DEVELOPMENT OF AMI, AN ISOTHERMAL MOLECULAR AMPLIFICATION PLATFORM TO ENABLE NEW DIAGNOSTICS SYSTEMS

L. LAROCCA; STOLOWICS FG; WERBAJH S; VOJNOV A; CARRILLO C

Congreso; REUNIÓN ANUAL DE SOCIEDADES DE BIOCIENCIA 2019; 2019

Infectious diseases have a great impact onhealth and productivity, particularly in lower income countries. Atimely diagnosis can make the difference between health andillness or mortality; but there still are many diseases that do nothave a diagnosis method that answer to public health needs. Inthe case of animals and plants, early infection detection canprevent irreparable losses in the productive sector. Our objectiveis to develop and transfer kits - and / or know-how - on diagnostictests (aimed at humans, animals and plants) that are quick,sensitive, economical and easy to use under any condition. Wehave created ?AMI?, an Isothermal Molecular AmplificationPlatform. Applying it, we have developed innovative diagnostictests, and started to produce and transfer kits and their StandardOperation 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 hasgreater sensitivity than Real Time PCR at a lower cost. The testscan be done using a simple thermal device -of any kind- (constanttemperature at 64 °C by one hour); and be performed by anoperator with a basic training who can do the analysis at the sameplace at which the sample was taken (field conditions or Point OfCare: ?POC?). The kits are stable for up to 18 months.?ChagasNeoKit?, our first product, detects Chagas in neonates. Itspecifically gives a positive reaction with the 6 discrete typingunits (DTU´s) of T. cruzi and does not cross-react with DNA fromother organisms. This NeoKit has successfully completed clinicaltrials in public hospitals (Durand and Ramos Mejía in CABA andPerrando in Resistencia), becoming de FIRST ARGENTINEREAGENT FOR MOLECULAR DETECTION APPROVED by ANMAT. ItsPatent is under revision and transference is being mediatedthrough an agreement between CONICET and a Consortium ofPublic-Private Partnership