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COAGULATION


and APTT tests. Using optical detection, the CN-Series offers the user the ability to examine the clot waveform (CWA), which can provide additional information of potential clinical benefit. This Research Use Only (RUO) tool gives laboratories greater clinical insight to discriminate the severity of haemophilia A and B patients. Clot waveform analysis on the CN-Series may also provide an inexpensive method for monitoring factor replacement therapy.6 The requirements of the ISO 15189


standards have been considered throughout the CN-Series software suite, including automated start-up and back-up routines, comprehensive audit trails and customisable user permissions. Sample results are displayed on a single screen, which provides reagent, QC and calibration information.


One-system solution The extensive range of assays and reagents provided by Sysmex utilises the Siemens Healthineers and HYPHEN BioMed SAS portfolios. This means that the CN-Series can provide a one-system solution for routine and specialty testing, with the test range including an ever- expanding number of liquid ready-to-use reagents. Fibrinogen and thrombin time are the latest to be released in this format.


The CN-Series was launched first in Japan and has shown a considerably increased level of reliability compared to previous-generation analysers available in the market. This has been confirmed during the multi-centre validation and verification work conducted in the UK to support the global market launch. However, the innovation has not finished yet as Sysmex is already planning two further additions to the CN-Series – the CN-6500 and CN-3500 – that will feature an integrated chemiluminescence module. Field testing of a portfolio of tests using this technology is underway, with UK customers again heavily involved, as Sysmex expands the ‘one-system’ concept of the CN-Series even further over the coming months.


References 1 Gardiner C, Lane P, Langley K, Tailor H,


Machin SJ, Mackie I. A comparative evaluation of the CN-6000 haemostasis analyser using coagulation, amidolytic, immuno-turbidometric and light transmission aggregometry assays. Int J Lab Hematol 2020 Jun 17. doi: 10.1111/ijlh.13271. Online ahead of print.


2 Mackie I, Cooper P, Lawrie A, Kitchen S, Gray E, Laffan M; British Committee for Standards in Haematology. Guidelines on the laboratory aspects of assays used


42


The CN-3500/6500 introduces chemiluminescence enzyme immunoassay (CLEIA) testing to the CN-Series.


Cross-mixing functionality on the CN-Series.


Clot waveform analysis (CWA) on the CN-Series.


in haemostasis and thrombosis. Int J Lab Hematol 2013; 35 (1): 1–13. doi: 10.1111/ ijlh.12004.


3 Baker P, Platton S, Gibson C et al.; British Society for Haematology, Haemostasis and Thrombosis Task Force. Guidelines on the laboratory aspects of assays used in haemostasis and thrombosis. Br J Haematol 2020 Jun 14. doi: 10.1111/bjh.16776. Online ahead of print.


4 Clinical and Laboratory Standards Institute. Determination of Coagulation Factor


Activities Using the One-Stage Clotting Assay, 2nd edn. CLSI guideline H48. Wayne, PA: CLSI, 2016.


5 Pengo V, Tripodi A, Reber G et al.; Subcommittee on Lupus Anticoagulant/ Antiphospholipid Antibody of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis. Update on the guidelines for lupus anticoagulant detection. Subcommittee on Lupus Anticoagulant/ Antiphospholipid Antibody of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost 2009; 7 (10): 1737–40. doi: 10.1111/j.1538- 7836.2009.03555.x.


PPi


6 Shima M, Thachil J, Nair SC, Srivastava A; Scientific and Standardization Committee. Towards standardization of clot waveform analysis and recommendations for its clinical applications. J Thromb Haemost 2013; 11 (7): 1417–20. doi: 10.1111/jth.12287.


For further information, please contact: Sysmex UK Sysmex House Garamonde Drive Wymbush


Milton Keynes MK8 8DF Tel: +44 (0)333 320 3460 Web: www.sysmex.co.uk


DECEMBER 2020 WWW.PATHOLOGYINPRACTICE.COM


PATHOLOGY IN PRACTICE


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