4.Feasibility study of a domestic fully automated NAT system for blood screening in blood donors
Fenglan YAO ; Rui WANG ; Jinghui HU ; Hongwei GE ; Chan LENG ; Yi ZHA ; Zifu ZHAO ; Zhengmin LIU
Chinese Journal of Blood Transfusion 2025;38(7):941-949
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.
5.Feasibility study of a domestic fully automated NAT system for blood screening in blood donors
Fenglan YAO ; Rui WANG ; Jinghui HU ; Hongwei GE ; Chan LENG ; Yi ZHA ; Zifu ZHAO ; Zhengmin LIU
Chinese Journal of Blood Transfusion 2025;38(7):941-949
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.
6.Effect of low-dose esketamine on median effective dose of ciprofol for inhibition of body movement in elderly patients undergoing prostate biopsy
Haotian YANG ; Kai ZHUANG ; Jinghui HU ; Fuhai JI ; Ke PENG
The Journal of Clinical Anesthesiology 2024;40(8):792-796
Objective To explore the effects of low-dose esketamine on the median effective dose(ED50)of ciprofol for sedation in elderly patients undergoing ultrasound-guided transperineal prostate biopsy.Methods Forty-nine elderly male patients,aged 65-75 years,BMI 18.5-30.0 kg/m2,ASA physical stutas Ⅰ-Ⅲ,who underwent ultrasound-guided transperineal prostate biopsy,were randomly as-signed into the esketamine-ciprofol group(group E,n=23)and the ciprofol group(group C,n=26).After intravenous administration of sufentanil 0.1 μg/kg,patients in group E received esketamine 0.2 mg/kg,while patients in group C received the same volume of normal saline.The up-and-down sequential allocation method was used to calculate the effective dose of ciprofol.The initial dose of ciprofol was 0.2 mg/kg in group E and 0.3 mg/kg in group C,and the dose gradient was 0.05 mg/kg for both groups.If there was no body movement during the first puncture of prostate after the loss of eyelash reflex,the ciprofol dose in the next patient was reduced by 0.05 mg/kg.Otherwise,the ciprofol dose in the next patient was in-creased by 0.05 mg/kg.The study was completed until 7 inflection points alternating between non-body movement and body movement achieved.The total amount of ciprofol,surgical time,recovery time,stay in recovery room,hypotension,bradycardia,respiratory depression,injection pain,nausea and vomiting,and adverse reaction of the mental system were recorded.The Probit method was used to calculate the ED50 and 95%effective dose(ED95)with 95%confidence interval(CI)of ciprofol for inhibition of body movement.Results Compared with group C,the total amount of ciprofol in group E was significantly reduced(P<0.05).There were no significant differences between the two groups in surgical time,recovery time,stay in recovery room,and adverse events.The ED50 of ciprofol in group E was 0.22 mg/kg(95%CI 0.19-0.26 mg/kg),and the ED50 in group C was 0.38 mg/kg(95%CI 0.31-0.46 mg/kg).Compared with group C,the ED50 in group E was significantly reduced(P<0.05).The ED95 of ciprofol in group E was 0.28 mg/kg(95%CI 0.25-0.49 mg/kg),and the ED95 in group C was 0.51 mg/kg(95%CI 0.44-1.25 mg/kg).Compared with group C,the ED95 in group E was significantly reduced(P<0.05).Conclusion The ED50 of ciprofol for inhibition of body movement in elderly patients undergoing ultrasound-guided transperi-neal prostate biopsy was 0.38 mg/kg,which was reduced to 0.22 mg/kg by using lose-dose esketamine 0.2 mg/kg as an adjuvant.
7.Effect of bupivacaine liposome for erector spinae plane block on quality of postoperative recovery in patients undergoing thoracoscopic lung resection
Xisheng SHAN ; Yang ZHANG ; Dawei LIAO ; Jinghui HU ; Ke PENG ; Huayue LIU ; Fuhai JI
Chinese Journal of Anesthesiology 2024;44(10):1165-1169
Objective:To investigate the effect of bupivacaine liposome for erector spinae plane block on the quality of postoperative recovery in patients undergoing thoracoscopic lung resection.Methods:From July 2023 to January 2024, 128 American Society of Anesthesiologists Physical Status classification ⅠorⅡ patients of either sex, aged 18-75 yr, with body mass index of 18-32 kg/m 2, scheduled for elective thoracoscopic lung resection at the First Affiliated Hospital of Soochow University, were assigned to either bupivacaine liposome group (BL group) or bupivacaine hydrochloride group (BH group) using a random number table method, with 64 patients in each group. Patients received an ultrasound-guided erector spinae plane block following anesthesia induction. BL group received an injection of bupivacaine liposome 20 ml (266 mg) plus normal saline 10 ml, while BH group received an injection of bupivacaine hydrochloride 20 ml (100 mg) plus normal saline 10 ml. The primary outcome was the Quality of Recovery-15 (QoR-15) score at 24 h postoperatively. Secondary outcomes included the QoR-15 score at 3 days postoperatively, time to first patient-controlled analgesia press, and total opioid consumption within the first 3 days postoperatively. Other outcomes assessed were the time to ambulation, duration of chest tube placement, length of hospital stay, patient satisfaction scores at discharge, and development of adverse reactions during hospitalization. Results:Compared to BH group, QoR-15 scores were significantly increased at 24 h and 3 days postoperatively, the time to first patient-controlled analgesia press was significantly prolonged, the consumption of opioid was reduced within the first 3 days postoperatively, the time to ambulation was shortened, and patient satisfaction scores at discharge were increased in BL group ( P<0.05). There were no statistically significant differences between the two groups in terms of the chest tube duration, length of hospital stay, and incidence of adverse reactions during hospitalization ( P>0.05). Conclusions:Bupivacaine liposome for erector spinae plane block can improve the quality of postoperative recovery in patients undergoing thoracoscopic lung resection.
8.Effects of different modes of ankle pump exercise on preventing femoral vein catheter-related thrombosis in patients with lung cancer
Shujie CHEN ; Jinghui ZHANG ; Jianmei HOU ; Lingxia LUO ; Guiyuan MA ; Zixin HU ; Sha PENG ; Ran XU ; Cailan ZHANG
Chinese Journal of Modern Nursing 2022;28(12):1547-1551
Objective:To explore the intervention effect of different modes of ankle pump exercise on femoral vein peripherally inserted central catheter (PICC) catheter-related thrombosis in patients with lung cancer.Methods:Using the convenient sampling method, 96 cases of lung cancer patients with femoral vein PICC catheterization admitted to Xiangya Hospital of Central South University from January 2019 to October 2020 were set as the control group and 97 cases of lung cancer patients with femoral vein PICC cannula from October 2020 to October 2021 were set as the observation group. They adopted the comfort angle ankle pump exercise and the maximum angle ankle pump exercise mode, respectively. The differences in the incidence of catheter-related thrombosis, the incidence of unplanned extubation, fatigue score and catheter indwelling time were compared between the two groups.Results:The incidence of catheter-related thrombosis and unplanned extubation in the observation group were lower than those in the control group, and the differences were statistically significant ( P<0.05) . The fatigue score and catheter indwelling time of the observation group were higher than those of the control group, and the differences were statistically significant ( P<0.05) . Conclusions:The maximum angle ankle pump motion mode can reduce the incidence of catheter-related thrombosis and unplanned extubation of femoral vein PICC catheterization in patients with lung cancer and improve the catheter indwelling time, but it is easy to cause patient fatigue, so clinical promotion and use should consider the patients' tolerance.
9.Classification management of HIV reactive blood donors based on test results
Rui WANG ; Ling LI ; Zhengmin LIU ; Jin GUO ; Jinghui HU ; Jing ZHANG ; Hongwei GE ; Zhong LIU
Chinese Journal of Blood Transfusion 2022;35(3):296-300
【Objective】 To explore the viability of classification management of HIV reactive blood donors based on test results in blood screening laboratory. 【Methods】 According to the HIV test results of blood donors (including twice ELISA and once NAT), the HIV reactive blood donors were divided into three groups. Group 1 was all-test reactive (both ELISA and NAT were reactive), group 2 serological reactive (only ELISA was reactive), and group 3 NAT reactive (only NAT was reactive). The HIV test results of 191 628 blood donors from May to December 2017 were analyzed. Samples with positive RIBA results and / or the repeated reactive NAT results were determined as HIV true positive. The yielding rates of HIV true positivity in each group were analyzed. Receiver operating characteristic curve (ROC curve) was used to elevate the S/CO limit under 99% specificity as the blood donor deferral limit for ELISA. 【Results】 A total of 180 HIV reactive samples were detected out of 191 628 blood donors, including 77 positive cases in group 1, 100 in group 2 and 3 in group 3. 1) The HIV reactive results were diverse. Among the 82 true positive blood donors, 4 were early HIV infection (3 HIV antibody+ antigen window period yield, 1 HIV antibody window period yield), 2 were suspected elite controllers, and 76 cases were both serology and NAT reactive. 2) The overall yielding rate of HIV was 47.67%, with group 1 (100%) = group 3 (100%) > group 2 (2.17%), showing statistically significant (P<0.01). 3) The blood donor deferral limit for ELISA1, ELISA2 was 5.40 and 9.69 (S/CO value), respectively, with the corresponding positive expective values of 98.73% and 91.14% (P>0.05). All true positive blood donors in group 1 and group 2 could be accurately screened by using the blood donor deferral limit for ELISA1 and ELISA2 simultaneously. 【Conclusion】 The composition of HIV results among blood donors is diverse and complex. It is necessary to continuously improve the awareness of HIV prevention and control. The classification of HIV reactive blood donors is conducive to conduct fine and scientific management. The blood donors in group 1 and group 3 should be permanently deferral, and the suspected HIV elite controllers in group 2 should be paid attention to and permanently deferral.
10.Effects of WeChat-based process in patients undergoing CT enhanced examination
Jinghui CAO ; Baoping WU ; Xiujuan HU ; Miao LI
Chinese Journal of Modern Nursing 2022;28(29):4107-4112
Objective:To explore the effects of WeChat-based CT enhanced examination process on the examination efficiency of patients undergoing CT enhanced examination.Methods:Totally 178 patients who received CT enhanced examination in the Department of Radiology (Intervention) , China-Japan Union Hospital of Jilin University from January 2019 to December 2020 were selected by random sampling, of which 87 patients from January to December 2019 were included in the control group, while 91 patients from January to December 2020 were included in the observation group. Patients in the control group were subjected to routine procedures, while patients in the observation group were subjected to WeChat-based enhanced CT examination procedures. The Patient Satisfaction Questionnaire Short Form (PSQ-18) and China Occupational Strain Scale (COSS) were used to investigate the patients and compare the CT-enhanced examination efficiency, patient satisfaction and occupational tension of medical staff between the two groups. Totally 12 medical staff who worked in the Department of Radiation (Intervention) of China-Japan Union Hospital of Jilin University from January 2019 to December 2020 were selected by random sampling to investigate the impact of process optimization on the working conditions of medical staff. A total of 12 questionnaires were distributed to medical staff in this study, and 12 valid questionnaires were recovered, with an effective recovery rate of 100.00%.Results:The appointment time, waiting time, preparation time before examination and total examination time of the observation group were all shorter than those of the control group, and the difference was statistically significant ( P<0.01) . In addition, the PSQ-18 scores and total scores of patients in the observation group were higher than those in the control group, except for interpersonal communication skills of the follow-up personnel and the communication level of the follow-up personnel, and the difference was statistically significant ( P<0.05) . The COSS scores and total scores of medical staff in the observation group were lower than those in the control group, and the difference was statistically significant ( P<0.05) . Conclusions:The WeChat-based CT enhanced examination process can help improve the inspection efficiency among patients undergoing CT enhanced examination, improve patient satisfaction, and reduce the occupational tension of medical staff.

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