Department of Gastroenterology, Fuyoukai Murakami Hospital, Aomori, Japan.
Aomori General Health Examination Center, Aomori, Japan.
Helicobacter. 2023 Jun;28(3):e12961. doi: 10.1111/hel.12961. Epub 2023 Feb 24.
Some patients find it difficult to discontinue proton pump inhibitors (PPIs). Unlike the C-urea breath test (UBT), the stool antigen test (SAT), particularly when domestically produced kits are used, may be less likely to yield false-negative results.
This prospective study included a convenience series of 35 healthy Japanese subjects. Based on a statistical calculation, acceptable numbers of subjects were considered at least 21 and 11 with and without Helicobacter pylori (H. pylori) infection, respectively. The H. pylori infection was determined using the UBT or rapid urease test. SATs were performed with three novel domestically produced kits (the rapid immunochromatography tests Quick Navi™-H. pylori [Navi™] and Quick Chaser® H. pylori [Chaser®], and the bioluminescent enzyme immunoassay test BLEIA® 'EIKEN' H. pylori Antigen [BLEIA®]) before and after oral PPI administration (30 mg lansoprazole once daily for 14 days). For each kit, the sensitivities and specificities were calculated and compared before and after PPI administration. Furthermore, the cutoff index (COI) values of BLEIA® before and after PPI administration were compared in H. pylori-infected subjects.
H. pylori infection was detected in 68.6% (24/35) of the included subjects. The sensitivities and specificities before versus after PPI administration were as follows: 79.2% (19/24) and 100.0% (11/11) versus 75.0% (18/24) and 100.0% (11/11) for Navi™, respectively (p = 1); 87.5% (21/24) and 100.0% (11/11) versus 75.0% (18/24) and 100.0% (11/11) for Chaser®, respectively (p = .371); 100.0% (24/24) and 100.0% (11/11) versus 95.8% (23/24) and 100.0% (11/11) for BLEIA®, respectively (p = 1). The median COI values of BLEIA® before and after PPI administration were 1389.0 and 3207.25, respectively (p = .0839).
In stool specimens, H. pylori antigenicity is maintained even during PPI use. SAT using a bioluminescent enzyme immunoassay is particularly recommended because of its extremely high sensitivity.
有些患者发现难以停止质子泵抑制剂（PPIs）的使用。与 C-尿素呼气试验（UBT）不同，粪便抗原检测（SAT），特别是当使用国产试剂盒时，不太可能产生假阴性结果。
这项前瞻性研究纳入了 35 名健康的日本受试者的便利系列。根据统计计算，认为至少有 21 名和 11 名有和没有幽门螺杆菌（H. pylori）感染的受试者分别具有可接受的数量。H. pylori 感染使用 UBT 或快速尿素酶试验确定。在口服 PPI 治疗（每日 30mg 兰索拉唑一次，共 14 天）前后，使用三种新的国产试剂盒（快速免疫色谱检测试剂盒 Quick Navi™-H. pylori [Navi™]和 Quick Chaser® H. pylori [Chaser®]，以及生物发光酶免疫测定试剂盒 BLEIA® 'EIKEN' H. pylori 抗原 [BLEIA®]）进行 SAT 检测。对于每种试剂盒，在 PPI 治疗前后计算并比较其敏感性和特异性。此外，还比较了 PPI 治疗前后 H. pylori 感染受试者中 BLEIA®的截止指数（COI）值。
纳入的受试者中，H. pylori 感染的检出率为 68.6%（24/35）。PPI 治疗前后的敏感性和特异性分别为：79.2%（19/24）和 100.0%（11/11）与 75.0%（18/24）和 100.0%（11/11）用于 Navi™（p=1）；87.5%（21/24）和 100.0%（11/11）与 75.0%（18/24）和 100.0%（11/11）用于 Chaser®（p=.371）；100.0%（24/24）和 100.0%（11/11）与 95.8%（23/24）和 100.0%（11/11）用于 BLEIA®（p=1）。PPI 治疗前后 BLEIA®的 COI 值中位数分别为 1389.0 和 3207.25（p=.0839）。
在粪便标本中，即使在使用 PPI 时，H. pylori 抗原性也得以维持。由于其极高的灵敏度，建议特别使用生物发光酶免疫测定法进行 SAT。
