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Leptospira IgM ELISA

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Catalog no.RE58941
Regulatory Status
EU: CE
Kit size
12 x 8
Method
ELISA
Incubation time
1 x 1h, 1 x 30min, 1 x 15min
Standard range
cut-off index
Specimen / Volumes
10µL serum, plasma
Substrate / isotope
TMB 450nm
instructions for usecertificateMSDS

Bacteria from rat urine

For the purpose of diagnosing leptospirosis, the most common zoonotic disease, IBL International now offers a new highly sensitive and specific ELISA for the detection of IgM and IgG antibodies :

  • Diagnostic sensitivity >99%; diagnostic specificity >96%
  • Indication: clinical suspicion of leptospirosis/Weil's disease
  • Detection of the immune response against all Leptospira serotypes
  • Qualitative results (positive, negative, cut-off control)
  • Adaptable to open-system ELISA analyzers

Leptospirosis is an acute to chronic zoonotic disease caused by pathogenic species of Leptospira. The sources of infection are rodents, mainly rats and mice. The animals excrete the pathogens in the urine. They can enter the human body through small cuts in the skin. The number of new cases worldwide is estimated at 300,000 to 500,000 cases. Major outbreaks have been observed in particular in the setting of flooding. In the industrialized nations, local outbreaks occur primarily in the context of recreational activities such as water sports or boat trips. Approximately 90% of patients have mild flu-like symptoms. The severe course of disease, also known as Weil's disease, is characterized by bleeding, renal failure, jaundice and fatal complications.

Pathogens can be recovered from blood cultures only in the first phase of the disease. The culture takes quite a long time as well, meaning that a successful antibiotic treatment cannot be instituted in a timely manner. For this reason, serological methods are increasingly used. The serological reference method is the microagglutination test, which, however, is time-consuming and carries a risk of infection because it employs live cultures. This accounts for the special significance of the ELISA method for the determination of specific antibodies, which can be detected within 5-7 days after the onset of clinical symptoms. The presence of specific IgM antibodies is conclusive for acute illness.

Evaluation of the diagnostic performance of Leptospira IgM ELISA

Method comparison of IBL International Leptospira IgM ELISA with the Leptospira IgM classic ELISA (Serion)

The comparison of 37 positive and negative sera resulted in an agreement of 96.7%.

Serion
positivenegative
IBL Internationalpositive51
negative 024
(Equivocal results were not included in the calculations)

Evaluation of the diagnostic performance of Leptospira IgG ELISA

Method comparison of IBL International Leptospira IgG ELISA with the Leptospira IgG classic ELISA (Serion)

The comparison of 45 positive and negative sera resulted in an agreement of 97.6%.

Serion
positivenegative
IBL Internationalpositive41
negative 037
(Equivocal results were not included in the calculations)

For concrete data please consult the Instruction for Use in the download box on the top right side.

Our Product Families

Our comprehensive immunoassay portfolio includes a number of specialty diagnostic immunoassays for endocrinology, immunology and autoimmunity, as well as for diagnosis of multiple infectious diseases. We are pioneers and market leaders in saliva diagnostics, with over 40 years of experience supplying a broad portfolio of luminescence- and ELISA-based tests, including our highly acclaimed HMGB1 and MuSK-Ab ELISAs.

And as experts in laboratory automation, we can support our customers with the protocols for open ELISA platforms, such as the Freedom EVOlyzer or Thunderbolt®.

All products are only available for sale to laboratory professionals and may not be available in all countries. Availability and regulatory status may vary across regions depending on local country-specific registration. Please always read and follow the instructions for use. 

All of our assays have been designed and manufactured to meet the highest global regulatory requirements and quality standards. Tecan is certified under ISO 9001:2015, ISO 13485:2016 and is audited by a notified body according to Medical Device Single Audit Program (MDSAP).

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This is who we are.

As part of the Tecan Group, we have a leading market position in diagnostics and research, with over 40 years of experience in the development, manufacture and supply of enzyme-, radiolabel- and luminescence-based immunoassays.

Our range of high-quality immunoassays is supported by a diverse portfolio of automated solutions, making us the perfect partner for you and your customers.

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At Tecan, we are driven to improve people’s lives and health.