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DiagnosticsDiagnostics
  • Article
  • Open Access

25 January 2021

10 Pages

Evaluation of Nine Commercial Serological Tests for the Diagnosis of Human Hepatic Cyst Echinococcosis and the Differential Diagnosis with Other Focal Liver Lesions: A Diagnostic Accuracy Study

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1
Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Verona, Italy
2
Department of Medical Sciences and Infectious Diseases, IRCCS San Matteo Hospital Foundation, 27100 Pavia, Italy
3
Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy
4
Department of Diagnostics and Public Health, University of Verona, 37129 Verona, Italy

Abstract

The differential diagnosis of hepatic cystic echinococcosis (CE) may be challenging. When imaging is insufficient, serology can be applied, but no consensus diagnostic algorithm exists. We evaluated the performances of nine serological tests commercialized in Europe for the diagnosis of “echinococcosis”. We performed a diagnostic accuracy study using a panel of sera from patients with hepatic CE (n = 45 “liquid” content stages, n = 25 “solid” content stages) and non-CE focal liver lesions (n = 54 with “liquid” content, n = 11 with “solid” content). The diagnosis and staging of CE were based on ultrasound (gold standard). Nine commercial seroassays (5 ELISA, 2 WB, 1 Chemiluminescence Immunoassay [CLIA] and 1 Immunochromatographic test [ICT]) were the index tests. Sensitivity (Se) ranged from 43 to 94% and from 31 to 87%, and specificity (Sp) from 68 to 100% and from 94 to 100%, when borderline results were considered positive or negative, respectively. Three seroassays (2 ELISA, 1 WB) were excluded from further analyses due to poor performances. When tests were combined, Sp was 98–100%. The best results were obtained using the WB-LDBIO alone (Se 83%) or as a third test after two non-WB tests (Se 67–86%). A validated WB or two non-WB tests, read with stringent criteria (borderline = negative and considered positive only if concordant positive), possibly confirmed by the WB, appear sensible approaches.

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