Objective: To validate the analytical performance, operational performance, and process control measures of a domestic fully automatic nucleic acid testing (NAT) system, thereby ensuring an efficient and orderly blood screening workflow. Methods: The concordance rate and sensitivity of WanTag-Vortex Plus system were verified using WHO standard reference panels of HIV-1, HCV and HBV, while precision was assessed using weak positive samples of HIV-1, HCV and HBV. As for its operational performance evaluation, cross-contamination resistance was assessed using strong positive samples, and throughput and stress testing were conducted using negative samples. Reagent stability was verified using weak positive samples, and inter-system performance consistency was assessed using verification panels. In addition, the process control measures were verified using the laboratory quality control demand scale. Results: 1) Verification of concordance rate: The detection results of negative and positive samples of HIV-1, HCV and HBV by WanTag-Vortex Plus system were all consistent with expectations, and the concordance rate was 100%. 2) Precision verification: the repeatability and intermediate precision were extremely high, and the coefficient of variation was less than 5%. 3) Verification of analytical sensitivity: The detection limit of 95% for standard strains of HIV-1, HCV and HBV by WanTag-Vortex Plus system in our laboratory was consistent with the analytical sensitivity provided by reagent manufacturers. 4) Verification of cross-contamination resistance: Five strong positive samples and 87 negative samples were placed according to the actual working conditions and equipment operation design, and the test results were consistent with expectations, with no cross-contamination in the testing system. 5) Throughput and stress testing: Each system completed the individual donor-nucleic acid amplification testing (ID-NAT) of 276 samples in three batches within 12 hours, and successfully completed the ID-NAT test of 828 samples in three consecutive days. 6) Verification of reagent stability: After extreme storage (unsealed storage for 1 week with 4 freeze-thaw cycles), the reagents maintained 100% detection rate in the weak positive samples of HIV-1, HCV, and HBV, showing no significant differences from the control group (Kappa=1). 7) Verification of inter-system performance consistency: The system has stable operation performance, and the performance comparison results across the four devices were consistent (Kappa=1). 8) Process control measures: WanTag-Vortex Plus system software accurately controlled the equipment operation process with strict quality control measures, and correctly interpreted and safely reported the test results. Conclusion: The analytical and operational performance of the WanTag-Vortex Plus system complies with manufacturer design standards and essential laboratory workflow requirements. Integrated with laboratory information system (LIS), the system's control software meets standard process control requirements, yet requires further improvement.

Objective: To validate the analytical performance, operational performance, and process control measures of a domestic fully automatic nucleic acid testing (NAT) system, thereby ensuring an efficient and orderly blood screening workflow. Methods: The concordance rate and sensitivity of WanTag-Vortex Plus system were verified using WHO standard reference panels of HIV-1, HCV and HBV, while precision was assessed using weak positive samples of HIV-1, HCV and HBV. As for its operational performance evaluation, cross-contamination resistance was assessed using strong positive samples, and throughput and stress testing were conducted using negative samples. Reagent stability was verified using weak positive samples, and inter-system performance consistency was assessed using verification panels. In addition, the process control measures were verified using the laboratory quality control demand scale. Results: 1) Verification of concordance rate: The detection results of negative and positive samples of HIV-1, HCV and HBV by WanTag-Vortex Plus system were all consistent with expectations, and the concordance rate was 100%. 2) Precision verification: the repeatability and intermediate precision were extremely high, and the coefficient of variation was less than 5%. 3) Verification of analytical sensitivity: The detection limit of 95% for standard strains of HIV-1, HCV and HBV by WanTag-Vortex Plus system in our laboratory was consistent with the analytical sensitivity provided by reagent manufacturers. 4) Verification of cross-contamination resistance: Five strong positive samples and 87 negative samples were placed according to the actual working conditions and equipment operation design, and the test results were consistent with expectations, with no cross-contamination in the testing system. 5) Throughput and stress testing: Each system completed the individual donor-nucleic acid amplification testing (ID-NAT) of 276 samples in three batches within 12 hours, and successfully completed the ID-NAT test of 828 samples in three consecutive days. 6) Verification of reagent stability: After extreme storage (unsealed storage for 1 week with 4 freeze-thaw cycles), the reagents maintained 100% detection rate in the weak positive samples of HIV-1, HCV, and HBV, showing no significant differences from the control group (Kappa=1). 7) Verification of inter-system performance consistency: The system has stable operation performance, and the performance comparison results across the four devices were consistent (Kappa=1). 8) Process control measures: WanTag-Vortex Plus system software accurately controlled the equipment operation process with strict quality control measures, and correctly interpreted and safely reported the test results. Conclusion: The analytical and operational performance of the WanTag-Vortex Plus system complies with manufacturer design standards and essential laboratory workflow requirements. Integrated with laboratory information system (LIS), the system's control software meets standard process control requirements, yet requires further improvement.

Group A Streptococci(GAS)can cause multiple diseases such as pharyngotonsillitis, scarlet fever, streptococcal toxic shock syndrome(STSS), necrotizing fasciitis, and so on, making it extremely difficult to monitor all GAS infections.Developed countries such as the United States and the United Kingdom have classified invasive GAS diseases/infections(iGAS) or certain specific types, such as STSS, as notifiable diseases.China only includes scarlet fever caused by GAS infections in the legal infectious diseases.Although case reports or clinical studies of STSS and necrotizing fasciitis in China can be found, there is a lack of investigation and summary on iGAS, and there are few materials to introduce its definition and diagnostic criteria.Based on a recently diagnosed typical case, this paper intends to introduce the definition and diagnostic criteria of iGAS adopted in the United States, the United Kingdom and other developed countries, as well as the valuable early manifestations and risk factors, and the incidence of iGAS.Given the epidemiological changes in GAS infections in recent years, this paper also emphasizes the importance of paying attention to GAS infections, especially iGAS, aiming to arouse the attention of China′s clinical doctors and urge them to carry out research on this group of diseases.

Hepatic encephalopathy is a clinical syndrome of central nervous system dysfunction caused by liver insufficiency.It severely affects the quality of life of patients and may lead to death.Accurate prediction of the risk of developing hepatic encephalopathy is crucial for early intervention and treatment.In order to identify the risk of hepatic encephalopathy in patients in advance,many studies have been devoted to efforts to develop tools and methods to identify the risk of hepatic encephalopathy as early as possible,so as to develop preventive and early management strategies.Most conventional hepatic encephalopathy risk prediction models currently assess the prob-ability of a patient developing hepatic encephalopathy by analysing factors such as clinical data and biochemical indicators,however,their accuracy,sensitivity and positive predictive value are not high.The application of artificial intelligence to clinical predictive modelling is a very hot and promising area,which can use large amounts of data and complex algorithms to improve the accuracy and efficiency of diagnosis and prognosis.To date,there have been few studies using AI techniques to predict hepatic encephalopathy.Therefore,this paper reviews the research progress of hepatic encephalopathy risk prediction models,and also discusses the prospect of AI application in hepatic encephalopathy risk prediction models.It also points out the challenges and future research directions of AI in HE risk prediction model research in order to promote the development and clinical application of hepatic encephalopathy risk prediction models.

Abiraterone is commonly used as a targeted drug for the treatment of prostate cancer， which commonly causes adverse drug reactions （ADR）， including abnormal liver function， fatigue， nausea and edema， etc. This study reports a 78-year-old man with a history of hepatitis B and liver cirrhosis after prostate cancer resection who was admitted to the First Affiliated Hospital of Henan University of Chinese Medicine. The patient received abiraterone treatment 1 month before admission and developed gastrointestinal symptoms 3 weeks after the treatment and worsened at 4th week with yellowing of the skin， sclera and urine. Unfortunately， the patient died after 5 weeks of abiraterone treatment （1 week after admission）. Based on test and examination results， the patient was diagnosed with acute-on-chronic liver failure （ACLF）. This paper analyzes the patient’s medical history and the relevant treatment in detail. It is evaluated that ACLF and abiraterone are “probably” related based on Naranjo ADR Probability Scale， suggesting abiraterone may induce severe ADR of liver failure in patients with chronic liver diseases such as cirrhosis. These patients should be monitored dynamically for changes in liver function and treated prophylactically with liver-protective drugs if necessary.

OBJECTIVE: To assess the value of chromosomal microarray analysis (CMA) to verify a fetus with partial 18p deletion signaled by non-invasive prenatal testing. METHODS: G-banding chromosomal karyotyping analysis was carried out on amniotic fluid sample of the fetus and peripheral blood samples from the parents. Amniotic DNA was also subjected to CMA analysis. The fetus was also subjected to systematic ultrasound scan. RESULTS: The fetus was found to have a karyotype of 46,XX,18p+. CMA has revealed a 5 Mb deletion at 18p11.32-p11.31, a 2.9 Mb duplication at 18p11.31-p11.23, and a 2.5 Mb duplication at 18p11.23-p11.22. No chromosomal aberration or microdeletion/microduplication was detected in either parent. CONCLUSION Non-invasive prenatal testing and CMA are both sensitive for the detection of chromosomal microdeletions and microduplications. CMA can help with clarification of genotype-phenotype correlation and facilitate prenatal diagnosis and genetic counseling for the family.
Chromosome Deletion ; Chromosomes ; Female ; Fetus ; Humans ; Karyotyping ; Pregnancy ; Prenatal Diagnosis

Objective To investigate the local anatomical characteristics of the associated membrane and mesangial space in the complete mesocolic excision (CME) of right hemicolectomy and provide the surgical practical anatomical evidence to CME.Methods The experimental study was conducted.Department of Anatomy of Capital Medical University provided 20 adult cadavers.The surgical pictures came from Beijing Friendship Hospital of Capital Medical University.The local anatomy of CME in 20 cadavers was simulated after fascia perfusion.Observation indicators:(1) the local anatomy of the visceral fascia and parietal fascia was studied by simulating the operation of CME in cadaver specimens;(2) observing the integrity and barrier action of the visceral layer of the membrane after fascia perfusion solution freezing;(3) distribution and variation of superior vessels of rightsemi mesocolon.Results (1) The local anatomy of the visceral fascia and parietal fascia was studied by simulating the operation of CME in cadaver specimens:posterior lobe of the interposition mesocolon merged completely with visceral fascia,parietal fascia and front fascia of duodenum,and superior mesenteric vein (SMV) and superior mesenteric artery (SMA) were found.The ureters and reproductive vessels were covered with Gerota fascia,with a complete membrane structure.The specimens from simulated CME in 20 adult cadavers and CME of right hemicolectomy accorded with a requirement of CME.(2) Observing the integrity and barrier action of the visceral layer of the membrane after fascia perfusion solution freezing:posterior lobe of the right-semi mesocolon merged completely with visceral fascia,with a complete parietal fascia structure and without exudation of fascia perfusion solution.The right ureter and reproductive vessels were completely covered with Gerota fascia.The serosal surface of right-semi mesocolon maintained integity,with exudation of fascia perfusion solution.(3) Distribution and variation of superior vessels of right-semi mesocolon:major blood vessels of right-semi colon included superior mesenteric vessels,including SMA and SMV.The major branches of vessels included ileocolic artery,right colic artery,middle colic artery,right and left branches of middle colic artery,ileocolic vein,middle colic vein and gastrocolic stem.The gastrocolic stem and main stem of right colic artery had more variations.Conclusion The posterior lobe of the interposition mesocolon merges with fascia,and complete visceral fascia,can be separated,these provide anatomical evidences for safety and radical resection of right hemicolectomy based on following the principles of CME.

Objective:By analyzing the norm data results of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-Ⅳ) in China,to prove the validity of the procedure and methods during the norming development.Methods:The whole process of the revision of WAIS-Ⅳ,the development of computer-assisted system and norm sampling plan,were introduced in more detail,and the distribution of actual norm data of 1757 cases was analyzed.Results:For area distribution,compared with planned sampling number,the number from North and Northeast China was statistically significant different (x2 =78.02,P ＜0.01).For age stages distribution,most of cases conformed to the requirements of sampling,except that some cases including high-level educational cases aged 16-17 years and above 65 years,and low-level educational cases aged 30-34 years were less than the planned sampling number.For gender distribution,male subjects were more,but there was no statistically significant difference between male and female subjects (x2 =228,P =0.131).For educational degree distribution,the sampling conformed to the requirements of sampling plan (x2 =2.74,P =0.603).For occupation,resident years and registered permanent residence,and the sample was basically representative.Conclusion:The process of the revision of the Chinese version of WAIS-Ⅳ is appropriate,and actual norm sampling basically conforms to planned sample distribution,providing the sufficient representativeness and reliability for national norm data of WAIS-Ⅳ.

OBJECTIVE: To study the mechanism of tumor necrosis factor( TNF)-α and its receptor( TNFR) signal transduction pathways in regulating cell apoptosis of alveolar macrophage( AM) in coal workers' pneumoconiosis( CWP).METHODS: Twenty-four coal workers with pneumoconiosis at stage Ⅰ were selected as CWP group and four observation subjects exposed to coal were chosen as observation group by using simple random sampling method. The bronchoalveolar lavage fluids of whole-lung lavage of two groups were collected. AMs were separated and purified. Then they were divided into 6 groups: a control group,a superoxide dismutase( SOD) group,a TNF/TNFR group,an anti-TNF-α antibody group,a Caspase-8 suppression group and a nuclear factor-κB( NF-κB) suppression group. The AMs of 6 groups with corresponding treatment were cultivated. After 24 hours,the cells were harvested and proteins extracted. The relative expression of TNF-α,TNFR1,TNFR2,Caspase-8,Caspase-3,NF-κB P50 and NF-κB P65 protein was detected by Western blotting. RESULTS: The protein relative expression of TNF-α,TNFR2,Caspase-8,Caspase-3,NF-κB P50 and NF-κB P65 in CWP group was significantly higher than those in the observation group( P < 0. 05). The protein relative expression of TNF-α,TNFR1,Caspase-8,Caspase-3 and NF-κB P50 in the TNF/TNFR group and the anti-TNF-αantibody group was lower than that of the control group( P < 0. 05). The above indexes in the anti-TNF-α antibody group were lower than that of the NF-κB suppression group( P < 0. 05). The protein relative expression of TNFR1,Caspase-8and Caspase-3 in the TNF/TNFR group was higher than that of the SOD group and the Caspase-8 suppression group( P <0. 05). The protein relative expression of TNFR1,Caspase-8 and NF-κB P50 in the TNF/TNFR group was lower than that of the NF-κB suppression group( P < 0. 05). Among the CWP patients,the relative expression of TNFR2 and NF-κB P65 in the TNF/TNFR group was lower than that of the control group( P < 0. 05),and higher than that of the SOD group( P <0. 05). CONCLUSION: AM apoptosis mediated by TNF-α/TNFR/NF-κB signal transduction pathway plays an important role in the occurrence and development of CWP. The TNF-α/TNFR/NF-κB signal transduction pathways inhibited or blocked at different stages can affect the expression of proteins related to AM apoptosis.