Objective: To analyze the clinical performance of TP antibody detection by CLIA kits and evaluate whether the CLIA kits made in China is suitable for clinical use.
Methods: 1200 samples were collected from Beijing Hospital including 300 samples with confirmed TP infection and 900 healthy control samples. To detect the TP antibody of the 1200 sanples separately by the CLIA kits and the ELISA kits at the same time. The test results were analyzed with statistical methods.
Results: The sensitivity and specificity of the CLIA kits were 99.3% and 99.9% respectively, and positive predictive value of 99.7%, negative predictive value of 100%. With the ELISA method, the positive coincidence rate was 98.7%, the negative coincidence rate was 99.8%, and the total coincidence rate was 99.5%.
Conclusion: The CLIA kits showed good clinical performance and the agreement rate with the ELISA kits was. The CLIA kits are suitable for clinical use.
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