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KMID : 1100720200400010068
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Annals of Laboratory Medicine
2020 Volume.40 No. 1 p.68 ~ p.71
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Evaluating Diagnostic Tests for Helicobacter pylori Infection Without a Reference Standard: Use of Latent Class Analysis
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Jekarl Dong-Wook
Choi Hyun-Yu
Kim Ji-Yeon
Lee Seung-Ok
Gweon Tae-Geun
Lee Hae-Kyung
Kim Yong-Goo
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Abstract
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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 Helicobacter pylori 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 H. pylori 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.
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KEYWORD
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Helicobacter pylori, Latent class analysis, Stool antigen test, Reference standard, Serum antibody test, Diagnosis
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