1.Data analysis of resolution discrepancies in minipool nucleic acid testing: A 2024 national study of Chinese blood stations
Ying YAN ; Qing HE ; Wei ZHENG ; Jie MA ; Le CHANG ; Huimin JI ; Huizhen SUN ; Lunan WANG
Chinese Journal of Blood Transfusion 2026;39(4):423-429
Objective: To investigate the incidence, characteristics, and influencing factors of resolution discrepancies within the minipool (MP) testing model across Chinese blood station laboratories in 2024. Methods: A nationwide, multicenter, cross-sectional study was conducted, including 334 blood station laboratories that reported nucleic acid reactive data among enzyme immunoassay non-reactive samples. Of these, 296 laboratories adopted the pool resolution model, with a total of 12 536 273 samples tested. Systematic analysis was performed on resolution data, focusing on the MP-NAT reactivity rate, the pool resolution concordance rate, and the resolution discrepancy rate. Subgroup analyses were conducted based on reagent types, viral targets, and Ct values. Potential causes were further explored through laboratory surveys and re-examination of raw amplification curves. Results: In 2024, the national average MP-NAT reactivity rate was 0.15%. The overall pool resolution concordance rate was 57.86%, which showed a gradual decline as Ct values increased across all reagents. The national average resolution discrepancy rate was 0.081‱(102/12 536 273), with 17.91%(53/296) of laboratories reporting at least one discrepancy. Nine reagent types were associated with these events, exhibiting reagent-specific patterns. For Reagent A2, the predominant discrepancy was HBV reactive pools resolving as HIV (36.36%); for Reagent D1, HBV pools frequently resolved as HCV (38.89%); and for Reagent E, the most common pattern was HIV pools resolving as HBV (48.00%). These resolution discrepancies were strongly associated with high Ct values: the median pool Ct for HBV exceeded 38, while those for HCV and HIV both exceeded 40. Investigations across 16 laboratories revealed that most discrepant samples exhibited “tailing” amplification curves, with some cases linked to cross-contamination or reagent batch-specific issues. Conclusion: While the incidence of resolution discrepancies in the MP-NAT model remains low in China, variations exist across different reagents and laboratories. These discrepancies are closely associated with low viral load, reagent performance, and laboratory operational practices.
2.Analysis of Dengue virus nucleic acid testing screening among blood donors in Xishuangbanna Dai Autonomous Prefecture, China
Xinru LIU ; Shaofang LU ; Ying YAN ; Jing DONG ; Ji WU ; Jie MA ; Le CHANG ; Huimin JI ; Huizhen SUN ; Mingwen DENG ; Xiaoqian GAO ; Lunan WANG
Chinese Journal of Blood Transfusion 2025;38(12):1662-1668
Objective: To investigate the prevalence of Dengue virus (DENV) infection among voluntary blood donors in Xishuangbanna Dai Autonomous Prefecture, and to evaluate the necessity of implementing nucleic acid testing (NAT) for blood donors during the rainy season (May-October). Methods: Prior to initiating donor screening, the Xishuangbanna Central Blood Center conducted in-house validation of reagent performance and participated in external quality assessment (EQA) organized by the National Center for Clinical Laboratories (NCCL). During the surveillance period (August-October 2024), a total of 2 919 donor samples were screened using a 6-sample mini-pool NAT strategy. Daily internal quality controls were recorded. Samples that tested positive in pooled screening were deconvoluted and retested in duplicate; only those reactive in both replicate wells were sent to the NCCL for confirmatory testing. At NCCL, samples underwent re-testing using five domestic NAT reagents, as well as serological assays for NS1 antigen and DENV-specific IgG/IgM. Confirmed positive samples were further characterized by serotyping, envelope (E) gene sequencing, and phylogenetic analysis using the maximum likelihood method. Results: The DENV NAT reagent demonstrated consistent detection of 40 copies/mL controls in individual donor (ID)-NAT test (mean CT: 35.61±0.40). During the 63-day quality control monitoring, DENV detection remained stable (mean CT: 22.53±0.72). The center achieved full marks in EQA assessments for 2023 and 2024. Three reactive pools were identified in initial screening, and subsequent individual testing confirmed three DENV RNA-positive donors (sample numbers: 2401, 2402, and 2403). The confirmatory test results from NCCL were: all five NAT platforms consistently detected DENV RNA in the three samples; for serological tests, 2 samples (2402, 2403) were positive for NS1 antigen, while all three samples were negative for both IgG and IgM antibodies. DENV serotyping reagents identified DENV-2 in all cases, which were further confirmed as DENV-2 Genotype Ⅱ-Cosmopolitan by E gene sequencing. Phylogenetic analysis indicated that samples 2401 and 2402 clustered with Southeast Asian strains (Thailand/MZ636802.1, Laos/PQ775621.1), while sample 2403 closely matched a previously reported local Yunnan strain (PV544686.1). Conclusion: DENV-2 infection was detected among blood donors in Xishuangbanna during the rainy season, indicating concurrent risks of imported and local transmission. We recommend implementing pooled NAT screening for blood donors in high-risk areas during dengue epidemic seasons, along with strengthened laboratory quality control, to enhance blood safety.
3.Analysis of the adjustment of current eligibility criteria for alanine aminotransferase levels in blood screening in China
Le CHANG ; Ying YAN ; Huimin JI ; Huizhen SUN ; Lunan WANG
Chinese Journal of Blood Transfusion 2025;38(4):465-473
[Objective] To obtain accurate data on alanine aminotransferase (ALT) levels among blood donors in China and to explore the necessity of adjusting the qualification criteria for ALT. [Methods] A collaborative study was conducted involving 26 blood centers and 7 central blood stations with an annual testing volume exceeding 100 000 samples. Between December 1 and 15, 2024, pre-donation ALT testing was suspended for 1-2 days for all whole blood donations. ALT levels were measured only post-donation using standard laboratory equipment and reagents. All transfusion-transmitted infectious disease-related serological and nucleic acid testing, including hepatitis E virus (HEV) RNA testing, were performed. Within one week of testing completion, anonymized data on basic donor information, routine test results, and HEV RNA results were collected and statistically analyzed. [Results] A total of 21 345 blood donors were included in the study, with an ALT disqualification rate of 7.6% (1 623/21 345). The disqualification rate was 9.6% (1 453/15 205) for males and 2.8% (170/6 140) for females. There were significant regional variations in both the disqualification rates and levels of ALT, with Shaanxi Province exhibiting the highest disqualification rate (12.3%, 87/710) and Yunnan Province the lowest (2.9%, 19/652). Among the provinces (autonomous regions and municipalities), Beijing recorded the lowest ALT levels. ALT levels varied across different age groups and genders. Among all samples tested by HEV RNA, the HEV RNA positive rate was 0.29‰ (6/21 003). HCV infection was found to directly affect ALT levels, while HBV, HIV, syphilis, and HEV infections did not significantly impact ALT disqualification rates. It is recommended to adjust the ALT qualification criteria to twice the upper limit of the clinical reference range, which would increase the number of eligible blood donations by 6.61% (1 293/19 550). [Conclusion] In China, the ALT levels of blood donors are correlated with gender, age, geographical region, and HCV infection status. Appropriately raising the ALT eligibility criteria to ≤100 U/L for male donors and ≤80 U/L for female donors could expand the pool of eligible donors and reduce the blood discard rate while ensuring blood safety.
4.Development of a stratified training program for operating room nurses in tertiary hospitals based on the Delphi method
Huizhen WANG ; Jie ZHANG ; Linjuan ZHANG ; Jingjing AN ; Li MU ; Lin ZHAO ; Yuhong SUN
Basic & Clinical Medicine 2025;45(8):1116-1120
Objective To develop a tiered training framework for operating room nurses in tertiary hospitals,provi-ding guidance for corresponding training curriculum development and clinical competency evaluation.Methods Delphi method was used to conduct two rounds of expert consultation on the preliminary training indicators,estab-lishing a comprehensive tiered training framework for operating room nurses.Results After two rounds of expert consultation,a tiered training framework for operating room nurses was constructed,which includes 6 primary indi-cators,19 secondary indicators and 62 tertiary indicators.The response rate of the two rounds of expert consultation for valid questionnaires were all over 99%and the expert authority coefficients were all over 0.87.Conclusions The consulted experts have good enthusiasm and authority;the developed framework comprehensively covers training content,laying a foundation for designing and implementing tiered training programs for operating room nurses.
5.Expert Consensus on Postoperative Patient-controlled Analgesia Follow-up in Adults(2025)
Xiaopeng HUO ; Yuhong SUN ; Huizhen WANG
Medical Journal of Peking Union Medical College Hospital 2025;16(4):899-907
Postoperative pain is a common clinical phenomenon,and patient-controlled analgesia(PCA)is currently the most widely used and optimal analgesic method.Postoperative follow-up can guide pa-tients in the correct use of PCA,thereby effectively alleviating postoperative pain.To date,there has been no expert consensus or guideline to standardize clinical practices in this regard.To address this gap,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,China-Japan Friendship Hospital,and the Clinical Anesthesia Quality Management Group of the Chinese Society of Anesthesiology jointly initiated and organized a panel of clinicians and nurses specializing in postoperative pain management and research to develop the Expert Consensus on Postoperative Patient-controlled Analgesia Follow-up in Adults(2025).Based on the latest evidence-based data and expert clinical experience,this consensus provides preliminary recommendations in three key areas:the composition of the Patient-controlled Analgesia follow-up team,suitable patient populations,and follow-up and nursing care.It aims to offer valuable guidance for the standardized management of PCA in postoperative patients.
6.Expert Consensus on Postoperative Patient-controlled Analgesia Follow-up in Adults(2025)
Xiaopeng HUO ; Yuhong SUN ; Huizhen WANG
Medical Journal of Peking Union Medical College Hospital 2025;16(4):899-907
Postoperative pain is a common clinical phenomenon,and patient-controlled analgesia(PCA)is currently the most widely used and optimal analgesic method.Postoperative follow-up can guide pa-tients in the correct use of PCA,thereby effectively alleviating postoperative pain.To date,there has been no expert consensus or guideline to standardize clinical practices in this regard.To address this gap,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,China-Japan Friendship Hospital,and the Clinical Anesthesia Quality Management Group of the Chinese Society of Anesthesiology jointly initiated and organized a panel of clinicians and nurses specializing in postoperative pain management and research to develop the Expert Consensus on Postoperative Patient-controlled Analgesia Follow-up in Adults(2025).Based on the latest evidence-based data and expert clinical experience,this consensus provides preliminary recommendations in three key areas:the composition of the Patient-controlled Analgesia follow-up team,suitable patient populations,and follow-up and nursing care.It aims to offer valuable guidance for the standardized management of PCA in postoperative patients.
7.Epidemiological characteristics of Chlamydia trachomatis infection in Hubei Province in 2008 - 2022
Danyang LI ; Huadao XIONG ; Xiong ZHOU ; Huizhen SUN ; Xue YANG ; Hui CHEN
Journal of Public Health and Preventive Medicine 2024;35(6):63-67
Objective To understand the epidemiological characteristics of Chlamydia trachomatis infection in Hubei province, and to provide scientific basis for prevention and control. Methods The data of Chlamydia trachomatis infection cases reported through the China Information System for Disease Control and Prevention from 2008 to 2022 were collected for epidemiological statistical analysis. Results The incidence of Chlamydia trachomatis infection in Hubei Province showed an increasing trend from 2008 to 2022, with an average annual reported incidence of 2.26/100 000. The top three reported incidence areas were Shiyan (6.04/100 000), Yichang (5.62/100 000) and Shennongjia (3.47/ 100 000). The reported incidence in southeast area was significantly higher than that in other areas (χ2=2869.603 , P < 0.001). The high incidence age group was 20-39 years old, accounting for more than 70%. The reported incidence in females was higher than that in males (χ2=1429.27 , P < 0.001). Housework and unemployment were the most common professions (43.54%). The case reporting institutions were mainly comprehensive hospitals (87.29%). Conclusion To effectively control the infection and transmission of Chlamydia trachomatis, it is necessary to strengthen the health popularization of STD knowledge, intervention and early active screening of high-risk groups.
8.Bronchoscopic transparenchymal nodule access in the diagnosis and management of pulmonary nodules.
Quncheng ZHANG ; Xuan WU ; Huizhen YANG ; Ya SUN ; Ziqi WANG ; Li YANG ; Nan WEI ; Yihua ZHANG ; Yuanjian YANG ; Xingru ZHAO ; Felix Jf HERTH ; Xiaoju ZHANG
Chinese Medical Journal 2023;136(13):1615-1617
9.Evaluation of ICUs and weight of quality control indicators: an exploratory study based on Chinese ICU quality data from 2015 to 2020.
Longxiang SU ; Xudong MA ; Sifa GAO ; Zhi YIN ; Yujie CHEN ; Wenhu WANG ; Huaiwu HE ; Wei DU ; Yaoda HU ; Dandan MA ; Feng ZHANG ; Wen ZHU ; Xiaoyang MENG ; Guoqiang SUN ; Lian MA ; Huizhen JIANG ; Guangliang SHAN ; Dawei LIU ; Xiang ZHOU
Frontiers of Medicine 2023;17(4):675-684
This study aimed to explore key quality control factors that affected the prognosis of intensive care unit (ICU) patients in Chinese mainland over six years (2015-2020). The data for this study were from 31 provincial and municipal hospitals (3425 hospital ICUs) and included 2 110 685 ICU patients, for a total of 27 607 376 ICU hospitalization days. We found that 15 initially established quality control indicators were good predictors of patient prognosis, including percentage of ICU patients out of all inpatients (%), percentage of ICU bed occupancy of total inpatient bed occupancy (%), percentage of all ICU inpatients with an APACHE II score ⩾15 (%), three-hour (surviving sepsis campaign) SSC bundle compliance (%), six-hour SSC bundle compliance (%), rate of microbe detection before antibiotics (%), percentage of drug deep venous thrombosis (DVT) prophylaxis (%), percentage of unplanned endotracheal extubations (%), percentage of patients reintubated within 48 hours (%), unplanned transfers to the ICU (%), 48-h ICU readmission rate (%), ventilator associated pneumonia (VAP) (per 1000 ventilator days), catheter related blood stream infection (CRBSI) (per 1000 catheter days), catheter-associated urinary tract infections (CAUTI) (per 1000 catheter days), in-hospital mortality (%). When exploratory factor analysis was applied, the 15 indicators were divided into 6 core elements that varied in weight regarding quality evaluation: nosocomial infection management (21.35%), compliance with the Surviving Sepsis Campaign guidelines (17.97%), ICU resources (17.46%), airway management (15.53%), prevention of deep-vein thrombosis (14.07%), and severity of patient condition (13.61%). Based on the different weights of the core elements associated with the 15 indicators, we developed an integrated quality scoring system defined as F score=21.35%xnosocomial infection management + 17.97%xcompliance with SSC guidelines + 17.46%×ICU resources + 15.53%×airway management + 14.07%×DVT prevention + 13.61%×severity of patient condition. This evidence-based quality scoring system will help in assessing the key elements of quality management and establish a foundation for further optimization of the quality control indicator system.
Humans
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China/epidemiology*
;
Cross Infection/epidemiology*
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Intensive Care Units/statistics & numerical data*
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Quality Control
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Quality Indicators, Health Care/statistics & numerical data*
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Sepsis/therapy*
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East Asian People/statistics & numerical data*
10.Design of internal quality control program for specific protein testing based on patient risk
Jiali LIU ; Huizhen SUN ; Yongjun GUO ; Xiangyi LIU ; Wei WANG ; Zhiguo WANG
Chinese Journal of Laboratory Medicine 2022;45(9):963-967
Objective:Patient risk-based statistical quality control (SQC) program was designed for 9 specific protein projects using Westgard sigma rules with run length.Methods:The cumulative coefficient of variation of immunoglobulin (Ig)G, IgA, IgM, C3, C4, rheumatoid factor (RF), antistreptolysin O (ASO), transferrin (TRF) and prealbumin (PA) from the laboratory department of Beijing Tongren Hospital between December 2018 to May 2019 were used as the estimated value of imprecision. The mean of the absolute value of the percentage difference of 10 batches in the laboratory, which was derived from the results of participating the external quality assessment (EQA), was used as the estimated value of bias. The National Center for Clinical Laboratories EQA evaluation criteria was used as an allowable total error (TEa), and the sigma value of each project (σ) was calculated. Westgard Sigma rule with run length was used to design appropriate SQC program for each project, including quality control rules, number of control measurements (N) and frequency of quality control.Results:The sigma value was larger than 6 for SQC procedure of IgG, IgA, IgM, C4 and TRF. SQC could be established with the use of 1 3s rule, number of control measurements (N)=2, number of runs (R)=1, and a run length of 1 000 patient samples. Combined with the average daily workload, internal quality control could be conducted once every 10 days for IgG, IgA, IgM and C4, every 50 days for TRF. The σ was 5.86 for C3, SQC program could be established with run length of 450 using 1 3S/2 2S/R 4s rule (N=2, R=1), combined with average daily workload, internal quality control could be conducted every 4.5 days. σ was between 3 and 4 for RF, ASO and PA. With the use of 1 3S/2 2S/R 4s/4 1s/6 X rule (N=6, R=1), SQC program with a run length of 45 and higher frequency internal quality control activities. Conclusion:It is feasible to use Westgard sigma rules with run length for the laboratories design of personalized risk-based SQC procedures, the method is very simple and intuitive. This tool is valued to be recommended to be actively applied by all clinical laboratories.


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