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基于胶乳增强免疫比浊法的抗组织转谷氨酰胺酶抗体检测在乳糜泻中的应用。

Antibody detection by agglutination-PCR (ADAP) assays for the analysis of tissue transglutaminase autoantibodies in celiac disease.

机构信息

Department of Clinical Sciences Malmö, Lund University, Sweden.

Department of Clinical Sciences Malmö, Lund University, Sweden.

出版信息

J Immunol Methods. 2023 Jul;518:113502. doi: 10.1016/j.jim.2023.113502. Epub 2023 May 29.

DOI:10.1016/j.jim.2023.113502
PMID:37257686
Abstract

BACKGROUND & AIMS: Tissue transglutaminase autoantibodies (tTGA) are used as diagnostic markers of celiac disease. Different methods have been developed for the detection of tTGA of which enzyme-linked immunosorbent assays (ELISA), radiobinding assays (RBA) and electrochemiluminescence (ECL) assays are the most commonly used. Here we aimed to evaluate a novel antibody detection by agglutination-PCR (ADAP) assay for the detection of tTGA.

METHODS

Included were 126 children with untreated celiac disease (UCD), 64 disease controls (DC), 21 children with potential celiac disease (PCD), and 1501 children from the general population. Tissue TGA were determined using an automated ADAP assay platform and compared with two RBAs for the detection of IgA-tTG and IgG-tTG, respectively.

RESULTS

ADAP detected tTGA in 123/126 (97.6%) UCD children compared with 122/126 (96.8%) using RBA-IgA-tTG and RBA-IgG-tTG (p > 0.9999), respectively. Among DC, ADAP detected 5/64 (7.8%) children with tTGA compared with 4/64 (6.3%) with RBA-IgA-tTG (p > 0.9999) and 8/64 (12.5%) with RBA-IgG-tTG (p = 0.5600), respectively. Tissue TGAs were equally detected in children with PCD in both assays. In the general population, 4/1501 (0.3%) were tTGA positive using ADAP compared with 3/1501 (0.2%) for RBA-IgA-tTG and RBA-IgG-tTG (p > 0.9999), respectively. The area under the curves (AUCs) were 0.998 for ADAP, 0.994 for RBA-IgA-tTG, and 0.999 for RBA-IgG-tTG, respectively.

CONCLUSIONS

No difference in specificity and sensitivity of tTGA for the diagnosis of celiac disease was reported between ADAP and RBA. ADAP could be recommended as the first-line screening method of larger populations for celiac disease.

摘要

背景与目的

组织转谷氨酰胺酶自身抗体(tTGA)被用作乳糜泻的诊断标志物。已经开发出不同的方法来检测 tTGA,其中酶联免疫吸附测定(ELISA)、放射结合测定(RBA)和电化学发光(ECL)测定最为常用。在这里,我们旨在评估一种新的通过凝集-PCR(ADAP)检测法检测 tTGA 的方法。

方法

纳入了 126 例未经治疗的乳糜泻(UCD)患儿、64 例疾病对照组(DC)、21 例潜在乳糜泻患儿(PCD)和 1501 例一般人群患儿。使用自动化 ADAP 检测平台检测组织 TGA,并与两种 RBA 分别检测 IgA-tTG 和 IgG-tTG 进行比较。

结果

ADAP 在 123/126(97.6%)UCD 患儿中检测到 tTGA,而使用 RBA-IgA-tTG 和 RBA-IgG-tTG 分别在 122/126(96.8%)患儿中检测到(p>0.9999)。在 DC 中,ADAP 在 5/64(7.8%)患儿中检测到 tTGA,而 RBA-IgA-tTG 在 4/64(6.3%)患儿中(p>0.9999)和 RBA-IgG-tTG 在 8/64(12.5%)患儿中(p=0.5600)检测到 tTGA。两种检测方法均在 PCD 患儿中检测到组织 TGAs。在一般人群中,ADAP 在 4/1501(0.3%)患儿中检测到 tTGA,而 RBA-IgA-tTG 在 3/1501(0.2%)患儿中(p>0.9999)和 RBA-IgG-tTG 在 3/1501(0.2%)患儿中(p>0.9999)。ADAP 的曲线下面积(AUC)为 0.998,RBA-IgA-tTG 的 AUC 为 0.994,RBA-IgG-tTG 的 AUC 为 0.999。

结论

ADAP 和 RBA 检测 tTGA 对乳糜泻的诊断特异性和敏感性无差异。ADAP 可作为乳糜泻较大人群的一线筛查方法。

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