tissue.Immunohistochemically,the tumor cells were diffusely positive for BCL-2,vimentin,and α-SMA and EMA were partially positive,while CD34,CD57,S-100,CD117,PLAP were negative.However,in case 2,only BCL-2 was positive,and MyoD1,GFAP,Olig-2,EMA,Syn,CD99,CgA,S-100,Myogenin,STAT6,CD34,desmin and α-SMA were negative.Molecular detection SYT-SSX fusion gene was detected in both cases.Conclusion MSS is a rare malignancy of soft tissue.The diagnosis of MSS depends on molecular pathology.The clinical and pathological findings are different from mucinous fibrosarcoma and solitary fibrous tumor.The treatment is surgical resection,combined with radiotherapy,with poor prognosis.
6.Study on the Stability of Baicalin Magnesium Salt
Haijian XU ; Yixin LIU ; Zhixuan WANG ; Hongru SONG ; Cuizhe LIU
China Pharmacy 2017;28(22):3076-3079
OBJECTIVE:To study the stability of baicalin magnesium salt. METHODS:The stability of baicalin magnesium salt at high temperature(60 ℃),high humidity(90%),strong illumination(4000 lx),different temperatures(20,37,50,60 ℃) and pHs(6.80,5.70,4.60,4.30,3.90,3.60,3.20) was investigated,and HPLC was used to detect the drug contents. RESULTS:High humidity test indicated that the quality of baicalin magnesium salt was increased by (6.17 ± 0.12)% in the 5th day and in-creased by(6.92±0.05)% in the 10th day. Drug contents in the 10th day were respectively(94.78±0.12)%,(94.79±0.20)%, (94.66±0.15)% in the high temperature,high humidity,strong illumination tests(n=3). In phosphate buffer solution(pH 6.80), baicalin magnesium salt was stable only when the temperature was below 20 ℃;and it was yet stable in pure water(pH 6.76)at 37 ℃. pH stability test showed that the most stable pH was 4.30. CONCLUSIONS:Baicalin magnesium salt has hygroscopicity to some extent. Strong illumination affects the stability more seriously than high temperature and high humidity. The stability of ba-icalin magnesium salt in pure water is superior to in phosphate buffer solution,and the salt is stable in weak acid solution.
7.Effect of cooperation by using iPAD for preoperative intervention undergoing phimosiectomy
Jianying LUO ; Qunhua JIANG ; Haijian LIU ; Rong LIU
Chinese Journal of Practical Nursing 2017;33(30):2358-2360
Objective To evaluate the effect cooperation by using iPAD for preoperative intervention undergoing phimosiectomy. Methods Totally 60 children,undergoing phimosiectomy,were divided into the experimental group and the control group with 30 cases each by random digits table method. A conventional preoperative interview was performed in the control group. In the experimental group, the parents and the children would be given education about the environment of operation room and materials of educational propaganda by watching video in a preoperative interview,furthermore,the children got the entitlement to chose their favorite cartoons, which would be played in operation room. The age, weight, time for surgery and the number for general anesthesia were recorded. The anxiety level of the parents, assessed by Hamilton Anxiety Scale, were carried out before and after operation. The satisfaction score, coming from the parents for operation room work and the surgeon for the operation process were also carried out. Results The anxiety level of the parents assessed by Hamilton Anxiety Scale, after the operation,the number for general anesthesia and the time for surgery were(44.2 ± 7.4)points,11 cases, (11.9 ± 3.2)points in the experimental group,and (51.2 ± 6.0)points,28 cases,(17.7 ± 5.8)points in the control group, and there were significant differences(t =4.005, 4.704, χ2=10.978, all P<0.01). The satisfaction score, coming from the parents for operation room work and the surgeon for the operation process were higher than that in the control group (χ2=10.162, 14.836, P<0.01). Conclusions The cooperation of the children,undergoing phimosiectomy,could be improved significantly by the application of iPAD in preoperative interview.
8.Relationship between serum PAPP-A expression and gene polymorphism with severity of coronary lesions in patients with coronary heart disease
Hui LIU ; Haijian LI ; Chuanyu GAO ; Shaofen MAO ; Yafei TAO ; Dongsheng REN
Chongqing Medicine 2016;45(18):2488-2490,2493
Objective To investigate the relationship between serum pregnancy associated plasma protein A (PAAA‐A) ex‐pression and gene polymorphism with the severity of coronary lesions in the patients with coronary heart disease (CHD) .Methods Ninety‐eight patients with CHD in the Nanyang Municipal Central Hospital were selected as the observation group and divided into single vessel lesion group and multiple vessel lesion group according to coronary angiographic results .Ninety‐eight individuals un‐dergoing healthy physical examination were selected as the control group .The venous blood was collected at the visiting hospital in the observation group and at the physical examination in the control group for detecting the serum PAPP‐A protein level by ELISA .PAPP‐A gene and IVS6+ 95 polymorphism were analyzed by adopting polymerase chain reaction restriction fragment length polymorphism(PCR‐RELP) .Results Compared with the control group ,peripheral blood PAPP‐A protein level in the obser‐vation group was significantly increased(P<0 .05) ,moreover the PAPP‐A protein level in the multiple vessel lesion group was sig‐nificantly higher than that of the single vessel lesion group (P<0 .05) .The peripheral blood PAPP‐A level was positively correlated with the severity of CHD .Three genotypes existed in PAPP‐A gene IVS6+95 locus ,including CG heterozygous ,homozygous CC and GG homozygous type .The CC homozygous allele frequency in the patients with multiple vessel lesion was higher than that in the patients with single vessel lesion (P<0 .05) .Conclusion The PAPP‐A protein level and IVS6+95 polymorphism have a close relation with the severity of coronary lesions in patients with CHD .CC genotype may be one of genetic susceptibility gene markers in the patients with CHD .
9.Effects of acyl-CoA synthetase 5 silencing by siRNA on expression and proliferation of colon carcinoma cell lines
Shihua DING ; Wenfang TANG ; Hongmei SHUAI ; Donghai WU ; Haijian GUO ; Jun LIU
Journal of Chinese Physician 2016;18(12):1808-1811
Objective To investigate the effects of acyl-CoA synthetase 5 (ACS5) silencing by siRNA on expression and proliferation of colon carcinoma cell lines.Methods The expression of ACS5 in 30 case colon carcinoma and adjacent tissues were analyzed by immunohistochemical staining.The siRNA of ACS5 with Lipofectamine2000TM was transfected into colon carcinoma cell lines (HT-29 and SW480).The expression of ACS5 in colon carcinoma cell lines (HT-29 and SW480) was detected by real-time reverse transcription polymerase chain reaction.Proliferation of colon carcinoma cell lines was analyzed by 3-(4,5-dimenthylthiazol-2-yl)-5-(3-carboxymethoxy-phenyl)-2-(4-sulfophenyl)-2H-tetrazolium (MTS).Results The expression of ACS5 in colon cancer was significantly higher than in adjacent tissues by immunohistochemical staining.The mRNA of ACS5 in siRNA-ACS5 group (0.18 ± 0.03) was significantly lower than in NC siRNA group (2.55 ± 0.31) and blank control group (2.48 ± 0.12) in HT-29 colon cancer lines,and the inhibition ratio was 92.96% (F =146.9,P <0.01).The mRNA of ACS5 in siRNA-ACS5 group (0.14 ± 0.01) was significantly lower than in NC siRNA group (1.21 ± 0.05) and blank control group (1 ± 0.03) in SW480 colon cancer lines,and the inhibition ratio was 88.5% (F =826.5.9,P < 0.01).Proliferation of HT-29 and SW480 colon cancer line in siRNA-ACS5 group was slower on 72 h and 96 h than in NC siRNA group and blank control group (P < 0.05).Conclusions Expression of ACS5 is elevated in colon cancer tissues.siRNA interference of colon cancer line downregulated ACS5 expression and inhibited the proliferation of the colon cancer cells.
10.Effects of Xuebijing on cerebral cortex apoptosis factors bcl-2 and bax in rats at early stage after cardiopulmonary resuscitation
Haijian LIU ; Li ZHANG ; Xihuan HE
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2016;23(5):495-498
ObjectiveTo observe the effects of different doses of Xuebijing on cerebral cortex apoptosis factors bcl-2 and bax in rats at early stage after cardiopulmonary resuscitation (CPR).Methods Thirty-two healthy SD rats aged 12 weeks were divided into four groups by using a random number table method (each,n = 8); all the rats were intubated through the opening of tracheotomy, and the blood pressure was measured through the left/right femoral artery catheter. Asphyxiation was applied to rats, resulting in cardiac arrest (CA), and then cardiopulmonary resuscitation (CPR) was carried out. After restoration of spontaneous circulation (ROSC), 0.9% normal saline 8 mL/kg, 0.9% normal saline 4 mL/kg + Xuebijing 4 mL/kg, 0.9% normal saline 2 mL/kg + Xuebijing 6 mL/kg and Xuebijing 8 mL/kg were given to model group, Xuebijing low dose group, middle dose group and high dose group respectively. The rat body weight, time of CA, CPR-ROSC time, ROSC ratio and the amounts of dopamine and 0.9% saline used in 24 hours were recorded. The positive protein expression levels of bcl-2 and bax in rat cerebral cortex and the ratio of bcl-2/bax was measured at 24 hours after ROSC.Results Compared with the model group, the amount of 0.9% normal saline (mL: 4.2±1.2, 2.6±1.0, 2.5±1.0 vs. 5.5±1.1,P < 0.05) and of dopamine used in 24 hours (μg: 1865±189, 1376±197, 1215±145 vs. 3526±141,P < 0.05), the levels of positive protein expression of bcl-2 (%: 33.4±4.3, 25.5±4.6, 26.1±4.2 vs. 38.5±5.1), and of bax at 24 hours after ROSC (%: 39.5±4.3, 32.8±3.8, 31.9±3.7 vs. 44.3±5.1) and the ratio of bcl-2/bax (0.87±0.16, 0.72±0.13, 0.71±0.14 vs. 0.89±0.11) was significantly decreased in low, middle and high dose groups (allP < 0.05). Compared with the low dose group, the amount of 0.9% normal saline and dopamine used in 24 hours, protein expression levels of bcl-2 and bax at 24 hours and the ratio of bcl-2/bax in middle dose and high dose groups were all lower than those in low dose group (allP < 0.05).Conclusion Xuebibing 6 mL/kg applied at early stage after CPR in rats may show relatively good protective effect on cerebral cortex.

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