Study on the correlation of CD8 +T cell with CD8low T cell subsets and CD8high T cell subsets / 中华检验医学杂志

Objective To investigate the relationship between the CD 8 +T cells results of clinical automatic analysis platform and the CD8lowT and CD8highT cell subsets.Methods A total of 1316 cases of lymphocyte and flow cytometry data were collected from the First Affiliated Hospital of China Medical University from December 2015 to September 2016 by cross-sectional study. There were 287 cases of malignant tumor , 389 cases of autoimmune disease , 320 healthy people and 320 cases of HIV infection , then to get automatic analysis platform returns result of CD 8+T cell.FlowJo software was used to analyze the CD8low T and CD8high T lymphocyte subsets in the patients , and the results were compared with the results of CD8 +T cells returned by the clinical automatic analysis platform .Results The results of clinical returns CD8 +T cells were consistent with the results of CD 8high T cells in patients with different diseases , and were not exactly the same as the results of CD8lowT cells, and the difference was as follows:the results of CD8low T cells in HIV-infected patients were significantly lower than those of healthy people (56.2 ±42.0, 68.8 ± 45.9, cells/μl P<0.001), which were different from the clinical results of CD 8 +T cells.The results of clinical report of CD8 +T cells were statistically correlated with CD8high T cells and CD8low T cells, and the correlation between CD8 +T cells and CD8highT were higher than that of CD8lowT cells.There was a positive correlation between CD8low T cell count and CD4 +T cell count ( r=0.204, P<0.001) .CD8low T was significantly higher in patients on antiviral treatment than that in untreated group (58.3 ±43.9, 42.9 ± 26.5, cells/μl, P<0.001).After treatment for more than 2 years, the CD8lowT cells in patients with CD4<500 cells/μl were significantly lower than those in patients with CD 4>500 cells/μl (50.1 ±47.0, 66.3 ±46.6, cells/μl, P<0.001).Conclusions The clinical report of CD8 +T cells was consistent with the results of CD8highT cells, and there was a great difference between the results of CD 8lowT cells and the results of CD8 +T cells.CD8low T cells were significantly reduced in HIV infected patients , and CD8low T cells could be effectively reconstructed by antiviral therapy .

Performance verification of the detection of serum copper in Roche Cobas 8000 automatic biochemical analyzer / 中国基层医药

Objective To evaluate the performance verification of serum copper detected by Roche Cobas 8000 automatic biochemical analyzer.Methods Referring to CLSI files and other documents,the precision,accuracy,analysis of measuring range and reference interval of serum copper from Roche Cobas 8000 automatic biochemical analyzer were verified.Results The coefficient of variations (CV) of within-run precision with high and low values were 2.96％,2.91％,respectively;CV of the between-run precision with high and low values were 3.07％,2.99％,respectively,which were all less than the CV provided by the manufacturer (10.00％).The bias between detection results and target value were 1.78％ and 1.56％,respectively,which were all within the measurement range of quality assessment.Analysis of measuring range of the detected items was in line with the linear range provided by the specification.The quotative biological reference range conformed to the group of this laboratory services.ConclusionThe main analytic characteristic of serum copper measurement by Roche Cobas 8000 automatic biochemical analyzer is consistent with acceptable quality standards,and the experimental evaluation project of CLSI shows maneuverability and practicability.

Analysis of the Sysmex XE 5000 blood cell analyzer for the analysis of abnormal lymphocytes and basophils / 中国基层医药

Objective To explore the value of Sysmex XE 5000 blood cell analyzer in alarm of atypical lymphocytes and basophil.Methods 198 samples of Sysmex XE 5000 blood cell analyzer and suggested that atypical lymphocytes and basophils, 915 copies of the instrument tip shaped specimens.Single lymphocyte increased blood smear microscopy for examination under a microscope to detect atypical lymphocytes as the gold standard and to verify the alarm not exactly.Results The microscopic examination results as the gold standard, and suggested that atypical lymphocytes and basophilia specimens after reinspection, eosinophilic granulocyte alkaline or positive value of 1.8%,in the normal range, the positive rate of atypical lymphocytes (129/198) was 65.2%,but the instrument alone atypical lymphocytes alarm specimens the positive rate of atypical lymphocytes after review of 72.4% microscope (663/915),the former was lower than the latter with significant difference (x2=4.521,P<0.05).Conclusion Sysmex XE 5000 blood cell analyzer at the same time of atypical lymphocyte and basophil alarm, two detection levels of interference, combined with microscope examination can improve detection accuracy, reduce the misdiagnosis rate, and provide reliable data for clinical treatment.

Performance verification of three ischemia-modified albumin reagents / 国际检验医学杂志

Objective To verify the performance of three kinds of ischemia‐modified albumin(IMA) reagents .Methods The performance of three IMA reagents(labeled as reagent A ,B ,C) using colorimetric method from Shanghai Aikang Biotechnology Co .,Ltd .,Zhejiang Kuake Bioscience Technology Co .ltd .and Beijing Jiuqiang Biotechnology Co .,Ltd .were assessed by using O‐lympus AU5800 automatic biochemistry analyzer .According to the National Committee for Clinical Laboratory(NCCLS) EP6‐A , EP15‐A and EP7‐A documents and WS/T 420‐2013 verificationof analytical performance of quantitative kits by clinical labo‐ratory ,the precision ,linearity range ,accuracy and anti‐interference capability were assessed .Results The within‐run coefficient of variations(CVs) of reagent A ,B and C were 0 .59% -0 .82% ,0 .27% -0 .54% and 0 .62% -0 .69% respectively .The between‐run CVs of reagent A ,B and C were 0 .98% -1 .74% ,0 .99% -1 .01% and 0 .71% -0 .78% ,respectively ,which were lower than decla‐rations of these reagent kits .The linearity range of reagent A ,B and C were 11 -142 U/mL(r2 = 0 .993) ,10 -120 U/mL(r2 =0 .996) ,14-123 U/mL(r2 =0 .992) respectively ,which showed good linearities .About interference tests ,no remarkable interfer‐ences(all Bias were less than ± 10% ) of reagent A ,B and C were detected when Vitamin C≤10 mg/dL ,hemoglobin≤200 mg/dL , bilirubin≤40 mg/dL and triglyceride≤500 mg/dL .Conclusion The three IMA reagents show high precision ,which could meet clinical requirements ,nevertheless ,differences of anti‐interference capabilities are observed in these three reagents .

The performance evaluation of UW2000 automatic urine system / 国际检验医学杂志

Objective To evaluate the performance of UW2000 automatic urine system .Methods Using UW2000 automatic u‐rine system ,to evaluate intra ,inter batch precision ,linear ,carryover ,and the accuracy of the urine visible components(RBC ,WBC);at the same time intra ,inter batch precision and accuracy of of urine dry chemistry component .Results The within‐run coefficients of variation(CV% ) of RBC in high ,middle and low‐value samples were 15 .6% ,6 .8% ,20 .3% ,WBC were 16 .4% ,10 .5% ,24 .6% , respectively .Inter‐run precision of variation(CV% ) of RBC in middle and low‐value were 12 .8% ,13 .2% ,WBC were 15 .3% , 22 .8% ,respectively .The correlation coefficient of RBC was 0 .991 and the linear range was 88-19 513/μL .The correlation coeffi‐cient of WBC was 0 .997 and the linear range was 7-8 254/μL .And carryover rate was 0 .00% for RBC and 0 .06% for WBC ;The coefficient of UW2000 and microscopy on RBC and WBC were 0 .992 ,0 .995 .Within‐run precision ,inter‐run precision and accuracy for urine dry chemical composition of high ,low controls were all within the requirements of standards .Conclusion UW2000 auto‐matic urine analyzer workstation was not only save manpower ,but also with high detection speed and save cost .Importantly ,the re‐sults are reliability .In addition ,it could meet the working requirement in the general hospital ,and has great application value .

Performance Verification of LP(a)Reagents in Clinical Laboratory / 现代检验医学杂志

Objective To validate the analytical performance of four LP(a)reagents with Immunoturbidimetry method used on the automatic biochemistry analyzer for preliminary clinical application.Methods The performance of four LP(a)reagents (labeled as A,B,C,D)with method from RANDOX,Zhejiang Kuake Co.,Beijing Leadman Co.and Beijing Jiuqiang Co.on Olympus AU5800 automatic biochemistry analyzer were assessed.The precision,linearity range,accuracy,disturbance (vita-min C,bilirubin,hemoglobin,TG)were assessed.Results The within-run CVs of the four reagents (A,B,C and D)were 0.64%~1.18%,3.59%~4.75%,1.33%~3.05% and 1.43%~2.01% respectively.The between-run CVs in A,B,C and D were 1.04%~1.7%,3.81%~4.93%,2.16%~4.76% and 2.33%~3.21% respectively,lower than the stated.The lin-earity range was 82~923 mg/L (r2 =0.997),130~935 mg/L (r 2 =0.996 4),120~1025 mg/L (r 2 =0.992 1)and 117~943 mg/L (r2 =0.999 5)in the four reagents,which demonstrated a sound linear correlation.For interference tests,no re-markable interferences (<±10%)of reagent A and reagent D were detected when Vitamin C≤10 mg/dl,hemoglobin≤200 mg/dl,bilirubin≤40 mg/dl and TG≤500 mg/dl.Interference of reagent B was found when VC≥5 mg/dl,TG≥250 mg/dl and when TG≥250 mg/dl reagent C was interfered significantly.The four LP(a)reagents were used to detect the lipid con-trol,and the deviations of the target value were - 8.07%,1.34%,- 8.05% and 7.38% respectively.Conclusion When used in automatic biochemical analyzer,the four LP(a)reagents showed high precision.The four reagents are all able to meet clinical test requirements,nevertheless,anti-interference capability were different.

O cuidado no hospital psiquiátrico sob a ótica da equipe de enfermagem / Care in psychiatric hospital under the perspective of a nursing team / Atención en hospital psiquiátrico bajo la perspectiva de enfermería del equipo

O presente estudo teve como objetivo descrever a percepção da equipe de enfermagem acerca do cuidado no hospital psiquiátrico. A pesquisa teve abordagem qualitativa, do tipo exploratória, com uso do grupo focal, com cinco participantes, em agosto de 2011, no município de Niterói, RJ, Brasil. A partir da análise dos dados, emergiram cinco categorias: escuta sensível; disponibilidade pessoal; projetos terapêuticos; fator humano da equipe; tensão “psiquiatria tradicional x paradigma psicossocial”. Concluiu-se que, apesar dos sujeitos da pesquisa atuarem ainda no modelo hospitalar, foi possível que trouxessem percepção do cuidado de forma humana e integral. Mas, esta percepção sobre o cuidado possuía fragilidade, pois não se evidenciaram as bases científicas da enfermagem. Recomenda-se que o profissional da equipe de enfermagem invista em seu papel no processo de cuidar no contexto da Reforma Psiquiátrica, em busca de uma abordagem centrada no sujeito e no seu modo de existir.

The present study is aimed at describing the perception of the nursing team concerning the care in a psychiatric hospital. The research used a qualitative approach, exploratory type, using focus group technique, with five participants, in August 2011, in Niteroi, RJ, Brazil. From the data analysis five categories emerged, covering: sensitive listening; personal availability; therapeutic projects; human issues of the team; Traditional Psychiatry vs. Psychosocial Paradigm tension. It was concluded that despite the research, the subjects were still working at the hospital model. It was possible to bring awareness in a human, comprehensive and complete manner. But this perception of care has frailties once it does not bring any evidence of scientific basis of nursing. It is recommended that the professional nursing team invest in their role of caring in the context of the Psychiatric Reform, in the pursuit of an approach centered on the subject and in his way of living.

El objetivo del presente estudio fue describir la percepción del personal de enfermería acerca de la atención en hospital psiquiátrico. Investigación con enfoque cualitativo, exploratorio, utilizando instrumentos de Análisis Institucional y de los grupos de enfoque con cinco participantes, en agosto de 2011, en Niterói, RJ, Brasil. A partir del análisis de datos, surgieroncinco categorías: escucha sensible; disponibilidad de personal; proyectos terapéuticos; factor humano de equipo; tensión “psiquiatría tradicional x paradigma psicosocial”. En conclusión, a pesar de los sujetos de investigación actuaren en el modelo hospitalario, fue posible traer percepción de cuidado humano e integral. Pero esta percepción poseía debilidad, porque no había evidencias de bases científicas de la enfermería. Se recomienda que el personal de enfermería invierta en su papel de cuidar en el contexto de la reforma psiquiátrica, en la búsqueda de enfoque centrado en el sujeto y su modo de existir.

Performance evaluation of the Beckman Coulter ACT-5DIFF AL automated hematology analyzer / 中国医师杂志

Objective To evaluate the performance of the Beckman Coulter ACT-5DIFF AL automated hematology analyzer and to verify whether it meets the clinical requirement.Methods The residual contamination rate,accuracy,precision,uncertainty,measurement range,reference interval,and sample injection pattern of detecting system were evaluated.Results The residual contamination of each parameter was less than or equal to 0.18％.According to room between qualitative evaluation results,compared to the target value,bias ranged from 0.32％ to 2.29％.Different concentrations of laboratory variation coefficient (namely precision) of each parameter ranged from 0.35％ to 4.46％,and both of which were less than a third of the CLIA'88 ability verification analysis quality requirements.The expanded uncertainty of each parameter was Uwhite blood cell (WBC) low =7.4％,UWBC high =3.8％,Ured blood cell (RBC) low =3.4 ％,U RBC high =2.8 ％,Uhemoglobin (HGB) low =3.9 ％,UHGB high =2.2 ％,Uplatelet (PLT) low =9.8 ％,UPLT high =7.6％,UMCV low =2.6％,and UMCV high =2.5％.Analysis had a wide measuring range:WBC (0.2 ～ 137.3) × 109/L,RBC(0.72 ～ 7.66) × 1012/L,HGB (20 ～ 231)g/L,PLT(25 ～983) × 109/L,and hematocrit (HCT) (6.1 ～68.0)％.All of them had a linear relationship,and the correlation coefficient of linear regression was close to 1.0.The reference interval quoted was suitable.Both of the automatic and the hand sample injection pattern had no significantly difference in result detection.Five categories of WBC were verified up to standard.Conclusions Under the circumstance of indoor quality control approved,each performance indicator approximately reached the laboratory quality requirements,and it also met the clinical requirements.

Establishment and evaluation of the review criteria of automatic urine analysis workstations / 中华检验医学杂志

Objective To establish the proper review rules for the microscopic screening of urine samples tested by automatic urinalysis work station.Methods A total of 3 154 random urine samples were enrolled to establish and validate review rules .All the samples were collected from the inpatients and outpatients of Shanghai First People′s Hospital from March to May 2013 and tested by urinalysis work station.Three thousands one hundred and fifty four urine samples were firstly tested by urinalysis work station,including both urine dry chemical analyzer and urine sediments analyzer .Then each urine sample was examined microscopically by two technicians-in-charge using double-blind method.The average results from the two technicians were used as review results .Compared with review results ,the review rules were set up.According to different test methods by automatic urinalysis work station , four microscopic review protocols were defined:(1)Protocol 1:based on chemistry results only ,microscopy review was performed when any of WBC,RBC,PRO and NIT was positive;(2)Protocol 2:based on urine sedimental analysis only ,microscopy review was performed when any of WBC ,RBC and CAST count was over upper limit of the reference range;(3)Protocol 3:if any of BLD ,RBC,LEU,WBC was different between two systems ,or quantitative results had two or more than two gradient differences ,microscopy review was performed;(4) Protoco1 4:if any of BLD, RBC,LEU ,WBC was different between two systems , or CAST was over upper limit of the reference range , or alarm appeared , microscopic review was performed .400 randomly selected urine samples were tested to validate the review rules .Omission diagnostic rate and review rate were used to evaluate the rules .Results According to the review rules,the positive samples rate was 43.47%(1 371/3 154) and the negative rate was 56.53%( 1 783/3 154 );Positive samples were composed of RBC ( 55.58%) , WBC ( 59.66%) and CAST(6.42%).The review rates of four protocols were 44.48%(1 403/3 154),45.69%(1 441/3 154), 26.09%(823/3 154),28.95%(913/3 154),respectively.The false negative rates (omission diagnostic rates)were 7.13%(225/3 154),4.53%(143/3 154),2.73%(86/3 154) and 1.02%(32/3 154), respectively .Protocol 4 was selected as an ideal plan.Additional 400 urine samples were tested using protocol 4 in order to confirm the review rule.The review rate, false negative rate were 26.25%(105/400), 0.75%( 3/400 ), respectively.After image review revised, the review rate was 14.50%(58/400).Conclusion This study formulates that the automatic urine analysis workstation review rules have clinical maneuverability and validity.

Establishment and evaluation of the review criteria of automatic urine analysis workstations / 中华检验医学杂志

ObjectiveTo establish the proper review rules for the microscopic screening of urine samples tested by automatic urinalysis work station which is composed of LabUMat urine dry chemical analyzer and Urised urine sedimental analyzer.Methods The paired comparison was used to analyze the results tested by microscopy and Urised.A total of 2015 random urine samples were enrolled to establish and validate review rules.All the samples were collected from the inpatients and ontpatients of General Hospital of the People's Liberation Army from May to November 2011 and tested by urinalysis work station.2015 urine samples were firstly tested by urinalysis work station,including both urine dry chemical analyzer and urine sediments analyzer.Then each urine sample was examined microscopically by two technicians-in-charge using double-blind method.The average results from the two technicians were used as review results.Compared with review results,we set up the review rules and evaluated the Irue positive rate,false positive rate,true negative rate,false negative rate (omission diagnostic rate) and review rate.According to different test methods by automatic urinalysis work station,four microscopic review protocols were defined:( 1 ) Protocol 1:based on chemistry results only,microscopy review was performed when any of WBC,RBC,PRO and NIT was positive; (2) Protocol 2:based on urine sedimental analysis only,microscopy review was performed when any of WBC,RBC and CAST count was over upper limit of the reference range ; (3) Protocol 3:if any of BLD vs.RBC,LEU vs.WBC was different between two systems,or quantitative results had two or more than two gradient differences,microscopy review was performed; (4) Protocol 4:if any of BLD vs.RBC,LEU vs.WBC was different between two systems,or CAST was over upper limit of the reference range,or alam appeared,microscopic review was performed.300 randomly selected urine samples were tested to validate the review rules.Omission diagnostic rate and review rate were used to evaluate the rules.Results According to our review rules,the positive samples rate was 41.14％ (829/2015) and the negative rate was 58.86％ ( 1186/2015 ) ; Positive samples were composed of RBC (50.30％),WBC (53.32％) and CAST (3.74％).The review rates of four protocols were 42.93％ (865/2015),39.70％ (810/2015),29.58％(596/2015),18.91％ (381/2015 ),respectively.The false negative rates (omission diagnostic rates) were 6.36％ (128/2015),4.42％ (89/2015),1.34％ (27/2015)and 1.04％ (21/2015)respectively.Protocol 4 was selected as an ideal plan.Additional 300 urine samples were tested using protocol 4 in order to confirm the review rule.The review rate,consistency rate,true positive rate,false positive rate,true negative rate,omission diagnostic rate were 19.67％ (59/300),91.67％ (275/300),35.67％ (107/300),7.67％(23/300),56.00％ (168/300),0.67％ (2/300),respectively.After image review revised,the review rate was 8.67％ (26/300).ConclusionThe review rules established by our research for Urinalysis Work Station can find the abnormal urine samples effectively and exactly and can reduce the workload significantly.(Chin J Lab Med,2012,35:810-814)

Performance validation of CLINITEK Atlas urine dry chemistry analyzer and its supplementary strips in clinical laboratory / 中华检验医学杂志

Objective To evaluate the clinical performance of CLINITEK Atlas urine dry chemistry analyzer and its supplementary strips,which could be used for other hospitals as reference.Methods Five hundred and one samples of random fresh urine were collected and analyzed by CLINITEK Atlas urine dry chemistry analyzer.10 parameters were reported for each sample,including SG,pH,BLD,LEU,PRO,GLU,KET,UBG,BIL and NIT.According to the medicals standard of the People's Republic of China,General Technical Requirements for Urine Analyzer(YY/T 0475-2004),General Technical Requirements for Chemical Reagent Strips for Urinalysis(YY/T 0478-2004)and physical,Chemical and Microscopic Examination of Urine(WS/T 229-2002),the precision,accuracy,carryover,stability,sensitivity and consistency of each parameter were evaluated.The agreement was assessed between the results for BLD and LEU obtained from CLINITEK Atlas analyzer and phase contrast microscope,and calculated the sensitivity and specificity of CLINITEK Atlas analyzer for BLD and LEU using phase contrast microscope as the gold standard.SG and pH test was performed among 200 specimens by CLINITEK Atlas analyzer,and then compared with the results obtained from MASTER-SUR-NM specific gravity refractometer and pH precision test strips respectively.In addition to SG and pH,the other eight parameters were compared with the results obtained from CLINITEK 500 urine analyzer,and Kappa value and consistency were calculated.Results The accuracy,precision,sensitivity,carryover and stability of 10 parameters could meet all the requirement of standards.SG and pH had good correlation with urine specific gravity refractometer (r =0.9838,P ＜0.001)and pH meter (r =0.8884,P ＜0.001),respectively.Compared with phase contrast microscope,BLD and LEU had coincidence rates of 90.4％ and 90.8％,respectively; Sensitivities were 90.7％ (301/332) and 83.3％ (200/240) ; Specificities were 89.9％ (152/169) and 97.1％ (255/261).Compared with CLINITEK 500,all the parameters,except for SG and pH,had good coincidence rates of ＞ 87.6％.Conclusion The performance of CLINITEK Atlas urine dry chemistry analyzer can meet the clinical requirements of all standards.

Evaluation for clinical application of UniCel DxH 800 hematology analyzer / 中华检验医学杂志

ObjectiveTo evaluate the improvement on test performance of UniCel DxH 800 automated hematology analyzer for complete blood count (CBC) by detecting its performance indicators and comparing the differences of the results with LH 750 hematology analyzer and ADVIA 2120 hematology analyzer.MethodsThe precision,carryover and linearity of UniCel DxH 800 in measurement of CBC were evaluated by using fresh blood samples and instrument quality control of products.To evaluate the accuracy of leukocyte differential count and reticulocyte count with the microscopic method as the “gold standard”.To calculate the bias and correlation between the results measured by LH 750,ADVIA 2120 and UniCel DxH 800 hematology analyzers and compare these three instruments on the validity of the alarm in abnormal cells.ResultsIntra-precision:The coefficient of variation (CV) of the results of RBC,Hb and MCV were less than 0.5％,the CV of WBC and PLT results were less than 1.5％.Inter-precision:the CV of the parameters above were less than 2.5％.The carryover rate of WBC,RBC,Hb,MCV and PLT were less than 0.51％.In the concentration range covered by clinical samples,the correlation coefficients between the measured values and theoretical value in testing WBC,RBC,Hb and PLT were greater than 0.999 ( P ＜0.01 ).The measurement results of WBC,RBC,Hb,MCV and PLT hy UniCel DxH 800,ADV1A 2120 and LH 750 hematology analyzers have good correlation (r ＞ 0.973,P ＜ 0.01 ).Correlation of reticulocyte count between the UniCel DxH 800 hematology analyzer and microscolpic method was significant (r =0.920,P ＜0.01 ).Correlation of leukocyte differential count about the grauulocytes, lymphocytes and eosinophils between the UniCel DxH 800 hematology analyzer and microscopic method was good (r =0.914,0.900 and 0.725,P ＜0.01 ),followed by monocytes ( r =0.612,P ＜0.01 ),which were better than the LH 750 with similar detection principle.The UniCel DxH 800 hematology analyzer demonstrated higher sensitivity (96.6％ ) for the alarm of abnormal cells and achieved a lower false-negative rate (2.5％ ).Meanwhile,the sensitivity of the neutrophil nuclei left shift was higher (90.5％ ) and the false-negative rate (5.0％) was lower.ConclusionsThe UniCel DxH 800 hematology analyzer for complete blood count shows advantages of high precision,low carryover rate and wide linear range.The results detected by the UniCel DxH 800 hematology analyzer have good correlation with the LH 750 and ADVIA 2120.

Small dense low density lipoprotein-cholesterol distribution in people with normolipidemia and hyperlipidemia and the correlation with serum lipids / 中华检验医学杂志

Objective To investigate the distribution characteristics of serum small dense low density lipoprotein-cholesterol (sdLDL-C) levels in healthy normolipidemia and hyperlipidemia and analyze the correlation between sdLDL-C and other serum lipids.Methods Totally 1012 normolipidemic subjects (18 93 years old,503 male,509 females) were grouped according to gender and age (18 -29,30 -69 and ≥70 years old).And 433 hyperlipidemic subjects (23 -90 years) were divided into the following 3 groups based on fasting triglyceride (TG) and low density lipoprotein-cholesterol (LDL-C)levels:hypertriglyceridemia (n =165 ),high-LDL-C ( n =129) and combined hyperlipidemia ( n =139 ).The sdLDL-C and other serum lipids were measured by Olympus AU2700 automatic analyzer.Analysis of Variance and Kruskal-Wallis H test was used for statistical analysis.Results The distribution of the sdLDL-C levels in normolipidemic subjects was near normal distribution.The sdLDL-C levels had differences in gender and age.In the 18 -29 and 30 -69 years old group,the mean values of sdLDL-C were significantly higher in males than in females [ (0.55 -0.21 ) mmol/L vs (0.47 ±0.22) mmol/L,t =2.212,P =0.028 and (0.66±0.28) mmol/L vs (0.62±0.25) mmol/L,t =2.121,P=0.034].In the ≥70 years old group,the difference of sdLDL-C levels in gender was not statistically significant [ male ( 0.54 ± 0.21 )mmol/L vs female (0.54 ± 0.22 ) mmol/L,t =0.022,P =0.982] ; the mean value was ( 0.54 ± 0.22 ) mmol/L The hyperlipidemic subjects had conspicuous higher levels of sdLDL-C compared with normolipidemia [ ( 1.25 ±0.44) mmol/L vs (0.60 ±0.26) mmol/L,t =29.306,P ＜0.001 ].Among all of groups,the combined hyperlipidemia group had the highest sdLDL-C level [ ( 1.52 ± 0.49) mmol/L,F =525.66,P ＜0.001 ] ; the hypertriglyceridemia group had the highest sdLDL-C/LDL -C level (0.47 ±0.12,F =287.93,P ＜0.001 ) and the high-LDL-C group had the highest level of non-sdLDL-C [LDL-C subtract sdLDL-C,(2.71 ± 0.52) mmol/L.F =336.32,P ＜ 0.001 ].The sdLDL-C showed a good positive correlation with TC,TG,LDL-C,ApoB and BMI ( rs =0.66,0.68,0.65,0.79 and 0.27,P ＜ 0.001 ),and negative correlation with HDL-C and ApoA1 ( rt =- 0.42 and - 0.37,P ＜ 0.001 ).Based on partial correlative analysis,sdLDL-C showed a different correlation with TG,LDL-C and TC ( r =0.42,0.28 and 0.15,P ＜ 0.001 ).Conclusions LDL-C and TG are the important factors influencing the sdLDL-C levels.However,TG has greater effect than LDL-C.The sdLDL-C is an appropriate and good index to evaluate the small dense low density lipoprotein (sdLDL) mass and the overall situation of lipid metabolism.In order to make full use of sdLDL in the clinical treatment and health assessment,it is necessary to establish sdLDL-C reference intervals through the survey of distribution of sdLDL-C levels in different geographic areas.

Analytical performance of three cysteine proteinase inhibitor c reagents applied in the automatic biochemistry analyzer / 中华检验医学杂志

Objective To validate the analytical performance of three Cys C reagents with particle-enhanced turbidimetric immunoassay(PETIA) method used on the automatic biochemistry analyzer for preliminary clinical application.Methods The performance of three Cys C reagents (labeled as A, B, C) with PETIA method from Shanghai Jing Yuan Co., Beijing Leadman Co. and Beijing Jiuqiang Co. on OlympusAU2700 automatic biochemistry analyzer were assessed.According to the standard of CLSI EP6-A, EP15-A and EP7-P, the precision, linearity range, disturbance (bilirubin, hemoglobin, chyle) were assessed, and compared with those of Cys C reagent based on particle-enhanced nephelometric immunoassay(PENIA) from Dade Behring Co.. The reference ranges for Cys C in serum of 120 healthy individual were evaluated.Results The within-run CVs of the three reagents (A, B and C) were 3.08%-3.2%, 2.3%-4.15% and 1.38%-1.53% respectively.The total CV in A, B and C were 3.29%-3.44%, 2.65%-5.18% and 1.67%-1.69% respectively, lower than the stated.Limits of quantitative determination (LOQ) of the three reagents were 0.41, 0.23 and 0.07 mg/L, basically meeting the testing requirement.The linearity range was 0.22-7.26 mg/L(r=0.996), 0.20-7.72 mg/L(r=0.999)and 0.20-7.62 mg/L(r=0.997)in the three reagents, which demonstrated a sound linear correlation. For interference tests, no remarkable interference (<±10%) of reagent C was detected when bilirubin≤684 μmol/L, hemoglobin≤9.7 g/L and Chyle turbidity≤6 200 FTU; and no significant interference of reagent B was found when bilirubin≤684 μmol/L, hemoglobin≤6.79 g/L and Chyle turbidity≤6 200 FTU; when bilirubin≤684 μmol/L, hemoglobin≤4.85 g/L and Chyle turbidity≤1 240 FTU reagent A was not interfered significantly. The comparison afte and before the high-speed centrifugation reveals that the average percentage of bias for reagents A, B, C measured Cys C in chylous serum samples of patients was -8.31%, 1.52%, 1.32%, respectively.In method comparison tests, the regression equations of the three reagents compared with Dade Behring PENIA Cys C reagent were as follows:Y=0.787X+0.492 (R2=0.976), Y=1.098X+0.137 (R2=0.982) and Y=1.037X+0.249 (R2=0.996), respectively. Agreement rates of the high Cys C in reagent A, B, C and Dade Behring Cys C reagent were 80% (Kappa=0.615,P=0.000), 100% (Kappa=1.000,P=0.000), 91.2% (Kappa=0.824,P=0.000); While for reference range of preliminary clinical assessment, diagnosis coincidence rate of reagent A increased to 98.8% (Kappa=0.974,P=0.000). Conclusions When used in automatic biochemical analyzer, the three Cys C reagent with PETIA showed high precision,sensitivity, and sound correlation with Dade Behring PENIA reagents.The three reagents are all able to meet clinical test requirements, nevertheless, anti-interference capability were diffierent and the reference range should be further validated.

Development and clinical application of microscopy review criteria of automated urine chemistry and sedimental analysis / 中华检验医学杂志

Objective To integrate urine strip chemistry analysis with urine sedimental analysis and set up the criteria for urine microscopy review following automated urine analysis.Methods A total of 1 714 urine samples were collected from Peking Union Medical College Hospital from November 2008 to October 2010.Out of 1 714 samples, 1 300 samples were used for the establishment of review criteria, and 214 samples were used for criteria verification.The other 200 samples from healthy donors were used to set up the normal reference range of fully automated urine sedimental analyzer UF-1000i.RBC,WBC,PRO and CAST in all the samples were measured by Siemens Bayer Clinitek 500 urine strip chemistry analyzer, Sysmex UF-1000i urine sedimental analyzer and microscopic examination.Based on the different laboratory automation in urine analysis, four microscopic review protocols were defined: (1) Protocol 1: based on chemistry results only, microscopy review was performed when any of WBC, RBC and PRO was positive; (2) Protocol 2: based on fully automated sedimental analyzer only,microscopy review was performed when any of WBC, RBC and CAST was over the upper limit of the reference range; (3) Protocol 3: All the results of urine chemistry analyzer and sedimental analyzer were integrated.If two WBC results were different between two systems (in one system WBC was positive or over the upper limit of the reference range but in another system WBC was negative or within the reference range), and any of RBC, PRO/CAST was positive or over the upper limit, microscopic review was performed; (4) Protocol 4: if any of WBC, RBC, PRO/CAST was different between two systems, microscopic review was performed.Review criteria were performed with Sysmex Laboman UriAccess 3.0 software.Results The reference ranges of UF-1000i parameters were RBC 0-7.5/μl (male), 0-15.9/μl (female); WBC 0-11.6/μl (male), 0-12.7/μl (female); Epithelial cell were 0-6.5/μl (male), 0-21.4/μl (female); CAST 0-1.3/μl.The results of microscopic examination revealed that positive samples were 47.46% (617/1 300) and negative samples were 52.54% (683/1 300). Among positive samples, majority showed the presence of RBC (60.13%,371/617), followed by CAST (8.43%,52/617).The false negative rates of four protocols were 8.38% (109/1 300), 4.69% (61/1 300), 0.62% (8/1 300) and 0.54% (7/1 300), respectively.The review rates were 47.85% (622/1 300), 59.38% (772/1 300), 72.85% (947/1 300) and 52.23% (679/1 300), respectively.Although there were false negative cases in protocol 4, all the patients had normal serum creatine level.In those 214 patients for verification, the false negative rate using protocol 4 was zero, the review rates were 53.74% (115/214).Conclusions Protocol 4 shows lest false negative rate and lower review rate.Importantly, there was no patients with serious renal function abnormality missed using protocol 4.Therefore, protocol 4 is an ideal criteria for microscopy review following automated urine analysis.

Study and application of the combination of urine dry chemistry examination and urine sediment flow cytometry examination on the microscopic screening of the urine formed component / 中华检验医学杂志

Objective To establish the proper review rules for the microscopic screening of urine analyzed by UF-1000i automatic urinalysis work station (composed of UF-1000i urine flow cytometer and AX-4030 urine dry chemical analyzer).Methods A total of 2 839 random urine samples were collected at Chinese People′s Liberation Army General Hospital from September 2009 to February 2010, and were analyzed using UF-1000i urinalysis work station.The parameters obtained from UF-1000i and AX-4030 included RBC, WBC, CAST and ERY, LEU, PRO.After analysis by urinalysis work station, each urine sample was examined microscopically by two technologists using double-blind method.The average results got from the two technologists were regarded as the judging criterion.Based on the criterion, the review rules for the 2 839 urine samples tested by urinalysis work station were created and adjusted, and the true positive rate, false positive rate, true negative rate, false negative rate and review rate of these review rules were calculated.After that, 299 randomly selected urine samples were tested to validate these review rules.Omission diagnostic rate and review rate were used to assess the clinical practicability of the review rules.Results Thirty seven rules for microscopic review and twenty seven rules without further microscopic examination were set up based on six parameters using UriAccess 3.0 Software.The microscopic examination result was taken as the judging criterion, the consistency rate of these rules was 81.11%(2 311/2 839), the true positive rate was 40.51%(1 150/2 839), the false positive rate was 16.17%(459/2 839), the true negative rate was 41.00%(1 164/2 839), the false negative rate(omission diagnostic rate) was 2.43%(69/2 839) and the review rate was 18.28% (519/2 839).Additional 299 urine samples were assayed using UriAccess3.0 software to further verify these review rules.The consistency rate was 82.27%(246/299), the true positive rate was 36.12%(108/299), the false positive rate was 16.39%(49/299), the true negative rate was 46.15%(138/299), the false negative rate(omission diagnostic rate) was 1.34%(4/299), the review rate was 19.06%(57/299). The 4 false negative samples selected by these review rules did not come from the nephropathy department or the urology department.Microscopic results of RBC and WBC form these 4 samples ranged 3-8 cells/HP. Thus, these review rules could avoid the missed diagnosis of those patients with severe renal dysfunction.Conclusion The review rules established from this study for the UF-1000i urinalysis work station can effectively detect abnormal urine samples and improve the efficiency and the quality of urinalysis in routine clinical practice.

Examination of the urine sediment and establishment of the criterion for microscopy review / 中华检验医学杂志

Urine sediment analysis is of importance for the diagnosis, differential diagnosis and prognosis in urinary system diseases.To understand the standardization of sediment analysis and its development, This article analyzes the advantage and disadvantage of automated instrument used in urine sediment analysis, and then developes the criteria for microscopy review following automated urinalysis.

Establishment of identification database of six common dermatophytes using Biolog automatic analyzer for microbes / 中华皮肤科杂志

Objective To investigate the application prospect of Biolog automatic analyzer for microbes in the identification of common dermatophytes. Methods Clinical isolates of dermatophyte were identified to species level based on phenotypes and DNA sequence. The strains of Trichophyton rubrum, Trichophyton mentagrophyte, Trichophyton tonsurans, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum were inoculated into FF microplates, and the utilization of 95 different carbon sources were recorded.The growth and reaction spectrum of these strains were described and identification database was set up. Results There was a great difference in the utilization of carbon sources among different fungal species. The utilization of raffinose could differentiate Trichophyton mentagrophyte and Trichophyton tonsurans from the other four Trichophyton. Sebacic acid could differentiate Trichophyton mentagrophyte from Trichophyton tonsurans.Meanwhile, Trichophyton rubrum could be differentiated from Microsporum gypseum, Epidermophyton floccosum and Microsporum canis by utilization of fumarate and succinate. Microsporum gypseum could be identified by use of alanine and phenylalanine. The utilization of dextrin could distinguish Epidermophyton floccosum from Microsporum canis. Conclusion The Biolog automatic analyzer for microbes has the ability to identify common dermatophytes to species level based on their specific phenotype.

Difficulties and doubts of examination of urine formed elements / 中华检验医学杂志

Examination of urine formed elements is an important diagnostic method of nephopathy. At present there are many defects in microscopic examination and automated analysis. Also the results of dry chemistry are unreliable. But staining is an effective way for identifying urine formed elements. The comprehensive quality control in the process of preanalysis, analysis and postanalysis is necessary prerequisite for the examination of urine formed elements.

Value evaluation of UF-1000i automated urine formed elements analyzer in the diagnosis of urinary tract infection / 中华检验医学杂志

Objective To evaluate the application value of UF-1000i automated urine formed elements analyzer in the diagnosis of urinary tract infection. Methods 150 urine specimens were analyzed using the UF-1000i in parallel with detection of leukocyte, yeast-like fungus, and bacteria. These detection results were collected for evaluation of urinary tract infection and scatter grams were recorded. At the same time, these samples were cultured for bacterial identification, which results were compared with that of the UF-1000i. The clinical diagnose criteria of the UTI was performed as golden standard. As compare with results obtained with UF-1000i, the sensitivity and specificity of UF-1000i for diagnosis of urinary tract infection were evaluated, and the consistency were analyzed among scatter grams, bacterial culture and final diagnosis. Results The statistical results from 146 specimens showed that the positive rate of UF-1000i was 32. 9% (48/146), the positive rate of urine culture is 28. 8% (42/146). There was no significant statistical difference found (χ2 = 1.79 ,P = 0. 18 )and Kappa test showed a considerable consistency (K = 0. 775 6). The UF-1000i detection results showed the sensitivity 76. 0% ( 38/50 ), specificity 89. 6% ( 86/96 ), positive predictive value 79. 2% ( 38/48 ) and negative predictive value 87. 8% ( 86/98 ), respectively. The distribution of coccus and bacilli obtained from the UF-1000i testing was basically in accordance with the results of bacterial culture. Conclusion The "UTI-information" of UF-1000i is very important for the diagnosis of urinary tract infections.