Chen Tseng-Shing, Chang Full-Young, Lee Shou-Dong
Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, and National Yang-Ming University, Taipei, Taiwan.
Dig Dis Sci. 2002 Nov;47(11):2519-22. doi: 10.1023/a:1020516211030.
The aims of the study were to evaluate the diagnostic accuracy of a rapid whole blood test (one-step BM-Test Helicobacter pylori) in different blood collections and compare it with a quantitative ELISA test (HEL-p TEST II). One hundred four dyspeptic patients were studied, and 53 (51%) were H. pylori-positive as determined by [13C] urea breath test. The area under the ROC curve was higher for HEL-pTEST II compared to the one-step BM-Test with either fingerstick or venipuncture (0.972 vs 0.721 and 0.714, P = 0.000). The most appropriate cutoff reading time was 5 min for the one-step BM-Test. The sensitivity, specificity, and accuracy were 52.8%, 88.2%, 70.2% for fingerstick; 62.3%, 80.4%, 71.2% for venipuncture; and 90.6%, 92.2%, 91.3% for HEL-pTEST II. We conclude that there is no difference in diagnostic performance between capillary and venous blood for rapid whole blood test, and extending the reading time beyond the manufacturer's suggestion for the one step BM-Test does not improve its accuracy.
本研究的目的是评估快速全血检测（一步法BM-Test幽门螺杆菌检测）在不同采血方式下的诊断准确性，并将其与定量酶联免疫吸附试验（HEL-p TEST II）进行比较。对104例消化不良患者进行了研究，通过[13C]尿素呼气试验确定其中53例（51%）幽门螺杆菌呈阳性。与采用指尖采血或静脉穿刺的一步法BM-Test相比，HEL-pTEST II的ROC曲线下面积更高（分别为0.972对0.721和0.714，P = 0.000）。一步法BM-Test最合适的判读时间为5分钟。指尖采血时一步法BM-Test的灵敏度、特异度和准确度分别为52.8%、88.2%、70.2%；静脉穿刺时分别为62.3%、80.4%、71.2%；HEL-pTEST II的分别为90.6%、92.2%、91.3%。我们得出结论，快速全血检测中毛细血管血和静脉血的诊断性能没有差异，并且将一步法BM-Test的判读时间延长至超出制造商的建议并不能提高其准确性。
