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The Study of the Method for Validating the Performance of Quantitative Tests for the Electrochemiluminescence Immunoassay System of Elecsys 2010

Author: YangJingRui
Tutor: ZhangRunLing
School: Lanzhou University
Course: Clinical Laboratory Science
Keywords: Evidence-based laboratory medicine Chemiluminescent immunoassay Reference range Human chorionic gonadotropin Quantitative detection performance verification
CLC: R446.6
Type: Master's thesis
Year: 2007
Downloads: 146
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Abstract


Objective: Evidence-based laboratory medicine (evidence-based laboratory medicine, EBLM) under the guidance of the Elecsys 2010 electrochemical luminescence immunoassay ( electrochemiluminescence immunoassay, ECLIA) analytical performance validation , explore performance ECLIA detection system analysis applies to authentication mode . Explore three different instruments detected the comparability of results of the same test items . Methods: ECLIA different concentrations of serum specimens for testing the performance of instrumental analysis precision , analytical sensitivity , linear range , accuracy and verification tests of the reference range ; application of three different instruments were used to detect the 60 serum samples , application SPSS10 .0 software for statistical analysis of the results . Results: imprecision of the coefficient of variation ( coefficient of variation , CV) of 1.07 % to 3.73% , and between CV_s 0.43 % to 2.12% of the total imprecision CV_s 1.81% to 4.90 % ; recovery test recovery of 94% -110 % ; analytical sensitivity < 0.1mIU/ml ; the linear range 0.1mIU/ml to 9897.225mIU/ml ; theoretical value with repeated measured values ??good linear ( r = 0.999 , P = 0.000 ) ; accuracy verification comparability of the comparative method detection results are not very satisfactory ( r = 0.63 , P = 0.000 ) ; 8w, 12w, 16wβ -HCG reference range than the manufacturers to smaller ( P <0.00 , P <0.002 , P < 0.010 ) . The three detection system ECLIA with CLA correlation coefficient of r = 0.72 ( P = 0.000 ) , by ECLIA and RIA correlation coefficient of r = 0.61 ( P = 0.000) , the RIA and CLA correlation coefficient r = 0.60 ( P = 0.000 ) . Conclusion : ECLIA is a high precision , analytical sensitivity , wide linear range, high accuracy and detection speed automated immunoassay technology has good prospects. Especially for its reference range whether hormones applies to people also need to be further explored . Comparability between the three kinds of instrument test results are not very satisfactory .

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CLC: > Medicine, health > Clinical > Diagnostics > Laboratory diagnosis > Immunology Examination
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