1.Comparison of Direct and Extraction Immunoassay Methods With Liquid Chromatography-Tandem Mass Spectrometry Measurement of Urinary Free Cortisol for the Diagnosis of Cushing’s Syndrome
Danni MU ; Jiadan FANG ; Songlin YU ; Yichen MA ; Jin CHENG ; Yingying HU ; Ailing SONG ; Fang ZHAO ; Qi ZHANG ; Zhihong QI ; Kui ZHANG ; Liangyu XIA ; Ling QIU ; Huijuan ZHU ; Xinqi CHENG
Annals of Laboratory Medicine 2024;44(1):29-37
Background:
Twenty-four-hour urinary free cortisol (UFC) measurement is the initial diagnostic test for Cushing’s syndrome (CS). We compared UFC determination by both direct and extraction immunoassays using Abbott Architect, Siemens Atellica Solution, and Beckman DxI800 with liquid chromatography-tandem mass spectrometry (LC-MS/MS). In addition, we evaluated the value of 24-hr UFC measured by six methods for diagnosing CS.
Methods:
Residual 24-hr urine samples of 94 CS and 246 non-CS patients were collected.A laboratory-developed LC-MS/MS method was used as reference. UFC was measured by direct assays (D) using Abbott, Siemens, and Beckman platforms and by extraction assays (E) using Siemens and Beckman platforms. Method was compared using Passing–Bablok regression and Bland–Altman plot analyses. Cut-off values for the six assays and corresponding sensitivities and specificities were calculated by ROC analysis.
Results:
Abbott-D, Beckman-E, Siemens-E, and Siemens-D showed strong correlations with LC-MS/MS (Spearman coefficient r = 0.965, 0.922, 0.922, and 0.897, respectively), while Beckman-D showed weaker correlation (r = 0.755). All immunoassays showed proportionally positive bias. The areas under the curve were 0.975 for Abbott-D, 0.972 for LCMS/MS, 0.966 for Siemens-E, 0.948 for Siemens-D, 0.955 for Beckman-E, and 0.877 for Beckman-D. The cut-off values varied significantly (154.8–1,321.5 nmol/24 hrs). Assay sensitivity and specificity ranged from 76.1% to 93.2% and from 93.0% to 97.1%, respectively.
Conclusions
Commercially available immunoassays for measuring UFC show different levels of analytical consistency compared to LC-MS/MS. Abbott-D, Siemens-E, and Beckman-E have high diagnostic accuracy for CS.
2.Evaluation and application of automated quality control of automatic pipeline in clinical biochemical and immunological detection
Li′an HOU ; Xuesong SHANG ; Chaochao MA ; Liangyu XIA ; Li LIU ; Ying ZHANG ; Yujun SU ; Xin LIU ; Ling QIU
Chinese Journal of Laboratory Medicine 2024;47(1):86-93
Objective:To assess the applicability of fully automatic pipeline automated testing for internal quality control (automated quality control).Methods:Stability, assay efficiency and implementation costs of 18 biochemical tests, 5 immunoturbidimetric tests and 11 chemical illuminescent tests in the Department of Laboratory Medicine of Peking Union Hospital from January 2019 to July 2022 were evaluated using automated quality control implementation methods. The detailed method is as follows: quality control materials for biochemical, immunoturbidimetric and chemiluminescent tests were stored in the refrigerator in the pipeline which was controlled by the intermediate software, and were automatically retrieved and tested as pre-set followed by documenting and storing. The quality control setup for the biochemical tests included refreshing quality control materials daily and weekly,both of which were paralleled for 3 months. The on-line storage stability of quality control materials in the pipeline was evaluated by comparing the coefficients of variation ( CV) of the quality control results between the two patterns. Effect of automated quality control application was evaluated using 6 indicators, including the results′ variation of automatically performed and manually performed quality controls, the out-of-controlled rate, the consumption of quality control materials, the change of staff workload, the impact on the testing time of the first sample, and the failure rate of automated quality control. Results:(1) Storage stability of quality control materials in the pipeline: under the pattern of weekly refresh of the biochemical quality control materials, except for total carbon dioxide (TCO 2) (the CVs of low and high level quality control were respectively 20.24% and 21.82%) and sodium (the CV of low level quality control was 1.51%) that were greater than the allowable variation set by the laboratory, the CVs of the rest tests meet the lab requirements on the allowable variations. (2) The results′ variation of quality control in automatically performed and manually performed control patterns: in the patterns of daily refresh of biochemical quality control materials and weekly refresh of immunoturbidimetric and chemiluminescent quality control materials, the CVs of both low and high levels of quality control were lower in the automatically performed control pattern than that in manually performed pattern for 8 chemiluminescent items of dehydroepiandrosterone sulfate, estradiol, follicle stimulating hormone, luteinizing hormone, serum ferritin, serum folic acid, vitamin B12 and testosterone, 3 immunologic items of complement 3, C reactive protein and immunoglobulin G, and 10 biochemical items of alkaline phosphatase, glucose, calcium, chloride, potassium, lactate dehydrogenase, sodium, urea, low density lipoprotein cholesterol, and adenosine deaminase. The out-of-control rates of biochemistry, immunoturbidimetric and chemiluminescence tests in both quality control patterns conformed with the clinical routine work requirements. (3) Comparison of quality control materials′ consumption: compared with manually performed quality control, weekly consumption of automatically performed chemiluminescent quality control materials decreased 37.5% (from 8 ml to 5 ml); weekly consumption of automatically performed immunoturbidimetric quality control materials decreased 33.3% (from 3 ml to 2 ml). (4)Comparison of staff workload and first sample testing time: compared with manually performed quality control, automatical quality control reduced manual work by about 156 steps per week, and the daily initial testing time was earlier by 15 min on average. The failure rate was 54.5% (37/64) during the early-stage application of the automated quality control which dropped to 10.2% (13/128) in the late-stage. Conclusion:The results of automated quality control detected in the pipeline system meet the quality indicators′ requirements of the laboratory, and the application of automated quality control can improve the quality control, save costs, reduce workload, and improve work efficiency.
3.A case of iatrogenic hypernatremia caused by multiple myeloma-associated pseudohyponatremia
Yuan HUANG ; Lu ZHANG ; Liangyu XIA ; Jinyan LEI ; Chong WEI ; Yongzhe LI
Chinese Journal of Laboratory Medicine 2024;47(10):1212-1214
The patient was a 55-year-old man. On February 16, 2024, he was admitted to Peking Union Medical College Hospital complaining of "weakness and poor appetite for more than half a year, and found creatinine increase for 1 week". The patient was diagnosed with multiple myeloma. During the treatment in our hospital, the patient sustained"hyponatremia"(Na 124-136 mmol/L measured by indirect ion selective electrode method), and combined with the patient′s clinical symptoms and serum osmotic pressure results (327 mOsm/kg H 2O), it was considered that hyperglobulinemia led to pseudohyponatremia. So no intervention was given. Subsequent failure to recognize pseudohyponatremia during treatment in other hospitals and the administration of hypertonic saline resulted in severe iatrogenic hypernatremia. By reviewing similar cases in our hospital, we found that hyperglobulinemia/hyperlipidemia associated pseudohyponatremia was not uncommon. This case reminds us that for patients whose serum solid phase ratio is higher than normal due to various reasons, the use of indirect ion selective electrode method to determine serum sodium is prone to false low, and direct ion selective electrode method can be used to re-test blood sodium to determine whether it is true, so as to avoid iatrogenic injury to patients.
4.Intelligent identification of livestock, a source of Schistosoma japonicum infection, based on deep learning of unmanned aerial vehicle images
Jingbo XUE ; Shang XIA ; Zhaojun LI ; Xinyi WANG ; Liangyu HUANG ; Runchao HE ; Shizhu LI
Chinese Journal of Schistosomiasis Control 2023;35(2):121-127
Objective To develop an intelligent recognition model based on deep learning algorithms of unmanned aerial vehicle (UAV) images, and to preliminarily explore the value of this model for remote identification, monitoring and management of cattle, a source of Schistosoma japonicum infection. Methods Oncomelania hupensis snail-infested marshlands around the Poyang Lake area were selected as the study area. Image datasets of the study area were captured by aerial photography with UAV and subjected to augmentation. Cattle in the sample database were annotated with the annotation software VGG Image Annotator to create the morphological recognition labels for cattle. A model was created for intelligent recognition of livestock based on deep learning-based Mask R-convolutional neural network (CNN) algorithms. The performance of the model for cattle recognition was evaluated with accuracy, precision, recall, F1 score and mean precision. Results A total of 200 original UAV images were obtained, and 410 images were yielded following data augmentation. A total of 2 860 training samples of cattle recognition were labeled. The created deep learning-based Mask R-CNN model converged following 200 iterations, with an accuracy of 88.01%, precision of 92.33%, recall of 94.06%, F1 score of 93.19%, and mean precision of 92.27%, and the model was effective to detect and segment the morphological features of cattle. Conclusion The deep learning-based Mask R-CNN model is highly accurate for recognition of cattle based on UAV images, which is feasible for remote intelligent recognition, monitoring, and management of the source of S. japonicum infection.
5.Explore the reasons affecting the consistency of reference intervals established by two types of indirect methods for 34 biochemical analytes
Chaochao MA ; Yicong YIN ; Li LIU ; Qian LIU ; Xin LIU ; Ying ZHANG ; Liangyu XIA ; Ling QIU
Chinese Journal of Laboratory Medicine 2023;46(10):1083-1093
Objective:To compare the differences of reference intervals (RI) established by two types of indirect methods for 34 biochemical analytes, and to explore the possible factors that affect the consistency of the two methods.Methods:This was a retrospective study. Based on data of albumin (Alb), alkaline phosphatase (ALP), alanine aminotransferase (ALT), apolipoprotein A1(ApoA1), ApolipoproteinB (ApoB), aspartate aminotransferase (AST), calcium (Ca), cholinesterase (ChE), chloride (Cl), creatinine (Cr), high-sensitivity C-reactive protein (hsCRP), Cystatin (CysC), direct bilirubin (DBil), free fatty acid (FFA), glycated albumin(GA), gamma-glutamyltransferase (GGT), glucose (Glu), high density lipoprotein cholesterol (HDL-C), potassium (K), lactate dehydrogenase (LD), low density lipoprotein cholesterol (LDL-C), lipoprotein a [Lp (a)], sodium (Na), phosphorus (P), prealbumin (PA), superoxide dismutase (SOD), total bile acid (TBA), total bilirubin (TBil), total cholesterol (TC), total carbon dioxide (TCO 2), triglyceride (TG), total protein (TP), uric acid (UA) and urea (UR) of individuals who underwent physical examination at Peking Union Medical College Hospital from January 1, 2018 to December 31, 2019, Box-Cox algorithm was used to improve the data distribution and Tukey method was used to identify outliers. Variance component model was established, and standard deviation ratio (SDR) was calculated to determine whether the RIs of 34 biochemical analytes should be established according to age or sex The non-parametric method and kosmic algorithm were used to establish the RIs and 90% confidence intervals (CIs) of 34 biochemical analytes, and the coincidence of the 90% CIs of the reference limits for two methods was compared. Results:The skewness coefficients of ALP(male, female18-59), ALT, AST, hsCRP, DBil, GGT, Lp (a), TBA, TBil, TG, Glu, HDL-C(male) and CysC, GA, UR in the elderly group deviated from 0, and their kurtosis coefficients also deviated from 3. For these biochemical analytes, the point estimates of the RIs established by the two methods differed greatly and the 90% CIs did not overlap. The analytes with good normality were Alb, ApoA1, ApoB, Ca, ChE, Cl, Cr(E), CysC(18-59), FFA, GA(18-59), HDL-C(female), K, LDL-C, Na, P, PA, SOD, TC, TCO 2, TP and UR. The consistency is good. Except for Ca, 90% CIs of reference limits for some analyte between the two methods coincide with each other. Conclusions:The consistency of different indirect methods is affected by the normality of data.
6.Construction and improvement of lab automation system in emergency lab
Hui WANG ; Liangyu XIA ; Lian HOU ; Ermu XU ; Qian LIU ; Ling QIU
Chinese Journal of Laboratory Medicine 2022;45(11):1123-1130
Objective:By exploring a construction and improvement system for total lab automation in emergency lab, this work aims to improve the success rates of project implementation and the effective utilization of medical resources.Methods:Firstly, clarify the short board of current solution and determine the configuration of the TLA solution which include the number of pre-analytic, post-analytic modules and analyzers by workflow and data analysis which based on the data from 16th to 22nd September 2019. Secondly, define the basic principles and design the optional solutions. Thirdly, determine the final solution based on the simulation results. Fourthly, evaluate the effectiveness of the solution by comparing the turnaroud time (TAT) before and after implementation.Result:We upgrade the system to improve the automation level of the track by add 1 online centrifuge module and upgrade the capacity of online storage module from 9 000 samples to 15 000 samples, and increase the throughput of the clinical chemistry analyzers form 2 500 tests/h to 5 400 tests/h and immunoassay analyzers from 668 tests/h to 1 320 tests/h with no more space. The 95th percentile TAT (from sample check in to validation) have 33% reduction on the premise of 9% increase on the workload of clinical chemistry and immunoassay, and it is highly consistent with the results obtained by data simulation whose 95th percentile TAT is 67 min.Conclusion:Good uasge of workflow and data analysis in the stage of solution design can help to ensure that the result can meet the expectations of the clinicians and effective utilization of medical resources.
7.Case report of pseudoelevated serum testosterone in women and literature review
Wei LUO ; Li′an HOU ; Songlin YU ; Ying ZHANG ; Jialei YU ; Yicong YIN ; Li LIU ; Xiaoyue LIANG ; Xin LIU ; Yujun SU ; Shaowei XIE ; Ling QIU ; Liangyu XIA
Chinese Journal of Laboratory Medicine 2022;45(12):1275-1278
Objective:The characteristics of women with false elevated testosterone were analyze and the literature was reviewed to provide reference for clinical laboratory identification of false elevated testosterone.Methods:The characteristics of three patients with false elevated testosterone in Peking Union Medical College Hospital were analyzed retrospectively, and the results of different detection platforms and methods for the determination of testosterone levels were compared. International and domestic literatures related to false elevation of testosterone and detection methods of testosterone were searched for a comprehensive analysis from PUBMED and CNKI.Results:The levels of testosterone in 3 female patients were elevated by immunoassay and normal by mass spectrometry. They were excluded from the diagnosis of hyperandrogenemia. A total of 38 literatures related to testosterone detection were retrieved, of which 9 case reports of pseudohyperandrogenemia, among which 12 cases of pseudohyperandrogenemia were reported in 2 domestic literatures in 2021. All cases were confirmed by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Previous studies have clearly indicated that the result of routine immunoassay in clinical laboratory for the determination of female testosterone have poor correlation with the results of LC-MS/MS, with varying degrees of deviation.Conclusions:Immunoassay tests for female testosterone is susceptible to interference and lead to elevated false results. It is suggested that clinical laboratories evaluate the detection methods used and establish a identification program, and confirm samples with suspected pseudoelevated testosterone elevation using other immune platforms or LC-MS/MS.
8.Reference Intervals for Thyroid-Associated Hormones and the Prevalence of Thyroid Diseases in the Chinese Population
Yutong ZOU ; Danchen WANG ; Xinqi CHENG ; Chaochao MA ; Songbai LIN ; Yingying HU ; Songlin YU ; Liangyu XIA ; Honglei LI ; Yicong YIN ; Huaicheng LIU ; Dianxi ZHANG ; Kui ZHANG ; Xiaolan LIAN ; Tengda XU ; Ling QIU
Annals of Laboratory Medicine 2021;41(1):77-85
Background:
Thyroid diseases are highly prevalent worldwide, but their diagnosis remains a challenge. We established reference intervals (RIs) for thyroid-associated hormones and evaluated the prevalence of thyroid diseases in China.
Methods:
After excluding outliers based on the results of ultrasound screening, thyroid antibody tests, and the Tukey method, the medical records of 20,303 euthyroid adults, who visited the Department of Health Care at Peking Union Medical College Hospital from January 2014 to December 2018, were analyzed. Thyroid-associated hormones were measured by the Siemens Advia Centaur XP analyzer. The RIs for thyroid-associated hormones were calculated according to the CLSI C28-A3 guidelines, and were compared with the RIs provided by Siemens. The prevalence of thyroid diseases over the five years was evaluated and compared using the chi-square test.
Results:
The RIs for thyroid stimulating hormone (TSH), free thyroxine (FT4), free triiodothyronine (FT3), total thyroxine (TT4), and total triiodothyronine (TT3) were 0.71–4.92 mIU/L, 12.2–20.1 pmol/L, 3.9–6.0 pmol/L, 65.6–135.1 nmol/L, and 1.2–2.2 nmol/L, respectively. The RIs of all hormones except TT4 differed significantly between males and females. The RIs of TSH increased with increasing age. The prevalence of overt hypothyroidism, overt hyperthyroidism, subclinical hypothyroidism, and subclinical hyperthyroidism was 0.5% and 0.8%, 0.2% and 0.6%, 3.8% and 6.1%, and 3.3% and 4.7% in males and females, respectively, which differed from those provided by Siemens.
Conclusions
Sex-specific RIs were established for thyroid-associated hormones, and the prevalence of thyroid diseases was determined in the Chinese population.
9.The application of wound care technologies combined with other multiple treatments in the hepatolithiasis patient who suffered from postoperative severe intestinal fistula
Hongling SUN ; Yan SUN ; Caiyun XU ; Jinping XIA ; Liangyu FANG
Chinese Journal of Practical Nursing 2021;37(16):1258-1261
Objective:To assess the nursing care experiences and curative effects of the application of wound care technologies combined with other multiple treatments in the hepatolithiasis patient who suffered from postoperative severe intestinal fistula.Methods:The wound care difficult points were analyzed,the wound care technologies combined with other multiple treatments including multiple debridement methods were applied according to the severity of the intestinal fistula:multiple debridement, new skin protection, continuous flushing and drainage with double cannula, improved negative pressure closure drainage and wound pull-in technology, combined with systemic treatment and nursing intervention.Results:The intestinal fistula was treated for 12 days, and the wound infection was controlled for 24 days. Finally the wound was healed after 43 days and patient was discharged from hospital.Conclusions:In the case of severe intestinal fistula after hepatolithiasis operation, the application of wound nursing technology combined with treatment scheme provides a new treatment idea and scheme for intestinal fistula and wound healing.
10.Maternal iron status in the first trimester is associated with gestational diabetes mellitus and macrosomia
Feiling HUANG ; Liangkun MA ; Shuai MA ; Yixuan HOU ; Aimin YAO ; Liangyu XIA ; Songlin YU ; Shanshan LI ; Haoze LUO ; Zikun ZHOU ; Jiaxin ZHANG ; Yanping LIU
Chinese Journal of Health Management 2020;14(6):515-520
Objective:To evaluate the association of maternal nutrition status in the first trimester with gestational diabetes mellitus (GDM) and macrosomia.Methods:378 pregnant women who took prenatal care in Shunyi Women′s and Children′s Hospital of Beijing Children′s Hospital were enrolled in the study. Blood samples were collected at first prenatal visit (<12 gestation weeks) to measure the level of hemoglobin and iron status indexes including serum iron, ferritin, transferrin, total iron binding capacity, iron saturation, transferrin saturation. The incidence of GDM and macrosomia were collected and Logistic regression was used to evaluate the associations of maternal nutrients status in the first trimester with GDM and macrosomia.Results:The incidence rate of GDM was16.9%,the incidence of anemia and iron deficiency in the first trimester were2.4% and 2.5%, respectively. After adjustment for variables such as maternal age, pre-pregnancy BMI, family history of diabetes, and parity, Logistic regression showed that in the first trimester, iron saturation>50% ( OR=0.238, 95% CI 0.068-0.831), transferrin saturation>50% ( OR=0.08, 95% CI 0.010-0.677) were protective factors of GDM; iron saturation 25%-50% ( OR=0.361, 95% CI 0.143-0.908); transferrin saturation 25%-50% ( OR=0.383, 95% CI 0.165-0.891); ferritin>30 ng/ml ( OR=0.418, 95% CI0.186-0.939) were protective factors of macrosomia. Conclusion:Maternal iron status in the first trimester might be associated with GDM and macrosomia. Thus, maternal iron status assessment in the first trimester is necessary.

Result Analysis
Print
Save
E-mail