| Background The development of immunodiagnostic technology in the IVD ushered chemiluminescence immunoassay(CLIA).At present,imported brands use technical barriers and first-mover advantages to occupy the majority of market share.To break the monopoly,our national brands must meet at least the same standards in product performance and clinical application in order to obtain users 'trust.Laboratory ISO15189 is already a major trend in the future development of major hospitals.It is an important part of the inspection instrument's compliance with ISO 15189 and CNAS.Future laboratory personnel need to have the ability to perform performance analysis of the instruments used with the help of the CLSI series of documents.With the development of medical and the clinical application of IVD products,it is particularly important to do a good job of standardization so that the medical clinical laboratory and the in vitro diagnostic industry can develop healthily in a regulated and orderly manner.Objective To systematically evaluate the analytical performance of the Auto Lumo A2000 Plus tumor marker series of Zhengzhouantu and compare the results with the market's mainstream imported brand instruments to assess the differences in analytical performance and test results between domestic and imported brands in the field of chemiluminescence,To provide evidence for clinical promotion of the use of such equipment.Methods1.The analytical performance indicators(detection limit,precision,accuracy,linearity,reportable range,interference test)of five products of Auto Lumo A2000 Plus tumor marker series of Zhengzhouantu are in accordance with ISO 15189.According to the CLSI series EP document requirements for a comprehensive evaluation.2.The clinical effects of the five projects were compared with those of the imported automatic instruments(Roche Cobas E 601).3.Using SPSS19.0 statistical analysis software for data processing and statistical analysis,the test results are tested by Kappa.If Kappa ? 0.75 indicates that the two are in good agreement and meet the experimental requirements;Using Medcalc 11.0 software to test the regression analysis of the data,if the correlation coefficient R > 0.90,it shows that the two values are well consistent and meet the experimental requirements.Results Analytical performance:1.Detection limits: The Lo B,Lo D and FS of five products are:AFP: 0.02 ng/m L,0.69ng/m L,1.00 ng/m L.CEA: 0.10 ng/m L,0.68 ng/m L,0.70 ng/m L.CA125: 0.66 U/m L,1.40U/m L,2.11 U/m L.CA15-3: 0.47 U/m L,1.81 U/m L,1.91 U/m L.CA19-9 : 0.11 U/m L,2.57 U/m L,2.62 U/m L.2.Precision: within-run precision ? 1/4 CLIA'88 TEa(about 6.25%),between-run precision ? 1/3 CLIA'88 TEa(about 8.33%),total imprecision ? 1/2 CLIA'88 TEa(about12.5%).3.Accuracy: The results of each concentration ? TEa.4.Linearity: The linear regression equation of five products(AFP,CEA,CA125,CA19-9and CA15-3)are y = 4.0055 + 0.9982 x,y = 4.4171 + 0.9912 x,y =-6.7160 + 1.0130x;y =0.6871 + 1.0171 x and y = 0.9656 + 0.9890 x respectively.5.Reportable range: AFP: 1.00-41298 ng/m L,CEA: 0.70-18342 ng/m L,CA125:2.11-4297 U/m L,CA15-3: 1.91-2550 U/m L,CA19-9: 2.62-4633 U/m L.6.Interference: The five items have no interference with hemoglobin,bilirubin and triglycerides at the manufacturer's claimed interferent concentrations(interference rate<10%).Clinical application:Coincidence:The total coincidence of five products(AFP,CEA,CA125,CA19-9 and CA15-3)with Roche e601 are 97.61%,91.89%,96.00%,95.47% and 89.75% respectively;kappa values are 0.883,0.860,0.906,0.9294 and 0.784 respectively,P < 0.001.Correlation: The correlation coefficient of five products(AFP,CEA,CA125,CA19-9 and CA15-3)with Roche e601 are 0.9964,0.9953,0.9846,0.9168 and 0.9088 respectively,P<0.001.Conclusion Zhengzhou Auto Lumo A2000 Plus Cancer Marks Series of five products analytical performance and detection results meet the requirements of industry standards and relevant CNAS requirements,can meet the needs of clinical applications. |
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