Analytical performance comparison of Siemens Atellica CI1900 and Roche Cobas Pure integrated analyzers across spectrophotometric, ion-selective electrode and immunoassay parameters.
The Siemens Atellica CI1900 and Roche Cobas Pure analyzers demonstrate good analytical agreement, supporting their use in routine clinical laboratory testing.
Where it sits
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This study evaluated the analytical agreement between the Siemens Atellica CI1900 and Roche Cobas Pure analyzers across various methodologies, including spectrophotometry, ion-selective electrode, and immunoassay techniques. Fourteen analytes were assessed using 464 serum samples. The findings indicated good analytical agreement between the two platforms.
Abstract
Background Harmonization of laboratory measurements across different analytical platforms is essential to ensure accurate and clinically reliable results. Variations between analytical systems may lead to discrepancies that could affect clinical decision-making and patient management. Objective This study aimed to evaluate the analytical agreement between the Siemens Atellica CI1900 and Roche Cobas Pure integrated analyzers across different analytical methodologies, including spectrophotometry, ion-selective electrode (ISE), and immunoassay techniques. Materials and methods Fourteen analytes were included in the comparison: spectrophotometric assays (glucose, creatinine, alanine aminotransferase [ALT], calcium [Ca], total bilirubin [TB], and direct bilirubin [DB]), ISE assays (sodium [Na], potassium [K], chloride [Cl]), and immunoassays (thyroid-stimulating hormone [TSH], free thyroxine [fT4], free triiodothyronine [fT3], human chorionic gonadotropin [hCG], and N-terminal pro-brain natriuretic peptide [NT-proBNP]). Analytical verification was first performed according to Clinical and Laboratory Standards Institute (CLSI) EP15-A3 guidelines. Subsequently, method comparison between the two analyzers was conducted following CLSI EP09-A3 recommendations using 464 serum samples. Agreement between the platforms was evaluated using Passing-Bablok regression, linear regression analysis and Bland-Altman plots. Results Spectrophotometric assays demonstrated excellent correlations for ALT, total bilirubin, glucose and creatinine (R2 ≥ 0.95), while calcium and direct bilirubin showed strong correlations (0.95≥R2 > 0.7) between the two systems. Among the ISE parameters, sodium and potassium showed strong correlations, whereas chloride demonstrated moderate agreement (0.7≥R2 > 0.3). For immunoassays, TSH and NT-proBNP demonstrated excellent correlations, fT4 and hCG showed strong correlations, and fT3 demonstrated moderate agreement. Bland-Altman analysis demonstrated generally small mean biases, and the corresponding 95% limits of agreement supported the overall analytical agreement between the two analytical platforms. Conclusion Overall, the Siemens Atellica CI1900 and Roche Cobas Pure analyzers demonstrated good analytical agreement across the evaluated measurement principles. These findings support the comparable analytical performance of the two platforms for routine clinical laboratory testing. Nevertheless, laboratory-specific method verification remains essential before implementing different analytical systems in routine clinical practice.
Background
This paper addresses the need for harmonization of laboratory measurements across different analytical platforms, which is crucial for accurate clinical decision-making. Prior studies have indicated that variations between analytical systems can lead to discrepancies in results. This study is significant as it compares two widely used analyzers to assess their analytical agreement across multiple methodologies.
Methods
The study design involved a comparison of fourteen analytes using two analytical platforms. A total of 464 serum samples were analyzed following Clinical and Laboratory Standards Institute (CLSI) EP15-A3 and EP09-A3 guidelines. The analytes included spectrophotometric assays, ion-selective electrode (ISE) assays, and immunoassays.
Results
The primary endpoint showed R2 ≥ 0.95 for ALT, total bilirubin, glucose, and creatinine in spectrophotometric assays. Strong correlations were observed for sodium and potassium in ISE parameters, while chloride showed moderate agreement (0.7 ≥ R2 > 0.3). For immunoassays, TSH and NT-proBNP demonstrated excellent correlations, and hCG showed strong correlations.
Interpretation
The results indicate that both analyzers have good analytical performance, which aligns with previous literature on the importance of analytical agreement in clinical settings. However, while the correlations are statistically significant, the clinical significance of these findings remains to be fully established. Limitations such as the absence of long-term follow-up and potential laboratory-specific variations may confound the conclusions drawn from this study.
Key findings
- R2 ≥ 0.95 for ALT, total bilirubin, glucose, and creatinine in spectrophotometric assays.
- 0.95 ≥ R2 > 0.7 for calcium and direct bilirubin in spectrophotometric assays.
- Strong correlations for sodium and potassium in ISE parameters.
- Moderate agreement for chloride with 0.7 ≥ R2 > 0.3.
- TSH and NT-proBNP showed excellent correlations in immunoassays.
- hCG and fT4 showed strong correlations in immunoassays.
Limitations
- Not reported in abstract.
- No long-term follow-up to assess durability of results.
- Laboratory-specific method verification remains essential.
- Potential confounding factors not addressed.