Performance comparison of two automated digital morphology analyzers for leukocyte differential in patients with malignant hematological diseases: Mindray MC-80 and Sysmex DI-60.

BACKGROUND: The MC-80 (Mindray, Shenzhen, China), a newly available artificial intelligence (AI)-based digital morphology analyzer, is the focus of this study. We aim to compare the leukocyte differential performance of the Mindray MC-80 with that of the Sysmex DI-60 and the gold standard, manual microscopy. METHODS: A total of 100 abnormal peripheral blood (PB) smears were compared across the MC-80, DI-60, and manual microscopy. Sensitivity, specificity, predictive value, and efficiency were calculated according to the Clinical and Laboratory Standards Institute (CLSI) EP12-A2 guidelines. Comparisons were made using Bland-Altman analysis and Passing-Bablok regression analysis. Additionally, within-run imprecision was evaluated using five samples, each with varying percentages of mature leukocytes and blasts, in accordance with CLSI EP05-A3 guidelines. RESULTS: The within-run coefficient of variation (%CV) of the MC-80 for most cell classes in the five samples was lower than that of the DI-60. Sensitivities for the MC-80 ranged from 98.2% for nucleated red blood cells (NRBC) to 28.6% for reactive lymphocytes. The DI-60's sensitivities varied between 100% for basophils and reactive lymphocytes, and 11.1% for metamyelocytes. Both analyzers demonstrated high specificity, negative predictive value, and efficiency, with over 90% for most cell classes. However, the DI-60 showed relatively lower specificity for lymphocytes (73.2%) and lower efficiency for blasts and lymphocytes (80.1% and 78.6%, respectively) compared with the MC-80. Bland-Altman analysis indicated that the absolute mean differences (%) ranged from 0.01 to 4.57 in MC-80 versus manual differential and 0.01 to 3.39 in DI-60 versus manual differential. After verification by technicians, both analyzers exhibited a very high correlation (r = 0.90-1.00) with the manual differential results in neutrophils, lymphocytes, and blasts. CONCLUSIONS: The Mindray MC-80 demonstrated good performance for leukocyte differential in PB smears, notably exhibiting higher sensitivity for blasts identification than the DI-60.

Comparison of results and age-related changes in establishing reference intervals for CEA, AFP, CA125, and CA199 using four indirect methods.

•The reference intervals calculated using RefineR, Kosmic, TMC, and non-parametric methods are similar.•TMC algorithm is more robust, demonstrates a high pass rate among the four methods and has the ability to automatically isolate outliers.•The reference intervals of CA125 and CA199 showed significant differences between age and sex.

Severity-associated markers and assessment model for predicting the severity of COVID-19: a retrospective study in Hangzhou, China.

BACKGROUND: The severity of COVID-19 associates with the clinical decision making and the prognosis of COVID-19 patients, therefore, early identification of patients who are likely to develop severe or critical COVID-19 is critical in clinical practice. The aim of this study was to screen severity-associated markers and construct an assessment model for predicting the severity of COVID-19. METHODS: 172 confirmed COVID-19 patients were enrolled from two designated hospitals in Hangzhou, China. Ordinal logistic regression was used to screen severity-associated markers. Least Absolute Shrinkage and Selection Operator (LASSO) regression was performed for further feature selection. Assessment models were constructed using logistic regression, ridge regression, support vector machine and random forest. The area under the receiver operator characteristic curve (AUROC) was used to evaluate the performance of different models. Internal validation was performed by using bootstrap with 500 re-sampling in the training set, and external validation was performed in the validation set for the four models, respectively. RESULTS: Age, comorbidity, fever, and 18 laboratory markers were associated with the severity of COVID-19 (all P values < 0.05). By LASSO regression, eight markers were included for the assessment model construction. The ridge regression model had the best performance with AUROCs of 0.930 (95% CI, 0.914-0.943) and 0.827 (95% CI, 0.716-0.921) in the internal and external validations, respectively. A risk score, established based on the ridge regression model, had good discrimination in all patients with an AUROC of 0.897 (95% CI 0.845-0.940), and a well-fitted calibration curve. Using the optimal cutoff value of 71, the sensitivity and specificity were 87.1% and 78.1%, respectively. A web-based assessment system was developed based on the risk score. CONCLUSIONS: Eight clinical markers of lactate dehydrogenase, C-reactive protein, albumin, comorbidity, electrolyte disturbance, coagulation function, eosinophil and lymphocyte counts were associated with the severity of COVID-19. An assessment model constructed with these eight markers would help the clinician to evaluate the likelihood of developing severity of COVID-19 at admission and early take measures on clinical treatment.

An evaluation of adult critical result policies in haematology in a teaching hospital in China.

BACKGROUND: Critical result (CR) reporting is one of the core policies in China, yet it varies in different hospitals. In addition, few reports of the evaluation of CR policies have been published. This study aimed to evaluate the adult CR policies for haematology in a teaching hospital. METHODS: The consistency was compared between CR policies in a tertiary hospital in China and the current standards, consensuses and literature. The incidences for the alert thresholds of white blood cells (WBC), haemoglobin (HgB), and platelets (PLT) and the turn-around time (TAT) for different phases of CR reporting in 2017 were investigated. On-site observation of the staff was used to assess CR implementation and compliance with CR policies. RESULTS: The clauses of adult CR policies in haematology were consistent with the requirements in the standards, consensuses and literature, and the CR items and alert thresholds were within the range reported in the literature. CRs in haematology were dominated by lower thresholds. The incidences of alerts due to WBC, HgB, and PLT levels were 37.5, 18.0 and 37.0 times/day, respectively. A total of 150 cases of CR implementation were observed on-site, and the procedures followed by the staff were consistent with the requirements of the polices. The TAT medians for CR verification in the outpatient, emergency and inpatient departments were ≤6 min. CONCLUSIONS: The consistency and implementation of CR policies were both good, which ensures patient safety.

Postprandial Lipid Concentrations and Daytime Biological Variation of Lipids in a Healthy Chinese Population.

BACKGROUND: Several latest guidelines and consensus statements from Europe and the United States specify that there is no need for fasting prior to routine lipid tests. However, the latest Chinese guidelines still recommend fasting tests owing to a lack of local evidence. This study aimed to investigate postprandial lipid concentrations and daytime biological variation of lipids in a healthy Chinese population. METHODS: Venous blood samples were collected from 41 ostensibly healthy Chinese volunteers at five time points during the day (06:30, 09:00, 12:00, 15:00, and 18:30). The same batch of reagents was used to determine lipid concentrations. A nested ANOVA was performed to calculate within-subject biological variation (CV(I)) and between-subject biological variation (CV(G)). RESULTS: Postprandial concentrations of triglyceride were higher than fasting concentrations, with the maximum change occurring at 12:00 (0.5 hours after lunch, 0.21±0.65 mmol/L difference). The daytime biological variation of triglycerides was relatively high (CV(I)=25%, CV(G)=35.9%). The postprandial concentrations of total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein A1, and apolipoprotein B were mostly lower than the fasting concentrations, and their daytime biological variations were relatively low (CV(I)=2.4-4.4%, CV(G)=11.8-18.7%). CONCLUSIONS: As most daytime lipid concentrations changed only slightly, non-fasting samples could be used for routine lipid tests. However, in cases of abnormal postprandial triglyceride concentrations, dietary factors and fasting time should be considered when interpreting the results.

Corrigendum to: Nurses' knowledge on phlebotomy in tertiary hospitals in China: a cross-sectional multicentric survey.

[This corrects the article DOI: 10.11613/BM.2018.010703.].

Analysis of laboratory repeat critical values at a large tertiary teaching hospital in China.

CONTEXT: As a patient safety measure, laboratories are required to have a critical values policy by regulatory agencies. Unfortunately, little information is available on repeat critical values for the same analyte(s) on the same patient. OBJECTIVE: To investigate the occurrence and distribution of repeat critical values and the relationship between the frequency of such values and patient outcome to provide information for hospitals on improving reporting policies. METHODS: Eleven laboratory critical value lists, including chemistry and hematology analytes, were selected from a tertiary hospital in China in the year 2010. The distribution and interval time for each repeat critical value were calculated. Serum potassium and platelet count were used as examples to illustrate the relationship between the frequency of the repeat critical values and patient outcome. RESULTS: All test items on the critical value list were prone to the occurrence of repeat critical values. On average, each patient who experienced critical values had 2.10 occurrences. The median interval time for each repeat critical value varied, with most being longer than 8 hours. For those patients who had repeat critical values of serum potassium and platelet count, along with the increased frequency, the patients had a longer hospital stay and a generally worse outcome. CONCLUSIONS: Patient can have a number of repeat critical values and the frequency of these values is closely related to patient outcome. A careful evaluation is warranted if a laboratory chooses to adopt a policy of not reporting each repeat critical value.

Performance evaluation and result comparison of the automated hematology analyzers Abbott CD 3700, Sysmex XE 2100 and Coulter LH 750 for cell counts in serous fluids.

BACKGROUND: Automated hematology analyzers are used to perform cell counts in body fluids. However, little is known about how the results compare between different analyzers. METHODS: A single batch of serous fluid samples was used to evaluate the cell counting performance of 3 hematology analyzers: CD 3700, XE 2100, and LH 750. Two hundred and seventy four serous fluid samples were used to evaluate the accuracy of the analyzers and to compare the results between different analyzers. RESULTS: The precision and linearity of the 3 analyzers were acceptable for both white blood cell counts and red blood cell counts with a low carryover rate. The limits of detection for white blood cells with the CD 3700, XE 2100, and LH 750 analyzers were 0.033×10(9)/l, 0.07×10(9)/l, and 0.20×10(9)/l, respectively. Performing background counts had no influence on cell counts for any of the analyzers. For those samples over the limit of detection, there was agreement between the automated and manual counting methods. There were also reasonably comparable cell count results between the 3 analyzers. CONCLUSIONS: When the serous fluid cell counts are over the limit of detection, the analyzers produce accurate test results. Additionally, the results are comparable between the 3 hematology analyzers.

Plasma gelsolin levels and 1-year mortality after first-ever ischemic stroke.

PURPOSE: Plasma gelsolin depletion has been associated with poor outcome of critically ill patients. We sought to investigate change in plasma gelsolin level after ischemic stroke and to evaluate its relation with disease outcome. MATERIALS AND METHODS: Fifty healthy controls and 172 patients with first-ever ischemic stroke were included. Plasma samples were obtained within 24 hours from stroke onset. Its concentration was measured by enzyme-linked immunosorbent assay. RESULTS: Plasma gelsolin level in stroke patients was significantly decreased compared with healthy controls. A multivariate analysis showed that plasma gelsolin level was an independent predictor for 1-year mortality (odds ratio, 0.945; 95% confidence interval [CI], 0.918-0.974; P = .0002) and negatively associated with National Institutes of Health Stroke Scale (NIHSS) score (t = -4.802, P < .001) and plasma C-reactive protein level (t = -4.197, P < .001). A receiver operating characteristic curve identified that a baseline plasma gelsolin level less than 52.0 mg/L predicted 1-year mortality of patients with 73.0% sensitivity and 65.2% specificity (area under curve [AUC], 0.738; 95% CI, 0.666-0.802). The predictive value of the gelsolin concentration was similar to that of NIHSS score (AUC, 0.742; 95% CI, 0.670-0.806; P = .940). Gelsolin improved the AUC of NIHSS score to 0.814 (95% CI, 0.747-0.869; P = .032). CONCLUSIONS: Plasma gelsolin level is a useful, complementary tool to predict mortality after ischemic stroke.

Simultaneous detection of influenza A, influenza B, and respiratory syncytial viruses and subtyping of influenza A H3N2 virus and H1N1 (2009) virus by multiplex real-time PCR.

A multiplex real-time PCR assay was developed to simultaneously detect and discriminate influenza A virus subtypes, including novel H1N1 (2009) and seasonal H3N2 virus, influenza B virus, and respiratory syncytial virus (RSV) in a single test tube, with detection sensitivity and specificity of 99% and 100%, respectively, for the four pathogens.

Assessing health-related quality of life in patients with inflammatory bowel disease in Zhejiang, China.

AIMS: The aim of this study was to assess health-related quality of life in patients with inflammatory bowel disease in Zhejiang, Mainland China. BACKGROUND: The incidence of inflammatory bowel disease in China is believed to be low but has been increasing in the past decade. The quality of life of Chinese patients with inflammatory bowel disease is unknown. DESIGN: A cross-sectional study. METHODS: The study was conducted in 92 patients with inflammatory bowel disease in Zhejiang, China, 52 with ulcerative colitis and 40 with Crohn's disease. Health-related quality of life was measured by the Chinese version of the Inflammatory Bowel Disease Questionnaire and Short Form-36, respectively. Disease activity was assessed by the Walmsley and Harvey-Bradshaw simple indices for ulcerative colitis and Crohn's disease, respectively. Demographic and clinical variables were also recorded. Short Form-36 data from the study sample were compared with a reference population of 1688 Chinese people residing in Hangzhou, Zhejiang, China. RESULTS: No significant health-related quality of life differences were found between patients with ulcerative colitis and Crohn's disease (p > 0.05). Pooled data showed that inflammatory bowel disease patients with active disease had significantly lower scores for all eight dimensions of Short Form-36 compared to those in remission (p < 0.01); those with active disease scored significantly lower than population norms in all dimensions of Short Form-36 except mental health (p < 0.05); whereas those in remission scored significantly lower than population norms in role physical (p < 0.01) and general health dimensions (p < 0.05). The regression analyses identified only disease activity index and employment status to explain variations in health-related quality of life (p < 0.01). CONCLUSIONS: Inflammatory bowel disease similarly impairs health-related quality of life in patients with both ulcerative colitis and Crohn's disease. RELEVANCE TO CLINICAL PRACTICE: The results suggest that any interventions that produce a stable clinical remission, whether medical or surgical, allowing patients to return to their usual work position can decrease the disease impact on their daily lives.

The prevalence of microalbuminuria and its relationships with the components of metabolic syndrome in the general population of China.

BACKGROUND: Few studies have examined the relationships between the prevalence of microalbuminuria and the metabolic risk factors in the general population of China. We performed a population based study to investigate the prevalence of microalbuminuria and its relationships with the components of the metabolic syndrome in Hangzhou, China. METHODS: The subjects of this cross-sectional study were the individuals from 19 to 87 y. The metabolic syndrome was defined based on the criteria of the Chinese Diabetes Society (CDS). Microalbuminuria was defined as a urine albumin-creatinine ratio of 30 to 300 mg/g. RESULTS: A total of 2985 subjects (average age of 44 y) were analyzed. Among them, the prevalence of the metabolic syndrome and microalbuminuria was 12.6% and 8.8%, respectively. Microalbuminuria prevalence rate was significantly higher in the population >60 y than <60 y. The prevalence of MAU in the group with metabolic abnormalities was significantly higher than the control group, and the prevalence rate of MAU in the metabolic syndrome group reached up to 20.3%. There was a significantly positive correlation between the prevalence of microalbuminuria and the corresponding components of the metabolic syndrome (P<0.001). CONCLUSIONS: Microalbuminuria was highly prevalent in the middle-aged and elderly Chinese population in the city of Hangzhou. There is an increasing likelihood of having microalbuminuria if subjects have the metabolic syndrome. Early screening strategies for prevention and treatment of MAU are strongly suggested, especially in the population >60 y and the ones with metabolic abnormalities.

[Application of a calling and queuing system in blood sampling in the clinical laboratory].

This paper introduces the application of a calling and queuing system for blood sample collection in a large hospital in China. Besides the basic function, it has following functions. (a) A real name system: get the number according to the laboratory application form to prevent the phenomena of buying a number and an empty number. (b) Two times waiting: the patient should wait at the main hall, then at the blood sampling window so as to improve the work efficiency. (c) The flowchart for an outpatient blood testing is as following: getting the number --> waiting --> blood sampling --> getting the test information report. This system is capable of not only optimizing the work flow, but also improving the clinical environment. It shortens the patient's waiting time and raises the laboratory quality as well.

[Research and development of a clinical laboratory information system].

A clinical laboratory information system consists of two parts--the information system and the management system. Its development is based on scientific and rational lab-workflow, consulting the international standard HL7 Protocol, and combined with barcode technique and instrument communication. The information system mainly manages the data which come from the whole lab testing process while the management system is dominating the lab office work and management decisions.