Evaluation of a High Throughput Multi-wavelength Blood Coagulation Analyser — Sysmex CS-5100

• Evaluation of a High Throughput Multi-wavelength Blood Coagulation Analyser — Sysmex CS-5100

AUTHOR(S)

A. S. LAWRIE, J. M. ISEPPI, I. J. MACKIE and S. J. MACHIN

Haemostasis Research Unit, Department of Haematology, University College London

SUMMARY

We assessed the performance of a prototype high throughput coagulation system ( CS-5100 ) from Sysmex Corporation Japan, in parallel with their intermediate throughput CS-2000i . The new analyser has the advantage of 20 multi-wavelength reaction detector positions as opposed to 10 on the CS-2000i , thereby approximately halving the processing time of most batched assays. In our evaluation we assessed performance in clotting ( prothrombin time [ PT ], activated partial thromboplastin time [ APTT ], Clauss fibrinogen [ Fbg ], one-stage factor VIII [ FVIII ] ) chromogenic ( antithrombin [ AT ], factor XIII [ FXIII ] ), immuno-turbidometric ( D-dimer [ DDi ], von Willebrand factor antigen [ VWF : Ag ] ) and platelet agglutination based ristocetin co-factor ( VWF : RCo ) test systems. For the FVIII and VWF:RCo assays, all samples were tested using the multi-dilution analysis ( MDA ) utility, to assess linearity and parallelism of the dose response curve to detect possible false results due to inhibitors or sample activation. For all other assays a single point determination was made with automatic redilution if the relative potency was outside the range of the standard curve. The CS-5100 methods showed good linearity and reproducible standard curves, and gave low inter-assay imprecision using commercial normal ( CV = 0.73-6.3% ) and pathological ( CV = 0.04-9.9% ) control plasmas ( preparations tested 10 times on each of 5 days ). Good correlations were observed between CS-2000i  and CS-5100 using clinical samples in each of the test systems ( PT, APTT, Fbg, FVIII, FXIII, VWF : Ag, VWF : RCo, AT and D-Dimer. R^２ = 0.96-0.99 ), with no clinically significant misclassification, and data points scattered closely around the line of identity. Our results demonstrated that using the CS-5100 analyser, routine coagulation testing and specialised assays can be performed with satisfactory imprecision and show good correlation with the CS-2000i .

KEY WORDS

Coagulation Analyser, High Throughput, Multi-wavelength Blood Coagulation Analyser