POC Test for Chagas Disease Available in US

As Chagas disease becomes more prevalent in the United States, the recent 510(k)-clearance by the U.S. Food & Drug Administration (FDA) marks the first point-of-care (POC) diagnostic test for Chagas disease available in the US.

A fusion antigen developed and patented by Infectious Disease Research Institute (IDRI) is part of this test – Chagas Detect Plus Rapid Test Kit (CDP) – created by InBios. CDP is a non-invasive diagnostic test for use in a primary care setting by personnel trained to obtain whole blood or serum samples. The rapid 2-step test is easy to use and results can be obtained in 20 minutes. In several clinical studies, CDP demonstrated over 95% sensitively and specificity in both endemic and non-endemic populations.

Estela Raychaudhuri, president of InBios, said, “We are excited to bring this long-awaited, fast, and affordable point-of-care Chagas test to the US market, developed in collaboration with the IDRI.”

Transmission of Chagas disease, caused by the parasite Trypanosoma cruzi, most often takes place in Latin America via an infected vector insect (in the Reduviidae family of insects). But it can also occur via blood transfers and has been globalized by vector-independent transmission. Although not endemic in the US, conservative estimates are that Chagas disease-related US healthcare costs are in excess of USD 118 million annually. Most predictions are that about 300,000 symptomatic cases exist in the U.S., with highest concentrations being in California, Texas, Florida, New York, and an additional 7 states.

Given the possibility of transmission by blood transfusion, blood and tissue products, national screening of the blood supply was instituted in the US in 2007. Now, the new assay is available in the US to detect Chagas disease infection in individuals.

“At IDRI, our goal is to develop products that are useful for diseases that are prevalent in the developing world, but more often we are seeing these diseases – like Chagas – become a threat in the developed world because of travel or vector-independent transmission, such as blood transfers,” said Steve Reed, PhD, president, CEO & founder of IDRI, “Rapid diagnosis is a key step in stopping infectious disease. We’re pleased to play a key role in getting this diagnostic to people who might be affected.”

CDP is useful for diagnosis when used in conjunction with other serological and clinical information. Definitive diagnosis of an acute phase infection (including acute congenital infection) must be made by alternative methods. This test is not intended for use on cord blood or for screening blood or plasma donors.