Evidence map›Paper›PMID 26086800›Full record

ArticlePloS one2015

Diagnosis of Leptospirosis: Comparison between Microscopic Agglutination Test, IgM-ELISA and IgM Rapid Immunochromatography Test.

Roshan Niloofa, Narmada Fernando, Nipun Lakshitha de Silva, Lilani Karunanayake, Hasith Wickramasinghe, Nandana Dikmadugoda, Gayani Premawansa, Rajitha Wickramasinghe, H Janaka de Silva, Sunil Premawansa and 2 more

Open access · goldAbstract readComparative Study
In one paragraph

Article in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 76 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 6 pooled it
8.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

76 citing papers in PubMed, 6 syntheses or guidelines pooled it, 166 citations in OpenAlex.

  1. Drivers of humanEpidemiology and infection · 2024
    Pooled it
  2. Pooled it
  3. Pooled it
  4. 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 · 2022
    Pooled it
  5. Pooled it
  6. 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 · 2019
    Pooled it
  7. Review
  8. Retrospective Molecular Detection and Characterization of PathogenicTropical medicine and infectious disease · 2026
    Article
  9. Review
  10. Laboratory Diagnosis of Leptospirosis.Methods in molecular biology (Clifton, N.J.) · 2026
    Review
  11. Review
  12. Article
  13. Human leptospirosis in the central division of Fiji: a retrospective epidemiological study.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2025
    Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Serologically Confirmed Human Leptospirosis in Colombia, 2015-2020.The American journal of tropical medicine and hygiene · 2024
    Article

16 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Roshan NiloofaInstitute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo, Colombo, Sri Lanka.
Narmada FernandoInstitute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo, Colombo, Sri Lanka.
Nipun Lakshitha de SilvaTropical Medicine Research Unit, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
Lilani KarunanayakeNational Reference Laboratory for Leptospira, Medical Research Institute, Colombo, Sri Lanka.
Hasith WickramasingheBase Hospital Homagama, Homagama, Sri Lanka.
Nandana DikmadugodaBase Hospital Homagama, Homagama, Sri Lanka.
Gayani PremawansaColombo North Teaching Hospital, Ragama, Sri Lanka.
Rajitha WickramasingheFaculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
H Janaka de SilvaFaculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
Sunil PremawansaFaculty of Science, University of Colombo, Colombo, Sri Lanka.
Senaka RajapakseTropical Medicine Research Unit, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
Shiroma HandunnettiInstitute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo, Colombo, Sri Lanka.
University of Colombo · LKSri Lanka Institute of Nanotechnology · LKUniversity of Kelaniya · LKColombo North Teaching Hospital · LKMedical Research Institute · LK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeptospirosis is diagnosed on clinical grounds, and confirmed by microscopic agglutination test (MAT). IgM-ELISA (Serion-Virion) and immunochromatography test (Leptocheck-WB) are two immunodiagnostic assays for leptospirosis. Their sensitivity, specificity and applicability in Sri Lanka have not been systematically evaluated.

methodsClinically diagnosed leptospirosis patients (n = 919) were recruited from three hospitals in the Western Province of Sri Lanka, during June 2012 to December 2013. MAT, IgM-ELISA and Leptocheck-WB were performed on all patient sera. MAT titer of ≥ 400 in single sample, four-fold rise or seroconversion ≥ 100 in paired samples were considered as positive for MAT. For diagnostic confirmation, MAT was performed during both acute and convalescent phases. Anti-leptospiral IgM ≥ 20 IU/ml and appearance of a band in the test window were considered as positive for IgM-ELISA and Leptocheck-WB test respectively. Patients with an alternative diagnosis (n = 31) were excluded. Data analysis was performed using two methods, i) considering MAT as reference standard and ii) using Bayesian latent class model analysis (BLCM) which considers each test as imperfect.

resultsMAT, IgM-ELISA and Leptocheck-WB positivity were 39.8%, 45.8% and 38.7% respectively during the acute phase. Acute-phase MAT had specificity and sensitivity of 95.7% and 55.3% respectively, when compared to overall MAT positivity. IgM-ELISA and Leptocheck-WB had similar diagnostic sensitivity when compared with acute-phase MAT as the gold standard, although IgM-ELISA showed higher specificity (84.5%) than Leptocheck-WB (73.3%). BLCM analysis showed that IgM-ELISA and Leptocheck-WB had similar sensitivities (86.0% and 87.4%), while acute-phase MAT had the lowest sensitivity (77.4%). However, acute-phase MAT had high specificity (97.6%), while IgM-ELISA and Leptocheck-WB showed similar but lower specificity (84.5% and 82.9%).

conclusionsBoth IgM-ELISA and Leptocheck-WB shows similar sensitivities and specificities. IgM-ELISA may be superior to MAT during the acute phase and suitable for early diagnosis of leptospirosis. Leptocheck-WB is suitable as a rapid immunodiagnostic screening test for resource limited settings.

Indexed as

AdolescentAdultAgedAged, 80 and overAgglutination TestsAntibodies, BacterialChromatography, AffinityEnzyme-Linked Immunosorbent AssayFemaleHumansImmunoglobulin MLeptospiraLeptospirosisMaleMiddle AgedReagent Kits, DiagnosticAntibodies, BacterialImmunoglobulin MReagent Kits, Diagnostic

Identifiers

PMID26086800
PMCPMC4472754
OpenAlexW1874879909

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.