An Evaluation of the Consistency Among Three Chemiluminescence Detection Systems for Detecting CA19-9
Objective To evaluate the consistency of the detection results of CA19-9 indicators by the New Industry,Roche,and Abbott luminescent systems.Methods We collected and confirmed recent Abbott CA19-9 test samples from the Department of Nuclear Medicine and saved them for retesting in the New Industry and Roche testing systems.Samples were grouped based on clinical diagnostic information.We compared the serological expressions of CA19-9 in the testing systems of various manufacturers through paired sample rank sum test,Passing Bablock regression analysis,and Kappa analysis.We then compared and analyzed the efficacy of various manufacturer indicators in diagnosing malignant tumors through ROC curves.Results The rank sum test showed that the three detection systems all detected CA19-9,and there was a significant difference in paired data.Correlation and Passing Bablock analysis showed that the correlation coefficient R2 between Roche and New Industries was 0.931,Y=0.8875X+1.3765,and there was no significant deviation in the linearity of the results of these two detection systems;The correlation coefficient R2 between Roche and Abbott was 0.5818,Y=1.7178X-6.4599,and there was a significant deviation in the linearity of the results of these two detection systems;The correlation coefficient R2 between the New Industry and Abbott was 0.5195,Y=0.4690X+5.5883,and there was a significant deviation in the linearity of the results of these two testing systems.The Kappa value of Roche and the New Industry group was 0.864,indicating a good consistency;The Kappa value of Roche and Abbott groups was 0.714,with a moderate consistency;The Kappa value of the New Industry and Abbott's group was 0.650,with an average consistency.AUC of the Roche for CA19-9 was 0.688,while AUC of the New Industry was 0.679 and AUC of the Abbott CA19-9 was 0.651.In the detection of malignant tumors,the sensitivity of Roche for CA19-9 was 73.91％,the specificity was 59.81％,and the overall conformity was 65.34％;The sensitivity of the New Industry for CA19-9 was 65.22％,the specificity was 65.42％,and the total conformity was 65.34％;The sensitivity of Abbott for CA19-9 was 63.77％,the specificity was 52.33％,and the total conformity was 56.82％.Conclusion The linearity of the comparison results between Roche and the New Industry has no significant deviation,and the consistency is high.The interchangeability of the test results between these two is relatively ideal;For the diagnosis of malignant tumors,both manufacturers'testing systems have good diagnostic efficacy for CA19-9;Based solely on the results of CA19-9 for the diagnosis of malignant tumors,the diagnostic efficacies of all three methods are not ideal.
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