BD launches 15-minute antigen test for COVID-19 with FDA emergency authorization

Fifteen minutes to know if you're contagious right now
The BD Veritor™ Plus detects active virus, not past exposure, enabling immediate isolation decisions.

En septiembre de 2020, mientras Perú enfrentaba una de las tasas de mortalidad por COVID-19 más altas del mundo, la empresa BD introdujo una herramienta diagnóstica capaz de responder en quince minutos la pregunta más urgente de la pandemia: ¿está esta persona contagiando ahora mismo? La prueba de antígenos BD Veritor™ Plus, validada tanto por la FDA como por el Ministerio de Salud peruano, representó un giro en la lógica del control epidémico —del rastreo del pasado inmunológico hacia la detección del peligro presente. En un país que comenzaba a reabrir su economía con más de 700.000 casos confirmados, la velocidad y la portabilidad de esta tecnología no eran simples ventajas técnicas, sino condiciones de posibilidad para una convivencia más segura.

  • Perú acumulaba casi 30.000 muertes y superaba los 700.000 contagios cuando la reapertura económica exigía herramientas diagnósticas que el sistema de salud aún no tenía.
  • Las pruebas serológicas dominantes en el país detectaban exposición pasada al virus, no infección activa, dejando un vacío crítico en la capacidad de aislar a personas contagiosas en tiempo real.
  • La BD Veritor™ Plus detecta proteínas del virus —no anticuerpos— en quince minutos mediante hisopado nasal, con una sensibilidad clínica del 84% y mayor eficacia en los primeros cinco días de síntomas.
  • Su bajo costo y diseño portátil permiten desplegarla fuera de hospitales: en centros de trabajo, escuelas y comunidades, donde interrumpir cadenas de transmisión tiene mayor impacto.
  • Con autorización de uso de emergencia de la FDA y validación del Instituto Nacional de Salud del Perú, la prueba se posiciona como infraestructura diagnóstica clave para contener futuras olas y sostener la reactivación económica.

En septiembre de 2020, cuando Perú atravesaba uno de los momentos más duros de la pandemia, la empresa de dispositivos médicos BD anunció el lanzamiento local de la BD Veritor™ Plus: una prueba de antígenos capaz de detectar infección activa por coronavirus en apenas quince minutos mediante un hisopado nasal. El resultado aparece en un dispositivo portátil y recargable que puede imprimir documentación, lo que la hace viable fuera del entorno hospitalario.

Lo que distinguía a esta prueba no era solo su velocidad, sino su lógica diagnóstica. Mientras las pruebas serológicas —entonces predominantes en Perú— detectaban anticuerpos generados semanas después de la exposición, la BD Veritor™ Plus identificaba las proteínas estructurales del virus en el momento de mayor carga viral, es decir, cuando la persona es más contagiosa. Para decisiones de aislamiento y rastreo de contactos, esa diferencia resultaba determinante.

Con una sensibilidad clínica del 84% en estudios clínicos, la prueba mostraba mayor fiabilidad en personas con síntomas de menos de cinco días. Su costo reducido y portabilidad la hacían accesible para un sistema de salud bajo presión extrema. Además, era la única prueba de su tipo con autorización de uso de emergencia de la FDA y validación del Ministerio de Salud y el Instituto Nacional de Salud del Perú.

José Luis Rodríguez, director regional de BD para la zona andina, subrayó que la herramienta permitiría a las autoridades sanitarias pasar de una respuesta reactiva a una contención proactiva: identificar a las personas infecciosas antes de que propaguen el virus. En un país que iniciaba su reapertura económica con más de 700.000 casos confirmados, esa capacidad no era un lujo técnico —era una condición para que la vida pública pudiera retomarse con algún grado de seguridad.

In September 2020, as Peru grappled with one of the world's highest COVID-19 death tolls, an American diagnostics company introduced a tool that promised to speed up the most basic act of pandemic response: knowing who was sick. BD, a multinational medical device manufacturer, announced the BD Veritor™ Plus—a fifteen-minute antigen test that could identify active coronavirus infection from a nasal swab, faster than the serological tests then in common use across the country.

The test works by detecting nucleocapside proteins, the structural components of the virus itself, using a technology called immunoassay. A healthcare worker collects the sample, and within a quarter hour, results appear on a portable, rechargeable device that can print documentation. The company reported an 84 percent sensitivity rate in clinical studies—a threshold considered clinically valid for diagnostic purposes. The test was most reliable in people showing symptoms within the first five days of infection, the window when viral load is highest and transmission risk most acute.

What made this announcement significant was not merely speed. The test detected active virus, not antibodies. This distinction mattered enormously in the early months of the pandemic, when serological tests—which identify immune response rather than current infection—dominated Peru's testing landscape. A serological test could tell you that someone had been exposed to coronavirus weeks earlier. An antigen test told you whether someone was contagious right now. For isolation decisions, for contact tracing, for the logistics of keeping workplaces and communities functioning, that difference was everything.

The device also carried regulatory weight. It was the first and only test of its kind in Peru to receive Emergency Use Authorization from the FDA, the United States drug and device regulator. Peru's own Ministry of Health and National Institute of Health had validated it as well. These approvals signaled that the test met standards for accuracy and reliability even under the compressed timelines of emergency authorization.

Cost was another advantage. Antigen tests were cheaper to manufacture and deploy than many alternatives, making them feasible for widespread use in a country where healthcare resources were already stretched thin. The portability meant testing could happen not just in hospitals and clinics but in workplaces, schools, and community settings—places where rapid feedback could prevent transmission chains from forming.

José Luis Rodríguez, the regional manager for BD's integrated diagnostic systems division in the Andean region, framed the announcement in terms of economic recovery and public health strategy. The test, he said, would help workers and the public make informed decisions about reopening. More importantly, it would allow health authorities to identify infectious people quickly and trace their contacts before those contacts spread the virus further. In the language of epidemiology, this was the difference between reactive response and proactive containment.

By mid-September 2020, Peru had recorded more than 700,000 confirmed cases and nearly 30,000 deaths—numbers that would climb much higher before vaccines arrived. The country was beginning to reopen its economy after months of lockdown, but without better diagnostic tools, that reopening carried real risk. A fifteen-minute test that could be deployed widely and cheaply represented a concrete step toward managing that risk. Whether it would be enough remained an open question.

The test is a portable solution for COVID-19 diagnosis that will help the population stay informed and better prepared for economic reactivation, while helping prevent new peaks by allowing public health workers to quickly identify infectious people and track their contacts.
— José Luis Rodríguez, BD regional manager for integrated diagnostic systems
A Conversa do Hearth Outra perspectiva sobre a história
Inventor

Why does it matter that this test detects active virus rather than antibodies?

Model

Because in the first days of infection, when someone is most contagious, their immune system hasn't yet produced detectable antibodies. An antigen test catches them immediately. An antibody test might show negative even though they're actively spreading the virus to others.

Inventor

So this changes how contact tracing works?

Model

Completely. If you can identify who's infectious within fifteen minutes, you can isolate them and reach their contacts the same day. With slower tests, by the time you have results, those contacts have already been exposed for days.

Inventor

The 84 percent sensitivity—is that good enough?

Model

It's clinically valid, meaning it's reliable enough for medical decisions. It's not perfect, but it's far better than guessing, and it's fast enough that you can retest if you're uncertain.

Inventor

Why was Peru specifically mentioned in this announcement?

Model

Peru was being devastated by the virus at that moment. They needed tools to reopen their economy without triggering new waves. A portable, cheap, fast test was exactly what they lacked.

Inventor

What happens to the people who test negative but are actually infected?

Model

That's the 16 percent gap in sensitivity. Some infectious people would be missed and sent back into the community. That's why rapid testing works best as part of a larger strategy—isolation protocols, masks, ventilation—not as a standalone solution.

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