Neokit: From Molecular Biology to the Development of Diagnostic Kits

ABSTRACT

Infectious diseases show a great impact on public health and productivity, particularly in low-income countries. Proper diagnosis access can make a great difference in reducing both human and economic losses. Currently, there is a vacancy in diagnostic methods adapted to the field possibilities of the user, the beneficiary, and the system in which they are immersed (infrastructure, equipment, etc.). Ten years ago, we have started to work to develop and transfer tests -and associated know-how- for the detection of infectious agents (in human, veterinary, and plant health), which were fast, affordable, and simple to use in any field conditions. The first development done by this group arose from the call of FITS CHAGAS, FONARSEC-National Agency for Scientific and Technological Promotion (today "Agencia I+D+i"), to develop a simplified molecular diagnostic test for vertical Chagas. The grant required us, as CONICET researchers, to form a Public-Private Partnership Consortium (CAPP) with companies. The two signatory companies were national SMEs. That developed kit, namely Chagas NeoKit, has shown adequate sensitivity and specificity, but also has resulted very easy to perform, from a blood sample in the liquid state, from purified DNA, or directly from a dry blood drop on a card from the Neonatal Screening Program (PPN). It only requires the use of a simple thermal device, since the reaction is based on a loop-mediated isothermal amplification (LAMP), and no pipettes, centrifuges, or other laboratory equipment are necessary. This kit has been the 1st ARGENTINE MOLECULAR DETECTION REAGENT APPROVED by ANMAT (Resol. 1-47-3110-1994/17-5). This experience has been the beginning of a great learning process to turn a molecular reaction into a tangible good, adding capabilities from the scientific, health, and industrial systems. The work team grew and received other funds from the Agency that allowed us to increase and consolidate this knowledge, systematizing it in a technological platform where the LAMP technique is combined with tools focused on simplifying both the processing of the sample. as well as the reading out method, to obtain effective, robust, fast and simple to apply kits to detect different infectious agents. With the advent of the pandemic, the NEOKIT COVID-19 was developed and clinically and analytically validated (with 2 presentations TecnoAMI and Plus), in record time, obtaining the approval of ANMAT in May 2020. This pandemic scenario has driven the installation of production capacities of approx. 1 million reactions/month and generated more than 10 job positions. Currently, in addition to accompanying the production process of the kit for COVID-19, work is being done on the development of kits for the detection of other infections, including vertical syphilis, dengue, zika, and chikungunya, among others. This is an example of the convergence of researchers from CONICET, the Pablo Cassara Foundation, and the Pablo Cassara SRL Laboratory, accompanied by state policies of the MINCyT, for transforming science and technology into diagnostic kits.