Abstract Number: PB0608
Meeting: ISTH 2020 Congress
Background: The Sysmex CN-Series haemostasis analysers have integrated haemostasis immunoassay modules that perform chemiluminescent-enzyme immunoassays (CLEIA) in addition to coagulation, turbidimetric, chromogenic and platelet aggregation tests.
Aims: To evaluate the performance the CN-Series CLEIA with the predicate device (Sysmex HISCL-800) for thrombin-antithrombin (TAT), plasmin α2 plasmin inhibitor complex (PIC), tissue plasminogen activator/ plasminogen activator inhibitor 1 complex (t-PAI-C) and thrombomodulin (TM).
Methods: Imprecision was assessed by testing high and low quality control plasmas x10 on each of 5 separate days. Comparability was studied in 230 plasmas from normal donors, patients with suspected disseminated intravascular coagulation, sepsis or liver disease, lipaemic, haemolysed and icteric samples. Linearity, limit of detection and limit of quantitation was determined by testing doubling dilutions of a pooled normal plasma. Carryover was assessed by testing samples with normal plasma and plasmas with TAT and TPAI-C above 100 ng/mL.
Results: The CN-Series performed 26 CLEIA tests per hour (time to first result was < 20 minutes), while simultaneous performing coagulation tests. Acceptable imprecision between-run was obtained for all four assays in high (%CV < 6%) and low (%CV < 7%) controls (Table 1). Excellent linearity was observed (slope 0.89 - 1.03; r2 >0.99) across the measurement range. The lower limits of detection and quantitation were: TM < 0.3/0.6 TU/mL, TAT >0.1/< 0.2 ng/mL, PIC < 0.004/< 0.008 µg/mL and TPAI-C < 0.01/< 0.1 ng/mL respectively. All four assays showed excellent correlation between instruments (Figure 1) and were unaffected by haemolysis, icterus or lipaemia. No carryover was observed in the TAT or TPAI-C assays.
Conclusions: Our data demonstrate that the performance of the CLEIA module of the CN-Series is comparable to that of a stand-alone immunoassay analyser.
| High QC | Mean HISCL-800 | SD HISCL-800 | %CV HISCL-800 | Mean CN-series | SD CN-series | %CV CN-series |
| TAT ng/mL | 36.89 | 1.39 | 3.77% | 38.00 | 1.59 | 4.17% |
| TM TU/mL | 113.0 | 2.5 | 2.46% | 115.0 | 3.8 | 3.29% |
| PIC μg/mL | 7.257 | 0.254 | 3.49% | 6.938 | 0.280 | 4.04% |
| TPAI-C ng/mL | 15.59 | 0.62 | 3.98% | 17.67 | 0.99 | 5.62% |
| Low QC | Mean HISCL-800 | SD HISCL-800 | %CV HISCL-800 | Mean CN-series | SD CN-series | %CV CN-series |
| TAT ng/mL | 9.56 | 0.32 | 3.36% | 9.69 | 0.39 | 4.01% |
| TM TU/mL | 27.4 | 0.7 | 2.48% | 27.7 | 0.8 | 2.93% |
| PIC μg/mL | 1.773 | 0.056 | 3.22% | 1.620 | 0.046 | 2.84% |
| TPAI-C ng/mL | 4.14 | 0.15 | 3.75% | 4.67 | 0.31 | 6.74% |
[Table 1]
[Figure 1]
To cite this abstract in AMA style:
Gardiner C, Lane P, Tailor H, Machin SJ, Mackie IJ. A Performance Evaluation of Chemiluminescent-Enzyme Immunoassays on a Routine Coagulation Analyser [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/a-performance-evaluation-of-chemiluminescent-enzyme-immunoassays-on-a-routine-coagulation-analyser/. Accessed November 26, 2020.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/a-performance-evaluation-of-chemiluminescent-enzyme-immunoassays-on-a-routine-coagulation-analyser/