无参考标准感染诊断测试的评估：潜类分析的应用。

Evaluating Diagnostic Tests for Infection Without a Reference Standard: Use of Latent Class Analysis.

机构信息

Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.

Laboratory for Development and Evaluation Center, The Catholic University of Korea, Seoul, Korea.

出版信息

Ann Lab Med. 2020 Jan;40(1):68-71. doi: 10.3343/alm.2020.40.1.68.

DOI:10.3343/alm.2020.40.1.68

PMID:31432642

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6713662/

Abstract

Evaluation of diagnostic tests requires reference standards, which are often unavailable. Latent class analysis (LCA) can be used to evaluate diagnostic tests without reference standards, using a combination of observed and estimated results. Conditionally independent diagnostic tests for infection are required. We used LCA to construct a reference standard and evaluate the capability of non-invasive tests (stool antigen test and serum antibody test) to diagnose infection compared with the conventional method, where histology is the reference standard. A total of 96 healthy subjects with endoscopy histology results were enrolled from January to July 2016. Sensitivity and specificity were determined for the LCA approach (i.e., using a combination of three tests as the reference standard) and the conventional method. When LCA was used, sensitivity and specificity were 83.8% and 99.4% for histology, 80.0% and 81.9% for the stool antigen test, and 63.6% and 89.3% for the serum antibody test, respectively. When the conventional method was used, sensitivity and specificity were 75.8% and 71.1% for the stool antigen test and 77.7% and 60.7% for the serum antibody test, respectively. LCA can be applied to evaluate diagnostic tests that lack a reference standard.

摘要

诊断测试的评估需要参考标准，但参考标准往往不可用。潜在类别分析（LCA）可以在没有参考标准的情况下使用，通过结合观察到的和估计的结果来评估诊断测试。需要进行独立的条件诊断测试来检测感染。我们使用 LCA 来构建参考标准，并评估非侵入性测试（粪便抗原测试和血清抗体测试）与传统方法（以组织学为参考标准）相比诊断感染的能力。2016 年 1 月至 7 月期间，共纳入了 96 名内镜组织学结果正常的健康受试者。确定了 LCA 方法（即，使用三种测试的组合作为参考标准）和传统方法的敏感性和特异性。当使用 LCA 时，组织学的敏感性和特异性分别为 83.8%和 99.4%，粪便抗原检测的敏感性和特异性分别为 80.0%和 81.9%，血清抗体检测的敏感性和特异性分别为 63.6%和 89.3%。当使用传统方法时，粪便抗原检测的敏感性和特异性分别为 75.8%和 71.1%，血清抗体检测的敏感性和特异性分别为 77.7%和 60.7%。LCA 可用于评估缺乏参考标准的诊断测试。