Dataset Information

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.

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.

SUBMITTER: Tamarozzi F

PROVIDER: S-EPMC7911993 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Tamarozzi Francesca F Longoni Silvia Stefania SS Vola Ambra A Degani Monica M Tais Stefano S Rizzi Eleonora E Prato Marco M Scarso Salvatore S Silva Ronaldo R Brunetti Enrico E Bisoffi Zeno Z Perandin Francesca F

Diagnostics (Basel, Switzerland) 20210125 2

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 (<i>n</i> = 45 "liquid" content stages, <i>n</i> = 25 "solid" content stages) and non-CE focal liver ...[more]

PMID: 33503986

Similar Datasets

Project description:BackgroundThe global tuberculosis epidemic results in nearly 2 million deaths and 9 million new cases of the disease a year. The vast majority of tuberculosis patients live in developing countries, where the diagnosis of tuberculosis relies on the identification of acid-fast bacilli on unprocessed sputum smears using conventional light microscopy. Microscopy has high specificity in tuberculosis-endemic countries, but modest sensitivity which varies among laboratories (range 20% to 80%). Moreover, the sensitivity is poor for paucibacillary disease (e.g., pediatric and HIV-associated tuberculosis). Thus, the development of rapid and accurate new diagnostic tools is imperative. Immune-based tests are potentially suitable for use in low-income countries as some test formats can be performed at the point of care without laboratory equipment. Currently, dozens of distinct commercial antibody detection tests are sold in developing countries. The question is "do they work?"Methods and findingsWe conducted a systematic review to assess the accuracy of commercial antibody detection tests for the diagnosis of pulmonary tuberculosis. Studies from all countries using culture and/or microscopy smear for confirmation of pulmonary tuberculosis were eligible. Studies with fewer than 50 participants (25 patients and 25 control participants) were excluded. In a comprehensive search, we identified 68 studies. The results demonstrate that (1) overall, commercial tests vary widely in performance; (2) sensitivity is higher in smear-positive than smear-negative samples; (3) in studies of smear-positive patients, Anda-TB IgG by enzyme-linked immunosorbent assay shows limited sensitivity (range 63% to 85%) and inconsistent specificity (range 73% to 100%); (4) specificity is higher in healthy volunteers than in patients in whom tuberculosis disease is initially suspected and subsequently ruled out; and (5) there are insufficient data to determine the accuracy of most commercial tests in smear microscopy-negative patients, as well as their performance in children or persons with HIV infection.ConclusionsNone of the commercial tests evaluated perform well enough to replace sputum smear microscopy. Thus, these tests have little or no role in the diagnosis of pulmonary tuberculosis. Lack of methodological rigor in these studies was identified as a concern. It will be important to review the basic science literature evaluating serological tests for the diagnosis of pulmonary tuberculosis to determine whether useful antigens have been described but their potential has not been fully exploited. Activities leading to the discovery of new antigens with immunodiagnostic potential need to be intensified.

Project description:BackgroundSerological (antibody detection) tests for tuberculosis (TB) are widely used in developing countries. As part of a World Health Organization policy process, we performed an updated systematic review to assess the diagnostic accuracy of commercial serological tests for pulmonary and extrapulmonary TB with a focus on the relevance of these tests in low- and middle-income countries.Methods and findingsWe used methods recommended by the Cochrane Collaboration and GRADE approach for rating quality of evidence. In a previous review, we searched multiple databases for papers published from 1 January 1990 to 30 May 2006, and in this update, we add additional papers published from that period until 29 June 2010. We prespecified subgroups to address heterogeneity and summarized test performance using bivariate random effects meta-analysis. For pulmonary TB, we included 67 studies (48% from low- and middle-income countries) with 5,147 participants. For all tests, estimates were variable for sensitivity (0% to 100%) and specificity (31% to 100%). For anda-TB IgG, the only test with enough studies for meta-analysis, pooled sensitivity was 76% (95% CI 63%-87%) in smear-positive (seven studies) and 59% (95% CI 10%-96%) in smear-negative (four studies) patients; pooled specificities were 92% (95% CI 74%-98%) and 91% (95% CI 79%-96%), respectively. Compared with ELISA (pooled sensitivity 60% [95% CI 6%-65%]; pooled specificity 98% [95% CI 96%-99%]), immunochromatographic tests yielded lower pooled sensitivity (53%, 95% CI 42%-64%) and comparable pooled specificity (98%, 95% CI 94%-99%). For extrapulmonary TB, we included 25 studies (40% from low- and middle-income countries) with 1,809 participants. For all tests, estimates were variable for sensitivity (0% to 100%) and specificity (59% to 100%). Overall, quality of evidence was graded very low for studies of pulmonary and extrapulmonary TB.ConclusionsDespite expansion of the literature since 2006, commercial serological tests continue to produce inconsistent and imprecise estimates of sensitivity and specificity. Quality of evidence remains very low. These data informed a recently published World Health Organization policy statement against serological tests. Please see later in the article for the Editors' Summary.

Dataset Information

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.

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets