Evaluation of Matrix Effect in Body Fluid Chemistry on Roche Cobas 8000 c702 System
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Background: Analysis of body fluids aids in diagnosis and monitoring disease. However, only a few testing platforms and reagents have been validated for a range of body fluids or analytes. In this study, we evaluated a testing system, which has been approved for blood samples, in analyzing body fluid specimens upon matrix mixing. Methods: Serum and body fluid samples, including cerebrospinal fluid (CSF), ascites, pleural fluid, amniotic fluid, and synovial fluid, were mixed, then the matrix effect and linearity for major analytes, namely amylase, chloride, glucose, LDH, and protein were evaluated (N = 30 serum-body fluid pairs) on the Cobas 8000 c702. The obtained data was compared with that of open reagents evaluated on the Architect c16000. Results: For all analyte-body fluid pairs, the mean percent recovery ranged from 98.4% to 101.7%, and this was within the acceptable range for matrix effect. In the linearity test, maximum non-linearity for each analyte-body fluid pair ranged from -5.0% to +4.2%. In interference test, proteins showed positive hemolytic, icteric, and lipemic interference in CSF and hemolytic interference in amniotic fluid. There was no significant interference in the other analyte-body fluid pairs. Results were highly correlated between the Cobas 8000 c702 and the Architect c16000 system. Conclusions: Our findings revealed that the matrix effect of major analytes in body fluid specimens can be excluded and they also validated the linearity of the analytes in the body fluid specimens. Therefore, reagents specified for blood samples can be readily adopted for the analysis of body fluids.
Abstract
Background: Analysis of body fluids aids in diagnosis and monitoring disease. However, only a few testing platforms and reagents have been validated for a range of body fluids or analytes. In this study, we evaluated a testing system, which has been approved for blood samples, in analyzing body fluid specimens upon matrix mixing. Methods: Serum and body fluid samples, including cerebrospinal fluid (CSF), ascites, pleural fluid, amniotic fluid, and synovial fluid, were mixed, then the matrix effect and linearity for major analytes, namely amylase, chloride, glucose, LDH, and protein were evaluated (N = 30 serum-body fluid pairs) on the Cobas 8000 c702. The obtained data was compared with that of open reagents evaluated on the Architect c16000. Results: For all analyte-body fluid pairs, the mean percent recovery ranged from 98.4% to 101.7%, and this was within the acceptable range for matrix effect. In the linearity test, maximum non-linearity for each analyte-body fluid pair ranged from -5.0% to +4.2%. In interference test, proteins showed positive hemolytic, icteric, and lipemic interference in CSF and hemolytic interference in amniotic fluid. There was no significant interference in the other analyte-body fluid pairs. Results were highly correlated between the Cobas 8000 c702 and the Architect c16000 system. Conclusions: Our findings revealed that the matrix effect of major analytes in body fluid specimens can be excluded and they also validated the linearity of the analytes in the body fluid specimens. Therefore, reagents specified for blood samples can be readily adopted for the analysis of body fluids.
참고문헌 (12)
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