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Currently, the management of domestic laboratory developed test (LDT) is still in the exploration stage, and new plans and ideas need to be investigated that are suitable for our national development. By analyzing encountered issues, combining the actual needs of the government, healthcare reform, and patients, this article proposes that "promoting healthy development of LDT projects and focusing on the organic combination of patients′ interest protection and innovation support" is an important direction for LDT management, around which the new idea for LDT project management is proposed, that is, LDT management model targeting product registration. The core of this management model is to target product registration and to ensure low service fees for patients and continuous real-time data monitoring. Benefit and risk analysis demonstrate that this management model can to a larger extent balance the realistic demands of patients, medical institutions, in vitro diagnostics companies, and government management departments, which benefits promoting the perfection and development of LDT projects in our country.
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Objective To investigate the susceptibility profile of clinical isolates in Zhujiang Hospital in 2015.Methods Susceptibility test was carried out using Kirby-Bauer method or automated systems.Results A total of 4 229 clinical isolates were isolated from January to December 2015,including 2 688 (63.6%) gram negative and 1 541 (36.4%) gram positive bacteria.Methicillin-resistant S.aureus (MRSA) and coagulase-negative Staphylococcus (MRCNS) accounted for 47.2% and 76.4%,respectively.The methicillin-resistant strains have much higher resistance rates to beta-lactams and other antimicrobial agents than methicillin-susceptible strains.Majority (94.0%) of MRSA strains were susceptible to trimethoprim-sulfamethoxazole,and 83.1% MRCNS strains were susceptible to rifampin.No staphylococcal isolates were found resistant to vancomycin,teicoplanin or linezolid.E.faecalis strains showed much lower resistance rate to most of the drugs tested (except chloramphenicol) than E.faecium.No enterococcal isolates were found resistant to vancomycin or teicoplanin.ESBLs were produced in 52.6% of E.coli and 39.7% of Klebsiella (K.pneumoniae and K.oxytoca) strains.ESBLs-producing Enterobacteriaceae strains had higher resistance rates to common antimicrobial agents than non-ESBLs-producing strain.Enterobacteriaceae isolates were highly susceptible to carbapenems,(<4% resistant).Acinetobacter spp.strains showed high resistance to imipenem (69.2% resistant) and meropenem (71.2% resistant).Conclusions The antibiotic resistance is still increasing in this hospital.The emerging multi-drug or pan-drug resistant strains pose a serious threat to clinical practice and implies the importance of strengthening infection control.
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Objective The number of children diagnosed with autism spectrum disorder (ASD)has increased dramatically in the past years.Parents of children with ASD usually experience a variety of chronic and acute stressors that may decrease marital satisfaction and family functioning.The aim was to explore the characteristics of parental per-sonality,mood disorders and family functions of the Children with ASD and to explore the relevance factors in order to draw out methods to improve parental family functions.Methods A cross -sectional survey was conducted and 593 outpatients with ASD diagnosed in Shanghai Mental Health Center,Shanghai Jiao Tong University School of Medicine form January 201 0 to January 201 4 were straight into the group,their parents were tested by Family Assessment Device (FAD),Zung Self -Rating Depression Scale(SDS),Zung Self -Rating Anxiety Scale(SAS)and Eysenck Personality Questionnaire(EPQ).SPSS 1 7.0 software was adopted to establish the database and statistical analysis.Results Ac-cording to FAD,parents of children with ASD had lower scores in problem solving[(2.1 0 ±0.37)scores]and roles [(2.09 ±0.27)scores](t =-6.669,P =0.000;t =-1 8.707,P =0.000)than the standard scores,while other di-mensions score were significantly higher than the standard scores in communicdtion[(2.25 ±0.35)scores],emotional reaction[(2.38 ±0.40)scores],emotional involvement[(2.36 ±0.37)scores],behavioral control[(2.31 ±0.27) scores]and general function[(2.1 2 ±0.38)scores],there were significant differences(t =3.1 35,1 1 .1 1 5,1 6.997, 37.1 1 6,8.064;P =0.002,0.000,0.000,0.000,0.000).For EPQ of parents,mother had obviously higher scores than father in psychoticism scale[(53.68 ±1 .36)scores vs (52.65 ±1 .1 7)scores,t =-1 3.841 ,P =0.000],and signifi-cantly lower scores in Lie scale[(52.27 ±0.79)scores vs (52.1 7 ±0.75)scores,t =2.449,P =0.01 4].Compared to fathers,mothers were coded as higher depression and anxiety scores(t =-6.276,-6.440,all P =0.000)and higher prevalence rate(χ2 =1 5.893,27.592,all P =0.000),which were statistically significant.According to the asso-ciation study of FAD and the others(especially in mood of parents),it was found that several dimensions showed obvious correlation.Conclusions Parents of children with ASD have family function damaged badly,except for prob-lem solving and roles.The parents showed different personality traits and mood disorders,particularly mothers′mood disorder problem was prominent.Parental family functioning were closely related to their personality traits and emotional disorders in various dimensionalities,which was worthy of attention.
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Objective To investigate the prevalence of autism spectrum disorders (ASD) of children aged 4-6 years in public kindergartens in Shanghai.Methods Songjiang district and Xuhui district were selected randomly as the representative sample.By means of "Clancy Autism Behavior Scale","Social Communication Questionnaire" and "high-functioning Autism Spectrum Screening Questionnaire",all of the 33 public kindergartens in chosen area,which contained 10 385 children aged 4-6 years,were surveyed.Those who were screened as suspected cases would be further diagnosed by "Autism Diagnostic Interview-Revised" and "Diagnostic and Statistical Manual of Mental Disorders,Fifth Edition".Results Among 9 665 valid questionnaires,9 children were diagnosed with ASD.The ratio of male to female was 8:1,the point prevalence rate was 0.93‰.The results of ADI-R corresponded with that of DSM-5.There were two children who never had medical records.For others,"language" problem was the most likely reason for their parents to seek medical help,while "deficits in social communication" was the main symptom of patients.Conclusion The prevalence of ASD was lower than those recorded in literature,home and abroad which might be related to some patients not going to public kindergartens.
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<p><b>OBJECTIVE</b>To assess the value of quantitative analysis of hepatitis B surface antigen (HBsAg) levels in the diagnosis and therapeutic evaluations in patients with chronic hepatitis B (CHB).</p><p><b>METHODS</b>According to the staging criteria defined by the American Association of Liver Diseases, 96 patients with CHB admitted in Zhujiang Hospital were classified in immune-tolerant (IT), HBeAg-positive hepatitis (EPH), inactive carrier (IC) and HBeAg-negative hepatitis (ENH) phases. Serum HBsAg, HBV-DNA and ALT levels were quantified and their correlations were evaluated in each phase of infection.</p><p><b>RESULTS</b>The mean HBsAg titers (measured in log10U/L) differed significantly between the phases of CHB (4.12 in IT, 4.02 in EPH, 2.85 in EPH, and 3.29 in ENH). The correlation coefficient of HBsAg with HBV-DNA was 0.6828 in IT, 0.5759 in EPH, 0.3280 in IC, and 0.1083 in ENH. Serum HBsAg titers were significantly higher in HBeAg-positive patients than in HBeAg-negative patients. No correlation was found between HBsAg level and ALT in each phase of CHB.</p><p><b>CONCLUSION</b>The median baseline serum HBsAg levels vary between different phases of CHB in Guangzhou, suggesting the value of HBsAg in accurate classification of hepatitis B patients and evaluation of the therapeutic effect and outcomes of the patients.</p>
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Humanos , ADN Viral , Sangre , Antígenos de Superficie de la Hepatitis B , Sangre , Virus de la Hepatitis B , Hepatitis B Crónica , Sangre , Pruebas SerológicasRESUMEN
<p><b>OBJECTIVE</b>To establish two double-antigen sandwich ELISA systems to detect anti-Afmp1cr and Afmp2cr antibodies of Aspergillus fumigatus.</p><p><b>METHODS</b>Recombinant Afmp1cr and Afmp2cr proteins of A.fumigatus expressed in Pichia pastoris were obtained. Double-antigen sandwich ELISA systems for detecting specific anti-Afmp1cr and anti-Afmp2cr antibodies were developed after chessboard titrating to determine the appropriate concentrations of the recombinant proteins and HRP-labeled proteins. The sensitivity of the assay was evaluated using serum samples of rabbits immunized with Afmp1cr and Afmp2cr. The specificity of the assay was evaluated by detecting serum samples from healthy donors and patients with other pathogenic fungal and baterial infections. The performance of the two ELISA kits was furthered evaluated using serum samples from patients with suspected Aspergillus infection.</p><p><b>RESULTS</b>The established ELISA kits were capable of detecting anti-Afmp1cr and anti-Afmp2cr antibodies in immunized rabbit serum at the maximum dilutions of 800 and 3200, respectively. No cross-reactivity was observed in detecting serum from patients with other pathogenic fungal or bactetial infections. Both of the two kits yielded positive results in sera from two established Aspergillus-infected cases and a suspected case.</p><p><b>CONCLUSIONS</b>Two antibody-capture ELISA kits were developed for the laboratory diagnosis of A.fumigatus infection and can be potentially useful in the clinical diagnosis of Aspergillosis infections.</p>
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Animales , Humanos , Conejos , Anticuerpos Antifúngicos , Antígenos Fúngicos , Aspergilosis , Diagnóstico , Aspergillus fumigatus , Reacciones Cruzadas , Ensayo de Inmunoadsorción Enzimática , Pichia , Proteínas Recombinantes , Sensibilidad y EspecificidadRESUMEN
Objective To screen monoclonal antibodies (mAbs) for early diagnosis of invisive Aspergillus. Methods Monoclonal antibodies against different antigens of Aspergillus fumigatus were produced. The two pairs of combinations of monoclonal antibodies were selected accoring the distinct epitopes and double-antibody sandwich ELISA based on mAbs above were established. The sensitivity and specificity of the methods were analyzed by detecting culture supernatants of clinical isolates and environmental isolatesof Aspergillus. spp, Penicillium Marneffei, Candidas, and serum from animal models and patients. The epitopes recognized by mAbs were identified by immunobotting. Results A total of 32 hybridoma cell lines that stably produced MAbs were obtained. Two double- antibody sandwich ELISAs were established. One method was specific for 19 clinical isolates and environmental isolates of Aspergillus. spp, whereas the other one was specific for the clinical and environmental isolates of Aspergillus fumigatus without cross-reation with other Aspergillus. spp. For the same kind of medium of Aspergillus fumigatus, the sensitivity of the first method was 10 fold higher than the second method. Conclusions The specific mAbs for early diagnosis of invisive Aspergillus were obtained. Antigen recognized by the specific mAbs was mannoprotein with molecular weights of approximately 25 000-75 000. This antigen was potential early diagnostic marker for invasive Aspergillus.