IVD Antibody Development Services for Chagas

With the rapid development of new biotechnologies, numerous antibodies (e.g., monoclonal, polyclonal, recombinant antibodies) are being developed and used for the diagnosis of diseases and infections. At Creative Biolabs, you can find the most comprehensive first-rate in vitro diagnostic (IVD) antibody development services for diversified diagnostic applications. Particularly, we provide custom development, manufacture, and commercial licensing of high-quality antibodies for the diagnosis of Chagas.

Introduction of Chagas Disease

Chagas disease is an anthropozoonosis caused by the hemoflagellate protozoan Trypanosoma cruzi, which was identified more than 100 years ago. Chagas disease has two successive phases: an acute phase and a chronic phase. Most acute phases are asymptomatic or have non-specific symptoms. The acute phase usually resolves spontaneously after which time patients remain chronically infected if untreated. Most people never develop symptoms but some may progress to clinical forms of the disease (cardiac, digestive and/or neurological), which can be life-threatening if left undiagnosed and untreated.

Fig.1 Vector-borne transmission and life cycle of T. cruzi. (Jr, A. R., 2015)

Laboratory Diagnosis of Chagas

The laboratory diagnosis of the Chagas disease mainly includes parasitological methods (e.g., microscopy, PCR) and serological testing. During the acute phase, diagnosis is made by detection of the parasite in the blood (parasitological methods), while during the chronic phase, diagnosis is made via the detection of antibodies against T. cruzi (serological techniques).

• Parasitological Methods – Traditional methods for direct detection of T. cruzi is made by direct microscopic visualization of a simple fresh blood examination or Giemsa-stained thin and thick blood smears. More recently, indirect methods such as PCR are developed, which are more sensitive and have proven to be very useful in the diagnosis of mother-to-child transmission.
• Serological Testing – In the chronic phase of the disease, parasitemia is low and intermittent, thus making direct parasitological and PCR-based diagnostic methods unreliable. Diagnosis of chronic infection, therefore, relies on serological testing through detection of IgG antibodies against T. cruzi. These tests are based on whole parasite antigens and purified extracts (conventional tests) and on recombinant antigens and synthetic tests (non-traditional tests). The most common tests are Indirect Immunofluorescence Assay (IFA), indirect haemagglutination (IHA), and Enzyme-Linked Immunosorbent Assay (ELISA). At least two serological assays with different antigens should be used to confirm a positive result.

Fig.2 Photomicrograph of Giemsa-stained T. cruzi.

• Rapid Diagnosis Tests (RDTs) – Serological testing is sensitive but requires qualified staff, specific equipment, and infrastructure, which is either unaffordable or unavailable in most regions where the disease is endemic. Thus, various RDTs are developed for either qualitative or semi-quantitative detection of T. cruzi infection. These tests rely on different test principles, such as immunochromatography, particle agglutination, immunofiltration or immunodot. These tests are not sufficiently sensitive to be used as first-line diagnostic tools, but they are good options for patients who have difficulty accessing health-care facilities or whenever large-scale screening is needed.

Antibody-based diagnostic tools are widely used to help clinicians to diagnose and assess the progression of different diseases. As an IVD antibody specialist, Creative Biolabs offers a full range of IVD antibody development services for different applications, such as lateral flow and ELISA. With abundant experience and advanced technology, we can provide antibodies that have the sensitivity and consistency to provide optimal performance in the immunoassays. Contact us to discuss your requirements and experience the great value of our expert services.

Reference

1. Jr, A. R., (2015). “Chagas Disease. Neglected Tropical Diseases” - Latin America and the Caribbean.

For Research Use Only.