FIND and EIKEN CHEMICAL CO. LTD. expand collaboration to Chagas disease

Geneva, Switzerland & Tokyo, Japan – 14 January 2014 – FIND, Foundation for Innovative New Diagnostics, a Geneva-based non-profit organization, and EIKEN CHEMICAL Co., Ltd., a Japan-based manufacturer of clinical diagnostics, today announced an agreement on financial support by FIND for development of a diagnostic test for congenital Chagas disease. This is an expansion of their collaboration in the development of rapid and simple molecular tests for diseases of poverty, for use in decentralized settings. It adds to their ongoing joint efforts in the development of a LAMP-based platform for tuberculosis (TB), malaria, sleeping sickness and leishmaniasis.

Chagas disease

Chagas disease is caused by infection with the parasite Trypanosoma cruzi and affects 8-11 million people worldwide. This neglected disease is endemic in Mexico, Central and South America, and most infections are transmitted by triatomine insect (kissing bug) vectors. However, infection is also acquired congenitally or through blood transfusion, organ transplantation, consumption of triatomine-contaminated food or drinks, or laboratory accidents. When Chagas disease is detected early, treatment is highly effective; however, acute infection is often subclinical, and most persons are unaware of their infection. If left untreated, the infection is lifelong. The majority of persons with chronic infection remain without signs or symptoms, but 20%–30% eventually develop clinical disease, most commonly, cardiomyopathy. Migration from endemic areas has led to hundreds of thousands of persons with chronic Chagas disease in many parts of the world, including women of reproductive age who risk transmitting the infection to their children.

Diagnosis of Chagas in newborns

It is recommended that all babies born from infected mothers be tested for Chagas disease within the first few weeks after birth. This is critical because infected newborns treated within the first few months of life can be cured with an almost 100% success rate, whereas delay is associated with considerable morbidity and progression to the chronic form of the disease.

During the first few weeks after birth, the number of parasites in the blood of infected babies is usually very low. In such situations, the widely used parasite-based detection of the disease by microscopy may not be sensitive or reliable enough. Yet serological diagnosis is not recommended before 9 months of age due to transplacental transfer of maternal antibodies. Studies using polymerase chain reaction (PCR) suggest that when performed early, molecular methods can detect almost all cases within the first weeks of life. However, the technical complexity of PCR limits its use, primarily to research settings.

Use of LAMP in diagnosis of congenital Chagas

Loop-mediated Isothermal Amplification (LAMP) detects pathogen DNA from patient samples with very high specificity and sensitivity. Unlike most other molecular tests, LAMP amplifies target DNA at a constant temperature, which means that it can be carried out with much less laboratory equipment than other such tests. The reagents for LAMP can be stored at room temperature, since they are dried down in the cap of the reaction tube. In addition, results can be detected by the naked eye, rather than with the complicated detection equipment required for more conventional methods. The new initiative aims to develop LAMP to detect parasite DNA directly from whole blood samples in under an hour, making it a valuable asset in the prompt diagnosis of congenital Chagas cases.