ABSTRACT
Abstract The ultramicroanalytic system (SUMA), created in the 1980s, is a complete system of reagents and instrumentation to perform ultramicroassays combining the sensitivity of the micro-enzyme-linked immunosorbent assay (ELISA) tests with the use of ultramicrovolumes. This technology permitted establishing large-scale newborn screening programs (NSPs) for metabolic and endocrine disorders in Cuba. This article summarizes the main results of the implementation during the 30 years of SUMA technology in NSP for 5 inherited metabolic diseases, using ultramicroassays developed at the Department of Newborn Screening at the Immunoassay Center. Since 1986, SUMA technology has been used in the Cuban NSP for congenital hypothyroidism, initially studying thyroid hormone in cord serum samples. In 2000, a decentralized program for the detection of hyperphenylalaninemias using heel dried blood samples was initiated. These successful experiences permitted including protocols for screening congenital adrenal hyperplasia, galactosemia, and biotinidase deficiency in 2005. A program for the newborn screening of CH using the thyroid-stimulating hormone Neonatal ultramicro-ELISA was fully implemented in 2010. Nowadays, the NSP is supported by a network of 175 SUMA laboratories. After 30 years, more than 3.8 million Cuban newborns have been screened, and 1002 affected children have been detected. Moreover, SUMA technology has been presented in Latin America for over 2 decades and has contributed to screen around 17 million newborns. These results prove that developing countries can develop appropriate diagnostic technologies for making health care accessible to all.
ABSTRACT
El Centro de Inmunoensayo (CIE) es una institución dedicada a investigación-producción orientada al desarrollo y producción de reactivos e instrumentos para el diagnóstico médico, basados en técnicas inmunoenzimáticas que aprovechan la gran especificidad de la interacción antígeno-anticuerpo y las ventajas de las reacciones catalizadas por enzimas. Su línea principal es el Sistema Ultra Micro Analítico (SUMA), que consiste en una tecnología integrada por equipos y reactivos para la realización de los análisis inmunoenzimáticos a un bajo costo de ejecución, lo cual lo hace particularmente adecuado para los programas de prevención de la salud, en los que se requiere el procesamiento de un gran número de muestras. Con el objetivo de lograr la garantía de la calidad se han desarrollado durante más de una década diferentes sistemas de software que se han utilizado en el proceso de evaluación de la calidad en el trabajo de los laboratorios. Con el nombre de SAC 2.0, el CIE desarrolló un sistema para el control de la calidad que puede realizar el proceso evaluativo de forma totalmente automatizada, que ofrece prestaciones similares a los sistemas más avanzados que existen actualmente. En este trabajo se describen elementos considerados en su concepción, así como las ventajas obtenidas con la automatización, las cuales demuestran cómo la herramienta desarrollada constituye un componente de vital importancia para el adecuado funcionamiento de los laboratorios de la tecnología SUMA, ubicados en Cuba y en el exterior(AU)
The Center of Immunoassay (CIE) is a research-production complex aiming at the development and production of reagents and instrumentation for medical diagnosis based on immunoenzymatic techniques using the great specificity of the antigen-antibody interactions and the advantages of the reactions catalyzed by enzymes. Its main line is the Ultra Micro Analytical System (SUMA), consists of a technology of equipments and reagents to perform immunoenzymatic analyses at a low cost, which makes it particularly adequate for prevention health programs that require the processing of a big number of samples. In order to achieve a desirable quality warrant, different software systems have been developed for more than a decade, that have been used in the quality assessment process in the laboratories. Under the name of SAC 2.0, the CIE has developed a version of a system for quality control that is able to perform the assessment process totally automated. This paper describes the elements considered in its conception as well as the advantages obtained from automation, which show how important the developed tools are for the proper functioning of the SUMA laboratories allocated not only in Cuba but in other countries as well(AU)
