Abstract Number: PB0609
Meeting: ISTH 2020 Congress
Background: We evaluated a newly released coagulation analyser (CN-6000, Sysmex Corporation, Japan) capable of clotting, chromogenic, Immuno-turbidimetric and platelet aggregation assays.
This new high-throughput analyser has a small footprint, improved sample volume usage and enhanced software allowing improved end point detection and abnormal clot waveform interpretation.
Aims: Compare the performance of CN-6000 against CS-5100.
Methods: Performance was evaluated against the CS-5100 (Sysmex Corporation, Japan) for clotting (prothrombin time, activated partial thromboplastin time, Clauss Fibrinogen, Thrombin time, Factor VIII), chromogenic (Antithrombin, Protein C) and immuno-turbidimetric (D-Dimer, VWF antigen, VWF activity) assays. All reagents supplied by Siemens Diagnostic Healthcare (Marburg, Germany).
For each assay more than 120 samples were tested from both patients and normal subjects in order to assess correlation over a wide measuring range.
Calibration curves were tested by running 3 calibration curves over two days on both instruments. Commercial controls were tested 20 times over 8 days to obtain imprecision data.
Throughput was measured by testing PT only and PT/APTT in samples representative of a typical laboratory workload.
Results: The CN-6000 showed good linearity with reproducible calibration curves, along with low inter-assay imprecision using commercial normal (CV = 0.6 – 4.7%) and abnormal (CV = 0.8 – 6.2%) control plasmas.
Results showed excellent correlation between the CN-6000 and CS-5100 for each assay (r2= 0.988 – 0.999) with no significant misclassification, and data points scattered close to the line of identity.
| PT | 0.999 |
| APTT | 0.988 |
| Fibrinogen | 0.990 |
| Thrombin Time | 0.997 |
| Factor VIII | 0.996 |
| Antithrombin | 0.991 |
| Protein C | 0.998 |
| D-Dimer | 0.998 |
| VWF Antigen | 0.994 |
| VWF Activity | 0.996 |
[Test/Method Comparion (r2 value)]
| PT | Normal Control 0.8% | Abnormal Control 1.2% |
| APTT | 0.6% | 0.8% |
| Fibrinogen | 4.7% | 6.2% |
| Thrombin Time | 2.3% | – |
| Factor VIII | 3.2% | 4.2% |
| Antithrombin | 3.0% | 4.7% |
| Protein C | 1.2% | 2.2% |
| D-Dimer | 3.4% | 2.0% |
| VWF Antigen | 2.0% | 2.8% |
| VWF Activity | 1.5% | 1.7% |
[%CV with Commercial Control Plasma]
There was a 9% increase in sample throughput for PT with the CN-6000 compared to the CS-5100 (430 versus 390). More impressively, there was a 33% increase in throughput for samples requested for both PT and APTT (456 versus 344).
Conclusions: Our results show that using the CN-6000 analyser, routine coagulation and specialist assays can be performed with acceptable levels of imprecision and excellent comparability with the CS-5100.
To cite this abstract in AMA style:
Woolley A, Kitchen S, Patel I, Wardle R. Assessment of the CN-6000; a Novel, High-Speed Coagulation Analyser, Utilising Coagulation, Chromogenic, Immuno-Turdibimetric and Light Transmission Aggregation Technologies [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/assessment-of-the-cn-6000-a-novel-high-speed-coagulation-analyser-utilising-coagulation-chromogenic-immuno-turdibimetric-and-light-transmission-aggregation-technologies/. Accessed October 2, 2023.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/assessment-of-the-cn-6000-a-novel-high-speed-coagulation-analyser-utilising-coagulation-chromogenic-immuno-turdibimetric-and-light-transmission-aggregation-technologies/