La ANMAT autorizó su venta en farmacias, pero debe realizarlo un profesional de la salud. Bioquímicos temen que, el nuevo test, pueda incurrir en la pérdida de información epidemiológica, poniendo en riesgo la salud pública y toda estrategia sanitaria posible.
Con la autorización de la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), comenzó a venderse en farmacias el Test Rápido de antígeno SARS-CoV-2 “Immunobio”, creado por el laboratorio chino Hangzhou Immuno Biotech Co Ltd. Si bien detalla que es para uso profesional, resulta muy complejo poder garantizar su correcto uso sin la supervisión de un profesional de la salud.
El nuevo test permite saber, a través de una muestra, si una persona es positiva de COVID-19. Solo demora entre 10 y 20 minutos y, aunque debe realizarlo un profesional, es de venta libre. Desde el Colegio de Bioquímicos del Chaco, aseguran que este nuevo producto, en lugar de contribuir al control del virus, genera preocupación por la incidencia directa que su utilización puede causar en el registro epidemiológico del COVID-19.
El test se lanzó a la venta en farmacias de todo el país con el objetivo de que quien lo compre, concurra a un profesional para que le haga el hisopado y, según resulte la prueba, el antecedente se registre y se pueda realizar el seguimiento correspondiente en caso que sea positivo. Resulta contradictorio entonces que se trate de un elemento de venta libre, si en definitiva necesita supervisión para su correcto uso.
El poder comprar un test en un farmacia, pone en riesgo la salud pública por múltiples causas. La primera, es la alta probabilidad de que el test se realice en el hogar y se elimine el material patógeno en los residuos domiciliarios. La segunda causa, y no menos importante, es la falta de trazabilidad del reactivo en caso de fallas por almacenamiento inadecuado. Y, por último, la brecha de datos que se podría generar de casos positivos en el registro epidemiológico del Sistema Integrado de Información Sanitaria Argentino (SIISA), ya que quien se realice el test en su casa no dejará rastros de su resultado.
Este tipo de test tienen una sensibilidad menor que las pruebas de biología molecular, es por eso, que solo sería útil en los casos de personas con síntomas. Y acá aparece un motivo más de alerta, para repensar la venta en farmacias de este test. Si la persona que se lo realiza, tiene una escasa carga viral (que sí es detectable por PCR) aumenta la posibilidad de obtener un resultado falso negativo y ser portador del virus, lo que amplifica el riesgo de circular y contagiar.
Desde el Colegio de Bioquímicos, consideramos fundamental que toda metodología rápida para la detección de antígenos virales o anticuerpos del SARS-Cov-2, debe realizarse siguiendo el protocolo vigente, en el contexto del sistema de salud, con personal capacitado, supervisión bioquímica y notificación epidemiológica al Sistema Nacional de Vigilancia de Salud (SNVS), según corresponda.
Es importante destacar que el abordaje del COVID-19 no sólo implica la detección de personas positivas, sino también, las medidas de salud pública, como el aislamiento inmediato ante el caso sospechoso, la investigación epidemiológica, el rastreo de contactos estrechos y el seguimiento que corresponda para el tratamiento y/o internación, para prevenir consecuencias extremas. La venta de estos productos, inevitablemente escapará al debido control que asegure, que quien lo adquiera, concurra de manera efectiva a un Laboratorio Bioquímico.
Si bien es comprensible la necesidad y urgencia por una detección de casos de forma sencilla y masiva, desde el Colegio de Bioquímicos del Chaco recomendamos enfáticamente mantener y respetar la cadena de trazabilidad que se origina con un testeo y finaliza con el resultado/atención del ciudadano/paciente. Por este mismo motivo, consideramos que el Test Rápido de antígeno SARS-CoV-2 “Immunobio” podría obstaculizar el control correcto y oportuno de la enfermedad COVID-19 y solicitamos que se revoque la autorización de venta libre, con el fin de garantizar los mecanismos de control correspondientes al proceso de detección del virus.
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