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Chagas (Trypanosoma cruzi)

We are constantly developing and improving our products in order to meet our costumer's needs. As a result we present our new NovaLisa® Chagas (Trypanosoma cruzi) IgG ELISA where we were able to increase both the sensitivity (99%) and specificity (99%).

Trypanosoma cruzi is the causative agent of the Chagas' disease (American trypanosomosis), which is a parasitic disease that affects about 7 to 8 million people worldwide, mostly in Latin America. However, in the past decades, it has been increasingly detected in Canada, USA and many European and Western Pacific countries.

It is caused by the flagellate protozoan parasite Trypanosoma cruzi. Chagas? disease is transmitted to animals and humans by blood-sucking triatomine insects (?kissing bugs?) in the family Reduviidae. In the intestine of the vector, the parasites convert into intensively multiplying epimastigote stages, and later into trypomastigote forms that are released with the feces when the triatomine insect takes a blood meal.

These insects become infected when they feed on the blood of animals that serve as reservoirs for the parasite. Wild and domestic mammals including humans, dogs, cats, rodents, opossums, armadillos and bats are known reservoirs of Trypanosoma cruzi. The natural habitats of reduviid bugs are nests, animal dens, and other places frequented by vertebrate animals whose blood provides their sustenance. Some species of Reduviidae have invaded domestic habitats. During the day, triatomine insects hide in crevices in the walls and roofs of poorly constructed housing in rural areas. The bugs emerge at night, when the inhabitants are sleeping.

The trypomastigotes enter the human host through the bite wound or through intact mucosal membranes, such as the conjunctiva. Once in the human body, the parasites are phagocytosed by macrophages or invade other cells, mainly muscle cells (heart, skeletal, or smooth musculature) as well as neurological cells. Within the cells, they differentiate into amastigotes and multiply. Cells filled with up to 500 parasites are called ?pseudocysts?. After 5 days the parasites convert back to trypomastigotes and return to the bloodstream.

Chagas? disease has an acute phase and a chronic latent stage. The acute phase, which follows an incubation period of 7-30 days, may have no or very mild symptoms. Symptoms include: fever, edema, lymph node swelling, hepatomegaly, splenomegaly, myocarditis and less frequently, meningoencephalitis. The most recognized symptoms of acute Chagas infection are the Romaña sign (conjunctivitis with eyelid edema) or the chagoma (local, inflammatory dermal reaction).

Beginning about 8-10 weeks after the acute phase the infection turns to an inapparent phase. Clinical manifestations of the chronic phase, often starting 10-20 years after the acute phase, are cardiopathy, digestive tract damage and neuropathies.

Besides from vector-borne Chagas? disease, Trypanosoma cruzi can also be transmitted through blood transfusions, organ transplants, transplacentally, or contaminated food and drink.

Infections may be diagnosed by:

Microscopy: Determination of trypanosomes in the acute phase in blood cultures.

Serology: Determination of specific antibodies based on the ELISA-technique

NovaLisa® Chagas ELISA / NovaLisa® Chagas IgG ELISA:

The NovaLisa® Chagas ELISA and NovaLisa® IgG ELISA are intended for the qualitative determination of antibodies against Trypanosoma cruzi in human serum or plasma (citrate).

Antigens:

Recombinant Trypanosoma cruzi antigens (TcF) 

 

Specific performance characteristics Chagas (TRYP0570):

Intraassay

Interassay

Sensitivity %

Specificity %

n

Mean

CV%

n

Mean

CV%

Chagas ELISA
(TRYP0570)

24

24

1.352

0.786

2.4

3.8

12

12

32.1

27.3

3.5

4.3

> 99

> 99

 

Specific performance characteristics Chagas IgG (CHAG0560):

Intraassay

Interassay

Sensitivity %

Specificity %

n

Mean

CV%

n

Mean

CV%

Chagas ELISA
(CHAG0560)

15

0.61

7.8

4

7

5.7

13.5

10.2

7.7

> 99

> 99

 

Comparison Table

Novalisa® Chagas (TRYP0570)

Old

New

Diagnostic Sensitivity

100%

> 99%

Diagnostic Specificity

98.9%

> 99%

NovaLisa® Chagas (Trypanosoma cruzi) IgG (CHAG0560)

Old

New

Diagnostic Sensitivity

99%

> 99%

Diagnostic Specificity

99%

> 99%

 

External Study

Objective: To evaluate the discriminatory efficiency of the commercial kit NovaLisa® Chagas (Trypanosoma cruzi) IgG-ELISA in a group of Colombian individuals, using the indirect immunofluorescence antibody testing (IFAT) and enzyme immunoassay (ELISA) tests as references.

Materials and methods: 78 samples from chronic chagasic patients (36 asymptomatic and 42 symptomatic) and 21 healthy controls were included. Seventeen samples from non-infected people with Chagas disease epidemiological risk, 7 with leishmaniasis or 9 with non-chagasic cardiomyopathy were also analyzed. Real time PCR was performed in 4 individuals whose results differed among tests.

 
Figure 1: Comparison of the medians OD values between the different groups in evaluated. The horizontal lines in the graphic represent the median of the OD values of the groups

Sanos = healthy patients;
SN con riesgo = negative patients with risk factor;
CD no infectados = patients with cardiopathy not infected;
Leishmania = patients positive for Leishmania
Asintomaticos = asymptomatic

Sintomaticos = symptomatic

Sensitivity = 96.15% (95% CI: 89.29% - 98.68%)
Specificity = 96.55% (95% CI: 82.82% - 99.39)
Agreement = 0.9074 (95% CI: 0.7181 to 1.097)

Please find the official publication at: http://www.revistabiomedica.org/index.php/biomedica/article/view/1580/2313

Order information:

ELISA

Number of Determinations

Product Number

Chagas ELISA

96

TRYP0570

Chagas
(Trypanosoma cruzi) IgG

96

CHAG0560

 

 

 

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