nlwxpearo
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 Posted: Mon 12:17, 07 Mar 2011 Post subject: Architect i2000 immunoassay analyzer serum tumor m |
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,[link widoczny dla zalogowanych]
Architect i2000 immunoassay analyzer serum tumor markers AFP,[link widoczny dla zalogowanych], CA125 preliminary evaluation
Significant. AFP intercept were significant differences (P O. 05 0.05> O. 05> O. 053 discussions Architecti2000 immunoassay system is based on CMIA technology, automatic immunoassay system. It uses the CMIA technology on antigen and antibody quantitation. In the determination of AFP, CA125 in the process. Test sample of AFP, CA125 and the package was the first anti-AFP, CA125 combination of particles, and then with labeled secondary antibodies acridine ester formation of a sandwich-like sandwich complexes. Acridine ester occurred in the alkaline medium chemiluminescence reaction, the reaction intensity in relative light units (relativelightunits, RLU) to represent. By measuring the RLU readings of the samples can be AFP, CA125 set of Practical Medicine 2009 Vol 25 No. 1 volume. A new clinical laboratory equipment or the introduction of any new approach should be to conduct a comprehensive evaluation (such as reproducibility, carryover,[link widoczny dla zalogowanych], linearity, and comparability of results, etc.). NCCLS developed a set of objective evaluation of the program correctly to evaluate the performance of the above. NCCLS Document EP10. A program to help evaluate the experimental methods or analytical laboratory instrument linearity,[link widoczny dla zalogowanych], bias, precision aspects of the initial evaluation. Compared with the traditional evaluation method, EPIO. A document not only the data needed fewer and more simple, using a specific sequence of test samples, so that samples of different concentrations of each other. Clinical specimens of patients closer to the situation, making the evaluation results more realistic. But also to complete the traditional evaluation methods do not have the degree of nonlinearity and drift test. The data using statistical tests, the results become more scientific and objective. In this test, AFP, CA125 measurement accuracy with bias, said no, AFP and CA1253 concentrations were lower than the absolute error tolerance, so the bias initial evaluation of the results are acceptable. AFP and CA125, with a total imprecision coefficient of variation that includes both intra and day imprecision. AFP high, medium and low 3 mixed serum concentrations of total imprecision were less than manufacturer specification requirements; CA125 mix of high value and the value of serum total imprecision were 6.8% less than the allowed imprecision. CV low as 8.525% serum, slightly larger than the allowable error range. But look at this evaluation,[link widoczny dla zalogowanych], determine the low positive results were lower than the clinical reference off the assembly line, somewhat less repetitive. Does not affect the clinical diagnosis, indicating that the total imprecision of the initial evaluation to meet the requirements. 5 by the regression equation parameters (intercept, slope, carryover, linearity, drift) for the t test, showing that drift and carryover effects on the precision of the difference was not statistically significant. AFP and CA125 intercept significant difference (P <0.01), show that the intercept is not zero; AFP also exist nonlinear difference was significant (P <0.O1), prompt us to process samples in the actual detection of AFP samples should pay attention to the impact of concentration on the linear range, when appropriate, can be diluted and then tested them. The results of this study amply demonstrated, Architecti2000 measured by immunoassay AFP, CA125 good accuracy and precision, and no carryover, drift and other factors have significant effect on performance, reliable, suitable for clinical laboratory use. 4
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