A performance evaluation of chemiluminescence enzyme immunoassays on the Sysmex CN‐6500 haemostasis analyser
| Autor: | Chris Gardiner, Ian J. Mackie, PJ Lane, Hitesh Tailor, Samuel J. Machin |
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| Rok vydání: | 2021 |
| Předmět: |
Analyte
Serial dilution medicine.medical_treatment Clinical Biochemistry Sensitivity and Specificity law.invention Immunoenzyme Techniques law Fibrinolysis medicine Coagulation testing Humans Blood Coagulation Chemiluminescence Automation Laboratory Detection limit Chromatography medicine.diagnostic_test Chemistry Biochemistry (medical) Reproducibility of Results Hematology General Medicine Haemolysis Immunoassay Luminescent Measurements Blood Coagulation Tests |
| Zdroj: | International Journal of Laboratory Hematology. 43:1593-1598 |
| ISSN: | 1751-553X 1751-5521 |
| DOI: | 10.1111/ijlh.13656 |
| Popis: | BACKGROUND The Sysmex CN-6500 is a new haemostasis analyser with an integrated immunoassay module that performs chemiluminescence enzyme assay (CLEIA) in addition to coagulation, turbidimetric, chromogenic and platelet aggregation tests. AIMS To evaluate the analytical performance of the CN-6500 against the predicate device (Sysmex HISCL-800) for soluble thrombomodulin (TM), thrombin-antithrombin (TAT), tissue plasminogen activator/plasminogen activator inhibitor 1 complex (tPAI-C) and plasmin α2 plasmin inhibitor complex (PIC) assays. METHODS Imprecision was assessed by testing two levels of quality control plasmas 10 times on 5 separate days. Comparability was studied in 230 plasmas from normal donors (n = 30), patients with suspected disseminated intravascular coagulation (DIC, n = 100), sepsis (n = 20) or liver disease (n = 20), lipaemic (n = 20), haemolysed (n = 20) and icteric samples (n = 20). Limit of detection, limit of quantitation and linearity were determined by testing serial dilutions of normal plasma. Sample carryover was assessed by testing samples with high and low normal levels of the analytes concerned. RESULTS The CN-6500 performed 21 CLEIA tests per hour, while simultaneously performing coagulation tests. Acceptable between-run imprecision was obtained using commercial controls with normal and high activity for each analyte (%CV 0.99) across the measurement range. The lower limits of detection and quantitation were as follows: TM 0.1/ |
| Databáze: | OpenAIRE |
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