Evaluation of latex turbidimetric immunoassay for detection of helicobacter pylori antibody

Objective To evaluate the performance of helicobacter pylori antibody test kit and its effectiveness in the diagnosis of helicobacter pylori(Hp)infection. Methods Helicobacter pylori antibody in human serum was detected by latex immunoturbidimetry assay.The results were compared with C13-Urea Breath Test to evaluate the diagnostic effect of this method on Hp infection.Meanwhile, other experiments were performed to evaluate the kit performance such as linearity, stability and anti-interference and etc. Results Helicobacter pylori samples in human serum were detected by latex immunoturbidimetry assay by comparing with C13-Urea Breath Test.The positive and negative coincidence rates of these two methods were 93.3% and 90.0%, respectively, and the total coincidence rate was 91.7%.In addition, the experiments showed that Hp antibody kit had good linearity, accuracy, specificity, anti-interference ability and so on. Conclusion The performance of the Hp antibody kit for diagnosis on Hp infection can meet the clinical testing requirement, and can be applied to clinical diagnosis and screening of Hp. Key words: Helicobacter pylori antibody; C13-urea breath test; Latex immunotidimetry; High sensitivity