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目的评价应用新型国产试剂进行微剂量(37KPq)14C-尿素呼气试验(14C-UBT)对幽门螺杆菌(HP)感染的诊断价值。方法59例HP阳性病人和47例HP阴性对照接受试验。试验所用试剂全部国产化,包括14C-尿素、CO2吸收剂、闪烁剂。ROC分析法确定14C-UBT最适判别值。19例志愿者第二日重复试验。结果ROC分析法得出14C-UBT最适判别值为250dpm/mmolCO2。实验对HP感染诊断的敏感性为96.6%(57/59),特异性95.7%(45/47),准确性96.2%(102/106),实验重复性良好。体重校正和使用液闪仪本底计算测试结果不影响诊断效能。结论国产试剂微剂量14C-UBT诊断HP感染具有高度的准确性,且简单和安全,试验无需试餐和加用非标记尿素,不需收集呼气本底,结果不需以体重校正
Objective To evaluate the diagnostic value of 14C-urea breath test (14C-UBT) in the diagnosis of Helicobacter pylori (HP) infection using a novel domestic reagent. Methods 59 cases of HP-positive patients and 47 cases of HP-negative control were tested. All domestic reagents used in the experiment, including 14C-urea, CO2 absorbers, scintillators. ROC analysis to determine the optimal 14C-UBT discriminant value. Nineteen volunteers repeated the test on the second day. Results ROC analysis obtained 14C-UBT optimum discrimination value of 250dpm / mmolCO2. The sensitivity of the experiment to the diagnosis of HP infection was 96.6% (57/59), the specificity was 95.7% (45/47) and the accuracy was 96.2% (102/106). The experiment had good repeatability. Body weight correction and the use of a liquid-flash instrument to calculate the test results do not affect the diagnostic performance. Conclusion The domestic reagent micro-dose 14C-UBT diagnosis of HP infection with a high degree of accuracy, and simple and safe, no test meal and add non-labeled urea, without the acquisition of expired background, the results do not need to be corrected for body weight