Enzyme-linked immunosorbent assay to diagnose human leptospirosis: a meta-analysis of the published literature

Abstract

We report an evaluation of the accuracy of ELISA for the detection of Leptospira-specific antibodies in humans. Eighty-eight studies published in 35 articles met all inclusion criteria and were submitted to meta-analysis. Pooled sensitivity and specificity were 0·779 (95% CI 0·770-0·789) and 0·913 (95% CI 0·908-0·917), respectively, and the area under the curve was 0·964. Heterogeneity across studies was statistically significant, but none of the sources of heterogeneity (disease stage, antigen used, antibody detected) could fully explain this finding. Although the convalescent stage of disease was significantly associated with higher diagnostic accuracy, IgM ELISA was the best choice, regardless of the stage of disease. Negative ELISAs (IgG or IgM) applied in the acute phase do not rule out leptospirosis due to the possibility of false-negative results. In this case it is advisable to request a second blood sample or to apply a direct method for leptospiral DNA.

Risk factors for leptospirosis seropositivity in slaughterhouse workers in western Kenya

“…12 13 The immunoglobulin M (IgM) ELISA has improved sensitivity and specificity over the IgG ELISA for leptospirosis at all stages of disease. 12 Unlike other infectious diseases, the development of IgG antibodies in patients with leptospirosis is highly variable, which makes it unsuitable for use in diagnostics. 14 IgM antibodies specific for different serovars have been shown to persist for up to 6 years.…”

“…19 An IgM ELISA was preferred to an IgG ELISA because of improved sensitivity and specificity. 12 The ELISA was conducted as per the manufacturer's instructions as previously described. 19 20 Statistical analysis Design-based adjustment was implemented using the 'svydesign' procedure in the 'Survey' package (T Lumley.…”

Evaluación de un panel reducido de cepas de leptospiras para el diagnóstico en humanos por microaglutinación (MAT)

“…Lo anterior deja ver que la selección de muestras en la primera etapa fue buena, a pesar de haber estado basada en estimaciones de años anteriores, ya que los resultados son comparables con los de la segunda etapa, en la cual, además se seleccionaron todas las muestras positivas a ELISA IgM, que es más sensible que el TR. 21,22 Los resultados obtenidos en la primera etapa indican que los serovares más prevalentes de Argentina están representados en el panel reducido utilizado para el diagnóstico de leptospirosis en el país, lo que a su vez coincide con los últimos hallazgos de este mismo grupo de trabajo -algunos no publicados-en los cuales se observó que, tanto los aislamientos obtenidos de muestras humanas en el INER 23 como las muestras de ADN tipificadas, 24,25 están representados en el panel reducido de la MAT.…”

Evaluation of different serological assays for early diagnosis of leptospirosis in Martinique (French West Indies)

“…MAT titer of ≥1:400 for a single or paired serum samples, as well as four-fold (or greater) increase in titers between acute and convalescent samples, are considered as positive for MAT. Most published studies comparing serological assays for the diagnosis of acute leptospirosis used MAT as gold standard; however, there are few reports arguing the capability of MAT being the reference method [18]. Indeed, in spite of its high specificity, MAT lacks sensitivity, especially during the acute phase of leptospirosis, when antibiotics are expected to have the greatest benefit [19].…”