L型和光纯药抗体J试验的效用

Usefulness of the l-type Wako antibody J test.

作者信息

Tokai Yoshitaka, Fujisaki Junko, Ishizuka Naoki, Osumi Hiroki, Namikawa Ken, Yoshimizu Shoichi, Horiuchi Yusuke, Ishiyama Akiyoshi, Yoshio Toshiyuki, Hirasawa Toshiaki, Miki Kazumasa, Tsuchida Tomohiro

机构信息

Department of Gastroenterology The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo Japan.

Department of Clinical Trial planning and Management The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo Japan.

出版信息

JGH Open. 2021 May 7;5(6):673-678. doi: 10.1002/jgh3.12553. eCollection 2021 Jun.

DOI:10.1002/jgh3.12553

PMID:34124385

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8171153/

Abstract

BACKGROUND AND AIM

antibody levels in the blood are currently measured using an ELISA. In April 2016, FUJIFILM Wako Pure Chemical Corporation launched the "l-type Wako antibody J" test, which is based on the latex agglutination turbidimetric immunoassay. In this study, we investigated the usefulness of the Wako test.

METHODS

We measured antibody levels using both the ELISA and Wako test in 180 patients who underwent upper gastrointestinal endoscopy at our hospital between September 2017 and February 2019. Ninety patients were infected with . We calculated the diagnostic accuracy, sensitivity, and specificity of each test and the concordance rate between the ELISA and Wako test. If lower limits of 90% confidence intervals (CIs) for each diagnostic validity exceeded the 85% threshold, the usefulness of the diagnostic test was confirmed.

RESULTS

The diagnostic accuracy, sensitivity, and specificity were 94.4% (90% CI, 90.8-97.0%), 94.4% (90% CI, 88.7-97.8%), and 94.4% (90% CI, 88.7-97.8%), respectively, when the Wako test was used, and 94.4% (90% CI, 90.8-97.0%), 88.9% (90% CI, 81.9-93.8%), and 100% (90% CI, 96.0-100%), respectively, when the ELISA was used. The concordance rate between the two tests was high ( = 0.8444).

CONCLUSIONS

We confirmed the usefulness of the Wako test, especially when screening for infection, due to its high sensitivity.

摘要

背景与目的

目前血液中的抗体水平通过酶联免疫吸附测定（ELISA）来检测。2016年4月，富士胶片和光纯药株式会社推出了基于乳胶凝集比浊免疫测定法的“和光抗体J型L检测”。在本研究中，我们调查了和光检测的实用性。

方法

我们对2017年9月至2019年2月期间在我院接受上消化道内镜检查的180例患者，同时采用ELISA和和光检测来测定抗体水平。其中90例患者受到[此处原文缺失某种感染相关信息]感染。我们计算了每种检测方法的诊断准确性、敏感性和特异性，以及ELISA与和光检测之间的一致性率。如果每种诊断有效性的90%置信区间（CI）下限超过85%阈值，则确认诊断检测的实用性。

结果

使用和光检测时，诊断准确性、敏感性和特异性分别为94.4%（90%CI，90.8 - 97.0%）、94.4%（90%CI，88.7 - 97.8%）和94.4%（90%CI，88.7 - 97.8%）；使用ELISA时，分别为94.4%（90%CI，90.8 - 97.0%）、88.9%（90%CI，81.9 - 93.8%）和100%（90%CI，96.0 - 100%）。两种检测方法之间的一致性率很高（κ = 0.8444）。