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Tetanus antitoxin is quantified in Cuba at blood banks, from the serum of immunized donors, to produce aspecific human gamma globulin. A heterogeneous indirect immunoenzymatic assay is used, using the serum as analytical sample. The possible use of plasma obtained from plasmapheresis as alternative sample was evaluated in this research, to minimize the volume of total blood extracted to the donors. One hundred plasma donors who came to donate between October and November 2013 were selected by simple random sampling. Serum sample was obtained for extraction of 5 mL of blood, deposited in dry glass tube. While the other sample took 1.5 mL of plasma in a plastic tube with cover, at the end of the donation directly of the unit of plasma collected. Comparison of the difference between the means of both groups was done using SPSS for Windows. It was found that the values obtained in serum were bigger than those obtained in plasma. Difference between the means of both groups was statistically significant (p 0.00). It is not advisable to use the obtained plasma of the plasmapheresis as analytic sample in this assay.

Para el diagnostico del virus de la hepatitis C, se utilizan las pruebas de Elisa, debido a su sensibilidad y especificidad. Gran parte de estas pruebas se basa en el empleo de peptidos sinteticos y, en la actualidad, de peptidos quimericos. En este estudio se sintetizo un peptido quimerico que comprende secuencias inmunodominantes de las regiones no estructurales NS4 y NS5 del virus de la hepatitis C. El peptido representativo de las dos secuencias esta separado por un brazo espaciador de dos residuos de glicina. El peptido se evaluo como antigeno en un ensayo UMELISA, utilizando muestras positivas (n=30), muestras negativas (n=40) y el panel de Boston Biomedica Inc. (n=40). Los resultados del peptido quimerico NS41 NS5 se compararon con los resultados de los peptidos individuales NS4 y NS5 y con la mezcla de estos dos peptidos. Los resultados de los peptidos individuales coinciden con los datos informados en la literatura. Con la mezcla de los peptidos, no aumento la deteccion de muestras positivas, pero con el peptido quimerico se logro aumentar la sensibilidad.

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.

Para el diagnóstico del virus de la hepatitis C, se utilizan ampliamente las pruebas de Elisa por su sensibilidad y especificidad. Gran parte de ellos se basa en el empleo de péptidos sintéticos. Una de las zonas más conservadas y de gran antigenicidad es la región estructural del virus. En este estudio, se sintetizaron siete péptidos de zonas informadas como altamente antigénicas de la región estructural del virus de la hepatitis C. Los péptidos sintetizados representan la región del núcleo del virus. Se realizó la evaluación y comparación de los resultades de los péptidos sintetizados, para lo cual se emplearon muestras positivas (n=72) y negativas (n=42). Con los péptidos más cercanos a la región amino terminal, la reactividad fue alta, pero fue disminuyendo a medida que nos acercábamos a la región carboxilo terminal. Estos resultados coinciden con lo informado por otros autores.

Congenital hypothyroidism (CH) is one of the most common preventable causes of mental retardation. Newborn screening and thyroid therapy started within 2 weeks of age can normalize the cognitive and motor impairment caused by lack of thyroid hormone during the early postnatal phase of brain development. The availability of assays to determine thyroxin (T4) and thyroid stimulating hormone has allowed the establishment of newborn screening programs for CH. The Immunoassay Center (Cuba) developed the T4 Neonatal UMELISA(r) to determine neonatal T4 levels in dried blood on filter paper using 5 mm discs of samples, standards and controls. The number of diseases which can be diagnosed in Neonatal Screening Programs has increased, so it is necessary to make the maximum use of blood samples collected on filter paper. This work shows the standardization of the T4 Neonatal UMELISA(r) modified in order to use 3 mm discs. The assay was completed in 3 1/2 hours, with a measuring range of 25-400 nmol/L. The intra- and inter-assay coefficients of variation (CV) were 6-10 % and 7-12 % respectively, depending on the T4 concentrations. The recovery ranged from 91.8-115.1 %. The modified assay showed high Pearson correlation (r = 0.877) and concordance correlation (?c = 0.867) with the T4 Neonatal UMELISA(r). The performed modifications do not affect the sensitivity, precision and accuracy of the assay, permitting a more rational use of newborn blood samples and the possibility to increase the number of diseases included in the newborn screening programs.