Objective:To analyze the diagnostic value of inflammatory markers, clinical characteristics of patients with different prognoses, and variations in antimicrobial susceptibility testing for Klebsiella pneumoniae bloodstream infection. Methods:This study involved 166 patients with positive blood cultures for Klebsiella pneumoniae from January 2018 to May 2023 as the Klebsiella pneumoniae-positive group, and 100 patients with negative blood culture results as the negative group. The diagnostic value of inflammatory markers for Klebsiella pneumoniae bloodstream infection was evaluated through receiver operating characteristic (ROC) curve. The differences in C-reactive protein (CRP) and procalcitonin (PCT) levels between Klebsiella pneumoniae bloodstream infections and non- Klebsiella pneumoniae bloodstream infections were analyzed. According to the prognoses, 166 patients with Klebsiella pneumoniae bloodstream infection were divided into two groups: favorable outcome group (105 cases) and adverse outcome group (61 cases). Clinical features, infection sites, empirical use of antibiotics, and antimicrobial susceptibility were compared between the patients with different outcomes. Results:The percentage of neutrophils ( Z=-3.645, P<0.001), CRP level ( Z=-6.809, P<0.001), and PCT level ( Z=-8.214, P<0.001) were significantly higher in the Klebsiella pneumoniae-positive group than in the negative group. The area under the ROC curve (AUC) values for CRP and PCT in diagnosing Klebsiella pneumoniae bloodstream infection were 0.755 and 0.849, respectively. There were variations in CRP ( H=20.902, P<0.001) and PCT ( H=33.521, P<0.001) levels among patients with bloodstream infection caused by Klebsiella pneumoniae, other common negative bacilli, common positive cocci, or Candida. The body temperature, albumin level, hemoglobin level, and length of hospital stay in the adverse outcome group were lower than those in the favorable outcome group ( P<0.05). Besides, the incidence of invasive operation, organ failure, shock, and rescue were also lower in the adverse outcome group ( P<0.05). In the adverse outcome group, co-infections mainly involved respiratory infections, accounting for 60.7% (37/61). Respiratory infections (49.5%, 52/105) were also the predominant co-infections in the favorable outcome group, followed by hepatobiliary infections (34.3%, 36/105). The pathogenic bacteria cultured from different infection sites were mainly Klebsiella pneumoniae. In the favorable outcome group, fluoroquinolones were the most commonly used medications for empirical therapy, with a usage rate of 76.2% (80/105), followed by β-lactamase inhibitor complex preparations (68.6%, 72/105), the usage rate of which were significantly higher than those in the adverse outcome group ( P<0.05). Carbapenems were the preferred drugs for the adverse outcome group, with a usage rate of up to 62.3% (38/61), which was significantly higher than that in the favorable outcome group ( P<0.05). The adverse outcome group showed high resistance rates to ciprofloxacin (40.98%, 25/61) and levofloxacin (37.7%, 23/61), while the resistance rates were 22.86% (24/105) and 32.38% (34/105) in the favorable outcome group. The resistance rates to other drugs were low and there was no significant difference between the two groups ( P>0.05). Conclusions:PCT and CRP have certain value in diagnosing bloodstream infections caused by Klebsiella pneumoniae, and have certain reference significance for differentiating bloodstream infections caused by Gram-negative bacteria, Gram-positive bacteria, and Candida species. The source of bloodstream infection in patients with adverse outcome may be the respiratory system, while in patients with favorable outcome, the main sources of bloodstream infection may be the respiratory and hepatobiliary systems. Antimicrobial susceptibility testing reveals the highest resistance rate to fluoroquinolones. Given their frequent use in empirical therapy, this may lead to treatment failure. Notably, carbapenems are more commonly administered as empirical antibiotics in the adverse outcome group.

Objective:To compare the differences in specimen results between the intelligent robotic phlebotomy group and the manual venipuncture group, and to evaluate the clinical applicability of the autonomous blood collection system.Methods:From January 20 to October 28, 2022, 154 volunteers at Zhongshan Hospital, Fudan University underwent paired blood collections (robotic and manual) within 5 minutes. The collected samples were analyzed for: hemolysis index (HI), alanine transaminase (ALT), aspartate transaminase (AST), L-γ-glutamyltransferase (γ-GT), lactate dehydrogenase (LDH), urea nitrogen (UREA), creatinine (CRE), uric acid (UA), glucose (GLU), total cholesterol (TC), triglyceride (TG), natrium (Na), kalium (K), chlorine (Cl), creatine kinase (CK), CK-MB, CK-MM, and neuron-specific enolase (NSE). Statistical analyses used t-tests and Wilcoxon signed-rank tests.Results:The results of two different blood collection methods revealed that the HI values of 154 specimens in the intelligent robot blood collection group were all less than 20SI, while 7 specimens (4.54%) in the manual blood collection group had HI values exceeding 20SI; In the comparison of 17 biochemical and immunological markers, there were statistically significant differences between groups in 8 items including γ-GT[20.00(15.00, 37.75)U/L vs. 19.00 (14.00, 36.25)U/L, Z=2.497, P<0.05], LDH[165.5 (147.0, 183.0)U/L vs. 173.0 (155.0, 193.0)U/L, Z=8.629, P<0.05], TC[(5.002±0.856)mmol/L vs.(5.031±0.870) mmol/L, t=-3.006, P<0.05], K[4.1 (4.0, 4.3)mmol/L vs. 4.3 (4.1, 4.4)mmol/L, Z=5.592, P<0.05], CK[97.00 (73.00, 133.00)U/L vs. 99.00 (74.75, 136.25)U/L, Z=3.490, P<0.05], CK-MB[13 (11, 15)U/L vs. 14 (12, 16)U/L, Z=6.581, P<0.05], CK-MM[84.00 (60.00, 119.00)U/L vs. 83.50 (58.75, 118.00)U/L, Z=3.790, P<0.05], and NSE[10.600 (9.500, 11.700)ng/ml vs. 11.950 (10.475, 13.725)ng/ml, Z=8.151, P<0.05]. Conclusions:In the collection of serum samples, intelligent blood collection robots can achieve standardization and normalization of specimen collection volume and mixing in the pre-analysis stage. The hemolysis related indicators of the collected specimens are lower than those of the manual collection group, and can be used for the collection of clinical serological specimens.

Objective To establish autoverification rules for six routine coagulation assays(PT,APTT,TT,Fib,DD,and FDP)based on the stratification of outpatients and inpatients,in accordance with CLSI AUTO-10A,AUTO-15,and WS/T 616-2018 guide-lines,and to validate the feasibility of this stratified strategy with clinical data while optimizing verification efficiency.Methods A to-tal of 323 451 coagulation test results from Zhongshan Hospital,Fudan University in 2022 were retrospectively analyzed to define auto-verification rules involving critical values,instrument flags,logical rules,historical comparison,and numerical ranges.A stratified au-toverification system was established by applying distinct rules for outpatient and inpatient populations.Subsequently,the rules were op-timized using 87 830 coagulation test results from January to March 2024,and the consistency between autoverification and manual veri-fication was prospectively evaluated using 33 968 consecutive coagulation specimens collected in April 2024.Results A stratified au-toverification system was successfully developed,comprising a total of 53 rules.The pass rate of overall verification was 77.16％(26 210/33 968),with a true-positive rate of 19.64％(6 672/33 968),a false-positive rate of 3.20％(1 086/33 968),a true-nega-tive rate of 77.16％(26 210/33 968),and no false negatives were detected.Conclusion The proposed autoverification system signifi-cantly improved verification efficiency.The stratified design based on outpatient and inpatient populations effectively minimized the risk of false negatives,and may provide a novel approach for the further development and optimization of coagulation test autoverification.

Objective:To analyze the diagnostic value of inflammatory markers, clinical characteristics of patients with different prognoses, and variations in antimicrobial susceptibility testing for Klebsiella pneumoniae bloodstream infection. Methods:This study involved 166 patients with positive blood cultures for Klebsiella pneumoniae from January 2018 to May 2023 as the Klebsiella pneumoniae-positive group, and 100 patients with negative blood culture results as the negative group. The diagnostic value of inflammatory markers for Klebsiella pneumoniae bloodstream infection was evaluated through receiver operating characteristic (ROC) curve. The differences in C-reactive protein (CRP) and procalcitonin (PCT) levels between Klebsiella pneumoniae bloodstream infections and non- Klebsiella pneumoniae bloodstream infections were analyzed. According to the prognoses, 166 patients with Klebsiella pneumoniae bloodstream infection were divided into two groups: favorable outcome group (105 cases) and adverse outcome group (61 cases). Clinical features, infection sites, empirical use of antibiotics, and antimicrobial susceptibility were compared between the patients with different outcomes. Results:The percentage of neutrophils ( Z=-3.645, P<0.001), CRP level ( Z=-6.809, P<0.001), and PCT level ( Z=-8.214, P<0.001) were significantly higher in the Klebsiella pneumoniae-positive group than in the negative group. The area under the ROC curve (AUC) values for CRP and PCT in diagnosing Klebsiella pneumoniae bloodstream infection were 0.755 and 0.849, respectively. There were variations in CRP ( H=20.902, P<0.001) and PCT ( H=33.521, P<0.001) levels among patients with bloodstream infection caused by Klebsiella pneumoniae, other common negative bacilli, common positive cocci, or Candida. The body temperature, albumin level, hemoglobin level, and length of hospital stay in the adverse outcome group were lower than those in the favorable outcome group ( P<0.05). Besides, the incidence of invasive operation, organ failure, shock, and rescue were also lower in the adverse outcome group ( P<0.05). In the adverse outcome group, co-infections mainly involved respiratory infections, accounting for 60.7% (37/61). Respiratory infections (49.5%, 52/105) were also the predominant co-infections in the favorable outcome group, followed by hepatobiliary infections (34.3%, 36/105). The pathogenic bacteria cultured from different infection sites were mainly Klebsiella pneumoniae. In the favorable outcome group, fluoroquinolones were the most commonly used medications for empirical therapy, with a usage rate of 76.2% (80/105), followed by β-lactamase inhibitor complex preparations (68.6%, 72/105), the usage rate of which were significantly higher than those in the adverse outcome group ( P<0.05). Carbapenems were the preferred drugs for the adverse outcome group, with a usage rate of up to 62.3% (38/61), which was significantly higher than that in the favorable outcome group ( P<0.05). The adverse outcome group showed high resistance rates to ciprofloxacin (40.98%, 25/61) and levofloxacin (37.7%, 23/61), while the resistance rates were 22.86% (24/105) and 32.38% (34/105) in the favorable outcome group. The resistance rates to other drugs were low and there was no significant difference between the two groups ( P>0.05). Conclusions:PCT and CRP have certain value in diagnosing bloodstream infections caused by Klebsiella pneumoniae, and have certain reference significance for differentiating bloodstream infections caused by Gram-negative bacteria, Gram-positive bacteria, and Candida species. The source of bloodstream infection in patients with adverse outcome may be the respiratory system, while in patients with favorable outcome, the main sources of bloodstream infection may be the respiratory and hepatobiliary systems. Antimicrobial susceptibility testing reveals the highest resistance rate to fluoroquinolones. Given their frequent use in empirical therapy, this may lead to treatment failure. Notably, carbapenems are more commonly administered as empirical antibiotics in the adverse outcome group.

Objective:To compare the differences in specimen results between the intelligent robotic phlebotomy group and the manual venipuncture group, and to evaluate the clinical applicability of the autonomous blood collection system.Methods:From January 20 to October 28, 2022, 154 volunteers at Zhongshan Hospital, Fudan University underwent paired blood collections (robotic and manual) within 5 minutes. The collected samples were analyzed for: hemolysis index (HI), alanine transaminase (ALT), aspartate transaminase (AST), L-γ-glutamyltransferase (γ-GT), lactate dehydrogenase (LDH), urea nitrogen (UREA), creatinine (CRE), uric acid (UA), glucose (GLU), total cholesterol (TC), triglyceride (TG), natrium (Na), kalium (K), chlorine (Cl), creatine kinase (CK), CK-MB, CK-MM, and neuron-specific enolase (NSE). Statistical analyses used t-tests and Wilcoxon signed-rank tests.Results:The results of two different blood collection methods revealed that the HI values of 154 specimens in the intelligent robot blood collection group were all less than 20SI, while 7 specimens (4.54%) in the manual blood collection group had HI values exceeding 20SI; In the comparison of 17 biochemical and immunological markers, there were statistically significant differences between groups in 8 items including γ-GT[20.00(15.00, 37.75)U/L vs. 19.00 (14.00, 36.25)U/L, Z=2.497, P<0.05], LDH[165.5 (147.0, 183.0)U/L vs. 173.0 (155.0, 193.0)U/L, Z=8.629, P<0.05], TC[(5.002±0.856)mmol/L vs.(5.031±0.870) mmol/L, t=-3.006, P<0.05], K[4.1 (4.0, 4.3)mmol/L vs. 4.3 (4.1, 4.4)mmol/L, Z=5.592, P<0.05], CK[97.00 (73.00, 133.00)U/L vs. 99.00 (74.75, 136.25)U/L, Z=3.490, P<0.05], CK-MB[13 (11, 15)U/L vs. 14 (12, 16)U/L, Z=6.581, P<0.05], CK-MM[84.00 (60.00, 119.00)U/L vs. 83.50 (58.75, 118.00)U/L, Z=3.790, P<0.05], and NSE[10.600 (9.500, 11.700)ng/ml vs. 11.950 (10.475, 13.725)ng/ml, Z=8.151, P<0.05]. Conclusions:In the collection of serum samples, intelligent blood collection robots can achieve standardization and normalization of specimen collection volume and mixing in the pre-analysis stage. The hemolysis related indicators of the collected specimens are lower than those of the manual collection group, and can be used for the collection of clinical serological specimens.

Objective To establish autoverification rules for six routine coagulation assays(PT,APTT,TT,Fib,DD,and FDP)based on the stratification of outpatients and inpatients,in accordance with CLSI AUTO-10A,AUTO-15,and WS/T 616-2018 guide-lines,and to validate the feasibility of this stratified strategy with clinical data while optimizing verification efficiency.Methods A to-tal of 323 451 coagulation test results from Zhongshan Hospital,Fudan University in 2022 were retrospectively analyzed to define auto-verification rules involving critical values,instrument flags,logical rules,historical comparison,and numerical ranges.A stratified au-toverification system was established by applying distinct rules for outpatient and inpatient populations.Subsequently,the rules were op-timized using 87 830 coagulation test results from January to March 2024,and the consistency between autoverification and manual veri-fication was prospectively evaluated using 33 968 consecutive coagulation specimens collected in April 2024.Results A stratified au-toverification system was successfully developed,comprising a total of 53 rules.The pass rate of overall verification was 77.16％(26 210/33 968),with a true-positive rate of 19.64％(6 672/33 968),a false-positive rate of 3.20％(1 086/33 968),a true-nega-tive rate of 77.16％(26 210/33 968),and no false negatives were detected.Conclusion The proposed autoverification system signifi-cantly improved verification efficiency.The stratified design based on outpatient and inpatient populations effectively minimized the risk of false negatives,and may provide a novel approach for the further development and optimization of coagulation test autoverification.

Objective:To investigate the clinical characteristics and drug resistance of Klebsiella pneumoniae infections at different systems, providing laboratory reference for the rational use of antibiotics in clinical practice.Methods:The clinical characteristics and drug resistance of patients with Klebsiella pneumoniae infections in respiratory, urinary, hematologic, and other systems who received treatment in Wuzhou Red Cross Hospital from January 2015 to December 2021 were analyzed.Results:From 2015 to 2021, there were 3 496 cases of Klebsiella pneumoniae infections in the hospital, among which the respiratory system was most affected with 2 250 strains (64.34%). The sex ratio of patients with Klebsiella pneumoniae infections at different systems was statistically significant ( χ2 = 266.77, P < 0.001). The respiratory system and hematological system were more commonly infected by Klebsiella pneumoniae in men, while the urinary system was more commonly infected in women. The sex ratio of patients with Klebsiella pneumoniae infections at other systems were similar. The age distribution of patients with Klebsiella pneumoniae infections at different systems was significantly different ( χ2 = 176.54, P < 0.001). Klebsiella pneumoniae infections of the respiratory, urinary, and hematological systems were the most common in people aged > 60-80 years, while Klebsiella pneumoniae infections in other systems were mainly found in people aged > 18-60 years. There were significant differences in the distribution of departments among different Klebsiella pneumoniae infection systems ( χ2 = 1 415.30, P < 0.001). The ICU had the highest incidence of Klebsiella pneumoniae infections in the respiratory system, while the department of internal medicine had the highest incidence of Klebsiella pneumoniae infections in the urinary and hematological systems, and the department of surgery had the highest incidence of Klebsiella pneumoniae infections in other parts of the body. The resistance rate of Klebsiella pneumoniae to common antibiotics for the hematologic system was lower than that of the other three infection systems. For infections in the respiratory system, urinary system, and other body parts, the resistance rates of Klebsiella pneumoniae to amikacin, meropenem, imipenem, and piperacillin/tazobactam were all below 10%, while the resistance rate to tobramycin was below 20%, and the resistance rate to cephalosporins was around 30%. Conclusion:The proportion of Klebsiella pneumoniae infections in different body parts varies by gender, age, and department. For Klebsiella pneumoniae infections in the hematological system, the resistance rate to commonly used antibiotics is lower than that for infections in the other three systems. In contrast, Klebsiella pneumoniae infections in the respiratory system, urinary system, and other systems have a particularly high resistance rate to third- and fourth-generation cephalosporins but are still sensitive to piperacillin/tazobactam and carbapenem antibiotics.

Objective To evaluate the clinical application of automatic coagulation detection assembly line in high-throughput specimen detection.Methods The relevant information of sodium citrate anticoagulation samples in Zhongshan Hospital Affiliated to Fudan University from June to August 2021 was collected,inclu-ding sample collection time,receiving time,instrument sucking time,test completion time,and whether it pas-sed autoverification or not.The sample pretreatment time,testing time and turnaround time(TAT)of the au-tomatic coagulation detection assembly line were compared before and after installation,and the detection speed of the automatic coagulation detection assembly line was evaluated.Results The automatic coagulation detection line was expected to detect 650-900 samples per hour.The increase in the number of turbidimetric tests would slow down the detection speed of the instrument.Automatic coagulation detection assembly line test specimen to clinic and ward of pretreatment time and testing time were shorter than single detection,the differences were statistically significant(P＜0.05).The automatic coagulation detection assembly line could shorten TAT(P＜0.05).After the application of automatic coagulation detection assembly line,the autoveri-fication rate was 25.6％.Conclusion The automatic coagulation detection assembly line is suitable for high-throughput specimen detection in laboratory.Compared with stand-alone coagulation detection,the automatic coagulation detection assembly line could shorten TAT and testing time,and help to reduce the work pressure of laboratory personnel.

Objective:To investigate the incidence of Helicobacter pylori ( Hp) infection in diabetes and cardiovascular diseases. Methods:A total of 500 people who received physical examination in Wuzhou Red Cross Hospital from June 2021 to May 2022 were randomly selected for this study. Hp detection was performed in all people included in this study. The Hp infection rate in patients with diabetes and cardiovascular disease were analyzed. Results:The Hp infection rate in healthy people, patients with diabetes mellitus, cardiovascular disease, or diabetes mellitus complicated by cardiovascular disease was 29.3%, 70.3%, 58.5%, and 90.2%, respectively, with a statistically significant difference ( χ2 = 106.45, P < 0.001). The Hp infection rate of patients with diabetes complicated by one, two, three or more cardiovascular diseases was 83.9%, 94.6%, and 100.0%, respectively, with a statistically significant difference ( χ2 = 8.82, P < 0.001). Conclusion:The Hp infections rate in patients with diabetes complicated by cardiovascular disease was higher than that in patients with diabetes mellitus or cardiovascular disease, in particular in patients with diabetes mellitus complicated by several cardiovascular diseases.

Objective:To assess the role of Delta-RBC parameters in the automated hematocrit analyzer RET channel for the recognition of cold agglutinins (CA) and to explore the value of RET channel optical method parameters in correcting interference with CA.Methods:This is a retrospective study. The Cas group included 68 samples with Cas interference and the control group included 45 samples without CA interference. All specimens were collected from Zhongshan Hospital Fudan University Outpatient Department from January 2022 to January 2023. Specimens in both the CA and Control group were examined using the CBC+RET channel at room temperature. Recorded and calculated the Impedance method test parameters RBC-I, HGB, HCT-I, MCH-I, MCV-I, MCHC-I and the Optical method test parameters RBC-O, HCT-O, MCH-O, R-MFV, MCHC-O, Delta-RBC. Examined the specimens in the CA group using the CBC channel after prewarmed at 37 ℃ for 2 h, and Impedance method parameters RBC-I 37 ℃ 2 h, HGB 37 ℃ 2 h, HCT-I 37 ℃ 2 h, MCH-I 37 ℃ 2 h, MCV-I 37 ℃ 2 h, MCHC-I 37 ℃ 2 h were recorded. The ROC curves were used to analyze the discrimination efficacy of Delta-RBC in identifying CA interference, and the Bland-Altman method was used to analyze the consistency between the results of the optical method RBC parameters at room temperature and the results of the impedance method after prewarming. The correlation analysis was performed using Pearson and Spearman correlation analysis to analyze the results of the RBC parameters before and after prewarming in the CA group. Result:If Delta-RBC was used as diagnostic indicators for the identification of CA interference, the best cut-off value was 1.065, with AUCs of 0.998. In the CA group, the correlation coefficients between RBC-O, HCT-O, R-MFV, MCH-O, MCHC-O, and RBC-I 37 ℃ 2 h, HCT-I 37 ℃ 2 h, MCV-I 37 ℃ 2 h, MCH-I 37 ℃ 2 h, MCHC-I 37 ℃ 2 h were 0.985, 0.981, 0.729, 0.870, and 0.649, respectively. The percentages within the limits of agreement of the percentage differences between the results of the two methods were 95.6%, 92.6%, 95.6%, 94.1%, and 95.6%, respectively. Conclusions:The RBC parameter Delta-RBC from RET channel optical method can be used as an indicator to effectively assist in the clinical determination of the presence of CA. Reporting results using the optical method RBC parameters of the RET channel can correct the interference of CA without specimen pre-treatment and obtain more correct results of complete blood counts.