Objective:To evaluate the clinical efficacy of methylation sensitive-high resolution melting curve (MS-HRM) detection of IFN-induced protein 44-like (IFI44L) gene methylation in the diagnosis of systemic lupus erythematosus (SLE), as well as the relationship between IFI44L gene markers and the early onset of SLE.Methods:From February 2020 to September 2022, the MS-HRM was used to detect the methylation level of the IFI44L gene in peripheral blood mononuclear cells of 602 SLE patients and 524 other autoimmune disease patients (excluding SLE) from Beijing Peking Union Medical College Hospital, Guangdong Provincial People′s Hospital, and Shenzhen People′s Hospital, totaling 1 126 patients. Compared with the 2012 SLICC criteria, the suspected cases were followed up for 6 months until the onset and clinical diagnosis of SLE were confirmed. The measurement data of normal distribution were expressed as mean±SD, and the consistency analysis was performed using the Kappa consistency test. The clinical diagnostic efficacy indicators were calculated using the receiver operating characteristic (ROC) curve. Results:RR (95% CI) of early suspected cases was 17.06 (9.43, 30.82). The results of IFI44L gene methylation level were in good agreement with the 2012 SLICC criteria, and the sensitivity, specificity and total coincidence rate were 90.53%, 92.56% and 91.47%, respectively. The Kappa value (95% CI) was 0.829(0.796, 0.862) ( P<0.001). The diagnostic efficiency of IFI44L gene methylation level ( Kappa value 0.817) was superior to anti-nuclear antibody, anti-SM antibody and anti-dsDNA antibody ( Kappa value 0.418, 0.216 and 0.440, respectively). The Kappa values (95% CI) of methylation between MS-HRM and pyrosequencing was 0.861(0.806, 0.916), P<0.001. Conclusion:The hypomethylation of IFI44L gene methylation level detected by MS-HRM is closely related to the occurrence and development of SLE, and its diagnostic performance is better than that of three autoantibodies in SLE diagnosis, which can be used for the early diagnosis of SLE.

The management of healthcare-associated infections(HAIs)outbreak is a critical component of hospi-tal infection prevention and control,playing a vital role in safeguarding the patients and healthcare workers.The"Standards for Control of Healthcare-Associated Infection Outbreaks(2025 edition)"that was issued by the Na-tional Health Commission was interpreted from the perspectives of scientific validity,applicability and operability.It covers the aspects such as the background of the revision,main contents(including management re-quirements,epidemiological survey,control effect evaluation.It is stressed on the role of information management systems in enhancing the capability for early detection and early warning of HAIs outbreaks.New additions include emergency response procedures for exposures to unconventional pathogens in healthcare settings,outlining specific response measures and key action points.The standard clarifies that infections evolve dynamically and must be cat-egorized based on whether the outbreak pathogen has a defined incubation period.It defines the longest incubation period for assessing effective outbreak control and establishes criteria for identifying new cases.This standard ap-plies to medical institutions of all levels and types and can also be referenced for the control of infection outbreak in temporary special settings during the prevalence of infectious diseases.

The management of healthcare-associated infections(HAIs)outbreak is a critical component of hospi-tal infection prevention and control,playing a vital role in safeguarding the patients and healthcare workers.The"Standards for Control of Healthcare-Associated Infection Outbreaks(2025 edition)"that was issued by the Na-tional Health Commission was interpreted from the perspectives of scientific validity,applicability and operability.It covers the aspects such as the background of the revision,main contents(including management re-quirements,epidemiological survey,control effect evaluation.It is stressed on the role of information management systems in enhancing the capability for early detection and early warning of HAIs outbreaks.New additions include emergency response procedures for exposures to unconventional pathogens in healthcare settings,outlining specific response measures and key action points.The standard clarifies that infections evolve dynamically and must be cat-egorized based on whether the outbreak pathogen has a defined incubation period.It defines the longest incubation period for assessing effective outbreak control and establishes criteria for identifying new cases.This standard ap-plies to medical institutions of all levels and types and can also be referenced for the control of infection outbreak in temporary special settings during the prevalence of infectious diseases.

Objective:To evaluate the clinical efficacy of methylation sensitive-high resolution melting curve (MS-HRM) detection of IFN-induced protein 44-like (IFI44L) gene methylation in the diagnosis of systemic lupus erythematosus (SLE), as well as the relationship between IFI44L gene markers and the early onset of SLE.Methods:From February 2020 to September 2022, the MS-HRM was used to detect the methylation level of the IFI44L gene in peripheral blood mononuclear cells of 602 SLE patients and 524 other autoimmune disease patients (excluding SLE) from Beijing Peking Union Medical College Hospital, Guangdong Provincial People′s Hospital, and Shenzhen People′s Hospital, totaling 1 126 patients. Compared with the 2012 SLICC criteria, the suspected cases were followed up for 6 months until the onset and clinical diagnosis of SLE were confirmed. The measurement data of normal distribution were expressed as mean±SD, and the consistency analysis was performed using the Kappa consistency test. The clinical diagnostic efficacy indicators were calculated using the receiver operating characteristic (ROC) curve. Results:RR (95% CI) of early suspected cases was 17.06 (9.43, 30.82). The results of IFI44L gene methylation level were in good agreement with the 2012 SLICC criteria, and the sensitivity, specificity and total coincidence rate were 90.53%, 92.56% and 91.47%, respectively. The Kappa value (95% CI) was 0.829(0.796, 0.862) ( P<0.001). The diagnostic efficiency of IFI44L gene methylation level ( Kappa value 0.817) was superior to anti-nuclear antibody, anti-SM antibody and anti-dsDNA antibody ( Kappa value 0.418, 0.216 and 0.440, respectively). The Kappa values (95% CI) of methylation between MS-HRM and pyrosequencing was 0.861(0.806, 0.916), P<0.001. Conclusion:The hypomethylation of IFI44L gene methylation level detected by MS-HRM is closely related to the occurrence and development of SLE, and its diagnostic performance is better than that of three autoantibodies in SLE diagnosis, which can be used for the early diagnosis of SLE.

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.

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.