Development of a multiplex serologic kit for the simultaneous detection of antibodies against infectious diseases

• Grant number: 19/22786-2
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: July 01, 2020
• End date: March 31, 2021
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Guilherme Maerschner Ogawa
• Grantee: Guilherme Maerschner Ogawa
• Company: Internacional Científica Ltda
• CNAE: Fabricação de produtos diversos não especificados anteriormente ; Atividades de serviços de complementação diagnóstica e terapêutica
• City: São José dos Campos
• Pesquisadores principais: Anakele Massi Monteiro ; Raquel Veturiano Barroso Orbolato
• Associated scholarship(s): 20/08671-5 - Development of a kit for a multiple and simultaneuos serologic detection of antbodies against infectious diseases, BP.TT

Abstract

Serological methods for the detection of infectious diseases are used for diagnostics, and several are designated as the international standard. The most used methods have a limitation of having only one biomarker, detecting only one analyte in one assay. The introduction of microspheres in serology (Bead based platform) expanded the use of up to 500 biomarkers in one assay, raising productivity and lowering costs. The development of magnetic microspheres, MagPix platform from Luminex, improved this technique making it easier to operate and lowering the costs of equipment and materials. This technology is becoming more popular, but still there are very few commercial kits available (for all its potential uses) are there is no kit for detection of infectious diseases. Due to the mandatory screening of infectious diseases, on pregnant women in Brazil, we propose here the development of a multiplex serologic kit for the detection of infectious diseases, focused on pre-natal screening. The kit will be based in the Magpix platform using antigens (biomarkers) specific for detection of antibodies (analites) against Toxoplamsa gondii, Rubella virus and human cytomegalovirus initially. The use of antigens in a multiplex bead based platform demands studies on coupling optimization and validation. With those antigens we foresee the development of two 3-Plex kits (one for IgG and one for IgM) with high sensibility and specificity. The aim is to lower the costs of analysis per sample, increase number of analysis per day, decrease human effort and offer option for automation. Our company already produces and sells a multiplex 4-Plex kit for the detection of TSH, T4, 17OH and IRT for newborn screening. There is a request, from our clients, for a multiplex kit for infectious diseases. The success on the development of this kit will open opportunities for addition of new antigens that can be used on other application, such as blood bank screening, routine exams in diagnostics labs and in scientific research for example. At the end of the phase 1 of the FAPESP-PIPE project we will have as a result a multiplex assay (IgG) with ate least two biomarkers for infectious diseases. For phase 2 our objectives are to incorporate more biomarkers, study IgM response and to validate the product according to Brazilian regulations. (AU)