Standardized method comparison for ACS:180 plus and Immulite sensitive PSA (sPSA) measurement methods
The aim of this study was to compare two immunoassay measurement methods, the ACS:180 Plus (Chiron Diagnostics) kit and the Immulite sPSA (DPC) kit. Method comparison analysis was performed according to EP9-A; approved guideline of NCCLS 51. Serum samples having a wide range of total prostate-specif...
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Veröffentlicht in: | Accreditation and quality assurance 2001-09, Vol.6 (9-10), p.424-426 |
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Sprache: | eng |
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Zusammenfassung: | The aim of this study was to compare two immunoassay measurement methods, the ACS:180 Plus (Chiron Diagnostics) kit and the Immulite sPSA (DPC) kit. Method comparison analysis was performed according to EP9-A; approved guideline of NCCLS 51. Serum samples having a wide range of total prostate-specific antigen (PSA) concentrations were evaluated in split-sample analysis. F-test, t-test analysis and regression statistics were performed. In Deming regression analysis the coefficients were as follows; the slope=0.967; y-intercept=-0.148, r=0.989. An acceptable bias was seen since the systematical error was calculated to have a value less than the total allowable error calculated from biological variations. Non-parametric evaluation of the area under ROC curves for ACS:180 Plus and Immulite sPSA were 0.997 and 0.987, respectively. Diagnostic accuracy was at the level of p= 0.000 and no statistical difference was found between the two assay methods. |
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ISSN: | 0949-1775 1432-0517 |
DOI: | 10.1007/PL00010466 |