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FDA Clears First Point of Care Rapid Diagnostic Test Kit for Chagas Disease

InBios announced today that it received 510K Clearance from the FDA for its Chagas Detect Plus Rapid Test Kit (CDP). The product is a rapid immunochromatographic strip assay for the qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood matrices (venous and capillary (finger prick) whole blood). CDP is a non-invasive diagnostic test for use in a primary care setting by personnel trained to obtain whole blood or serum samples. Reactive test results will be presumptive evidence of infection with T. cruzi.

This simple two-step rapid diagnostic test is offered in a convenient cassette format, and results can be obtained in 20 minutes. In several clinical studies, the CDP demonstrated greater than 95% sensitivity and specificity in both endemic and non-endemic populations. The kit can be stored at room temperature for up to 24 months.

This is the first point-of-care diagnostic test available in the United States for Chagas. Primary care settings now have a highly sensitive and specific reliable test to detect Chagas in minutes. The kit is also CE marked and available internationally.

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. The CDP utilizes InBios’ proprietary multi-epitope recombinant antigen target in combination with a proprietary lateral flow system. The assay was developed in part through funding from the National Institutes of Health and in collaboration with the Infectious Disease Research Institute (Seattle, WA).”

About Chagas Disease:

In the United States, Chagas disease is considered one of the neglected parasitic infections, a group of five parasitic diseases that have been targeted by CDC for public health action. It is reportable in at least four states: Arkansas, Arizona, Texas and Tennessee.
Chagas disease is caused by the parasite Trypanosoma cruzi, which is transmitted to animals and people mostly by contact with feces or urine of triatomine bugs, known as 'kissing bugs”.

T. cruzi can also be transmitted by:

  • consumption of food contaminated with T. cruzi
  • blood transfusion from infected donors;
  • the passage from an infected mother to her newborn during pregnancy or childbirth;
  • organ transplants using organs from infected donors; and
  • laboratory accidents.

About six to seven million people worldwide are infected, mostly in Latin America. It has been increasingly detected in the United States of America, Canada, and many European and some Western Pacific countries. This is due mainly to population mobility between Latin America and the rest of the world.

Signs, Symptoms and Complications:

Chagas disease has an acute and a chronic phase. If untreated, infection is lifelong.
Trypanosoma cruzi infection is curable if treatment is initiated soon after infection.

The initial, acute phase lasts for about two months after infection. During the acute phase, a high number of parasites circulate in the blood, but in most cases, symptoms are absent or mild. In less than 50% of people bitten by a triatomine bug, characteristic first visible signs can be a skin lesion or a purplish swelling of the lids of one eye. Additionally, they can present fever, headache, enlarged lymph glands, pallor, muscle pain, difficulty in breathing, swelling, and abdominal or chest pain.

During the chronic phase, the parasites are hidden mainly in the heart and digestive muscles. Up to 30% of patients suffer from cardiac disorders and up to 10% suffer from digestive (typically enlargement of the esophagus or colon), neurological or mixed alterations. In later years the infection can lead to sudden death or heart failure.

In people who have suppressed immune systems (for example, due to AIDS or chemotherapy), Chagas disease can reactivate with parasites found in the circulating blood. This occurrence can potentially cause severe disease.

About InBios International, Inc.

InBios International, Inc., located in Seattle, WA, USA, develops and manufactures high-quality proprietary diagnostic tests for infectious diseases. The facility is FDA registered, USDA licensed and ISO 13485:2003 Certified. InBios develops and markets a comprehensive range of diagnostic products affecting global public health including the only emergency use authorized commercial Zika IgM ELISA in the United States. InBios also offers FDA cleared ELISA kits for dengue and West Nile and rapid test kits for Visceral and Cutaneous Leishmaniasis. The company offers several CE marked products internationally including Chikungunya ELISA kits. All products are manufactured in the USA.

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