Abstract： Objective To evaluate the performance of M16 Magnetic Sensitive Immunoanalyzer.Methods Using the detection reagent kit of troponin I (cTnI) , myoglobin (Myo) and creatine kinase isoenzyme (CK-MB) (magnetoimmunity method) , the precision, linear performance and trueness of M16 Magnetic Sensitive Immunoanalyzer were evaluated.Concentrations of Myo, CK-MB in thirty heparin anticoagulation blood samples, which collected from outpatients and inpatients in Yongchuan Hospital, Chongqing Medical University in May 2018, were detected by M16 Magnetic Sensitive Immunoanalyzer and Roche Cobas E602 automatic electrochemical luminescence detector simultaneously.The two results were conducted correlation analysis.Results The coefficient of variation (CV) for precision of M16 Magnetic Sensitive Immunoanalyzer was lower than 15%.Linearly dependent coefficients of cTnI, Myo and CK-MB were all greater than 0.99.Measurement relative bias for trueness was less than 15%.These performance parameters were comply with the manufacturer′s stated performance.Myo and CK-MB results obtained by M16 Magnetic Sensitive Immunoanalyzer and electrochemical luminescence detector had better correlation, and R2 equal to 0.984 and 0.986 respectively.Conclusion M16 Magnetic Sensitive Immunoanalyzer, as a typical third generation POCT, can provide fast, accurate and reliable decision support for clinicians.
Keyword： magnetic sensitive immunoassay; POCT; myocardial infarction; biomarkers;
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