TY - JOUR AB - Background: The Sysmex CN-6000 is a fully automated high-throughput coagulation analyzer. The objective of this study was to evaluate the analytical performance of the analyzer for routine and special coagulation testing in a high-throughput central laboratory of a university hospital. Methods: The within- and between-day precision and accuracy of 29 coagulation parameters were evaluated on the Sysmex CN-6000 using commercially available quality control materials. Patient plasma samples were used to compare results of coagulation measurements between the Sysmex CN-6000 and the Atellica COAG 360, including plasma samples with visual interference. The sample throughputs of both analyzers were compared using plasma samples from healthy volunteers. Results: Within- and between-day coefficients of variation were acceptable for all assays tested on the Sysmex CN6000. High correlation and good agreement were observed when comparing coagulation results from the Sysmex CN-6000 and the Atellica COAG 360. Samples with visual interference showed comparable coagulation results between the two analyzers, with slightly better detection by the Sysmex CN-6000. The sample throughput per hour for analysis of a panel of five coagulation parameters was higher with the Sysmex CN-6000 compared to the Atellica COAG 360 (247 vs. 193 tests). Conclusions: The Sysmex CN-6000 demonstrated excellent analytical performance for a large number of coagulation parameters and has a high throughput capacity, ideal for the needs of a central laboratory with a high volume of routine and specialized coagulation testing. (Clin. Lab. 2025;71:493-501. DOI: 10.7754/Clin.Lab.2024.240922) AU - Kocijancic, M.* AU - Roche, J.* AU - Peter, A. AU - Hörber, S. C1 - 73944 C2 - 57185 CY - Im Breitspiel 15, Heidelberg, D-69126, Germany SP - 493-501 TI - Evaluation of the sysmex CN-6000 coagulation analyzer for routine and specialized coagulation testing in a central laboratory. JO - Clin. Lab. VL - 71 IS - 3 PB - Clin Lab Publ PY - 2025 SN - 1433-6510 ER - TY - JOUR AB - Background: Determination and quantification of serum free light chains (FLC) is essential for the diagnosis and monitoring of patients with monoclonal gammopathies. Currently, the Freelite assay (The Binding Site, United Kingdom) and the N Latex FLC assay (Siemens Healthineers, Germany) are available for FLC determination. Data concerning stability of FLC following long-term storage are limited. Therefore, the aim of the present study is to investigate the stability of FLC in frozen samples determined by the N latex FLC assay. Methods: One hundred eighty-eight serum samples from 47 patients with monoclonal gammopathies were analyzed at the beginning and after long-term storage (-20°C, 193 - 568 days). Serum free light chain kappa (κFLC) and lambda (λFLC) concentrations were measured, and the corresponding kappa/lambda (κ/λ FLC) ratios were calculated. All samples were analyzed with the N latex FLC assay on a single BNII System. Results: Comparison analyses between fresh and stored samples revealed very strong correlations for the determination of κFLC (r = 0.993), λFLC (r = 0.998) and the calculated κ/λ FLC ratio (r = 0.997). Median percentage changes of κFLC (-0.5%) and λFLC (-0.8%) measurements and the calculated κ/λ FLC ratios (-3.7%) were within the calculated analytical imprecision of the FLC assay. Changes of κFLC (r = 0.17, p = 0.02) and λFLC (r = 0.28, p < 0.01) concentrations and of the κ/λ FLC ratio (r = 0.18, p = 0.01) over time were very weak, but statistically significant. Conclusions: Serum free light chains in serum samples are sufficiently stable following long-term frozen storage and are therefore suitable to be measured with the N Latex FLC assay. AU - Hörber, S. AU - Klein, R.* AU - Peter, A. C1 - 56266 C2 - 46946 CY - Im Breitspiel 15, Heidelberg, D-69126, Germany SP - 845-851 TI - Effects of long-term storage on serum free light chain stability. JO - Clin. Lab. VL - 65 IS - 5 PB - Clin Lab Publ PY - 2019 SN - 1433-6510 ER - TY - JOUR AB - Background: Currently available assays for the widely used marker for neuroendocrine tumors chromogranin A have a weak comparability, involve manual work, and require batch processing of the samples. In this study, we evaluated the automated chromogranin A KRYPTOR assay compared with the widely used DAKO ELISA. Methods: 83 samples were measured with the DAKO ELISA (EDTA plasma) and the KRYPTOR assay (serum), since different sample materials are recommended. Furthermore, different sample materials were compared. Results: The results between the two assays were highly correlated KRYPTOR serum (ng/mL) = 2.887 ELISA EDTA (U/L) + 5.028; r = 0.99). The inter-assay variation for the KRYPTOR assay was determined as 5.56% at low (95 ng/mL; n = 34) and 6.21% at high (530 ng/mL; n = 33) chromogranin A concentrations. EDTA plasma samples revealed significantly lower results than serum in the KRYPTOR assays and could not be used. Conclusions: In conclusion, the new chromogranin A KRYPTOR assay is fast, reliable, and compares well to an established test after adaptation of sample material and reported units. AU - Wolf, M.* AU - Riedlinger, I.* AU - Lehmann, R. AU - Häring, H.-U. AU - Schleicher, E. AU - Peter, A. C1 - 43295 C2 - 36547 CY - Heidelberg SP - 2103-2106 TI - Comparison of the automated KRYPTOR chromogranin A assay with the DAKO ELISA. JO - Clin. Lab. VL - 60 IS - 12 PB - Clin Lab Publ PY - 2014 SN - 1433-6510 ER -