Performance verification and evaluation of 4 domestic chemiluminescence systems on 8 tumor mark-ers / 中华核医学与分子影像杂志

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.

Comparability of serum total prostate-specific antigen measurement by four domestic chemilumines-cence immunoassays and electrochemiluminescence immunoassay / 中华核医学与分子影像杂志

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.

Composing and evaluating the measurement uncertainty of two kinds of chemiluminescence detection system / 中华核医学与分子影像杂志

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.

Stem cell marker LGR5：a new target for cancer therapy / 中国组织工程研究

BACKGROUND:Recent studies have shown that cancer stem cels play a key role in the development of tumors, therefore, the research about cancer stem cels’ markers can deepen the understanding of the development and clinical diagnosis of the tumor. OBJECTIVE:To review the research progression of stem cel marker LGR5. METHODS: The first author retrieved PubMed database and Wanfang database for papers regarding LGR5 and stem cel/cancer stem cel published between January 1998 and December 2014 using the key Words “LGR5, stem cel, cancer stem cel” in English and Chinese, respectively. A total of 178 papers were initialy retrieved. After 123 papers with independent objective and out-of-date contents were excluded, 55 papers were suitable for final analysis. RESULTS AND CONCLUSION: LGR5 is the surface marker of intestinal, stomach, hair folicle stem cels, which has a great relationship with occurrence, development and prognosis of colorectal cancer, stomach cancer, lung cancer, ovarian cancer, liver cancer, basal cel carcinoma. As a candidate marker of cancer stem cels, LGR5 can be the new treatment target. Studies have shown that R-spondins (RSPOs) is a high affinity ligand of LGR5. They participate in the Wnt signaling pathway, regulating cel proliferation and differentiation.