Diagnostic Test Accuracy of Commercial Tests for Detection of Shiga Toxin–Producing Escherichia coli: A Systematic Review and Meta-Analysis

Abstract

Background Rapid detection of Shiga toxin–producing Escherichia coli (STEC) enables appropriate monitoring and treatment. We synthesized available evidence to compare the performance of enzyme immunoassay (EIA) and PCR tests for the detection of STEC. Methods We searched published and gray literature for studies of STEC EIA and/or PCR diagnostic test accuracy relative to reference standards including at least one nucleic acid amplification test. Two reviewers independently screened studies, extracted data, and assessed quality with the second version of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Bivariate random effects models were used to meta-analyze the clinical sensitivity and specificity of commercial EIA and PCR STEC diagnostic tests, and summary receiver operator characteristic curves were constructed. We evaluated the certainty of evidence with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results We identified 43 articles reflecting 25 260 specimens. Meta-analysis of EIA and PCR accuracy included 25 and 22 articles, respectively. STEC EIA pooled sensitivity and specificity were 0.681 (95% CI, 0.571–0.773; very low certainty of evidence) and 1.00 (95% CI, 0.998–1.00; moderate certainty of evidence), respectively. STEC PCR pooled sensitivity and specificity were 1.00 (95% CI, 0.904–1.00; low certainty of evidence) and 0.999 (95% CI, 0.997–0.999; low certainty of evidence), respectively. Certainty of evidence was downgraded because of high risk of bias. Conclusions PCR tests to identify the presence of STEC are more sensitive than EIA tests, with no meaningful loss of specificity. However, given the low certainty of evidence, our results may overestimate the difference in performance.

Primary Human Renal Proximal Tubular Epithelial Cells (pHRPTEpiCs): Shiga Toxin (Stx) Glycosphingolipid Receptors, Stx Susceptibility, and Interaction with Membrane Microdomains

“…Ruminant animals are deemed to serve as a critical environmental reservoir of STEC [ 9 , 10 ]. The rapid detection of STEC at genetic and phenotypic level enables appropriate monitoring, assessment of the relative virulence of the strains, and treatment of STEC infections [ 11 , 12 ]. Protection can be provided either by inhibiting the binding of Stx toward the cell surface using therapeutics based on chemical analogs of the Stx receptor [ 13 , 14 , 15 ], interfering of small-molecule inhibitors with any of the subsequent steps upon retrograde trafficking that act at the endosome/Golgi interface required for the toxin’s intracellular destructive effects [ 16 , 17 , 18 ], or blocking of transcriptional and translational inhibitors that may be of value in treating EHEC infections [ 19 ].…”

Clinically Important Toxins in Bacterial Infection: Utility of Laboratory Detection

“…Broadly, they include enzyme immunoassays (EIAs), which detect Stx1 and Stx2 antigens, and PCR, which detects stx1 and stx2 . A recent meta-analysis of 43 articles and over 25,000 specimens evaluated the performance characteristics of EIA and PCR [ 33 ]. The STEC EIA pooled sensitivity and specificity were 0.68 and 1.00, respectively, whereas PCR demonstrated improved sensitivity (1.00) and similar specificity (0.99).…”