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Objective:To explore the influencing factors of false-positive serological reaction of syphilis.Methods:A total of 166 patients with false-positive serological reaction of syphilis (false-positive group), 145 patients diagnosed with early syphilis without treatment (positive control group) and 124 persons undergoing entry physical examination (negative control group) were included from January 2017 to February 2020 in Beijing Tongren Hospital, Capital Medical University. The gender, age and underlying diseases of the three groups were compared. Logistic regression was used to analyze the influencing factors of false-positive serological reaction of syphilis. The efficacies of chemiluminescence immunoassay (CLIA) and toluidine red unheated serum test (TRUST) were compared. Paired t test or chi-square test was used for statistical analysis. Results:In the false-positive group (166 cases), the age of 117 cases were more than 50 years old and 49 cases <50 years old. There were significant differences in age ((53.1±13.8) vs (24.7±2.8), t=22.56, P<0.01), autoimmune disease (36.7%(61/166) vs 6.5%(8/124), χ2=35.93, P<0.01), hepatitis (9.6%(16/166) vs 3.2%(4/124), χ2=4.92, P=0.026) and tumor (6.6%(11/166) vs 0.8%(1/124), χ2=4.68, P=0.030) between the false-positive group and the negative control group. There were significant differences in gender (there were 91(54.8%) males and 75(45.2%) females in the false-positive group, and 103(71.0%) males and 42(29.0%) females in the positive control group, χ2=8.67, P=0.003), age ((53.1±13.8) vs (34.4±12.9), t=20.13, P<0.01) and autoimmune disease (36.7%(61/166) vs 6.9%(10/145), χ2=39.14, P<0.01) between the false-positive group and the positive control group. Multivariate logistic regression analysis showed that gender (odds ratio ( OR)=2.692, 95% confidence interval ( CI) 1.504-4.816, P=0.001), age ≥50 years old ( OR=30.512, 95% CI 15.959-58.335, P<0.01), autoimmune disease ( OR=2.677, 95% CI 1.258-5.695, P=0.011) and hepatitis ( OR=4.408, 95% CI 1.799-10.799, P=0.001) were the influencing factors of false-positive serological reaction of syphilis. In the false-positive group, the positive rate of TRUST was 84.9% (141/166), which was higher than that of CLIA (23.5%(39/166)). The difference was statistically significant ( χ2=126.25, P<0.01). CLIA was 1.0-10.0 cut off index (COI) in 36 patients, and >10.0 COI in three patients.The difference was statistically significant ( χ2=52.51, P<0.01). The titers were ≤1∶4 in 139 patients and≥1∶8 in two patients with TRUST positive.The difference was statistically significant ( χ2=262.35, P<0.01). The sensitivity and specificity of CLIA were 95.2% and 96.0%, respectively, and those of TRUST were 77.2% and 91.1%, respectively. Conclusions:The influencing factors of false-positive serological reaction of syphilis include patients age ≥50 years and with autoimmune disease or hepatitis. The false-positive rate of TRUST is significantly higher than CLIA.
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Objective@#To evaluate the levels of 1ipoprotein lipase protein (LPL)and mRNA in cerebrospinal fluid (CSF) for children retinoblastoma(RB)and evaluation of the chemotherapy.@*Methods@#Case-control study. Total 36 cases were collected in Beijing Tongren Hospital From October 2015 to May 2017. There were two groups, 19 cases of central nervous system(CNS) metastasis and 17 cases of non CNS metastasis according to laterality, age and gender. The changes of neuronspecific enolase (NSE) in serum and cerebrospinal fluid (CSF), chloride, glucose and quantitative protein and white blood cell count in CSF were compared between the two groups before initiating chemotherapy and after the third and sixth cycles of chemotherapy. LPL expression was assessed by Western blot and RT-PCR.Comparisonsbetweenthetwo groups of general data were performed usingt-test. The measurement data were expressed by mean ± standard deviation, and variance analysis was conducted.@*Results@#The level of CSF-NSE from CNS metastasis group was significantly higher than non CNS metastasis group(F=16.43, P=0.002). The level of serum NSE from CNS metastasis group was significantly higher than non CNS metastasis group before chemotherapy(F=41.06, P=0.006). There were significant differences in the level of serum NSE in CNS metastasis group before and after chemotherapy (F=7.06, P=0.001). CSF-LPL protein expression in the CNS metastasis group was significantly higher than that of non CNS metastasis group (F=2.57, P=0.001). There were significant differences of LPL expression in CNS metastasis group before and after chemotherapy (F=2.63, P=0.003)).@*Conclusion@#The expression of LPL protein in CNS may be related to the progression and chemotherapyof RB with CNS metastasis. (Chin J Lab Med, 2018, 41: 608-614)
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Objective To establish a liquid chromatography-tandem mass chromatography ( LC-MS/MS) method for determination of vancomycin concentration in human serum and compare its methodological performance with chemiluminescence microparticle immuno-assay (CMIA). Methods The proteins in serum sample were precipitated by methanol and then vancomycin was eluted and separated on Agilent Poroshell 120EC C18 column (2.1 mm×50 mm, 2.7 μm) with mobile phase of methanol and water in a gradient percentage. Both phases of methanol and water contained 0.1% formic acid. The flow rate was 0.5 mL/min. Norvancomycin was applied as internal standard. Electrospray ionization source was applied and operated in positive ion mode of multiple reaction monitoring (MRM). A total of 112 serum samples collected from the patients taking vancomycin in our hospital, and the results were compared with those of CMIA. Results The method exhibited good linearty within the concentration range of 1 to 100 μg/mL (r2＝ 0.9964).The intra-and inter-day accuracy and precision were all satisfactory for the requirements of quantitative drug testing. No matrix effect and carry-over effect were observed. The results of Wilcoxon symbol rank test showed a difference with statistical significance was found between the serum con-centrations of vancomycin determined by LC-MS/MS and CMIA (P＜0.05), but strong positive correlation and good linear regression were shown between the two methods (Y＝1.06X－0.37, r＝0.986). Conclusion LC-MS/MS should be a cost-saving method superior to CMIA. Its results highly correlated with those of CMIA method. The advantages of LC-MS/MS on accuracy and precision obviously outperformed those of CMIA. Since all the results of LC-MS/MS are comparable to CMIA, this method should be promising to use in determining concentration of vancomycin in serum samples with high clinical value.
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Objective To establish the reference intervals of serum iron and total iron binding capacity (TIBC) among 60+ years people in Beijing.Methods Collected Beijing TongRen Hospital,Capital Medical University from 60 to 79 year-old male 167 cases,173 cases of female serum samples of healthy subjects using Beckman's DXC-800 serum iron,total iron binding capacity,and comparative analysis of two kinds of indicators.Results The normal reference range of serum iron in Beijing (60 to 79 years) was 7.9～23.1 μmol/L.The values were 17.45±5.67 μmol/L in male,and 17.52±6.2 μmol/L in female (t=1.32,P ＞0.05).The normal reference range of total iron binding capacity was 37.8～ 62.2 μmol/L.The values were 50.78±9.17 μmol/L in male,and 52.17±9.75 μmol/L in female (t=1.75,P＞0.05).Conclusion There was no significant difference between serum iron and total iron binding capacity in elderly men and women.The investigation gave the reference intervals of serum iron and total iron binding capacity in Beijing Han elderly (60 to 79 years),which can provide useful reference to clinical.
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Objective To develop a new risk model for predicting type 2 diabetes (T2D) in a rural Chinese population in north China.Methods A village-based cohort study was performed.Data from Handan Eye Study conducted from 2006-2013 comprising 4 132 participants aged 30 years old (1 793 male and 2 339 female) with complete diabetes data at baseline and follow-up were analyzed.The blood biomarkers of T2D incident risk were screened and a new risk model was derived by using unconditional stepwise logistic regression after adjustment of age,body mass index (BMI),waist circumference,and family history of diabetes in random two-thirds of the sample cohort (selected randomly).In addition,a simple point system for T2D risk was built according to the procedures as described in Framingham Study,and the new risk score was subsequently validated in the final one-third of the sample cohort.Results The new risk score included age (8 points),BMI (6 points),waist circumference (8 points),family history of diabetes (9 points),fasting plasma glucose (23 points),and triglycerides (4 points).The score ranged from 0 to 58.The AUC was 0.802 (0.780-0.822) in the validation sample.At the optimal cutoff value of 27,the sensitivity and specificity were 70.27％ (58.50％-80.30％) and 80.83％ (78.60％-82.90％) respectively.Conclusions A new risk model for predicting T2D have been developed in a rural Chinese population in north China,and the risk score can be used in rural basic health care settings after validation.
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ObjectiveTo establish the reference intervals of serum triiodothyronine (TT3),the thyroxine ( TT4 ),free triiodothyronine ( FT3 ),free thyroxine ( FT4 ) and thyroid-stimulating hormone (TSH)in the apparently healthy individuals of Beijing and Shanghai.Methods According to the requirement for laboratory support for the diagnosis and monitoring of thyroid diseases in the National Academy ofClinicalBiochemistry(NACB)laboratorymedicinepracticeguidelines, therewere 390 apparently healthy individuals tested (221 male,169 female,18 -65 years old) from Beijing and Shanghai for serum TT3,TT4,FT3,FT4 and TSH on American Beckman UniCel DXI 800 Automatic Chemiluminescent Analyzer.All markers were analyzed between gender,region,age group using t test and ANOVA.The reference intervals of all markers were determined by P2.5 - P97.5.ResultsTT3,TT4,FT3,FT4,TSH levels in the male group were ( 1.90 ± 0.32) nmol/L,( 116.77 ± 18.02) nmol/L,( 5.28 ±0.67) pmol/L,( 11.54 ± 1.97) pmol/L,( 1.92 ± 1.12 ) mIU/L,respectively,while the above indicators in the female group were ( 1.82 ± 0.32) nmol/L,( 115.73 ± 14.39 ) nmol/L,(5.04 ± 0.59 ) pmol/L,( 10.94 ± 1.45) pmol/L,( 2.37 ± 1.86 ) mIU/L,respectively.When comparing the results in genders,statistical significance was shown in TF3,FT3,FT4 and TSH of two gender groups( t =2.377,3.642,3.471,2.520,all P ＜ 0.05 ).When comparing different regions,statistical significance was only shown in FT3 ( t =6.410,P ＜ 0.05 ),in which Beijing group was (5.01 ± 0.63) pmol/L,and Shanghai group was (5.41 ±0.61 ) pmol/L,and no significant difference were shown in other four markers.Correlation analysis showed that TT4 was positively correlated with age (r =0.22,P ＜ 0.001 ) while TSH was negatively correlated with age ( r =- 0.12,P ＜ 0.05 ).TT3,TT4,FT3,FT4,TSH reference intervals were ( 1.22 - 2.50 ) nmol/L,(83.37 - 149.37 ) nmol/L,( 3.88 - 6.48 ) pmol/L,( 7.70 - 14.86) pmol/L,( 0.38 - 5.58 ) mIU/L,respectively.ConclusionDifferences of serum thyroid hormones were observed in different areas of China,It is important to establish reference intervals of the serum thyroid hormones in Chinese population.
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ObjectiveTo evaluate the suitability of Nordtest guideline in estimating measurement uncertainty of routine tests in clinical laboratory.MethodsData of clinical laboratory of Beijing Tongren Hospital were collected,which came from 176 days of Internal Quality Control ( IQC ) from July 2010 to December 2010 and 6 times of External Quality Assesment ( EQA ) of NCCL from 2009 to 2010.The combined and expanded uncertainties of 21meaurements (sodium, potassium, chlorine,calcium,phosphrous,glucose,urea nitrogen,creatinine,uric acid,total protein,albumin,total bilirubin,direct bilirubin, alanineaminotransferase, aspartateaminotransferase, alkalinephosphatase, lactate dehydrogenase,glutamyl transpeptidase,creatine kinase,triglyceride and total cholesterol) were evaluated according to Nordtest guideline.ResultsOf all the measurements,expanded uncertainty of direct bilirubin ( 17.69％ ) was the highest.For some enzymes such as ALT,AST,ALP and LDH,expanded uncertainties were all over 10％ markedly influenced by the calibrator uncertainty.Expanded uncertainty of triglyceride was 12.7％,also largely influenced by calibrator uncertainty,while that of total cholesterol was 6.96％.ConclusionsNordtest guideline is suitable to evaluate the measurement uncertainty of routine assays in clinical laboratory.However,calibrator uncertainty should be taken into account in the process of evaluation.
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@#Objective To investigate the relationship between polymorphism in methylenetetra-hydrofolate reductase (MTHFR ) and acute cerebral infarction (CI), observe the variation regular of fasting plasma homocysteine (Hcy) level.Methods Using Homocysteine Microplate STE Assay to examine the fasting plasma homocysteine level of 28 CI patients during their initial stage (flaring up between 1 to 3 days) and later stage (flaring up 10 to 15 days) of acute period and 27 healthy controls. The presence of the MTHFR genetic type was determined by polymerase chain reaction (PCR) assay and subsequent restriction enzyme digestion.Results There was no significant difference among the three MTHFR genotypes in distributed frequency of the CI group, normal controls and the 677 allelic gene (P>0.05). The discrepancy of Hcy level in various kinds of genotypes: heterozygote mutation and homozygoto mutation were much higher than wild type (P<0.01). Homozygoto mutation was higher than heterozygote mutation, but there was no significant difference between them (P>0.05). The high homocysteine of group CI during the acute early stage were found out more frequent than normal control (P<0.05). There was no significant difference of fasting plasma Hcy level between the initial stage and later stage of CI group which were in acute period (P>0.05), both of the Results were higher than normal control (P<0.01). There was no significant difference among the Hcy level of various genetypes in CI group during the initial stage and later stage of acute period (P<0.05).Conclusion MTHFR gene C677T mutation is one of the cause of high homocystinemia, while it dose not lead to CI directly. High Hcy level is the independent risk factor of CI, but has no concern to the course of acute CI.