ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012
Fool's gold: Why imperfect reference tests are undermining the evaluation of novel diagnostics: a reevaluation of 5 diagnostic tests for leptospirosis.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 100 papers, 7 of them syntheses that pooled it.
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Who cites it
100 citing papers in PubMed, 7 syntheses or guidelines pooled it, 214 citations in OpenAlex.
- Accuracy of rapid lateral flow immunoassays for human leptospirosis diagnosis: A systematic review and meta-analysis.PLoS neglected tropical diseases · 2024Pooled it
- Diagnosis of human leptospirosis: systematic review and meta-analysis of the diagnostic accuracy of the Leptospira microscopic agglutination test, PCR targeting Lfb1, and IgM ELISA to Leptospira fainei serovar Hurstbridge.BMC infectious diseases · 2024Pooled it
- Rapid diagnostic test (Leptocheck-WB) for detection of acute leptospirosis: a meta-analysis of diagnostic accuracy.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2022Pooled it
- Nucleic acid and antigen detection tests for leptospirosis.The Cochrane database of systematic reviews · 2019Pooled it
- Diagnostic accuracy of leptospirosis whole-cell lateral flow assays: a systematic review and meta-analysis.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2019Pooled it
- A Systematic Review of the Mortality from Untreated Leptospirosis.PLoS neglected tropical diseases · 2015Pooled it
- Sensitivity of diagnostic tests for human soil-transmitted helminth infections: a meta-analysis in the absence of a true gold standard.International journal for parasitology · 2014Pooled it
- Subclinical Leptospiral Infections and Antibody Waning During Pregnancy: A Population-Based Cohort Study from Rural Sri Lanka.The American journal of tropical medicine and hygiene · 2026Article
- Molecular detection and genetic characterisation of a large flood-borne outbreak of human leptospirosis in Jakarta, Indonesia: A retrospective analysis of surveillance data.PLoS neglected tropical diseases · 2026Article
- Diagnosis of leptospirosis in animals: challenges and perspectives.Journal of clinical microbiology · 2026Review
- Retrospective Molecular Detection and Characterization of PathogenicTropical medicine and infectious disease · 2026Article
- Addressing the burden of leptospirosis in Africa.Tropical diseases, travel medicine and vaccines · 2025Review
- Leptospirosis.Nature reviews. Disease primers · 2025Review
- Seroprevalence and carrier status ofIranian journal of veterinary research · 2025Article
- Evaluation of Serological Tests for Different Disease Stages of Leptospirosis Infection in Humans.Tropical medicine and infectious disease · 2024Article
- Serologically Confirmed Human Leptospirosis in Colombia, 2015-2020.The American journal of tropical medicine and hygiene · 2024Article
- All that glitters is not gold: An interpretive framework for diagnostic test evaluation using Ascaris lumbricoides as a conceptual example.PLoS neglected tropical diseases · 2024Article
- Prediction of response to neoadjuvant chemo-immunotherapy in patients with esophageal squamous cell carcinoma by a rapid breath test.British journal of cancer · 2024Article
- Leptospiral uveitis- "Transition 'from epidemic to endemic form" difficulties in laboratory confirmations.Indian journal of ophthalmology · 2023Article
- Seroprevalence of leptospirosis among blood donors in an endemic area.Scientific reports · 2023Article
40 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 3 countries.
Funding
Abstract
backgroundWe observed that some patients with clinical leptospirosis supported by positive results of rapid tests were negative for leptospirosis on the basis of our diagnostic gold standard, which involves isolation of Leptospira species from blood culture and/or a positive result of a microscopic agglutination test (MAT). We hypothesized that our reference standard was imperfect and used statistical modeling to investigate this hypothesis.
methodsData for 1652 patients with suspected leptospirosis recruited during three observational studies and one randomized control trial that described the application of culture, MAT, immunofluorescence assay (IFA), lateral flow (LF) and/or PCR targeting the 16S rRNA gene were reevaluated using Bayesian latent class models and random-effects meta-analysis.
resultsThe estimated sensitivities of culture alone, MAT alone, and culture plus MAT (for which the result was considered positive if one or both tests had a positive result) were 10.5% (95% credible interval [CrI], 2.7%-27.5%), 49.8% (95% CrI, 37.6%-60.8%), and 55.5% (95% CrI, 42.9%-67.7%), respectively. These low sensitivities were present across all 4 studies. The estimated specificity of MAT alone (and of culture plus MAT) was 98.8% (95% CrI, 92.8%-100.0%). The estimated sensitivities and specificities of PCR (52.7% [95% CrI, 45.2%-60.6%] and 97.2% [95% CrI, 92.0%-99.8%], respectively), lateral flow test (85.6% [95% CrI, 77.5%-93.2%] and 96.2% [95% CrI, 87.7%-99.8%], respectively), and immunofluorescence assay (45.5% [95% CrI, 33.3%-60.9%] and 96.8% [95% CrI, 92.8%-99.8%], respectively) were considerably different from estimates in which culture plus MAT was considered a perfect gold standard test.
conclusionsOur findings show that culture plus MAT is an imperfect gold standard against which to compare alterative tests for the diagnosis of leptospirosis. Rapid point-of-care tests for this infection would bring an important improvement in patient care, but their future evaluation will require careful consideration of the reference test(s) used and the inclusion of appropriate statistical models.
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