ANMAT approved a new kit for diagnosing dengue

ANMAT approved a new kit for diagnosing dengue

October 31, 2024 – 11:42

The test allows us to detect the disease in the acute stage, between 2 and 7 days after the onset of symptoms. The device is intended to be used in clinical analysis laboratories by professionals, it will not be available for free sale.

The test allows detecting the disease in the acute stage, between 2 and 7 days after the onset of symptoms.

The National Administration of Drugs, Foods and Medical Technology (ANMAT) approved a new kit to know the diagnosis of dengue and it was developed in the laboratories of the Leloir Institute and CONICET.

In addition, a vaccine called Qdenga® was developed and approved by the ANMAT in 2023.developed by the Takeda laboratory, where its use was approved after efficacy and safety studies (phase III), and phase IV studies will be carried out in 2025. This also implements the prevention of the disease.

In dialogue with Agencia Noticias Argentinas, one of the collaborators in the development of the kit, Belén García Fabiani explained how the technological innovation process was: “It lasted approximately six monthswhich taught us a lot and strengthened the relationships we have with our network of collaborators.” He also added: “This network was key because they gave us samples of patients who were or were not suffering from dengue and that allowed us to develop our test, in addition to understanding what the weak points are, that’s how we optimized it.”

Vaccine against Dengue.jpg

In addition to the test, ANMAT approved the vaccine called Qdenga® in 2023, which was developed by the Takeda laboratory.

In addition to the test, ANMAT approved the vaccine called Qdenga® in 2023, which was developed by the Takeda laboratory.

Photo: DLTV

The ANMAT allowed us to approve the kit after testing around 500 samples and they were people who were previously verified as positive or negative.. They also enabled us to have the checkup so that it can be performed by a person of any age.in a respective public and private laboratory,” clarified García Fabiani.

It will not be free sale

“This test allows the diagnosis of dengue in the acute stage of the disease of infection by this virus, that is, among 2 at 7 days from the onset of symptomsTherefore, if there are any, what this test detects is the viral protein that is in circulation,” the scientist explained. In addition, she added: “This device is intended to be used in clinical analysis laboratories by professionals. It is not a quick test, nor will it be sold in a pharmacy so that one can perform it at home.but is intended for laboratories of medium to high complexity”.

On the other hand, The kit will be available starting approximately the following month and will be awarded to the health system, both public and private. with all the necessary tools. Finally, García Fabiani said: “Before releasing it to the public, we did a survey before starting our projects among hospital colleagues and biochemists to understand what the weak points or failures had been during the last outbreak. For that reason, we decided undertake this project and happily today we can offer it to both public and private laboratories. We hope that it will be well received and that it will meet the needs of biochemists and those who will use it.

Source: Ambito

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