Development of ?AMI?, an isothermal molecular amplification platform to enable new diagnostics systems

LAROCCA L; STOLOWICZ FG; WERBAJH S; VOJNOV AA; CARRILLO C

Mar del Plata

Congreso; Reunión Anual de Sociedades de Biociencias; 2019

SAP, SAB, SAFE, SAIC

Infectious diseases have a great impact on health and productivity, particularly in lower income countries. A timely diagnosis can make the difference between health and illness or mortality; but there still are many diseases that do not have a diagnosis method that answer to public health needs. In the case of animals and plants, early infection detection can prevent irreparable losses in the productive sector.Our OBJECTIVE is to develop and transfer kits - and / or know-how - on diagnostic tests (aimed at humans, animals and plants) that are quick, sensitive, economical and easy to use under any condition.We have created ?AMI?, an Isothermal Molecular Amplification Platform. Applying it, we have developed innovative diagnostic tests, and started to produce and transfer kits and their Standard Operation Procedures (SOPs) to produce and to use them.?NeoKits? do not require complex purification or processing steps, the process takes less than 90 minutes to yield a result and has greater sensitivity than Real Time PCR at a lower cost. The tests can be done using a simple thermal device -of any kind- (constant temperature at 64°C by one hour); and be performed by an operator with a basic training who can do the analysis at the same place at which the sample was taken (field conditions or Point Of Care: ?POC?). The kits are stable for up to 18 months. ?ChagasNeoKit?, our first product, detects Chagas in neonates. It specifically gives a positive reaction with the 6 discrete typing units (DTU´s) of T. cruzi and does not cross-react with DNA from other organisms. This NeoKit has successfully completed clinical trials in public hospitals (Durand and Ramos Mejía in CABA and Perrando in Resistencia), becoming de FIRST ARGENTINE REAGENT FOR MOLECULAR DETECTION APPROVED by ANMAT. Its Patent is under revision and transference is being mediated through an agreement between CONICET and a Consortium of Public-Private Partnership.