OBJECTIVE To improve the diagnosis and treatment level of critically ill infectious diseases， standardize the clinical application of nanopore sequencing and promote the sound development of the technology. METHODS Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society and Expert Committee of Precision Medicine for Clinical Treatment of Guangdong Pharmaceutical Association initiated and organized multidisciplinary experts to discuss and determine the consensus writing outline by using the nominal group method， forming a preliminary consensus draft； expert consultation was performed by using Delphi method， and then experts’ opinions were analyzed and revised to form consensus. RESULTS & CONCLUSIONS Consensuses of Experts on the Application of Nanopore Sequencing Technology in the Detection of Pathogenic Microorganisms covers targeted sequencing， metagenomic sequencing and whole genome sequencing， and is standardized in terms of sample collection and storage， detection process， bioinformatics analysis and report interpretation； the recommendations are provided for the key issues.

With widespread popularization, the radiological diagnosis and treatment technology has played an increasingly important role in clinical practice. The tertiary general hospital is generally featured as multiple types of radioisotope and radiation equipment, wide involvement of departments and persons, and many ways of use and potential harms of the radiological diagnosis and treatment technology. Radiation protection has become a content that cannot be ignored in hospital management. This article analyzes the radiation protection management structure of the tertiary general hospital - Guangdong Provincial People’s Hospital. The hospital radiation protection management is gradually improved by clarifying the main leading department, refining duties and responsibilities, strengthening multi-departmental communication and cooperation, and sorting out key connection links. A closed loop of refined management is formed through digging and correcting problems and continuously improving the management level and work efficiency. Valid qualifications are ensured to be obtained in time by radiation workers, radioactive drugs, equipment, and the venues to guarantee the radiation safety of radiation workers and patients and to further promote the construction of the Safe Hospital.

Sepsis is a clinical syndrome caused by the host reaction disorder induced by infection, which leads to serious organ function damage. Sepsis is a serious disease with high mortality, which is the main reason of death caused by infection. Single nucleotide polymorphisms (SNP) is one of the most common genetic variants in human, and is closely related to the genetic susceptibility, early diagnosis, disease development and prognosis of sepsis. This article makes a review on the relationship between CD14, Toll like receptor (TLR), tumor necrosis factor (TNF), interleukins (IL-1 and IL-6), plasminogen activator inhibitor 1 (PAI-1), angiotensin converting enzyme (ACE) and other gene polymorphisms and genetic susceptibility of sepsis, in order to affect in sepsis on the early prediction, diagnosis, and treatment.

Objective To explore the value of UF-5000 urinary sediment analyzer in assistant examination of urinary tract infections by comparing the results of bacteria and white blood cells for UF-5000 with those of routine laboratory methods.Methods A total of 1 021 clean mid-stage urine samples suspected urinary tract infection were collected from the inpatients and outpatients of the Guangdong Provincial People's Hospital from October to December 2017.All specimens were detected by UF-5000 to evaluate the repeatability,linearity,carrying contamination rate,stability and efficiency of review flag by the instrument.Urine bacterial culture and clinical diagnosis were used as reference standards to calculate the coincidence rate of bacterial test results with purified bacteria,coincidence rate with bacterial culture,and agreement rate with cultured colonies.The urinary fungal culture and clinical diagnosis were used as reference standards to calculate the coincidence rate,sensitivity and specificity of the fungal test.Based on the results of bacterial culture and clinical diagnosis,UF-5000 was used to detect the efficacy of white blood cells and bacteria for the diagnosis of UTI.The results of UF-5000 detection,the results of urinary dry chemistry analyzer UC-3500,and the results of bacterial smear microscopy were compared with the results of urinary bacterial culture to determine the sensitivity,specificity and sensitivity of each method,and the coincidence rate of with the culture method.Statistical analysis was performed using variance analysis,Wilcoxon rank sum test,coincidence rate test (Kappa test),and receiver operating characteristic curve (ROC curve).Results UF-5000 was used to detect bacteria and white blood cells,UC-3500 was used to detect neutrophil esterase and nitrite with good repeatability,which met the EP5-A requirements;the linear relationship between bacteria was very good in the range of 0-10 000/ml,R=0.999;the contamination rate of UF-5000 was 0.00％ for bacteria,0.01％ for white blood cells.The rate of UC-3500 was qualified;the bacteria was stable for 2 hours at room temperature and 6 hours at 4 ℃,and the white blood cells were stable for 4 hours at room temperature and 4 hours at 4 ℃.Compared with UF-1000i,the review flag rate of UF-5000 reduced about 77.8％.The coincidence rate of detection and purification of UF-5000 bacteria was 100.0％(16/16),that of Gram-negative bacteria (G-) was 94.0％ (110/117),that of Gram-positive bacteria (G+) was 82.2％(37/45).The agreement rate of compared with bacterial colonies was 95.1％(216/227),and that of fungi culture was 77.1％ (749/972),that of sensitivity was 81.9％(118/144),and that of specificity was 76.2％(631/828).UF-5000,UC-3500,and bacterial smear microscopy showed that the ability of bacterial infection of urinary tract was compared with the results of traditional bacterial culture.The UF-5000 urinary tract infection flag (UTI) had the highest agreement rate,reaching 84.1％ (180/214).The sensitivity was 70.3％ (52/74),the specificity was 91.4％ (128/140);the coincidence rate of UC-3500 was 73.8％ (158/214),the sensitivity was 25.7％ (19/74),and the specificity was 99.3％ (139/140);the consistency of bacterial smear microscopy was 66.4％ (142/214),the sensitivity was 82.4％ (61/74),and the specificity was 57.9％ (81/140).Conclusion The total number of bacteria and white blood cell counted by UF-5000,the flag of bacterial and the UTI information,have partial clinical significance in the rapid detection of urinary tract infection.

Objective To observe the clinical Resultsof ambroxol combined with glucocorticoids in the treatment of otitis media with effusion.Methods 81 cases fron June 2015 to 2016 October, were randomly, double-blind principle divided into observation group(42cases)and control group(39cases).The control group glucocorticoid therapy observation group were treated with ambroxol combined with glucocorticoid treatment, pure tone was observed before and after treatment were compared listen valve measured air conduction hearing level, hearing recovery and clinical efficacy.ResultsThe observation group were pure tone hearing valve after treatment was measured air conduction hearing level was significantly higher (P<0.05);drum pipe tobacco functioning proportion of patients in the observation group after treatment was 85.71%, significantly higher than 48.72% (P<0.05);The observation group total effective rate was 92.86%, significantly higher than 74.36% (P<0.05).Conclusion Ambroxol combined with glucocorticoids be effective in treating secretory otitis media, otitis media with effusion improve the clinical efficacy, and easy to operate, and is worthy of clinical application.

The development of diagnostic techniques played an important role in the prevention and treatment of infectious diseases.The traditional diagnostic techniques , such as gram stain , microscopy , culture, antigen/antibody detection and polymerase chain reaction , were widely used in the clinical diagnosis.But they couldn′t meet the demands of clinic and infectious diseases surveillance.Therefore, the point of care testing and multiplex testing based on advanced diagnostic platforms were developing rapidly , which might have the potential to change infectious diseases diagnostics.

Objective To explore the verification methods for the performance of quantitative detection kit of anti-dsDNA antibodiy with enzyme-linked immunosorbent assay (ELISA).Methods The precision was verified according to the EP15-A2 document approved by the American Clinical and Laboratory Standards Institute(CLSI).The accuracy was verified by detecting the samples of previous external quality evaluation(EQA),compared with the comparative kits and recovery test.The lower limit of detection(LLD) was calculated by the results of blank samples.The cut-off value was verified according to the C28-A3C document approved by CLSI and CNAS-CL39:Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Qualitative Immunology respectively.The improved Doumas method was used to verify the range of linearity.Results The measured intra-assay and inter-assay coefficients of variation were lower than those announced by the manufacturer or the calculated values according to the EP15-A2 document.The coincidence rates for negative and positive EQA samples between detected and expected values were 98.4％ (63/64) and 100％ (20/20) respectively.The total coincidence rate was 98.8％ (83/84).The coincidence rate for negative and positive samples between the results from candidate and comparative kits were 91.2％ (52/57) and 87.0％ (40/46) respectively.The total coincidence rate was 89.3％ (92/103) and the Kappa value was 0.783 (P =0.062),which implied excellent consistency between the two kits.The mean recovery rate was 99.65％.The measured LLD was 0.5 IU/mL which was lower than 1 IU/mL as claimed by the manufacturer.The measured cut-off value according to the CNAS-CL39 document was 18.51 IU/mL,which was close to 20 IU/mL announced by the manufacturer.Based on the C28-A3C method,the cut-off value could be approved.The linear regression equation was Y =0.978 8X-3.125 4,r2 =0.996 1.There was no statistical difference between the intercept (-3.125 4) and 0 (t =-0.772,P =0.483).The range of linearity was from 1.6 to 212.5 IU/mL,which was consistent with the values declared by the manufacturer.All the verifications of the five performances above-mentioned could be passed.Conclusion The precision,accuracy,LLD,cut-off value and range of linearity of the candidate quantitative ELISA kit for anti-dsDNA antibody were consistent with the statement of the manufacturer,which indicated the performance of the kits may meet the requirements of clinic diagnosis and treatment.A series of methods used in this study provided a simple protocol for verifying the performance of quantitative ELISA kits.

Objective To understand the development of healthcare-associated infection(HAI)management organ-izations in China in the past 30 years.Methods Development of HAI management organizations in 12 provinces (municipalities,autonomous regions)in China was surveyed.Results A total of 166 hospitals were surveyed,96 (57.83%)were tertiary hospitals.Among 164 hospitals which had a history of development of HAI management department,46(28.05%)before 1995,63(38.14%)in 1995-2005,and 55(33.54%)in 2005-2015 set up HAI management departments.HAI management professionals per 1 000 beds in 165 hospitals decreased from 4.80 in 1995 to 4.09 in 2015,occupational categories in HAI management departments in 1995 -2015 were significantly different (χ2 =26.22,P <0.01).The constituent ratios of education background and profession of HAI manage-ment professionals in each province in 1995-2015 were significantly different(χ2 =242.91,47.10,respectively,all P <0.01).In 1995 and 2005,70.81%,53.30% of professionals were with college degree or below;in 2015,the percentage of professionals with bachelor’s degree,doctoral degree,and master’s degree were 53.79%,2.45%, and 22.86% respectively.Most professionals were nursing staff,but the percentage decreased from 58.38% in 1995 to 45.96% in 2015.Conclusion Although HAI management organizations have developed for 30 years and made some achievements,there still remain some problems,the proportion of professionals needs to be enhanced,and personnel structure should be optimized.

Objective To explore the direct economic loss caused by healthcare-associated infection(HAI)in general hospitals in China.Methods 68 hospitals were selected,a retrospective 1:1 matched survey was conducted to compare the direct medical cost in patients with and without HAI between January 1,2015 and December 31,2015. Results A total of 2 123 pairs of patients with and without HAI were included in the survey.The average cost of hospitalization in HAI and non-HAI groups were ￥25 845.30 and ￥12 006.14 respectively,￥13 839.16 on average was increased due to HAI.The average economic loss in provincial and ministerial levels of hospitals were￥21 409.83.The average economic loss in different regional hospitals were ￥9 725.42-￥18 909.59,and north China ranked the first.Economic loss caused by bloodstream infection and lower respiratory tract infection were more than other sites,which were ￥23 190.09 and ￥18 194.50 respectively.Conclusion HAI resulted in considerable direct economic loss.Prevention and control of HAI,especially bloodstream infection and lower respiratory tract infection should be paid more attention.

Objective To understand the current situation of occupational exposure and protection among health care workers (HCWs ), and provide evidence for formulating preventive measures of occupational exposure. Methods From April 6,2016 to May 6,2016,questionnaire surveys were conducted in 158 different levels of hos-pitals in 13 provinces in China,occupational exposure,protection management,and monitoring of occupational expo-sure in the first year,2010,and 2015 was surveyed by cluster random sampling method.Results Occupational ex-posure in 81.65% (129/158)of hospitals was responsible by healthcare-associated infection management depart-ments;98.73%(156/158)of hospitals set up the relevant rules and regulations;77.22%(122/158)of hospitals had missing report of occupational exposure.A total of 11 116 times of occupational exposure occurred (1 542 cases in the first year,2 474 in 2010,and 7 100 in 2015).Of various types of occupational exposure,sharp injury accounted for 96.76%;among HCWs sustained occupational exposure,nursing staff accounted for 53.90%;the major de-partment that HCWs who sustained occupational exposure were general wards,operating rooms,and intensive care units;the main medical appliances related to occupational exposure were syringes,scalp needles,and surgical suture needles;high-risk behavior causing occupational exposure were intravenous injection,putting needles into the sharp con-tainers,and surgical suturing;among occupational exposure sources,HBV accounted for 58.69%.Conclusion HCWs in China face a high risk of occupational exposure,occurrence of occupational exposure should be reduced through gov-ernment legislation,application of safety appliances,standardizing behavior of HCWs,proper using of personal pro-tective equipment,strengthening education and training of HCWs,and establishing a sound occupational exposure report,evaluation and follow-up system.