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.

Hearing loss is the most prevalent disabling disease. Cochlear implantation（CI） serves as the primary intervention for severe to profound hearing loss. This consensus systematically explores the value of genetic diagnosis in the pre-operative assessment and efficacy prognosis for CI. Drawing upon domestic and international research and clinical experience, it proposes an evidence-based medicine three-tiered prognostic classification system（Favorable, Marginal, Poor）. The consensus focuses on common hereditary non-syndromic hearing loss（such as that caused by mutations in genes like GJB2, SLC26A4, OTOF, LOXHD1） and syndromic hereditary hearing loss（such as Jervell & Lange-Nielsen syndrome and Waardenburg syndrome）, which are closely associated with congenital hearing loss, analyzing the impact of their pathological mechanisms on CI outcomes. The consensus provides recommendations based on multiple round of expert discussion and voting. It emphasizes that genetic diagnosis can optimize patient selection, predict prognosis, guide post-operative rehabilitation, offer stratified management strategies for patients with different genotypes, and advance the application of precision medicine in the field of CI.
Humans ; Cochlear Implantation ; Prognosis ; Hearing Loss/surgery* ; Consensus ; Connexin 26 ; Mutation ; Sulfate Transporters ; Connexins/genetics*

AIM:To investigate the improvement effect of blood flow-limited resistance training on renal fibro-sis in type 2 diabetes mellitus(T2DM)rats and its potential mechanism to attenuate renal fibrosis by inhibiting the trans-forming growth factor β1(TGF-β1)/Smad3 signaling pathway.METHODS:The T2DM model was prepared by combining a high-fat diet and streptozotocin(STZ),and after successful modeling,the rats were randomly divided into a T2DM con-trol group,a low-load resistance training group,a high-load resistance training group,a blood flow restriction group and a blood flow restriction combined with resistance training group for 8 weeks of exercise.The renal index,fasting blood glu-cose(FBG),serum creatinine(SCr),and blood urea nitrogen(BNU)were recorded in each group.The morphological changes of the kidneys were observed by hematoxylin and eosin(HE)and Masson's trichrome staining,and the collagen volume fraction was calculated.The mRNA expression levels of renal Klotho,TGF-β1,and α-smooth muscle actin(α-SMA)were detected by RT-qPCR.The protein expression levels of renal Klotho,TGF-β1,Smad3,phosphorylated Smad3(p-Smad3),α-SMA and connective tissue growth factor(CTGF)were detected using Western blot.RESULTS:Compared with the other groups,FBG,SCr,BNU,and renal collagen volume fraction were significantly decreased in the blood flow restriction combined with resistance training group of rats(P<0.05),Klotho expression was significantly in-creased(P<0.05),and the expression of TGF-β1,p-Smad3,CTGF and α-SMA was significantly decreased(P<0.05),and there was no significant change in the expression level of Smad3(P>0.05).CONCLUSION:Blood flow restriction combined with resistance training attenuates renal fibrosis in T2DM rats,the mechanism of which may be related to the up-regulation of Klotho expression,disruption of the TGF-β1/Smad3 signaling pathway,and inhibition of the deposition of epi-thelial-mesenchymal transformation.

Seeds are the source for the production of Chinese medicinal materials. The seed authenticity and quality of directly affect the effectiveness and safety of Chinese medicinal materials. The seed quality is faced with the problems such as mixed sources， existence of adulterants and seeds stocked for years， low maturity， and low purity. To ensure the high-quality and sustainable development of the Chinese medicinal material industry， it is urgent to standardize the seed market and identify and evaluate the quality of the seeds circulating in the market. Seed identification methods include visual inspection， microscopic observation， micro-character identification， chemical fingerprinting， molecular identification， electronic nose， X-ray diffraction， electrochemical fingerprinting， spectral imaging， and artificial intelligence. These methods have different application scopes and unique advantages and disadvantages. According to the different species of Chinese herbal medicines and different requirements of testing sites， suitable methods can be selected to achieve rapid and accurate identification with low costs. In the future， the seed identification methods should be developed based on emerging technologies with interdisciplinary knowledge， and intelligent， nondestructive， and single-grain detection methods are needed for the modern Chinese medicinal material industry. This paper introduces the seed identification technologies currently applied in research and production， compares the principles， applicability， advantages， and disadvantages of different technologies， and provides an outlook on the future development of seed identification technologies， aiming to provide a reference for the identification and quality evaluation of seeds of Chinese medicinal material.

Objective To explore the impact of macrophage-to-myofibroblast transition(MMT)on pulmonary fibro-sis induced by acute lung injury by LPS.Methods Totally 21 male mice were randomly classified into 7 groups:control group,model group(LPS-PF)at different time points and intervention group of clodronate-liposomes(CL-LIP)treatement at different time points(n=3).Pulmonary fibrosis was identified by HE and Masson staining microscopy.The immuno-fluorescence technology was used for the evaluation of numbers of macrophage-to-myofi-broblast transition cells(MMT cell which co-expressed CD68 and α-SMA).Bone marrow-derived macrophages(BMDMs)were randomly classified into two group:control(Ctrl)group and TGF-β1-treated group induced by transforming growthfactor-β1.α-SMA,FN and Col1 were detected by RT-qPCR.The expression of α-SMA,Smad3 and p-Smad3 protein was evaluated by Western blot.Results At day 7,the Ashcroft score of lung tissue in LPS-PF mouse model was significantly increased when compared with the Ctrl group(P＜0.01);While the score signifi-cantly declined when the model was pretreated with CL-LIP(P＜0.05).As detected by immuno-fluorescence stai-ning,in CL-LIP group the number of CD68-positive cells co-labeled with α-SMA was obviously less then that of LPS-PF group of the corresponding time point(P＜0.01).When the BMDMs were stimulated by TGF-β1 at 24 h,48 h and 96 h respectively,a higher expression of α-SMA,FN,Col1,were found in TGF-β1-treated group than that in Ctrl group at the corresponding time point(P＜0.01).The expression of Smad3,p-Smad3 significantly higher in LPS-PF group(at both day 7 and day 10)and TGF-β1-treated group(at both 48 h and 96 h)as compared to cor-responding control group(P＜0.01).Conclusions MMT promotes pulmonary fibrosis induced by ALI via LPS.Smad3 is proved to be involved in the MMT process.

ObjectiveTo observe the effect of Xiaoke drink on insulin resistance in ob/ob mice and explore the mechanism. MethodEighteen ob/ob mice were randomly assigned into model， Xiaoke drink （17.68 g·kg^-1）， and atorvastatin （0.01 g·kg^-1） groups （n=6）， and six C57BL/6 mice were selected as the normal group. Mice in the normal and model groups were administrated with the same amount of distilled water. Fasting body weight， weekly food intake， and weekly water intake were measured at a fixed time. Fasting plasma glucose （FPG） and 2-hour post-load plasma glucose （2 hPG） were measured before and after 8-week intervention. After intervention， total cholesterol （TC）， triglyceride （TG）， fasting insulin （FINS）， Homeostasis Model Assessment-Insulin Resistance （HOMA-IR）， blood routine， and alkaline phosphatase （ALP） were measured. Western blot was employed to determine the expression levels of ubiquitin-specific protease 20 （USP20） and 3-hydroxy-3-methylglutaryl coenzyme A reductase （HMGCR） in the liver. The pancreas was stained with hematoxylin-eosin for observation. ResultCompared with the model group， the Xiaoke drink group showed decreased body weight of ob/ob mice （P<0.05， P<0.01）， declined growth trend of body weight （P<0.05， P<0.01）， reduced weekly average water intake， lowered levels of FPG， 2 hPG， TC， and HOMA-IR （P<0.05， P<0.01）， and down-regulated expression level of USP20 in the liver （P<0.05）. HMGCR content was positively correlated with USP20 expression. In addition， Xiaoke drink promoted the recovery of islet tissue morphology and function in ob/ob mice. ConclusionXiaoke drink can ameliorate insulin resistance in ob/ob mice by inhibiting USP20/HMGCR expression， reversing cholesterol biosynthesis process， and reducing cholesterol level.

italic>Platycodon grandiflorum (Jacq.) A. DC is one of the most commonly used bulk medicinal herbs. It has important value in the fields of medicine, food and cosmetics, and its market demand is increasing year by year, and it has a good development prospect. In this study, based on 403 distribution records and 8 environmental variables, we used Maxent model to predict the potential distribution of P. grandiflorum under climate change. The results showed that the model simulation effect was the best when the Maxent parameter was FC (feature combination) = LQPH (L: linear features; Q: quadratic features; P: product features; H: hinge features) and RM (regularization multiplier) = 2.1, AUC (area under curve) = 0.901, and the model prediction showed that P. grandiflorum was widely distributed in 28 provinces of China under the current climate conditions, with a suitable area of 2 337 419.98 km². Under the influence of climate change in the future, the area of suitable habitat of P. grandiflorum showed a decreasing trend, and the distribution center as a whole showed a trend of northward and eastward shift. The distribution area of P. grandiflorum in the three main producing areas is affected by climate change, and the overall trend is that the future suitable distribution area of Chifeng in Inner Mongolia increases, while the future suitable distribution area of Zibo in Shandong and Taihe, Bozhou in Anhui decreases or even disappears under the SSP5-8.5 scenario (shared socioeconomic pathways). It is suggested to maintain and protect the ecological environment and germplasm resources of the reserved area suitable for the growth of P. grandiflorum, and increase the cultivation research in the expansion area of P. grandiflorum, so as to lay a foundation for the subsequent expansion of P. grandiflorum planting and to promote the protection and sustainable development of P. grandiflorum resources.

OBJECTIVE To study the relationship between frequency specific free-field tone burst cortical auditory evoked potentials(CAEP)and aided behavioral audiometry to provide rapid,reliable insights for predicting hearing intervention efficiency in hard to cooperate cochlear implant patients.METHODS The study comprised of 22 cochlear implant pediatric patients(22 ears)free-field tone burst CAEP P1 response thresholds,free-field behavioral thresholds determined within the group across frequencies 0.5,1,2 and 4 kHz were collected for correlation analysis.RESULTS The free-field tone burst CAEP P1 response thresholds and free-field behavioral audiometric thresholds in cochlear implant pediatric patients for testing frequencies 0.5,1,2,4 kHz were compared and r correlation coefficients found were 0.567,0.670,0.637 and 0.762 across the frequencies respectively(P<0.01).The mean difference between free-field CAEP P1 response threshold and free-field behavioral thresholds for cochlear implant patients differ by 5-8 dB with statistical significance.CONCLUSION Free-field tone burst CAEP can be used for cochlear implant programming validation in patients that fail to cooperate in behavioral testing,thus is applicable in cochlear implant programming clinical practice.

Objective To evaluate the reliability and validity of the Chinese version of the hyperacusis scale and estimate its applicability in the Chinese population.Methods The patients admitted to the Department of Oto-laryngology of Xijing Hospital from June 2017 to December 2017 were surveyed.A total of 300 questionnaires were sent out and 293 valid questionnaires were collected with effective response rate of 97.67％.All participants comple-ted a basic information survey,pure tone audiometry and fill in the Chinese version of the hyperacusis scale.The re-liability and validity of this scale were evaluated.Results Among the 293 respondents,243(82.93％)were compli-cated with tinnitus.A total of 181 cases(61.77％)were subjectively diagnosed with hyperacusis through question-naire survey.According to the scale evaluation,174 cases(59.39％)were diagnosed with hyperacusis,and the Kappa value of conformity test of the two methods was 0.81(P＜0.001).Reliability analysis indicated a Cronbach'sα coefficient of 0.93 for the entire scale.Each dimension had a Cronbach's α coefficient＞0.60.The split-half relia-bility coefficient for the entire scale was 0.86,and for each dimension,it was＞0.60.Exploratory factor analysis of validity suggested that 25 items could be grouped under 4 factors,such as functional part,social part,emotional part and harmonic sensitivity part.These factors had eigenvalues greater than 1,accounting for 59.42％of the total variance.Post-rotation,the 25 items were distributed across the 4 components,with each item having a factor load-ing＞0.40.Confirmatory factor analysis of validity showed model fit parameters as:x2/df=1.98,GFI=0.91,AGFI=0.83,CFI=0.92,TLI=0.89,RMSEA=0.08.Each item had a standardized factor loading＞0.40.Con-clusion The Chinese version of the hyperacusis scale demonstrated strong reliability and validity,making it suitable for use among the Chinese population.