Department of Pediatrics, Faculty of Medicine, Saga University, Saga 849-8501, Japan.
Department of Internal Medicine, Faculty of Medicine, Saga University, Saga 849-8501, Japan.
Can J Gastroenterol Hepatol. 2022 Apr 21;2022:5571542. doi: 10.1155/2022/5571542. eCollection 2022.
BLEIA ™ "EIKEN" antigen (B[EIA]) is based on the bioluminescent enzyme immunoassay (BLEIA) method that was newly developed with high sensitivity in detecting () antigen in feces.
In the project for screening and treatment in Saga Prefecture in 2019, 141 students received the stool antigen test as a secondary test. For 141 students, a comparative test was conducted between B (EIA) and extracorporeal diagnostic agents that were marketed in Japan as of 2019. The detection performance of ATCC43504 standard strain and antigen in commercial human fecal specimens were conducted.
The comparison of B (EIA) with Quick Chaser (Q [IC]) revealed positive and negative concordance ratios of B (EIA) to Q (IC) of 100.0% (110/110) and 71.0% (22/31), respectively. A comparative test was conducted between B (EIA) and extracorporeal diagnostic agents that were marketed in Japan as of 2019, and B (EIA) was most sensitive on "detecting antigen of ATCC43504 standard strain" and "detecting antigen in commercial human fecal specimens," compared with other kits. Nine dissociated specimens that were negative for Q (IC) and positive for B (EIA) were confirmed. The measured value of B (EIA) in the dissociation samples were 1.3-87.4 cutoff index in the range that can be evaluated as negative by other fecal antigen test kits, all the dissociation samples were antigen-positive cases, and finally the cause of result divergence was presumed as false negative due to insufficient sensitivity of Q (IC).
B (EIA) that is based on the BLEIA method, which applies firefly luciferase luminescence, is more sensitive than stool antigen test kits that are currently marketed in Japan and is very useful in diagnosing infection, especially in situations where noninvasive tests are preferred, such as in children.
BLEIA“EIKEN”抗原（B[EIA]）基于生物发光酶免疫测定（BLEIA）法，该方法在检测粪便中 ()抗原方面具有高灵敏度，是一种新开发的方法。
在 2019 年佐贺县的筛查和治疗项目中，有 141 名学生接受了粪便抗原检测作为二级检测。对这 141 名学生，我们对截至 2019 年在日本上市的 B（EIA）和体外诊断试剂进行了对比检测。检测了 ATCC43504 标准菌株和商业人体粪便标本中的抗原。
B（EIA）与 Quick Chaser®（Q[IC]）的比较显示，B（EIA）对 Q（IC）的阳性和阴性符合率分别为 100.0%（110/110）和 71.0%（22/31）。与截至 2019 年在日本上市的其他体外诊断试剂进行了对比检测，B（EIA）在“检测 ATCC43504 标准菌株的抗原”和“检测商业人体粪便标本中的抗原”方面最为敏感。9 份与 Q（IC）阴性但与 B（EIA）阳性的分离标本得到了确认。B（EIA）在分离样本中的测量值为 1.3-87.4 截止指数，在其他粪便抗原检测试剂盒可评估为阴性的范围内，所有分离样本均为阳性，最终结果差异的原因被认为是由于 Q（IC）灵敏度不足导致的假阴性。
基于萤火虫荧光素发光的 BLEIA 方法的 B（EIA）比目前在日本上市的粪便抗原检测试剂盒更敏感，对于诊断感染非常有用，尤其是在偏好非侵入性检测的情况下，例如在儿童中。
