Alzheimer's disease (AD) is the most common neurodegenerative disease globally and presents a significant challenge to the aging population of China. Early diagnosis and intervention are core to delaying disease progression; however, the early stages of AD manifest in subtle behavioral changes and are difficult to detect. The pathophysiological mechanisms of AD are characterized by amyloid beta (Au03B2) deposition and abnormal tau protein phosphorylation. Current detection methods, such as positron emission tomography (PET) imaging and cerebrospinal fluid (CSF) analysis, are limited in clinical application because of high costs and the invasive nature of CSF collection. Consequently, blood biomarkers of AD are urgently sought because they are minimally invasive and cost effective. Biochemical mass spectrometry methods, such as immunoprecipitationu2010mass spectrometry and liquid chromatographyu2010tandem mass spectrometry can precisely detect lowu2010abundance biomarkers. These platforms boast sensitivities at the femtogram/milliliter level with specificities exceeding 99%, and are capable of simultaneously quantifying multiple markers. For example, the plasma Au03B242/Au03B240 ratio [area under the curve = 0.967] and plasma pu2010tau217 [correlation coefficient with CSF = 0.891] have demonstrated diagnostic performance comparable to PET/CSF but at a fifth to one tenth of the cost, making them viable diagnostic markers for AD. This review examines the significance and the domestic and international research status of AD blood biomarkers based on biochemical mass spectrometry platforms, and outlines the challenges and prospects for their future clinical application.

OBJECTIVE:This study aimed to evaluate the diagnostic ability of interleukin 2 (IL-2) and interferon gamma (IFN-γ) release assay induced by the fusion protein (ESAT-6/CFP-10/Rv1985c) for detecting active tuberculosis (ATB) in clinically visiting patients. METHODS:A total of 970 subjects (215 in ATB group and 755 in non-ATB group) underwent both an interferon-γ release assay (IGRA) and a TB-DNA PCR assay. Using clinical diagnosis as the gold standard, both qualitative and quantitative test results for IL-2 and IFN-γ were analyzed. Subsequently, the diagnostic ability of IL-2 and IFN-γ to screen for ATB among the high-risk population was then evaluated. RESULTS:IL-2 exhibited higher specificity, while IFN-γ demonstrated higher sensitivity in distinguishing between ATB and non-ATB subjects. The sensitivity of the serial application of IL-2 and IFN-γ had no significant difference (p = 1.000) compared with IFN-γ; the specificity of the serial application of IL-2 and IFN-γ had no significant difference (p = 0.708) compared with IL-2. Quantitative analysis of the results revealed that the IL-2 and IFN-γ values were significantly higher in the ATB group compared with the non-ATB group. Additionally, the combined predictors of IL-2 and IFN-γ did not show a significant difference compared with IL-2 alone (p = 0.324) or IFN-γ alone (p = 0.405). CONCLUSIONS:This study demonstrated that IL-2 and IFN-γ release assays induced by the fusion protein (ESAT-6/CFP-10/Rv1985c) were valuable for distinguishing ATB from non-ATB subjects, with IL-2 exhibiting higher specificity and IFN-γ demonstrating higher sensitivity.

Sepsis is a life-threatening condition caused by a dysregulated host response to infection, leading to organ dysfunction. Early diagnosis and accurate prognosis are crucial for improving patient outcomes. Traditional biomarkers such as C-reactive protein (CRP) and procalcitonin (PCT) are widely used but have limitations in sensitivity and specificity. Monocytic human leukocyte antigen-DR (mHLA-DR) has emerged as a promising immunological marker reflecting immune status and severity in sepsis patients. This study aimed to compare the clinical value of mHLA-DR, PCT, and CRP in diagnosing and predicting sepsis outcomes, providing better guidance for clinical management. A retrospective analysis was conducted on 83 sepsis patients and 86 non-sepsis patients admitted to the ICU of our hospital between August 2018 and July 2023. Sepsis patients with clear prognostic outcomes were divided into a survival (24 cases) and death groups (41 cases). Flow cytometry was used to detect mHLA-DR expression, while serum PCT and CRP levels were measured using an automated biochemical immunoassay analyzer. Differences in these indicators were compared between the sepsis and non-sepsis groups as well as between the survival and death groups. Receiver operating characteristic (ROC) curves were employed to analyze the diagnostic and prognostic values of these markers in sepsis. The mHLA-DR, PCT, and CRP levels were significantly higher in the sepsis group compared with the non-sepsis group ( p  < 0.001). The area under the ROC curve (AUC) values for diagnosing sepsis were 0.780 for mHLA-DR, 0.837 for PCT, and 0.839 for CRP, with optimal diagnostic cutoff values of 49.46%, 1.95 ng/mL, and 67.91 mg/L, respectively. The respective sensitivities were 76.7%, 86.7%, and 88.0%, while the respective specificities were 75.9%, 70.9%, and 64.0%. The combined analysis of these three indicators yielded an AUC value of 0.890 with an 86.7% sensitivity and 75.6% specificity. In the sepsis cohort, mHLA-DR expression levels were significantly higher in the survival group compared with the death group ( p  < 0.001), while PCT levels were significantly lower in the survival group ( p  = 0.045). CRP levels showed no significant difference between the survival and death groups ( p  = 0.833). The prognostic efficacy of mHLA-DR was significantly superior to that of PCT, with mHLA-DR displaying an AUC value of 0.841, an optimal cutoff value of 30.14%, and an 87.5% sensitivity and 73.2% specificity. The combined application of mHLA-DR, PCT, and CRP could improve the diagnostic accuracy for sepsis. Overall, mHLA-DR is a significant biomarker for assessing immune suppression and prognosis in sepsis patients.

Background/Objectives: To compare and analyze the application of a Helicobacter pylori (H. pylori, Hp) serum antibody typing test (Hp-sATT) and the 13C-urea breath test (13C-UBT) in the diagnosis of Hp infection against an empirical therapy background. Methods: The detection of Hp-sATT using a combination of the quantum dot immunofluorescence method and the 13C-UBT was carried out in 237 patients who visited the Department of Gastroenterology at Beijing Tsinghua Changgung Hospital. The diagnostic consistency and correlation with gastric lesions of the two detection methods were analyzed by integrating the detection results, clinical information, and special staining of Hp in histopathological tissues (SS-Hp). Results: For the 13C-UBT, 104 (43.88%) cases were positive and 133 (56.12%) were negative. Positive results were found in 127 (53.59%) patients by using the Hp-sATT, with 67 (28.27%) cases of Type I Hp infection and 60 (25.32%) cases of Type II Hp infection. The consistency analysis between the Hp-sATT and 13C-UBT for all the patients showed a Kappa value of 0.339 (p < 0.001); the consistency analysis between the Hp-sATT and the 127 patients with SS-Hp showed a Kappa value of 0.427 (p < 0.001); and the consistency analysis between the 13C-UBT and the 127 patients with SS-Hp indicated a Kappa value of 0.621 (p < 0.001). However, in 191 patients without a history of Hp eradication, the consistency analysis results for the three methods improved, with Kappa values of 0.467 (p < 0.001) and 0.457 (p < 0.001) for the Hp-sATT with the 13C-UBT and SS-Hp, respectively, and 0.646 (p < 0.001) for the 13C-UBT with SS-Hp. In addition, a positive correlation was found between the signal values of anti-urease antibodies and the Delta Over Baseline (DOB) values of the 13C-UBT. The results also indicated that Hp-infected patients exhibited more pronounced gastric lesions, while cases with Type I Hp infection did not. Conclusions: In patients without a history of Hp eradication, the consistency between the Hp-sATT and 13C-UBT is moderate. However, Hp eradication therapy can reduce the consistency of the test results. When screening for Hp infection using the Hp-sATT, it is necessary to consider the patient’s history of Hp eradication.

To assess the real-world analytical performance of Bayer Contour TS (Bayer) Point-of-Care Testing (POCT) glucose meters in long-term actual clinical settings. Based on the ISO 15197:2013, EN ISO 15197:2015, and CLSI POCT12-A3 standards, the analytical performance of 202 Bayer POCT glucose meters was evaluated using 2,931 paired glucose comparative results compared to the central laboratory biochemical analyzer over a continuous five-year period (2020–2024) in a tertiary teaching hospital. The coefficients of variation (CV) of Bayer POCT glucose meters were 2.0

Disseminated tuberculosis (TB) is a severe form of TB associated with high mortality typically occurring in individuals with impaired host defenses. It results from the lymphohematogenous dissemination of Mycobacterium tuberculosis from the primary infection site. Diagnosis can be particularly challenging when pulmonary symptoms are absent. We present a case of disseminated TB in a 73u2010yearu2010old woman who presented with nausea, poor appetite, and lowu2010grade fever. Imaging studies revealed multiple lesions in the lungs, sacroiliac joints, and brain. The nonspecific nature of her initial symptoms, which were inconsistent with the extent of disease involvement, posed significant diagnostic challenges. In this case, metagenomic nextu2010generation sequencing played a pivotal role in confirming the diagnosis of disseminated TB.

AbstractObjectiveThis study aimed to evaluate the system accuracy of four types of blood glucose monitoring systems (BGMSs) and explore the differences in the system accuracy acceptability of each BGMS against five different standards.MethodsThe glucose measurement values obtained from four types of BGMSs (Roche Accu‐Chek® Performa, Bayer Contour™ TS, Sinomedisite Glupad® H1 Plus, and Sinocare® Gold‐Accu) were evaluated against the reference values obtained from the biochemical analyzer of the central laboratory. The system accuracy acceptability of each BGMS was determined using the criteria specified in five standards, namely the International Organization for Standardization (ISO) 15197:2003, Clinical Laboratory Standards Institute (CLSI) POCT12‐A3, ISO 15197:2013, Chinese Society of Laboratory Medicine (CSLM) consensus, and US Food and Drug Administration (FDA) guidelines.ResultsFrom 2018 to 2022, 10,980 pairs of measurement values were obtained from 366 glucose meters of four types of BGMSs. Significant correlations were observed between the glucose measurement values from the BGMSs and the reference values from the biochemical analyzer of the central laboratory. The correlation coefficient r was 0.995 for Roche Accu‐Chek® Performa, 0.994 for Bayer Contour™ TS, 0.983 for Sinomedisite Glupad® H1 Plus, and 0.997 for Sinocare® Gold‐Accu. The acceptability criteria specified in ISO 15197:2003 were met by 100.00% (135/135) of the glucose meters of Roche Accu‐Chek® Performa, 100.00% (109/109) of Bayer Contour™ TS, 81.61% (71/87) of Sinomedisite Glupad® H1 Plus, and 100.00% (35/35) of Sinocare® Gold‐Accu. Whereas, the acceptability criteria specified in ISO 15197:2013 were met by 99.26% (134/135) of the glucose meters of Roche Accu‐Chek® Performa, 88.07% (96/109) of Bayer Contour™ TS, 58.62% (51/87) of Sinomedisite Glupad® H1 Plus, and 91.43% (32/35) of Sinocare® Gold‐Accu.ConclusionsAmong the four types of BGMSs evaluated, the glucose meters of Roche Accu‐Chek® Performa exhibited superior system accuracy. The system accuracy acceptability of each BGMS varied significantly against the acceptability criteria specified in the five different standards.

ObjectiveTo evaluate the accuracy of Roche Accu‐Chek Performa glucose meters at a low glucose concentration of <5.55 mmol/L (100 mg/dL) over a 9‐year period.MethodsThe accuracy of the Roche Accu‐Chek Performa glucose meters at low glucose concentrations was evaluated using annual comparison data for 9 consecutive years from 2015 to 2023, according to the acceptability criteria specified in International Organization for Standardization (ISO) 15197:2013. Blood samples with low glucose concentrations of <5.55 mmol/L were prepared by incubation and glycolysis. The glucose concentration was detected using Roche Accu‐Chek Performa glucose meters and a biochemical analyzer in the central laboratory.ResultsA total of 2978 pairs of comparison results from 211 glucose meters at a low glucose concentration of <5.55 mmol/L were retrospectively analyzed from 2015 to 2023. The clinical use duration spanned from 1 to 9 years and 40.76% (86 out of 211 glucose meters) had been used for more than 2 years. The correlation coefficient r between glucose meter measurements and laboratory reference values was 0.98 (p < 0.001). The mean according to Roche Accu‐Chek Performa glucose meters was 0.05 mmol/L (0.9 mg/dL) higher than that of the biochemical analyzer (Z = −13.82, p < 0.0001). The results showed that 100.00% (211 out of 211) of the Roche Accu‐Chek Performa glucose meters met the acceptability criteria specified in ISO 15197:2013. At a low glucose concentration of <5.55 mmol/L, 99.90% (2975 out of 2978) of the comparative data pairs in the error distribution fell within the range of ±0.83 mmol/L (15 mg/dL). Parkes consensus error grid analysis showed that 100.00% (2978 out of 2978) of comparative data pairs fell within region A.ConclusionsThis study demonstrated that Roche Accu‐Chek Performa glucose meters successfully met the accuracy standards of ISO 15197:2013 for measuring blood glucose within the hypoglycemic range. Greater attention should be given to the performance of blood glucose monitoring systems in the low glycemic range, especially for patients with diabetes who are prone to hypoglycemia and require precise measurements.

After the COVID-19 pandemic, fever clinics urgently require rapid nucleic acid tests to enhance their capacity for timely pathogen detection. This study evaluated the analytical performance and clinical utility of the Flash10 SARS-CoV-2 point-of-care test (Flash10 POCT) for detecting SARS-CoV-2 in patients with fever in the adult fever clinic in Beijing Tsinghua Changgung Hospital from August 1 to August 30, 2023. The analytical performance and clinical utility of the Flash10 POCT for detecting SARS-CoV-2 were assessed in 125 patients with fever syndrome in the adult fever clinic. The Flash10 POCT demonstrated an analytical precision of 3.1% for the Ct values of the ORF1ab gene and 2.9% for the Ct values of the N gene in SARS-CoV-2 nucleic acid testing. Furthermore, the Flash10 POCT demonstrated a lower limit of detection (LoD) of 100 copies/mL, with no detected aerosol contamination leakage. Of the 125 patients (median age 61.9 years, 52% male and 48% female), both the Flash10 POCT and RT-PCR tests yielded positive results for 100 patients and negative results for 25 patients (Fisher’s exact test, p < 0.0001). The median turn-around-time for the Flash10 POCT was significantly shorter, at 1.05 h, compared to 16.15 h required for RT-PCR tests (Wilcoxon signed rank test, p < 0.0001). The Flash10 POCT showed high analytical performance, achieving a 100% detection rate for SARS-CoV-2 compared to RT-PCR tests, while also exhibiting a significantly shorter turn-around-time. Implementing the Flash10 POCT had the potential to expedite the care of adults presenting with fever.

Background/Objectives: Static reference intervals (RIs) fail to capture the dynamic changes in bioanalytes. This study aimed to develop gender-based continuous age- and season-related RIs for neuron-specific enolase (NSE) using real-world data and to compare them with partitioned RIs. Methods: The NSE results from 4097 individuals were included after rigorous screening. Partitioned RIs were determined using the Hoffmann method. Generalized additive models for location, scale and shape (GAMLSS) were selected to develop continuous RIs. Results: The partitioned RIs are as follows: <16.4 µg/L for males aged ≥19 years; <14.47 µg/L for females aged 19–49 years; and <17.25 µg/L for females aged ≥50 years. For continuous RIs, NSE levels in males remain stable with age, while in females, NSE levels evidently increase around the age of 50. Although less impactful than age, seasonal changes still affect NSE levels. Dynamic changes and continuous RIs for NSE are visualized in this study. Conclusions: We developed gender-based continuous age- and season-integrated RIs for NSE in North China, highlighting the variation in NSE levels in females with age and season. Compared to static RIs, continuous RIs are more responsive to NSE, potentially enhancing the precision and individualization of health assessments.

IntroductionRespiratory viral infection (RVI) is of very concern after the outbreak of COVID-19, especially in pediatric departments. Learning pathogen spectrum of RVI in children previous the epidemic of COVID-19 could provide another perspective for understanding RVI under current situation and help to prepare for the post COVID-19 infection control.MethodsA nucleic acid sequence-based amplification (NASBA) assay, with 19 pairs of primers targeting various respiratory viruses, was used for multi-pathogen screening of viral infections in children presenting influenza-like illness (ILI) symptoms. Children with ILI at the outpatient department of Beijing Tsinghua Changgung Hospital during the influenza epidemic from 12/2018 to 01/2019 were included. Throat swabs were obtained for both the influenza rapid diagnostic test (IRDT) based on the colloidal gold immunochromatographic assay and the NASBA assay, targeting various respiratory viruses with an integrated chip technology.Results and discussionOf 519 patients, 430 (82.9%) were positive in the NASBA assay. The predominant viral pathogens were influenza A H1N1 pdm1/2009 (pH1N1) (48.4%) and influenza A (H3N2) (18.1%), followed by human metapneumovirus (hMPV) (8.8%) and respiratory syncytial virus (RSV) (6.1%). Of the 320 cases identified with influenza A by NASBA, only 128 (40.0%) were positive in the IRDT. The IRDT missed pH1N1 significantly more frequently than A (H3N2) (P<0.01). Influenza A pH1N1 and A (H3N2) were the major pathogens in <6 years and 6-15 years old individuals respectively (P<0.05). In summary, influenza viruses were the major pathogens in children with ILI during the 2018-2019 winter influenza epidemic, while hMPV and RSV were non-negligible. The coexistence of multiple pathogen leading to respiratory infections is the normalcy in winter ILI cases.

Influenza B virus circulates yearly with lower activity than that of influenza A virus in China. During winter 2017 to 2018, a sharp surge of influenza activity dominated by type B/Yamagata lineage virus caused unprecedented medical burden in Beijing. This research aimed to understand the underlying mechanism for this circulation and prepare for epidemics in the future. Sera samples collected from the patients in 2016–2017 and 2017–2018 flu seasons were tested for profiling hemagglutinin inhibition (HI) antibodies against both prevailing Victoria and Yamagata lineages of type B influenza viruses. It showed that the seroprevalence against both lineages of the virus in 2017–2018 winter was higher than that in 2016–2017, while no difference of the seroprevalence was observed between the two viruses. Meanwhile, significant elevated geometric mean titer (GMT) against both lineages of influenza B viruses was found in the specimens collected during 2017–2018 flu season than that from 2016 to 2017, suggesting the viruses might undergo antigenic changes. These results also suggested that lower GMT against both type B variants in 2016–2017 might serve as an immunological niche for the dominating of B/Yamagata virus in China during 2017–2018 winter season. Our findings have implication that there was a significantly elevation of HI antibodies to influenza viruses B in 2017–2018 than in 2016–2017. On the other hand, the low level of HI antibodies to both B/Y and B/V in 2016–2017 could contribute to the severe B/Y epidemic in 2017–2018 to some extent.

目的 探讨应用间接法建立北京地区成年人血清维生素K缺乏或拮抗剂Ⅱ诱导的蛋白(protein induced by vitamine K absence or antagonist-Ⅱ,PIVKA-Ⅱ)生物参考区间.方法 收集2018年12月1日至2021年7月1日清华大学附属北京清华长庚医院实验室信息系统数据库中体检中心表观健康人群的血清PIVKA-Ⅱ测定结果928例.采用偏度-峰度值检验对数据进行正态性检验,自然对数(ln)进行数据转换后,利用箱式图与茎叶图法剔除离群值.应用非参数检验分析男、女间血清PIVKA-Ⅱ水平差异,利用Spearman法分析血清PIVKA-Ⅱ水平与参考个体年龄的相关性.利用非参数排序法建立血清PIVKA-Ⅱ生物参考区间,并进行参考区间验证.结果 北京地区健康成年人血清PIVKA-Ⅱ水平与参考个体年龄无相关性,血清PIVKA-Ⅱ在男、女组间比较[24.16(20.49～28.28)mAU/ml比20.82(17.63～24.19)mAU/ml],差异有统计学意义(Z=-9.221,P＜0.05),制订不同性别单独的生物参考区间.建立的PIVKA-Ⅱ生物参考区间为男性＜34.6 mAU/ml,女性＜29.4 mAU/ml.20例男性样本中,19例血清PIVKA-Ⅱ＜34.6 mAU/ml,通过率为95.0％;20例女性样本中,19例血清PIVKA-Ⅱ＜29.4 mAU/ml,通过率为95.0％,参考区间验证通过.结论 应用间接法建立的血清PIVKA-Ⅱ生物参考区间与说明书提供的生物参考区间有一定差异,其更适用于北京地区成年人群使用.

艾滋病(AIDS)是由人类免疫缺陷病毒(HIV)引起的传染性疾病,主要通过性、血液或血制品、母婴等方式传播.有研究表明新报告的 HIV感染病例主要来源于医疗机构[1].为了解综合性医院就诊患者 HIV 感染状况及人群特征,也为科学开展HIV筛查及监测工作提供依据,本研究对 2015-2019 年北京清华长庚医院 HIV筛查检测结果进行回顾性研究分析.

开展新型冠状病毒核酸检测前要进行严格的生物安全风险评估,本文参考相关指南及标准,结合实验室实践活动,介绍在生物安全二级实验室中开展新型冠状病毒核酸检测的生物安全风险管理的流程和要点.

Rotavirus (RV) is the most common cause of viralgastroenteritis among children younger than 5-year-old worldwide. RV has nine groups (Group A to I) and Group A (RVA) is the main cause of severe gastroenteritis disease in children.

Background Fecal calprotectin (FC) is widely used to discriminate between patients with inflammatory diseases such as inflammatory bowel disease (IBD) and functional diseases such as irritable bowel syndrome (IBS). ELISA is a time-consuming method for the measurement of FC, whereas a fluorescent immunochromatography test can obtain results in around 30 minutes and thus enables a rapid response to clinical decision. Methods Two methods, the Proglead(R) calprotectin (FC Proglead) and the BuHLMANN fCAL(R) ELISA (FC BuHLMANN), were used to quantitatively examine FC in 111 stool samples. The comparison and bias estimation of both assays were assessed using CLSI EP09c protocol. Results The two methods were highly correlated (rho = .96). Deming regression was employed to calculate the regression equation, with a slope of 1.01 and an intercept of -4.98 mu g/g. The estimated median bias (FC Proglead - FC BuHLMANN) was -4.19 mu g/g with the 95% limits of agreement (-55.59 to 47.21 mu g/g), and the estimated median percent bias was -8.71% with the 95% limits of agreement (-50.31% to 32.90%). There was 4.50% (5/111) of values outside the 95% limits of agreement. Percent biases at the FC cutoff values of 50 and 200 mu g/g between both methods evaluated by Deming regression were 8.96% and 1.49%, respectively. The biases were all less than the acceptable standard (10%). And, 99.10% of FC results were in agreement between both methods (kappa = .99, P < .001). Conclusions FC Proglead may be used as a suitable alternative to FC BuHLMANN for the disease activity assessment for patients with IBD, considering its convenience and shorter turnaround time.

In the winter of 2017-2018, there was significant influenza activity in China, resulting in unprecedented usage of influenza rapid antigen tests (IRAT) and neuraminidase inhibitors (NAIs). The aim of this study was to characterize the most prevalent influenza virus type in a clinical setting with respect to diagnosis and concomitant NAI treatment. From Dec 2017 to Jan 2018, 3257 patients with influenza-like illness (ILI) were screened using IRAT. We summarized and compared the results with the last influenza season. Subtyping of influenza B viruses and identification of NAI drug resistance mutations were carried out by sequencing the HA and NA genes and aligning these with genetic isotypes. The performance of IRAT and RT-PCR was compared. Screening results indicated that influenza B virus was the leading cause of this influenza epidemic, with children being more susceptible to infection than adults. Phylogenetic analysis revealed that the prevailing influenza B virus belonged to the Yamagata lineage and were genetically similar to strains isolated from North America in the same influenza season. Cross-continental spread of influenza/B/Yamagata occurred. NAI resistance mutations were not identified in the 18 samples analyzed. The current antiviral protocol was still effective for influenza B control. RT-PCR positivity was significantly higher than that of IRAT (P = 0.004). IRAT and RT-PCR had a consistency rate of 86.9%, with the consistency rates of the positive and negative cases being 54.3% and 97.3%, respectively. Clinicians should be alert to the possibility of obtaining false negative results when using IRAT, and RT-PCR is recommended to improve the accuracy of pathogen detection.

We retrospectively analyzed serum IgM antibodies (Abs) to influenza viruses from two tertiary hospitals in Beijing from December 2016 to February 2018. Samples from 36,792 patients, aged 0-98 years, were collected and tested. Among the patients, 923 children from two winter flu seasons were assayed with both antigens and IgM Abs to Flu A and Flu B and assigned as paired groups. Another 2,340 adults and 1,978 children with only antigen tested in the 2016 and 2017 winter flu seasons were named as unpaired groups. IgM Abs-positivity rates in children were 0.80% and 36.57% for Flu A and Flu B, respectively, peaking at 4-5 years of age. For adults, the Flu A and Flu B IgM Abs-positivity rates were 10.34% and 21.49%, respectively, peaking at 18-35 years of age. The trend of temporal distribution between the children and the adults was significantly correlated for IgM Abs to Flu B, but not for Flu A. Compared with unpaired groups, the detection rate of Flu A antigen was significantly higher than IgM Abs in children, whereas frequencies of IgM Abs were higher than antigen in adults. Incidence of Flu B antigen was sharply increased in 2017 winter than in the 2016 winter in both children and adults, but no concomitant increase was observed in IgM Abs to Flu B. For paired children groups, incidence of Flu B antigen in the 2017 flu season was significantly higher than that in the 2016 flu season; in contrast, positive rates of IgM Abs in the 2017 flu season were even lower than those in 2016. Considering antigen detection may reflect the Flu A/Flu B epidemic, our results indicate single-assayed IgM Abs were less effective in the diagnosis of acute influenza virus infection, and the use of this assay for epidemiology evaluations was not supported by these findings.

目的 运用QCC手法降低血液样本异常率,以减少分析前错误对检验结果的影响.方法 对近2年的异常血液样本进行统计分析,对比检验科与护理部组建品管圈(QCC)前后的异常指标的改善,验证QCC手法及改善措施的有效性.结果 820844支血液样本中异常样本为2581支,按血液样本异常原因占比从高到低排序,前五位为:溶血(37.27％)、凝固(33.90％)、样本量不足(13.29％)、容器错误(5.97％)、脂血(4.49％),其次为样本类型错误(2.17％)、输液同侧采血(0.81％)、条码错误(0.70％)及其他错误(1.40％);血液样本异常率按来源从高到低排序,依次为:新生儿科(2.83％,3.5 sigma)、急诊科(0.64％,4.0 sigma)、ICU(0.51％,4.1 sigma),外科(0.48％,4.1 sigma)、妇产科(0.44％,4.2 sigma)、内科(0.39％,4.2 sigma)、体检中心(0.20％,4.4 sigma)、门诊部(0.06％,4.8 sigma);QCC实施前血液样本异常率为0.40％(4.2 sigma),实施后下降到0.26％ (4.3 sigma),改善幅度为35％.结论 人为因素是引起血液样本异常的主要因素,运用QCC手法,检验与护理进行跨部门协作可有效降低血液样本异常率.