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Patient based real time quality control (PBRTQC) is a quality control method that uses the test results of clinical specimens from patients to monitor the analysis performance of the test process in real time and continuously. Although the International Federation of Clinical Chemistry and Laboratory Medicine PBRTQC working group had recommended that this method should be popularized in clinical practice in 2020, there is still certain lagging in cognition, research and application of PBRTQC in domestic clinical laboratories. This paper highlights the research progress, operation categories, clinical application value, domestic standard guidelines, PBRTQC procedure establishment, performance verification, implementation principles, application status and prospects of PBRTQC, so as to promote the recognition, acceptance, reference and wide application of PBRTQC in domestic clinical laboratories.
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Objective@#To investigate the effects of glycosylated hemoglobin A1c (HbA1c) from the patients with double heterozygotes Hb Q-H and Hb J-Bangkok combined with β-thalassemia on the results of different HbA1c detection systems. @*Methods@#Blood samples from 20 healthy adults and 20 patients with type 2 diabetes mellitus (T2DM) were collected to assess the results of five glycosylated hemoglobin detection systems. Blood samples from one Hb Q-H patient and one Hb J-Bangkok patient with β-thalassemia were also collected, and they were performed hemoglobin capillary electrophoresis with Capillarys2 and globin gene analysis by gap-PCR, PCR-RDB and DNA sequencing. The levels of HbA1c in all samples were detected by BioRad VARIANT Ⅱ (VⅡ), BioRad VARIANT ⅡTurbo2.0 (V Ⅱ-T2.0), Capillarys 2 Flex Piercing (C2FP), Primus Ultra2 (Ultra2) and Roche PPI 800 (PPI 800) glycosy lated hemoglobin detection instruments, respectively. For the samples with double heterozygotes, the levels of HbA1c were detected for 3 times each sample, and the results were preserved and analyzed. @*Results@#The genotype of the Hb Q-H sample was --α QT /--SEA;β N /β N , and HbA1 CD74 G＞C mutation occurred in globin α1 chain, forming Hb Q-Thailand hemoglobin variant without normal α-globin peptide chain. The genotype of Hb J-Bangkok combined with β-thalassemia was αα/αα;βCD56/βCD41-42, and the point mutation of GGC＞GAC occurred at codon 56 of globin β-chain, forming Hb J-Bangkok hemoglobin variant without normal β-globin peptide chain. For the Hb Q-H sample, HbA1c results were reported by 3 of 5 HbA1c detection systems. The chromatograms of VⅡ and VⅡ-T2.0 detection systems were obviously different from normal chromatograms, and HbA1c results were not reported. However, the chromatograms of the C2FP system were similar to normal chromatograms, and the result of HbA1c was 3.7%. The Ultra2 system and PPI system reported the HbA1c results, 5.3% and 5.7%, respectively, without abnormal alarm. For the Hb J-Bangkok with β-thalassemia sample, HbA1c results were also reported by 3 of 5 HbA1c detection systems. The chromatograms of VⅡ and Sebia detection systems were obviously different from normal chromatograms, and HbA1c results were not reported. However, the chromatograms of VⅡ-T2.0 system were different from normal chromatograms, and a P4 peak (84.9%) was found. The HbA1c result was reported as 4.7%. The Ultra2 system and PPI system reported the HbA1c results, 4.7% and 3.8%, respectively, without abnormal alarm. @*Conclusion@#The samples from the Hb Q-H patient and the Hb J-Bangkok patient with β-thalassemia do not contain normal HbA, and there should be no HbA1c results. The chromatograms of VⅡ and VⅡ-T systems are obviously abnormal, indicating that the results can not be reported. The C2FP system is interfered obviously by Hb Q-H, but reports the HbA1c results, while it does not report the HbA1c results of Hb J-Bangkok combined with β-thalassemia. Both of Hb Q-H and Hb J-Bangkok have obvious interference to PPI and Ultra2 detection systems.
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Objective To improve the efficiency of result reporting and ensure the accuracy of the results by establishing autoverification system in Clinical Chemistry and Immunology Laboratory.Methods The study followed the requirements of the Clinical Laboratory Standards Institute(CLSI)AUTO-10A and ISO 15189:2012.In addition,seven categories of verification rules were encoded using the autoverification function of the CentraLink?Data Management System on the Aptio?Automation platform.These rules included Clinical Diagnostic Standard(CS), Sample Status(SS), Quality Control Severity(QS), Instrument Error Flags Severity(IS), Normal Severity(NS), Delta Check Severity(DS), and Logical Assessment Standard(LS).Various modules of Aptio Automation,laboratory information system(LIS)and hospital information system(HIS)were integrated using the CentraLink system to establish the autoverification system.Results The autoverification system was set up and tested from August 2015 to April 2016.In total, the system ran 4 496 425 tests on 366 180 chemistry specimens.The overall autoverification rate for tests performed increased from 53.4% to 87.0%.Glucose had the highest rate (98.3%)while CKMB had the lowest rate(63.6%).Average TAT for result verification decreased by 97.7%,from 46.3 minutes to 3.7 minutes.The system ran 410,040 tests on 160 119 chemiluminescence specimens.The autoverification rate for tests performed increased from 40.2%to 89%.C-P had the highest rate(98.4%)while A-TPO had the lowest rate(58.7%).Average TAT for result verification decreased by 77.4%,from 14.6 minutes to 3.3 minutes.From May 2016 to January 2017(when autoverification was employed),compared with the same period in 2014(when manual verification was employed),the following changes were observed with no increase in staff capacity:a)Volume of routine chemistry tests increased by 46.4%,and median TAT for tests decreased by 41.9%, from 118 minutes to 83 minutes; b)Volume of chemiluminescence tests increased by 24.5%and median median TAT for tests decreased by 52.4%, from 131 minutes to 86 minutes;c)Median TAT for critical values decreased by 50.5%; d)Rates of tests that did not go through autoverification were 88.2% for NS,6.05% for SS, 2.40% for DS,2.00% for LS, 0.97%for IS,and 0.43% for CS; e)Rates of abnormal specimen status identified by Aptio Automation were 7.13‰for jaundice,5.39‰ for blood lipids,2.20‰ for hemolysis,0.17‰ for barcode error, and 0.15‰ for insufficiency;f)Error rate decreased to 0.00%;and g)staff satisfaction increased from 85%to 100%.Conclusion Autoverification of results by using the CentraLink Data Management System can achieve quality control over the entire process of clinical laboratory testing, ensure accuracy of test results, improve work efficiency, decrease TAT, minimize the error rate, avoid skill variation of staff, reduce the pressure of performing manual verification,and improve medical security.
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Objective To research the establishment and application of real-time monitoring system of temperature-humidity in clinical laboratories.Methods The collection net for temperature-humidity data was set up using wireless temperature-humidity recorders and repeaters,and a management software which connected to LIS seamlessly was developed according to the management standard for temperature-humidity in clinical laboratories and the requirements for real-time monitoring.Results The real-time monitoring system sent the collected data of temperature-humidity as needed to repeaters by wireless signal and then transferred to host computer.As long as the data was out of the allowable range,the monitoring system could trigger alarm by sending message or E-mail to administrator who accessed the host through web browser to view the status of system,save attendance records,export data and generated reports.Conclusion The automatically monitoring for temperature-humidity of circumstances and instruments in the laboratories was achieved for 24-hours of every day by the developed system and met with the relevant requirements of real-time monitoring for temperature-humidity in clinical laboratories.
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Objective To develop an efficient and all-round management system of personnel information based on the standards of quality management in clinical laboratory.Methods ASP.NET and database technology were used to construct a web platform and develop the management modules of personnel information.Results The developed system consisted of 4 modules.The module of onestop management for personnel archives was realized,which could be viewed and self-maintained by individuals and auto-retrieved by the system.The module of job post for staff attendance record was realized by continuous,dynamic management and permanent retrievability of registered responsibilities.The module of training and examination could publish the information for staff to complete self-training within deadline and evaluated the training effects and competence by online tests,and granted appropriate authority to staff.The module of performance assessment could evaluate the performances of staff statically and dynamically by using objective indicators and review mechanism.After the application of the system,staff archives were updated in real time instead of once for year.The time for reviewing archives of staff reduced from fifteen minutes to one minute,the error incidents of staff reduced by 20％,workload for staff training and examination reduced by 60％,and the satisfaction degree of customers for staff increased from 93％ to 96.5％.Conclusion The developed management system could realize all-round standard management with high efficiency,so it should be more effective and cost-saving than traditional manners.The staffs would be willing to accept and cooperate with it.
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Objective To observe the interference of glucose-6-phosphate dehydrogenase (G6PD) deficiency on glycated hemoglobin (HbA1c) detected by three measurement systems.Methods A total of 286 cases of blood and serum samples were collected at Zhongshan Hospital of Sun Yat-Sun University from August 2012 to April 2016.The blood samples were divided into healthy control group (122 cases),diabetes group (82 cases),glucose-6-phosphate dehydrogenase deficiency group (61 cases) and diabetes with G6PD deficiency group (21 cases).The levels of HbA1 c were detected by three measurement systems,including Primus Ultra2,Variant lⅡ Turbo 2.0 and Modular P.The results of HbA1c were converted into the estimated average blood glucose concentration (eAG).The values of A eAG-FPG in different groups were calculated and statistical analysis was performed for evaluation of the differences from the three measurement systems.Results The HbA1c results measured by the three systems and AeAG-FPG values in G6PD deficiency group were all lower than healthy control group(all P ＜0.05).The measured results were similar in both diabetes group and diabetes with G6PD deficiency group.Conclusion G6PD deficiency may cause false H-bA1c results detected by three measurement systems.In the case of HbA1c for evaluating blood glucose control,the interference of G6PD deficiency should be noticed.
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Objective To estimate the methodology for evaluating the analytical measurement range ( AMR) and the clinically reportable range ( CRR) in lab-developed system in clinical chemistry .Methods Method evaluation .Take serum CK for instance , a series of samples were prepared from both a specimen with a high concentration of the analyte of interest and a specimen with a low concentration for the following assays.Average slope method , linear dilution recovery method and the method recommended by Clinical and Laboratory Standards Institute ( CLSI ) EP6-A were used to established AMR in the lab-developed clinical chemistry system.Based on the maximum valid dilution of the specimen and the results of AMR , CRR were determined.One-half of the total error allowance ( TEa) of Chinese health standard was set up as allowance error (7.5%).Results X-Y scatter plot was made by assigning sample numbers to the horizontal axis and actual measured values to the vertical axis , which determined the upper limit of AMR was approximate 1 651 U/L.The results analyzed by average slope method indicated that the linear correlation between expected values and actual measured values was determined , the correlation (r), the intercept (a) and the slope (b) met the linear standard, and AMR was 5-1 699 U/L.The results analyzed by EP6-A indicated that the best fitting curve was obtained by using cubic polynomial method , and the linearity deviation of the minimum concentration was -77.1%, which exceeded one-half of TEa.Followed by the deletion of the maximum concentration , the resumed experiment was done .The results showed that the nonlinear coefficient c of quadratic polynomial and the nonlinear coefficient c and d of cubic polynomial have no significant difference to 0, and AMR was 7.5-1 458.0 U/L.By linear dilution recovery method , the linear correlation between expected values and actual measured values was determined , the correlation ( r) , the intercept ( a) and the slope ( b) met the linear standard , the recovery rates was between 100.0%and 104.8%, and AMR is 5 -1 699 U/L.The CRR was determined to be 5 -33 880 U/L, which met the standard of TEa . Conclusions Average slope method, linear dilution recovery method and EP 6-A method were all used to established AMR in lab-developed clinical chemistry system .Without complicated statistical analysis , linear dilution recovery method was suitable for clinical use .The linearity deviation of the minimum concentration analyzed by EP6-A did not meet the standard of the quality objective system , suggesting defects in the statistical analysis of the results .CRR was feasibly determined by using linear dilution recovery method align with AMR.
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Objective To investigate the precision, trueness, and accuracy of self-developed detection system in clinical chemistry.Methods This was a methodological evaluation.Take serum creatine kinase( CK) for instance, 6 serum sampleswith different leves ( on the upper or lower limit of the reference range or close to the medicine decide levels ( MDLs) , were collected for within-run precision( repeatability) and within-laboratory precision ( intermediate precision ) experiments.5 proficiency testing ( PT ) samples, 5 samples assigned value by reference method, and 40 fresh-frozen serums were measured and compared with reference method for trueness verification.Drawing method evaluation decision chart, calculating total errors and sigma level evaluation experiment based on the CV, bias, and allowed total errors(TEa)were used to evaluate the accuracy performance.The precision, trueness, and accuracy were compared with the quality indicators.Results The within-run precision and within-laboratory precision were less than the highest requirement of Chinese industrial standard.The mean bias was -8.96%, didn′t reachthe required standard (5.5%).After taking corrective actions, all samples but one ( -5.8%) met the required standard. Compared with the reference method, the mean bias on the MDLs was less than TEa.The performance points of the method evaluation decision chart indicated excellence performance.The total errors on MDLs were 14.2%, 10.4% and 7.6%, less than 15%.The sigma levels on MDLs were 5.9, 7.5 and 15, also achieved excellent level. Conclusions The precision, trueness, and accuracy performance of CK measured by self-developed detection system achieved excellent level of the Chinese industry standard, and the same results were found from different evaluation methods.
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Objective To explore the relationship between glucose-6-phosphate dehydrogenase deficiency and type 2 diabetes and to provide reference for clinical diagnosis,monitoring and treatment of Type 2 diabetes.Methods Subjects were selected from our hospital,including 173 cases of healthy volunteers assigned to the control group;1 95 cases with type 2 diabetes conforming to the diagnostic criteria of WHO were assigned to the diabetic group.97 cases were diagnosed with glucose-6-phosphate dehydrogenase deficiency in our hospital,of whom 82 cases were assigned to simple glucose-6-phosphate dehydrogenase deficiency group,and 1 7 cases were assigned to the diabetes with glucose-6-phosphate dehydrogenase deficiency group.The correlation of glucose-6-phos-phate dehydrogenase activity and diabetes was measured by each detected value.Results Compared with the control group,the glu-cose-6-phosphate dehydrogenase activity and RBC count in diabetic group were higher(P <0.05).Positive correlations between glu-cose-6-phosphate dehydrogenase activity and RBC count in the two groups were significant(P <0.05).HbA1c and FBG showed a significant positive correlation in the control group,diabetic group and diabeties with glucose-6-phosphate dehydrogenase deficiency group(P <0.05).But there was no significant correlation in the glucose-6-phosphate dehydrogenase deficiency group.The rate of screening for glucose-6-phosphate dehydrogenase deficiency in diabetes group was 3.6%,and the rate in the control group was 1. 1%.When HbAlc≥6.5%,the rate of screening for glucose-6-phosphate dehydrogenase deficiency in the diabetes group was signifi-cantly higher than that in the control group (χ2 =4.239,P =0.039).Conclusion The level of HbA1c is discordant with that of blood glucose in diabetic patients with glucose-6-phosphate dehydrogenase deficiency group.Diabetes leads to the increasement of the rate of glucose-6-phosphate dehydrogenase deficiency.The glucose-6-phosphate dehydrogenase activity of diabetic patients with non-glucose-6-phosphate dehydrogenase dificiency is higher than that of the normal group.It may be associated with the level of RBC or increase of compensatory.Further more,glucose-6-phosphate dehydrogenase activity may be a good indicator for controlling diabetes,which remains to be further studied.
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Objective To investigate the interference of hyperlipidemia and hyperbilirubinaemia to HbA1c measurements by ion‐exchange high‐performance liquid chromatography(IE‐HPLC) method .Methods Fresh whole‐blood samples collected with EDTA‐K2 anticoagulant tubes were divided into four groups :control group(HbA1c<6 .2% ) ,diabetes group(HbA1c≥6 .2% ) ,hyperlipi‐demia group(TG 3 -20 mmol/L);hyperbilirubinaemis group (TBIL 21 -549 μmol/L) .HbA1c of these samples were measured with affinity chromatography(AC‐HPLC) and IE‐HPLC respectively .Results When HbA1c≤18 .7% ,r=0 .993 ;95% confidence interval(CI) of HbA1c results by using IE‐HPLC method was -0 .71 -0 .89 ;coefficient of variation was -5 .8% -6 .8% ;P=0 .198 and the difference was not statistically significant .When HbA1c< 16 .3% ,r= 0 .997;95% CI of HbA1c results with IE‐HPLC method is -0 .31-0 .67;coefficient of variation was -5 .8% -4 .3% .P=0 .000 and the difference was statistically signifi‐cant .No interference was detectded with the results ;When HbA1c was 16 .3% -18 .7% ,positive bias was observed with the re‐sults .When TG≤20 .78 mmol/L ,r=0 .995;95% CI of HbA1c results with IE‐HPLC method was -0 .26-0 .50 ;coefficient of var‐iation was -5 .5% -5 .8% .P=0 .000 and the difference was statistically significant .No interference was detectded with the re‐sults;When TBIL≤549 .3 μmol/L ,r=0 .990 ;95% CI of HbA1c results with IE‐HPLC method was -0 .08 -0 .63;coefficient of variation was -14% -4 .1% .P=0 .000 and the difference was statistically significant .When TBIL≤342 .1 μmol/L ,r= 0 .994 ;95% CI of HbA1c results with IE‐HPLC method was -0 .09-0 .50;coefficient of variation was -5 .5% -4 .1% .No interference was detectded with the results .When TBIL was 380 .7-549 .3 μmol/L ,negative bias was observed with the results .Conclusion Our data indicated that HbA1c measurement with IE‐HPLC method could resist the interference of hyperlipidemia;When TBIL≤380 .7 μmol/L and HbA1c<16 .3% ,the results could meet the needs of general clinical detection .Clinical staff should choose more specific HbA1c measurement method according to the patient's condition .
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Objective To investigate the Influence of beta-thalassemia minor on four different HbA1c detection systems.Methods All 65 blood samples from March 2014 to August 2014 were collected from Zhongshan Hospital of Sun Yat-sen University , and divided to normal control group ( 40 cases ) , no diabetic group(20 cases) and diabetic group (5 cases) combining with beta-thalassemia minor.The fresh mixed whole-blood samples were used for transferring value-assignment in order to improve the comparability of Bio-Rad variant ⅡTurbo, Primus Ultra2 ,Roche Modular PPI to Bio-Rad Variant Ⅱwhich was NGSP Ⅰlaboratory certificated.The whole-blood concentration of HbA 1c were measured by four detection systems . Differences between normal control group and no diabetic group were compared using the Independent Samples T Test.Then Taking the Primus Ultra 2 as comparable system and others as experimental system ,the HbA1c results from no diabetic group and diabetic group were compared by the standardization NGSP Ⅰlaboratory and statistical techniques of consistency test .Results Compared with Variant Ⅱ detection system, after transferring value-assignment, deviations of Variant Ⅱ, Modular PPI and Variant Ⅱ Turbo were -6%to +6%.The HbA1c testing results from normal control group and no diabetic group had no statistical significance (P>0.05).Linear regression analysis demonstrated that the correlation coefficient of Primus Ultra2 with Variant Ⅱ, Modular PPI, VariantⅡTurbo were 0.995, 0.999 and 0.995, respectively (P<0.01).The percentage deviation of the reference system and experimental system was -6.0% to+6.0%.Conclusion There was no obviously significant influence of beta-thalassemia minor on Bio-Rad Variant Ⅱ,Bio-Rad variant ⅡTurbo,Primus Ultra2,Roche Modular PPI detection systems.
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Objective To estimate the prevalence of Glucose‐6‐phosphate dehydrogenase(G6PD) deficiency in Zhongshan area . Methods The activity of G6PD in red blood cells was determined by using ultra‐violet rate method for neonates ,couples of child‐bearing age and suspected patients who had clinical symptoms in Zhongshan area from 2012 to 2013 .Results The total detection rate of G6PD deficiency was 4 .37% (1 030/23 595);in male the detection rate was 9 .42% (513/5 447);in female the detection rate was 2 .85% (517/18 148) .Conclusion The incidence of G6PD deficiency were high in Zhongshan area .Therefore ,more attention should be paid to the screening of the disease in neonates and couples of childbearing age so as to reduce the incidence of G6PD defi‐ciency and prevent the complications caused by the disease .
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Objective To evaluate the diagnostic value of procalcitonin (PCT) in patients with infection complicated by heart failure.Methods A total 2454 patients,which with simple heart failure,simple bacterial infection and bacterial infection complicated with heart failure,from Sun Yat-sen University affiliated zhongshan hospital were enrolled in this case-control study.244 heathly controls were aslo evaluated at the same time.The serum PCT levels in different groups were analyzed by Cobas E601.ROC curve was employed to compare the diagnostic values of PCT between simple heart failure group and infection complicated with heart failure group,and the cutoff value of PCT testing for infection complicated by different grades heart failure was determined.The difference between test groups was analyzed using Kruskal-Walis H method.Results PCT levels in simple heart failure group (3.46 ± 3.07) were significantly higher than those in control group (0.04 ± 0.03) (t =4.262,P ＜ 0.01).Besides,PCT levels in infection complicated by heart failure group(18.18 ± 10.33)were significantly higher than those in simple infection group(8.97 ± 6.20) (t =2.694,P ＜ 0.01).Although PCT could still be a biomarker for diagnosis of bacterial infection in patients with or without heart failure (areas under the ROC curve were 80％,82％,85％,88％,respectively),the positive predictive values of PCT were declined in line with the heart failure degree increasing [z(1,2) =-6.24,P＜0.01; z(l,3) =-4.35,P＜0.01; z(1,4) =-5.19,P＜0.01; z(2,3) =-5.33,P＜0.01;z(2,4) =-2.86,P＜0.05; z(3,4) =-2.46,P＜0.05].There are significant differences between areas under ROC curve [z(1,2) =-2.55,P ＜ 0.05 ; z(1,3) =-5.42,P ＜ 0.01; z(2,3) =-2.90,P ＜ 0.05],and the cutoff values of PCT to identify infection patients complicated with Ⅱ,Ⅲ,Ⅳ degrees heart failure were 0.086,0.192 and 0.657 μg/L,respectively.Conclusion PCT levels were increased in heart failure patients so we should pay more attention to the degree of heart failure and PCT level on patients which suffered both infection and heart failure.
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Objective To evaluate the precision,accuracy,linear range and anti-interference performance of HbA1c assay by u-sing Primus Trinity Ultra2 automated analyzer.Methods According to Document EP published in 2004 by American Clinical and Laboratory Standards Institution(CLSI)and relative literatures,the precision,accuracy,linear range and anti-interference perform-ance were evaluated.Results The within-run and between-run CVs of HbA1c determination were both less than that announced by manufacture.In the tests of samples with certain concentrations,all the results were within the verification range respectively.In the linear verification,regression equation between the theoretical and measured values demonstrated that r2 >0.95,and a value was within the range of 0.97-1.03.For Primus Trinity Ultra2 the limit of interference effect didn′t exceed the allowable error at the medical decision concentrations.Conclusion The precision,accuracy,linear range and anti-interference was evaluated of the Primus Trinity Ultra2 automating HbA1c all could meet the manufacture′s declaim and the clinical needs.
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Objective To compare the capabilities of NT-proBNP and BNP in diagnosis of heart failure when complicated with acute cerebral infarction.Methods EP15-A2 document,was employed to verify the precision and accuracy of NT-proBNP and BNP assays on chemiluminescence analyzer Cobas E601 and ADVIA Centaur respectively for 363 samples from patients with chronic heart failure,cerebral hemorrhage and acute cerebral infarction,cerebral infarction complicated with heart failure and normal controls were collected and analyzed by Cobas E601 and ADVIA Centaur,and then determined the changing trends of NT-proBNP and BNP.Moreover,ROC curve was employed in diagnostic value comparison of NT-proBNP and BNP in heart failure groups.Results Cobas E601 and ADVIA Centaur showed good repeatability and accuracy in the detection of NT-proBNP and BNP that both total non-precision were below 3.5％ and the deviations to calibrator were below 3.91％.The level of NT-proBNP an BNP didn't elevate in normal people and cerebral hemorrhage patients.However,they significant elevated in heart failure,acute cerebral infarction and cerebral infarction complicated with heart failure patients (P ＜ 0.01).Their levels were heart failure grade dependent.The levels of NT-proBNP in cerebral infarction complicated with grade Ⅰto Ⅲ heart failure patients were significantly higher than those in chronic heart failure patients,with same heart failure(P ＜ 0.05).However,compared to chronic heart failure patients,the level of BNP in cerebral infarction complicated with heart failure patients didn't elevate significantly until grade Ⅲ heart failure happened.Areas under the ROC curve (AUCs) of NT-proBNP and BNP were botb above 93％ in the diagnosis of chronic heart failure.But for patients who suffered cerebral infarction complicated with heart failure,the diagnostic value of NT-proBNP and BNP were decreased due to cerebral infarction interference.However,the ROC area of BNP was larger than that of NT-proBNP(P ＜ 0.05).Conclusion In the diagnosis of cerebral infarction complicated with heart failure,BNP could be a better choice to determine the degree of heart failure.
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ObjectiveTo evaluate analytical performance of NT-proBNP on Electro-Chemiluminescence Immunoassay system.MethodsThe precision,accuracy,limit of blank ( LoB ),limit of detection (LoD),functional sensitivity (FS),analytical measure range (AMR),maximal dilution rate,clinical reportable range(CRR) and the analytical anti-interference ability of NT-proBNP were evaluated according to EP documents issued by CLSI and related references.The analytical performance data were compared to quality standards declared by the manusfacturers.According to CLSI C28-A2,80 healthy volunteers,aged from 18 to 74, were chosen and divided into 4 groups on average for biological reference intervals verification.Results The within-run CV and total CV were 1.1％ -2.2％and 1.5％ -2.9％ respectively.The deviations from controls distributed by National Center for Clinical Laboratory and affiliated calibrators were 2.7％ -5.9％ and 2.7％ -7.5％,respectively.The results of LoB,LoD and FS were 2.5,7.8 and 8.8 pg/ml,respectively.AMR was 8 -35 126 pg/ml,and the most suitable dilution rate was 1∶ 2,so the CRR was 9 -70 252 pg/ml.428 μmol/L bilirubin,2 g/L haematoglobin and 2 200 FIU chyle didn't interfere with the NT-proBNP assay.Moreover,almost all the data from different age groups were in the range of biological reference intervals declared by the manusfacturers, except one test data (167 pg/ml).Conclusions The analyticalperformance of NT-proBNP analyzed on Roche Cobas E601electrochemiluminescence immunoassay systemisconsistentwiththestandarlswhichmanufacturershas proclaimed.The establishment of LoD,FS,maximal dilution and CRR for NT-proBNP assay could provide the quality assurance for clinical use and the biological reference intervals declared by manusfacturers could meet the clinical needs.
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Objective To figure out the differentially expressed proteins using proteome technology in leukemia cells induced into different lineages and investigate the application value in early screening of leukemia.Methods With induction of ATRA and NSC67657, the differentiation models was constructed using HL60 cells which has the potentiality to be induced into different lineages by different inducers.Then the differentially expressed proteins in the process of differentiation was separated using two-dimensional electrophoresis and identified using MALDI-TOF MS.The expression of 3 proteins FE1A1, TLE1, NME3 were chosen to be verified in myeloid samples of 5 leukemia patients and 1 normal volunteer using RT-PCR and WB.Results WB showed that NME3 was differentially expressed after both granulocytic and monocytic differentiation( Normal A value = 0.227, NSC67657 A value= 0.079, ATRA A value = 0.064, P ＜ 0.01 ).However, only in 4 of 5 tested patients' myeloid samples, the NME3 protein expression were differentially expressed compared to the normal myeloid sample( Normal A value = 0.082,2 acute leumia transferred from chronic granulocytic leumia A value = 0.274,0.269, acute monocytic leukemia A value = 0.297, one patient with chronic granulocytic leukemia A value = 0.258.There was significant difference between normal and leukemia group, P ＜0.05 ).A value was 0.121 for another patents with chronic granulocytic leukemia The NME3 protein expression was not differentially expressed compared to the normal myeloid sample,P ＞0.05.Conclusions It is still a long way to go for proteome technology from basic research to clinical application.However, the identification of NME3 protein related to differentiation in leukemia patients' myeloid samples had set the foundation for the early diagnosis of leukemia using proteome technology.
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Objective To validate the biology reference interval of the Dartial biochemistry test items and provide accurate diagnosis basis for the clinic.Methods According to NCCLS C28-A2 recommendation method,two biochemistry analyzers'performance was validated.20 healthy persons for the asexual biological difference project and female group as well as male group (each group consist of 20 persons)for the sex biology difference project were recruited according to the laboratory SOP.If the validation had doubt,other two groups were need.The sera from these individuals were examined by the full-automatic ADVIA 1650 biochemistry analysis system.Results Two full-automatic ADVIA 1650 biochemistry analyzes conformed to the requirements.In 16 test items participating in this investigation.the analysis showed more than 5%results fell outside the biology reference interval for GGT and HDL-C,whereas 95% results fell in the biology reference interval for TP.All other results fell in the biology reference interval.Conclusions This validation indicats that except GGT and HDL-C,the biology reference intervals which are currently being used are suitable for our laboratory.This verification is persuasive and calpable of finding the deviation of biology reference interval.Setting up verification system warrants further generalization.
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Patient,competition and change are characteristics of the modern hospital manage environment,clinical laboratory management must be more scientific and more religious.This article lists the main items of clinical laboratory management using ISO15189,and raised some idea on clinical laboratory management using ISO15189 and points out the difficulties of popularization using ISO15189 in clinical laboratory management.