Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia

AUTHOR SUMMARY

Chagas disease is an infectious parasitic disease affecting more than 400,000 people in Colombia. The Pan American Health Organization (PAHO) has estimated that 70% of infected people do not present clinical symptoms. To determine if a person has the infection, blood tests must be performed in laboratories that are generally not located near primary health care centers. Although diagnostic coverage has improved recently, the way Chagas disease is diagnosed needs to be further simplified in order to test more people for the infection and provide early treatment. For this, rapid diagnostic tests (RDTs) are needed. RDTs are small devices that, using a drop of blood taken from a finger, can determine in a few minutes whether a person is likely to have T. cruzi infection, the parasite responsible of Chagas disease. These tests can be quickly performed while a person receives care, even outside a hospital or medical center, because they are easy to use and do not need specialized training to be done. There are several commercially available RDTs for T. cruzi detection, but more information is needed about their performance in diagnosing the disease in the Colombian population. For this reason, 11 RDTs, commercially available in the Latin American region, have been assessed under controlled laboratory conditions, to determine their ability to diagnose T. cruzi infection in the Colombian population. This study found seven RDTs which are more than 90% effective in diagnosing Chagas disease. Now, those RDTs with the best diagnostic performance need to be evaluated in the real world in field studies, outside controlled laboratory conditions. If the field performance of these tests proves to be optimal (i.e. comparable to the current laboratory-based diagnostic methods), RDTs could be incorporated into the Colombian diagnostic protocol, thus allowing decentralization of diagnosis and helping improve access and health care coverage for people at risk of suffering from Chagas disease.