Manes G, Zanetti M V, Piccirillo M M, Lombardi G, Balzano A, Pieramico O
Department of Gastroenterology, Cardarelli Hospital, Naples, Italy.
Dig Liver Dis. 2005 Oct;37(10):751-5. doi: 10.1016/j.dld.2005.03.012.
The enzyme immunoassay based on polyclonal antibodies (HpSA) represents a valid method for the detection of Helicobacter pylori antigens in stool specimens, but some controversial results were reported in post-eradication setting. A new monoclonal enzyme immunoassay (FemtoLab H. pylori, Connex) has been developed. The present study compares the diagnostic accuracy of the two tests after eradication therapy.
Stool samples were collected and urea breath test and endoscopy performed in 325 patients (161 F, 164 M, age 17-78 years), 4-8 weeks after standard triple eradication therapy. The FemtoLab and HpSA tests were performed in accordance with the manufacturer's protocol. H. pylori infection was confirmed if culture alone or both urease test and histology were positive and was considered absent if all three tests were negative.
H. pylori was eradicated in 231 patients (71.1%). Urea breath test showed the best performances with sensitivity 98.9% and specificity 99.5%. The sensitivity of FemtoLab was 88.3%, specificity 94.8%, positive and negative predictive values 87.4% and 95.2%. Corresponding HpSA values were 73.4%, 97.8%, 93.2% and 90%. Sensitivity and negative predictive value of FemtoLab were significantly better than HpSA. Adjusting the cut-offs according to a ROC curve improved not significantly the sensitivity of the two tests.
Urea breath test shows the best accuracy in the assessment of H. pylori infection. Between the stool tests, the FemtoLab due to its higher sensitivity is to prefer in the post-eradication assessment of H. pylori infection.
基于多克隆抗体的酶免疫测定法（HpSA）是检测粪便标本中幽门螺杆菌抗原的有效方法，但在根除治疗后的情况下报告了一些有争议的结果。一种新的单克隆酶免疫测定法（FemtoLab幽门螺杆菌检测，Connex）已被开发出来。本研究比较了根除治疗后两种检测方法的诊断准确性。
在325例患者（161例女性，164例男性，年龄17 - 78岁）中，在标准三联根除治疗后4 - 8周收集粪便样本并进行尿素呼气试验和内镜检查。FemtoLab和HpSA检测按照制造商的方案进行。仅培养阳性或尿素酶试验和组织学均阳性则确诊幽门螺杆菌感染，若所有三项检测均为阴性则认为未感染。
231例患者（71.1%）幽门螺杆菌被根除。尿素呼气试验表现最佳，敏感性为98.9%，特异性为99.5%。FemtoLab的敏感性为88.3%，特异性为94.8%，阳性预测值和阴性预测值分别为87.4%和95.2%。相应的HpSA值分别为73.4%、97.8%、93.2%和90%。FemtoLab的敏感性和阴性预测值显著优于HpSA。根据ROC曲线调整临界值对两种检测的敏感性改善不显著。
尿素呼气试验在评估幽门螺杆菌感染方面显示出最佳准确性。在粪便检测中，FemtoLab因其较高的敏感性在幽门螺杆菌感染的根除后评估中更受青睐。
