da Silva-Etto Joyce Matie Kinoshita, Mattar Rejane, Villares-Lopes Cibele Aparecida, Marques Sergio Barbosa, Carrilho Flair José
Division of Clinical Gastroenterology and Hepatology, Hospital das Clínicas da FMUSP, Department of Gastroenterology, University of São Paulo School of Medicine, São Paulo, Brazil.
Division of Clinical Gastroenterology and Hepatology, Hospital das Clínicas da FMUSP, Department of Gastroenterology, University of São Paulo School of Medicine, São Paulo, Brazil.
Clin Biochem. 2017 Nov;50(16-17):959-962. doi: 10.1016/j.clinbiochem.2017.05.005. Epub 2017 May 5.
The stool antigen assay for H. pylori infection diagnosis with monoclonal antibodies is a simple and recommended technique by the Maastricht V/Florence consensus report. Recently, Pylori K-Set K-1219 (Coris Bioconcept Sprl, Belgium) and HP-F23 (Symbiosys, Brazil) have been made commercially available in Brazil. Thus, the aim of this study was to evaluate the diagnostic accuracies of these two rapid stool antigen tests by immunochromatographic assays (index tests) for the clinical practice.
A total of 98 patients who underwent upper gastrointestinal endoscopy and C-urea breath test entered the study. H. pylori infection status was defined by the combination of the rapid urease test and the C-urea breath test (reference standard). Two observers who were aware of H. pylori status performed the reading of index tests. Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value with 95% confidence intervals, positive likelihood ratio, negative likelihood ratio and kappa index measure of agreement) were determined.
The index tests where in perfect agreement with the H. pylori status with kappa values of 0.87 for Pylori K-Set K-1219 and 0.92 for HP-F23. The sensitivity of HP-F23 was 97.9% (IC95%: 87.5-100) and specificity was 93.8% (IC95%; 84-97.2).The positive likelihood ratio was 15.8, and the negative likelihood ratio was 0.02. The Pylori K-Set K-1219 had a sensitivity of 87.7% (IC95%: 74.5-94.9) and a specificity of 100% (IC95%: 91.6-100); the positive likelihood ratio was ∞, and the negative likelihood ratio was 0.1. The test line on the cassette device of HP-F23 was stronger than of the Pylori K-Set K-1219.
The HP-F23 test performed better in clinical practice. Nonetheless, the C-urea breath test is more reliable technique. Moreover, caution must be paid to the trace or clear pale test line readings that were observed in false positive and false negative results, leading to incorrect management of the patient.
使用单克隆抗体的粪便抗原检测法诊断幽门螺杆菌感染是一种简单的技术，并且被马斯特里赫特V/佛罗伦萨共识报告所推荐。最近，幽门螺杆菌K组K-1219（比利时科里斯生物概念公司）和HP-F23（巴西共生公司）已在巴西上市。因此，本研究的目的是通过免疫层析法（指标检测）评估这两种快速粪便抗原检测在临床实践中的诊断准确性。
共有98例接受上消化道内镜检查和碳-尿素呼气试验的患者进入本研究。幽门螺杆菌感染状态通过快速尿素酶试验和碳-尿素呼气试验联合确定（参考标准）。两名知晓幽门螺杆菌感染状态的观察者对指标检测结果进行判读。确定诊断准确性（敏感性、特异性、阳性预测值、阴性预测值及95%置信区间、阳性似然比、阴性似然比和kappa一致性指数）。
指标检测结果与幽门螺杆菌感染状态完全一致，幽门螺杆菌K组K-1219的kappa值为0.87，HP-F23的kappa值为0.92。HP-F23的敏感性为97.9%（95%CI：87.5 - 100），特异性为93.8%（95%CI；84 - 97.2）。阳性似然比为15.8，阴性似然比为0.02。幽门螺杆菌K组K-1219的敏感性为87.7%（95%CI：74.5 - 94.9），特异性为100%（95%CI：91.6 - 100）；阳性似然比为∞，阴性似然比为0.1。HP-F23试剂盒上的检测线比幽门螺杆菌K组K-1219的更强。
HP-F23检测在临床实践中表现更好。尽管如此，碳-尿素呼气试验是更可靠的技术。此外，对于在假阳性和假阴性结果中观察到的检测线痕迹或清晰淡色读数必须谨慎对待，这可能导致对患者的错误处理。
