Abstract Number: PB0544
Meeting: ISTH 2020 Congress
Background: A fully-automated coagulation analyzer is a key component of a high-throughput laboratory. The CN-6000 (SYSMEX, Kobe, Japan) is a new haemostasis analyser with blood coagulation, amidolytic, immunoturbidometric, and light transmission aggregometry capabilities. The CN-6000 has a smaller footprint yet a higher throughput than the CS-5100 and maintains the ability for cap piercing, detection at multiple wavelengths and HIL check function; the same as CS-5100.
Aims: In this study, we have evaluated basic performance of CN-6000 and throughput compared with CS-5100.
Methods: An Interfering substances study based on CLSI guideline EP07A2 was conducted to evaluate the effects of lipaemia, hemoglobin and bilirubin. A precision study based on CLSI guideline EP05A3 was conducted to evaluate; repeatability and within-device performance. In both studies, results from the coagulation, chromogenic and immunoturbidimetric assay methods were analyzed with Analyze-it software as recommended by CLSI guidelines. Throughput of the CN-6000 and CS-5100 were compared for the following test parameters; PT, APTT, Fbg, AT, FDP and D-Dimer.
Results: The interference study showed better performance with the CN-6000 compared to the CS-5100. This was achieved by the new function “gain change function of light source”. In the precision study, the Coefficient of Variations (CV) in ‘repeatability’ and ‘within-device’ were found to be less than 5% and 6.5%, respectively. The CN-6000 achieved greater throughput in comparison to the CS-5100 for all assay parameter sets. For the multi-assay parameter set; PT, APTT, Fbg, AT, FDP and D-Dimer, throughput of the CN-6000 and CS-5100 was 235 and 141 tests per hour, respectively.
Conclusions: Our results showed that the CN-6000 can provide high analytical performance with reduced impact from interfering substances from a high throughput analyzer whilst maintaining accuracy and precision. The CN-6000 showed great suitability for total laboratory automation.
To cite this abstract in AMA style:Narisada R, Nishimura N, Sakayori T. Basic Evaluation of Novel Automated Coagulation Analyzer CN-6000 [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/basic-evaluation-of-novel-automated-coagulation-analyzer-cn-6000/. Accessed May 18, 2021.
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