【Objective】 To evaluate the performance and clinical application of a high-throughput nucleic acid blood screening detection system for SARS-CoV-2, so as to provide basis and technical means for its application in detection of plasma from recovered COVID-19 patients. 【Methods】 The SARS-CoV-2 nucleic acid was detected by real-time fluorescence quantitative PCR, and the sensitivity, precision, anti-interference and other parameters were evaluated. Blood donor samples collected during COVID-19 epidemic period were screened using the detection system to evaluate its applicability. 【Results】 The detection limits of gene N and ORF 1ab were 3.98 copies/mL and 9.38 copies/mL, respectively. The CV of high and low concentration samples were both less than 5%. Hemoglobin at 500 mg/dL and triglyceride at 3g/dL had little effect on the results. The detection system can effectively prevent carryover, thus avoiding false positive results. The SARS-CoV-2 nucleic acid blood screening was carried out in a total of 39 306 blood samples, and all samples were negative. 【Conclusion】 The established method can meet the needs of SARS-CoV-2 nucleic acid screening therefore ensure the safe application of plasma from recovered COVID-19 patients.

【Objective】 To verify the key performance parameters of Roche Cobas S201 multiplex NAT for blood donors, so as to provide data for the conformation of multiplex NAT performance and establish a scientific and feasible verification scheme. 【Methods】 Comprehensive performance verification on four key parameters of ROCHE COBAS S201 multiplex NAT system, including the 95% detection limit, compliance rate, anti-interference ability and operator comparison were conducted. The data were compared with the specifications provided by the manufacturer to evaluate the performance of laboratory testing system and ensure the quality of blood testing. 【Results】 2 sets of COBAS S201 multiplex NAT system in our laboratory were used to perform 5 times of the 95% detection limit value declared by the manufacturer for individual tests. The experimental results showed that the target NAT can be detected 100% and the lower limit of determination was verified. Single-virus NAT was performed to detect 5 different HBV DNA concentrations (25 ~400 IU/mL), 5 different HCV RNA concentrations (25 ~400 IU/mL), 5 different HIV RNA Concentration (100~1 000 IU/mL), and 5 negative tubes. The experimental results showed that all detected values of 20 tubes were 100% consistent with the true value, and the performance parameter "coincidence rate" was verified. Samples containing lipoemia, hemolysis, with ALT>50 mL/L and syphilis-positive endogenous interfering substances with 3 times of the 95% detection limit value were tested for 3 times, and results showed both response rate (3/3) and yielding rate reached 100%. In the control group (with none or in the normal range of interfering substances), reactivity was detected in samples with extremely low concentration of 3 times of the 95% detection limit, showing no significant difference (P>0.05). Above results fully showed that the existence of interference substances (lipidemia, hemolysis, ALT ≥ 50 and syphilis positive) in the blood of donors had no significant effect on the yielding of HBV/HCV/HIV virus target nucleic acids. Different operators performed the sample loading tests with same instrument, reagent and specimen showed 100% consistency in the results. It could be preliminarily assessed that there was no difference in the operations between the operators in this verification. 【Conclusion】 The verification scheme of the multiplex NAT system for methodology performance index (95% detection limit, coincidence rate, anti-interference ability, and operator comparison) established in this study, showed simple, flexible, scientific and feasible characteristics and could provide reference and data support for domestic blood transfusion services in acid detection.

【Objective】 To establish a routine screening method for unexpected antibodies of blood donors, analyze the results of centralized screening for unexpected antibody of blood donors in the blood center, and compare the cost of centralized and decentralized screening modes. 【Methods】 A total of 35 591 blood donors were screened for unexpected antibodies from March 31, 2021 to July 31, 2021, using microcolumn gel method. Unexpected antibody screening reactive samples were further confirmed by the Transfusion Research Institute of Shenzhen Blood Center, and the demographic characteristics were further determined through the analysis of unexpected antibody positive population. The direct cost and indirect cost of centralized and decentralized unexpected antibody screening mode were compared. 【Results】 Forty unexpected antibody positive samples were confirmed in Shenzhen, with the positive rate at 0.11%(40/35 591), among which MNS, Rh and Lewis system accounted for 35% (14/40), 32.5% (13/40) and 17.5% (7/40), respectively. Males and females accounted for 45% (18/40) and 55% (22/40), respectively (P<0.01). No significant difference was noticed by age and repeated-donor or not (P>0.05). Unexpected antibody screening in a centralized way saved about 1.16 million yuan per year. 【Conclusion】 It is necessary to carry out unexpected antibody screening for all blood donors, and centralized screening is more economical than decentralized screening.

Human platelet lysates(HPL), as a new type of biomaterial, can promote tissue repair, cell proliferation and inflammation control. This paper introduced the development of HPL in the field of regenerative medicine and cell therapy and summarizes their application. The potential of HPL to promote cell proliferation was used as an entry point to show its advantages as a supplement of cell culture medium. Since there is currently no standard procedure for HPL preparation, this paper sorts out the standardization elements such as raw materials source, donor variability and preparation technology, in order to provide reference for the establishment of standards of relevant industry in the future.

【Objective】 To establish the indicator and fuzzy evaluation model for the procurement demonstration of key instruments and equipment, in order to provide a scientific and reliable method for the procurement demonstration of equipment in blood centers. 【Methods】 Through literature review and Delphi method, the procurement evaluation indexes of key instruments and equipment in blood centers were established. The weights of each index were calculated using analytic hierarchy process (AHP) by sending questionnaires to experts. According to the established indicator and fuzzy comprehensive evaluation method, a scoring model of procurement demonstration of key instruments and equipment was constructed. The blood screening total laboratory automation was analyzed and verified using the established demonstration model. 【Results】 A total of 4 first-level evaluation indicators and 16 second-level evaluation indicators were established. The weights of urgency, social benefit, economic benefit and technical condition were 0.496, 0.300, 0.051 and 0.153, respectively. For the blood screening assembly line system to be procured, the evaluation value was 0.629, and it passed the procurement demonstration. 【Conclusion】 The quantitative and scientific evaluation of the procurement evaluation can be carried out by establishing the evaluation index and fuzzy comprehensive evaluation method for the key instruments and equipment of blood centers.

【Objective】 To establish and improve the emergency recruitment strategy of voluntary blood donors under public health emergencies in Shenzhen and verify its effectiveness. 【Methods】 Blood donor recruitment strategies under routine, emergency and combined situation were developed. The blood collection data from 2017 to 2019 before the outbreak of COVID-19 pandemic was used as the control group, and those from 2020 to 2022 after the outbreak was used as the experimental group, and the feasibility and effectiveness of this emergency recruitment strategy was confirmed through statistical analysis of key indicators of blood collection and supply. 【Results】 Through the application of the emergency recruitment strategy for blood donors in Shenzhen under public health emergencies, statistical analysis of the experimental group and the control group showed a year-on-year increase of 14.11%(73 647.25/521 855.5) in whole blood collection, 42.33%(28 891.47/68 250.95) in platelet collection, 0.33%(529/161 033) in first-time donors, 33.25%(3 154/9 487) in repeated donors and 16.78%(32 585/194 149) in the number of 400 mL donors. The inventory of various types of red blood cell maintained between 6-18 days. After the implementation of the emergency recruitment strategy the blood donation population has shown characteristics as younger age, localization, increased repeated donation and a higher proportion of donors with college education or above. 【Conclusion】 The emergency recruitment strategy of blood donors under public health emergencies is feasible and effective, which can quickly and efficiently improve the blood recruitment ability.

Objective    To summarize the experience and lessons of right ventricular decompression in children with pulmonary atresia and intact ventricular septum (PA/IVS) and to reflect on the strategies of right ventricular decompression. Methods    The clinical data of 12 children with PA/IVS who underwent right ventricular decompression in our hospital from March 2015 to December 2019 were reviewed retrospectively. There were 10 males and 2 females with a median age at the time of surgery was 5 d (range, 1-627 d). Correlation analysis between the pulmonary valve transvalvular pressure gradient and changes in Z score of tricuspid valves after decompression was performed. Results    One patient died of refractory hypoxemia due to circulatory shunt postoperatively and family members gave up treatment. There were 2 (16.67%) patients received postoperative intervention. The pulmonary transvalvular gradient after decompression was 31.95±21.75 mm Hg. Mild pulmonary regurgitation was found in 7 patients, moderate in 2 patients, and massive in 1 patient. The median time of mechanical ventilation was 30.50 h (range, 6.00-270.50 h), and the average duration of ICU stay was 164.06±87.74 h. The average postoperative follow-up time was 354.82±331.37 d. At the last follow-up, the average Z score of tricuspid valves was 1.32±0.71, the median pressure gradient between right ventricle and main pulmonary artery was 41.75 mm Hg (range, 21-146 mm Hg) and the average percutaneous oxygen saturation was 92.78%±3.73%. Two children underwent percutaneous balloon pulmonary valvoplasty at 6 and 10 months after surgery, respectively, with the rate of reintervention-free of 81.8%. There was no significant correlation between pulmonary transvalvular gradients after decompression and changes in Z score of tricuspid valves (r=–0.506, P=0.201). Conclusion    For children with PA/IVS, the simple pursuit of adequate decompression during right ventricular decompression may lead to  severe pulmonary dysfunction, increase the risk of ineffective circular shunt, and induce refractory hypoxemia. The staged decompression can ensure the safety and effectiveness for initial surgery and reduce the risk of postoperative death.

Objective: To construct the mutants of ARID1A gene, which is an important component in human chromosomal remodeling complex Switch/Sucrose Non Fermentable (SWI/SNF), and identify their overexpression in liver cancer HepG2 cells. Methods: Overlap PCR was used to construct domain truncated mutantss pcDNA6-ARID1A/ΔARID and pcDNA6-ARID1A/ΔD UF3518 based on wild type plasmids pcDNA6-ARID1A. Lipofectionmethod was used to transfect the wild type and mutants into HepG2. Real-time PCR and western blotting were used to confirm the overexpression of ARID1A and the mutants. Results: SDS-PAGE and sequencingresult confirmed the successful construction of pcDNA6-ARID1A/ΔARID and pcDNA6-ARID1A/ΔDUF3518. Real-time PCR and western blottingresult confirmed the overexpression of both mRNA and protein of wild type ARID1A and ARID1A/ΔARID. The mRNA levels indicated that ARID1A/Δ DUF3518 were overexpressed, but the protein levels were quite low. Conclusions Functional domain truncated mutants of ARID1A were successfully constructed. Overexpression of wild type ARID1A and ARID1A/ΔARID in liver cancer HepG2 cells was successful. Loss of ARID1A/ΔDUF3518 protein suggest that DUF3518 may contribute to the protein structure stability.

【Objective】 In an effort to prevent transfusion-transmitted hepatitis B infection, universal HBsAg screening, HBsAg+ MP nucleic acid test(NAT) for HBV and HBsAg + individual(ID) NAT were analyzed for cost-effectiveness. 【Methods】 On the basis of screening data and the documented parameter, the number of window period infections, chronic infections and occult infections was constructed, and cost-benefit analysis was conducted. 【Results】 Of 132 208 donations, the yield rate of ID NAT for HBsAg-/DNA+ (0.11%) was significantly higher than HBsAg+ MP NAT(0.058%). Furthermore, the predicted preventing transfusion transmitted HBV cases by ID NAT is 1.25 times as that by MP-6 NAT, so did the benefits. The cost-benefit of the three screening models were 1∶63.6、1∶28.6 and 1∶53.4. 【Conclusion】 Universal HBsAg in combination with ID HBV NAT screening was the most effective among all screening strategy. It is necessary to applied HBsAg and ID HBV NAT screening for the safety of blood transfusion.

【Objective】 To establish scrap indicators for key equipment in blood screening laboratory of blood centers and quantitatively assess the running status of key equipment, so as to provide a scientific method for equipment scrap. 【Methods】 Through the literature review and Delphi method, the scrap indicators of key equipment in blood screening laboratories were established in terms of applicability, economy and advancement of the equipment. The weights of relevant indicators were calculated by analysis hierarchy process (AHP), and the quantitative assessment model of equipment scrap priority was established according to the indicators and its weight. The equipment running data from January 2020 to December 2020 of Laboratory Department were collected and analyzed using the model, and its accuracy was verified based on experience. 【Results】 Thirteen second-level scrap indicators were established, and the weights of the three first-level indexes of applicability, economy and advancement were 0.582, 0.114 and 0.306, respectively. Among the total 30 key equipment, the model score of 4 equipment was less than 0.5, and the running status after manually checking met the scrap standard. 【Conclusion】 The model can accurately assess the scrap priority of key equipment and facilitate the procurement budget and scrapping identification in advance, which can avoid the waste of resources and ensure safe, efficient and orderly laboratory work.