Chagas IgG ELISA Kit (Trypanosoma Cruzi)

Full Name: Chagas IgG ELISA Kit (Trypanosoma Cruzi)
Reactivity: Human
Sample Type: Plasma, Serum
Sensitivity: diagn. 99%

BACKGROUND

Chagas disease is known to occur predominately in the continental part of Latin America and it is a life threatening illness that is caused by the protozoan parasite known as Trypanosoma cruzi (T. cruzi). It is estimated that around 6-7 million people worldwide are infected by this parasite, it is mainly vector borne transmitted by either contact with urine or faeces of triatomine bugs.

The Chagas disease is presents itself in 2 phases. The initial acute phase (lasts two months). Where there is a high number of parasites which are circulating in the blood but the symptoms are often absent or mild and also non-specific. The second chronic phase, where the parasite is located in the digestive muscles and heart. This leads to cardiac disorders, digestive disorders (typically enlarged oesophagus and colon), neurological and many other mixed alterations.

INTENDED USE

Human Chagas IgG ELISA kit can be used for analysing in-vitro concentrations of IgG antibodies to Chagas (Chagas IgG, Trypanosoma cruzi IgG) in human serum and plasma samples. This assay has a minimum analytical sensitivity limit to a diagn. 99%.

CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

• Chagas Coated Microplate.
• Sample Diluent.
• Washing Buffer (20x conc.).
• Protein A Conjugate.
• TMB Substrate Solution.
• Positive Control.
• Cut-off Control.
• Negative Control.

SENSITIVITY

The minimum detection sensitivity level of human IgG antibodies against Trypanosoma cruzi (T. cruzi, Chagas) using current Chagas IgG ELISA kit was diagn. 99%. The dynamic range for this assay was to a specific cut-off point.

ASSAY CHARACTERSTICS

– Cut-off: 10 U
– Positive: > 11 U
– Equivocal 9 – 11 U
– Negative: < 9 U
– Diagnostic Specificity: 100%
– Diagnostic Sensitivity: 100%
– Interferences: Interferences with hemolytic, lipemic or icteric samples are not observed up to a concentration of 10 mg/mL hemoglobin, 5 mg/mL triglycerides and 0.5 mg/mL bilirubin.
– Cross Reactivity: Cross reaction of the antigens with antibodies against Leishmania, Malaria, Trypanosoma brucei cannot be excluded.

REFERENCES

1. IgG subclass reactivity to Trypanosoma cruzi in chronic chagasic patients. Arch Cardiol Mex. (2001) 71 (3): 199-205. Hernández-Becerril N., et al.
2. Dried blood as an alternative to plasma or serum for Trypanosoma cruzi-IgG detection in screening programs. Clin Vaccine Immunol. (2013) 20 (8): 1197-202. Holguín A., et al.
3. [Preliminary evaluation of the commercial kit Chagas (Trypanosoma cruzi) IgG-ELISA ® in Colombian individuals]. Biomedica. (2014) 34 (2): 228-36. Spanish. Llano M., et al.
4. The use of IgG antibodies in conventional and non-conventional immunodiagnostic tests for early prognosis after treatment of Chagas disease. J Immunol Methods. (2011) 370 (1-2): 24-34. Wendling A.P., et al.
5. In-house ELISA method to analyze anti-Trypanosoma cruzi IgG reactivity for differential diagnosis and evaluation of Chagas disease morbidity. Rev Soc Bras Med Trop. (2012) 45 (1): 35-44. Santos L da S., et al.

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