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Objective To validate the performance of 4 domestic chemiluminescence immunoassay (CLIA) systems on 8 tumor markers quantitative assay kits. Methods Four domestic CLIA systems were randomly marked as A, B, C, D and 8 tumor markers, including carbohydrate antigen (CA)125, CA15-3, CA19-9, ferritin (Fer), alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), prostate-specific an-tigen (PSA) and free PSA (fPSA) were determined. According to the standard of Clinical and Laboratory Standards Institute (CLSI), the precision, methodological comparison and analytical measure range of 4 systems were validated. Clinical serum samples were obtained from patients in Suzhou Hospital. According to the CLSI EP9-A3 protocol, imported equipment was used as the reference system. The biases of medical de-cision points were assumed, and Pearson correlation analysis and Spearman correlation analysis were used to analyze the data. Results The precision verification of CA125 and PSA on A, CA125 and AFP on B, CA125, CEA, AFP and PSA on C, and all 8 tumor markers on D could meet the laboratory quality control requirements. The correlations of the test results between A-D and the imported equipment were significant (all P<0.05) with the correlation coefficients 0.79-0.99, 0.47-0.99, 0.90-0.98 and 0.78-1.00, respec-tively, and the number of acceptable tests at the level of medical decision was 5, 2, 5, 4. All tests were certified to meet the analytical measure range validation. Conclusions The detection performance of 4 do-mestic CLIA systems for all 8 tumor markers are different. The performance of domestic CLIA systems should be tested when choosing one that can meet laboratory quality control requirements.
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Objective To study the comparability of total prostate specific antigen ( tPSA) meas-urement by four domestic chemiluminescence immunoassays ( DCI) and electrochemiluminescence immuno-assay ( ECI) . Methods A total of 45 serum samples that requested tPSA tests were selected. Four DCIs ( Snibe MAGLUMI 4000, Mindray CL-2000i, Autobio A2000, HYBIOME AE180) and ECI ( Roche Cobas e601) were used to measure tPSA. The precisions of the methods were evaluated. The four DCIs were com-pared with Roche ECI respectively, and the comparability of the test results was analyzed. Wilcoxon signed rank test and Spearman correlation analysis were used to analyze the data. Results The precisions of five methods were good. The tPSA levels measured by Roche Cobas e601, Snibe MAGLUMI 4000, Mindray CL-2000i, Autobio A2000, and HYBIOME AE180 were 14.11(9.92, 36.09), 12.00(8.56, 27.23), 12.10 (8. 60, 29.87), 13.35(9.51, 32.85) and 14.50(9.88, 40.06) μg/L, respectively. The correlation coeffi-cients of Roche with Snibe MAGLUMI 4000, Mindray CL-2000i, and Autobio A2000 were 0.992, 0.989, 0. 957 and 0.983, respectively (all P<0.001). Assuming the tPSA medical decision point for regression equation was 4.0μg/L, the proportional biases of Snibe MAGLUMI 4000, Mindray CL-2000i, Autobio A2000, and HYBIOME AE180 compared with Roche were -10. 88％, -18. 07％, 0. 23％ and 22. 31％, respectively. Conclusion The comparability of tPSA test results is different between 4 DCIs and Roche ECI, which pro-vides some references for clinical application and standardization of the DCI test results.
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Objective To investigate the value of leucine-rich repeat-containing G protein coupled receptor 5 (LGR5) and aldehyde dehydrogenase 1A1 (ALDH1A1) in progression and prognosis of non small-cell lung cancer (NSCLC),in order to find new targets for NSCLC-targeted imaging and radiation therapy.Methods Fresh tissues (n =24) and paraffin embedding tissues (n =109) of patients with NSCLC were collected from the First Affiliated Hospital of Soochow University between November 2009 and March 2012.Quantitative real time-PCR was used for the investigation of expression of LGR5 and ALDH1A1 mRNA in 24 NSCLC patients.Immunohistochemistry (IHC) was used for detecting LGR5 and ALDH1A1 expressions in NSCLC tissues and adjacent normal tissues.Data were analyzed by Mann-Whitney u test,x2 test,Pearson correlation analysis,Kaplan-Meier method,Cox proportional hazards regression model.Results Compared with adjacent normal tissues,LGR5 and ALDH1A1 mRNA were frequently increased in NSCLC tissues (u values:150,74,both P＜0.01),and the expression of LGR5 and ALDH1A1 mRNA was significantly correlated (r=0.416,P＜0.05).Positive LGR5 and ALDH1A1 expression was defined in 28.44％ (31/109) and 41.28％ (45/109) of the NSCLC tumors,respectively.Further analysis indicated that 24 of the LGR5 positive samples (77.42％,24/31) expressed ALDH1A1 (r=0.388,P＜0.01).LGR5 and ALDH1A1 ex pressions in NSCLC with higher TNM stage were significantly higher than those in NSCLC with lower TNM stage (x2 values:4.64,5.24,both P＜0.05).Coexpression of LGR5 and ALDH1A1 in NSCLC with lymph node metastasis was higher than that in NSCLC without lymph node metastasis (x2=4.12,P＜0.05).High expression of LGR5 or ALDH1A1 was related to poor prognosis (x2 values:6.24,4.18,both P＜0.05),and NSCLC patients with coexpression of LGR5 and ALDH1A1 had a poorer prognosis than the others (x2 =10.63,P＜0.01).Both of them were independent risk factors of a poorer prognosis (corrected hazard ratio (95％ CI):2.361(1.106-5.037),2.306(1.101-4.830);both P＜0.05).Conclusions The expressions of LGR5 and ALDH1A1 are closely associated with the tumorigenesis,metastasis and poor prognosis of NSCLC.LGR5 and ALDH1A1 might be new targets for NSCLC-targeted tumor imaging and radiation therapy.
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Objective To compose and evaluate the measurement uncertainty of two kinds of chemiluminescence detection system using different methods.Methods The measurement uncertainty was composed by 4 different methods:(1) U 1％ was composed of within-run CV(CVw ％),between-run CV(CVB ％)and bias (CVBias ％);(2) U2％ was composed of CVB ％ and uncertainty of calibration (CVcal ％);(3) U3％ was composed of CVW％,CVs％ and CVcal％;(4) U4％ was composed of CVW％,CVB％,CVBias％ and CVcal％.The measurement uncertainty of Architect i2000SR system (Abbott,USA) and DXI800 system (Beckman,USA) was assessed.Pearson correlation analysis,Spearman correlation analysis,Paried t test and Mann-Whitney u test were performed to analyze the data.Results For Architect i2000SR system,U1％,U2％,U3％ and U4％ were significantly correlated (r=0.727-0.988,all P＜0.05),U3％ and U2％ were significantly different (t =6.88,P＜0.05),U4％ and U1％ were significantly different (t =6.21,P＜0.05).For DXI800 system,U1％,U2％,U3％ and U4％ were also significantly correlated (r =0.608-0.975,all P＜0.05),no significant difference was found between U3％ and U2％ (z=-1.33,P＞0.05),or between U4％ and U 1％ (z =-1.04,P＞ 0.05);the expanded measurement uncertainty was correlated with CVW％,CVB％,CVBias％(rs=0.653-0.912,all P＜0.05),but not with CVcal％(rs=0.548,P＞0.05).Conclusions For Architect i2000SR system,the fourth method is more proper to compose the measurement uncertainty (U4％).For DXI800 system,the first method is more appropriate (U1％).According to the contribution of different components to the measurement uncertainty,the measurement quality could be improved by reducing the imprecision and bias.