Abstract
INTRODUCTION : The Sysmex CS coagulation series system is a high performance coagulation station that allow laboratories to perform routine and specialized testing including platelet function tests on the same platform. The CS is equipped with an optical fiber that supplies light at five wavelengths (multiwavelength detection) that simultaneously measure multiple parameters using clotting, chromogenic, immunoassay and aggregation methods. It has clot curve analysis feature.
AIMS & OBJECTIVES : The aim of the present study was to evaluate the performance of the instrument as per the lab's current & future needs. The tests performed were routine coagulation (PT, APT, TT, fibrinogen, factor VIII, Lupus Anticoagulant), chromogenic (Innovance antithrombin III and Berichrom Protein C) and immunologic assays (Innovance Free Protien S). Additionally, the operational performance of the Sysmex CS- 2000i System was compared with the existing automated coagulation analyzer Sysmex CA-530.
MATERIALS & METHODS :Sample collection and Preparation Blood collected in 3.2% sodium citrate vacutainers (BD) were centrifuged for 10 min at 3000g to prepare platelet poor plasma (PPP). Multiple coagulation assays were done on a total of 642 patient samples to evaluate the system. The number of tests done for different routine and specialized assays are as follows: PT (597);APTT-FS (555);APTT-FSL (545);TT (297);Fibrinogen (165);Factor VIII (23);Bethesda assay (2); Protein C (65); Free Protein S Ag(60);ATIII (76); LA1(23); LA2 (14). All assays were performed according to the manufacturers' specifications and standard laboratory methods.
RESULTS : 1.Precision for PT,APTT was found to be <1% whereas for fibrinogen it was within 5%.(Table 1)
2.Accuracy for PT,fibrinogen,AT III and factor VIII was performed and found close to the target values. (Table 2)
3.Biological reference intervals were established for PT,APTT(FS,FSL),TT,LA1 and LA2. (Table 3)
4.Mixing Study was carried out for a sample when a patient's PT, APTT, TT and LA were prolonged and outside the upper limit of reference range. This was done to determine the cause of prolongation in correlation with the clinical history. The mixing studies results helped clinicians to make decision regarding factor deficiencies and circulating inhibitors.
5.Linearity: 21mg/dl for fibrinogen and 0.9% for factor VIII lowest limit of detection (LOD) was obtained.(Figures 1 & 2). The CS analyzer can save upto 10 calibration curves for each of the parameters viz fibrinogen,factor VIII, free protein S, Protein C, ATIII.
6.Free Protein S, Protein C activity and ATIII assays were performed on CS-2000i to investigate the possibility of thrombotic disorders. The calibrators and controls were found to be within acceptable limits.
7. We assessed the ability of CS-2000i to perform the platelet aggregation and examine the effect of agonist ADP at different concentrations (Figure 3). We intend to perform Plt Agg with the other agonists to enable diagnosis of platelet function defects.
8. The results of the study between the CS-2000i and CA- 530 were correlated and the results are shown for PT, APTT, and Fibrinogen in Figures 4, 5 & 6.
CONCLUSIONS: 1. The analytical performance for routine and specialized assays on CS-2000i was compared to that of Sysmex CA-530 using the same Siemens reagents on both systems. The agreement between the two systems was excellent.
2.It has cap-piercing technology which supports clinical and workflow excellence by helping to prevent sample contamination and deliver accurate results.
3.Platelet aggregation can be performed on CS-2000i along with routine and other specialized coagulation assays thus avoiding the requirement of procuring a separate platelet aggregometer.
4.Sysmex CS analyzer showed good precision, accuracy, linearity and provided faster turn around time.
No relevant conflicts of interest to declare.
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