1.Reference change values and quality standards for thyroid function assay
Xiaoling LI ; Mei ZHANG ; Hengjian HUANG
International Journal of Laboratory Medicine 2015;(4):506-507
Objective To evaluate the reference change values (RCV),individual indexes of TSH,T4,T3,FT3,and FT4 and the limitations of population-based reference ranges.Furthermore,to determine the quality standards based on the biological varia-tion.Methods Acorrding to intra-and inter-individual biological variations,and analytical variations ,RCV and individual indexes of TSH,T4,T3,free T3,and free T4 were calculated,and analytical variations of quality standards based on biological variation were induced.Results RCV of TSH,T4,T3,FT3,and FT4 is 54.0%,16.8%,26.8%,42.8%,23.8%,respectively.Individ-uality index is 0.78,0.45,0.49,0.47,0.45,respectively,and satisfied analytical variation based on biological variation is less than 9.6%,2.5%,4.4%,2.9%,4.0%,respectively.Conclusion When monitoring thyroid functions,the RCV values should be considered.It is important to recognize population-based reference ranges limitations for use in individuals.Quality standards based on biological variation should be meeted when laboratory analysis of variance is determined.
2.Imaging Features of Blast Lung Injury
Lina HUANG ; Hengjian NI ; Jianwei JIANG
Chinese Journal of Medical Imaging 2015;(6):458-460,465
Purpose Blast lung injury is severe, and is the main causes of death in explosion. This paper aims to explore the imaging features of blast lung injury, and to provide reference for clinical diagnosis and care. Materials and Methods The clinical data of 37 patients with primary blast lung injury stricken in the 8.2 Kunshan explosion in 2014 were retrospectively studied, with regard to the degree of burn, area, auxiliary emergency treatment and medical history. The imaging manifestations of X-ray and/or CT were also analyzed. Results ① The X-ray and/or CT findings of chest showed that 6 cases (16.2%) presented no obvious abnormality of lung parenchyma, 14 cases (37.8%) manifested increase of lung markings and spot-like clouding opacity, 6 cases (16.2%) presented ground glass opacity, 7 cases (18.9%) manifested patchy shadow, 4 cases (10.8%) showed diffuse consolidation. 6 cases (16.2%) with pleural effusion, 6 cases (16.2%) complicated with pneumothorax and hydropneumothorax, 4 cases (10.8%) with enlarged podoid and pericardial effusion, 2 cases (5.4%) with mediastinal hematoma, 9 cases (24.3%) with rib fracture. The positive rate of X-ray film inspection was 72.2% (13/18), yet that of CT reached 92.9% (13/14). ② Five patients who had not been seen obvious abnormal in emergency lung examination appeared mottling shadows or flake fuzzy shadows in the examination on the second day; 9 cases with aggravated symptoms and infection signs displayed relieved signs, expanded or changed primary lesions. Conclusion Imaging examination is an important tool in the diagnosis of primary blast lung injury. CT is superior to X-ray film on the detection of lesions; therefore, CT examination on chest should be carried out as soon as possible if conditions are allowed.
3.Optimation of analytical run length for clinical laboratory internal quality control with the combination of patient-based and control-based quality control
Ping LI ; Yuanyuan LI ; Hengjian HUANG ; Kehe XU
Chinese Journal of Clinical Laboratory Science 2006;0(03):-
Objective The main purpose is to establish a simple method of analytical run length definition through combination of control-based quality control(QC) and average of normals method(AON).Methods Eight test items with different analytical performance were chosen.First,the individualized control-based quality control strategy was designed in the direction of sigma metrics,and the suitable AON rules were selected for each analyte.Then,the selected AON rules were applied to the patient data of successive five workdays.Meanwhile,new individualized control-based QC procedures were also used at 8:00,10:00,12:00 and 14:00 in those days.At last,AON QC result were compared with control-based QC result to define the analytical run for 8 items and the strategy through which laboratory can optimize analytical run length.Results The error detection power of AON algorithms was as good as control-based QC whose performance was excellent.Analytical run length for 8 items involved in this study were defined as follows:triglyceride,potassium,total protein: 8 hours,Chlorine: 6 hours,magnesium:4 hours,calcium,carbon dioxide combining power,sodium: 2 hours.Conclusions For the items with performance above 3.5 sigma,the analytical run was defined mainly depending upon control-based QC,and AON QC was just used to validate control-based result.For the items with performance below 3.5 sigma,the analytical run was defined mainly depending upon AON QC.
4.256-Slice CT perfusion imaging in transcatheter arterial chemoembolization for hepatocellular carcinoma
Lina HUANG ; Hengjian NI ; Jianwei JIANG ; Yunjuan YIN ; Haiyan HOU
Chinese Journal of Hepatobiliary Surgery 2015;21(8):512-516
Objective To explore the clinical value of 256-slice CT whole hepatic perfusion imaging in transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC).Methods Twenty-three patients with hepatocellular carcinoma underwent whole hepatic perfusion with the JOG technique one week before TACE.The scanning data of cancer and liver tissues were analyzed using the perfusion software.The cancer tissue perfusion was repeated 4 to 6 weeks after treatment and was compared with that before treatment.Results (1) Before TACE,the HCC lesions were shown on the hepatic arterial perfusion (HAP) map as homogeneous hyper-perfusion lesions in 8 patients and as inhomogeneous hyper-perfusion lesions in 15 patients.The HAP and hepatic arterial perfusion index (HAPI) values of the tumor were higher than those of the liver tissues,while the hepatic portal perfusion (HPP) values of the tumor was lower than that of the liver tissues.The differences were all significant (P < 0.05).(2) Mter TACE,the tumors were totally filled with lipiodol in 3 patients,partially filled with lipiodol in 13 patients,and sparsely filled with lipiodol in the remaining 3 patients.There was no blood perfusion in the lipiodol-filled areas and in the cancer necrotic tissues,but in the sparsely or partially lipiodol-filled areas blood perfusion could still be seen.21 patients received another session of TACE 6 to 8 weeks later.The results between the hepatic arterial digital subtraction angiography (DSA) and the CT perfusion were 100% matching.The HAP and HAPI values of the tumor decreased when compared with before treatment,and the difference was significant (both P <0.05).The HPP values decreased slightly with no significant difference (P > 0.05),while higher HAP and HPI and lower HPP were observed in the active cancer tissues when compared with the liver tissues after treatment (P < 0.05).Conclusion 256-slice MSCT whole liver perfusion imaging can quantitatively reflect abnormal perfusion of hepatocellular carcinoma tissues and postoperative active tissues,and has important guiding significance in the preoperative evaluation,and the postoperative follow up of patients treated with TACE.
5.Application of six sigma quality management strategy to assess total quality performance and design quality control rules in clinical laboratory
Yuan-Yuan LI ; Ping LI ; Hao-Lan SONG ; Hengjian HUANG ; Jun ZHOU ;
Chinese Journal of Laboratory Medicine 2003;0(12):-
Objective To apply sigma metrics to assess key indicators designed in the laboratory improvement plan to find problems and promote quality improvement.Methods Sigma metrics were calculated to reflect the performance of analytic phase including imprecision,inaccuracy and Turn around time(TAT).The quality control strategy was designed accordingly.Quality goal index(QGI)was calculated to find the cause of any error for the items exceeding 6 sigma.Quality of pre-,post-analytic and total analytic phase,such as quality of specimen,TAT,panic value notification and satisfaction of physicians and patients were measured in sigma metrics too.Results The average sigma metric of analytic phase was 4.44,while sigma metric for 8 of 27 test items were above 6?.The main cause of performance under 6o" was poor precision.The sigma metrics of quality of specimen,panic value notification,satisfaction of customer and emergent/routine TAT were 4.9,2.9,5.6,2.8,and 2.9 respectively.Conclusion Sigma metrics provide the objective marker for the evaluation of performance in each stage of analytic process.
6.Quality assurance of clinical biochemistry testing:a mualti-center study based reference interval for clinical chemistry tests in the Chinese population
Chuanbao ZHANG ; Xianzhang HUANG ; Lanlan WANG ; Runqing MU ; Baishen PAN ; Jie ZHANG ; Wenxiang CHEN ; Junha ZHUANG ; Hengjian HUANG ; Yueyun MA ; Xiaoou YU ; Wei GUO ; Rui QIAO ; Hong SHANG
Chinese Journal of Laboratory Medicine 2015;(5):301-305
Objective To verify and monitor the performance of accuracy, precision and comparability of 26 clinical biochemical analytes (29 methods) in the six centers involved in multi-centers reference intervals research, and to ensure the reliability of theirmeasurement results.Methods During the period of the systems evaluating, two levels of commercial quality control materials and fresh frozen human serum reference materials were applied to verify the performance of inter-laboratory precision and accuracy of analysis systems. During the period of samples testing, the commercial quality control materials were measured whenever samples were analysed, the fresh frozen serum reference materials were measured once a month.The coefficient of variations (CVs), bias and total errors were calculated to assess the precision, accuracy and comparability.Results Verification of precision and accuracy: ( 1 ) the ranges of CVs of 29 methods in the six laboratory laboratories were 0.4%-6.0%, the CVs of all 29 methods met the criterion . (2) The overall average bias of the analysis systems of 21 analytes (24 methods) ranged from -5.15%( ALT) to 4.46% ( Ur ) .Among 24 methods the overall average bias of TP, Glu-GOD, Ur, Cl, Ca exceeded the acceptable range.The quality assessment during the period of samples testing:(1) The overall average bias ranged from -1.95%(Ca) to 2.92%(Ur), median 1.26%, they all met the requirements of relevant standards.( 2 ) When commercial control materials were tested, the requirements of CVs were fulfilled for most methods in the six laboratories,and the CVs of TP, Alb, Cl, Ca exceeded the acceptable range.The overall average TE of all methods met the quality specification for the C-N controls material.For the C-P control material, only the overall average TE of TP (5.05%) exceeded thearceptable range while the other methods met the requirement in criterion.Conclusions The performance of precision and accuracy of the analysis systems used in the six laboratories passed the verification.During the period of sample testing, the performance of precision and accuracy of the most methods in the 6 laboratories met the requirements of quality specifications, and the overall performance was good.Because of the limitation of current technology the performance of some methods didn't fulfill the requirement of specifications, and need to be improved.
7.Phylogenetic study of drug resistance genes from clinical isolates of Helicobacter pylori.
Baoning WANG ; Li WAN ; Yongjun ZHOU ; Mingjiang BIE ; Zhenmei AN ; Hengjian HUANG ; Chengzhi TANG
Chinese Journal of Medical Genetics 2018;35(3):380-384
To carry out phylogenetic analysis for drug-resistance genes from clinical isolates of Helicobacter pylori (Hp) among patients with gastric diseases from Tibet, China.
METHODSHp strains were isolated and cultured from saliva and gastric mucosal tissues derived from patients with gastric diseases. Nine strains (including 5 isolated from oral tissues, 1 isolated from gastric tissues, and 3 representative strains of SS international standard strains used for animal models) were tested for common antibiotic resistance. Together with an ACTT 11637 international standard strain, these were subjected to re-sequencing to obtain drug-resistance genes. Such genes from various sources were compared with the resistance genes of Hp strains recorded by the NCBI website. Combined with results of drug-resistance experiments, correlation between molecular evolution and drug-resistance was analyzed.
RESULTSTesting of gastric mucosal tissues and salivary samples from 217 patients has found 89 Hp strains, which yielded a total infection rate of 41.01%. The resistance rates of 9 representative Hp strains for clarithromycin, amoxicillin, metronidazole, levofloxacin and tetracycline were 77.8%, 77.8%, 44.4%, 77.8%, and 77.8%, respectively. Compared with the reference strain, the similarity between clarithromycin-resistance genes was 99%, and that between amoxicillin- and metronidazole-resistance genes was 96%-97%. A2143G mutation was also found in clarithromycin-resistant genes of three Hp strains.
CONCLUSIONThe sensitivity of Hp to metronidazole is much higher in patients from Tibet region, and the sensitivity of Hp to clarithromycin, amoxicillin, levofloxacin and tetracycline is poor. Resistance mutations are consistent with drug resistance.