The National Administration of Medicines, Food and Medical Technology (ANMAT) has approved a new dengue diagnostic kit developed in the laboratories of the Leloir Institute and CONICET.
Additionally, a vaccine called Qdenga®, approved by ANMAT in 2023 and created by the Takeda laboratory, has been developed. Its use was approved after efficacy and safety studies (phase III), and phase IV studies will be conducted in 2025, thus implementing disease prevention.
Technological Innovation Process
In an interview with the Argentine News Agency, Belén García Fabiani, a collaborator in the kit development, explained that the technological innovation process lasted approximately six months. “The network of collaborators who provided us with samples from patients with or without dengue was crucial, allowing us to develop and optimize our test,” she commented.
Characteristics of the Kit Approved by ANMAT
“ANMAT approved the kit after testing around 500 samples verified as positive or negative. This test allows the diagnosis of dengue in the acute stage of the disease, between 2 and 7 days from the onset of symptoms, detecting the viral protein in circulation,” detailed García Fabiani.
Use of the Kit in Laboratories
The kit is intended for clinical analysis laboratories and will not be sold in pharmacies for domestic use. It will be available from the following month and will be provided to the healthcare system, both public and private, with all the necessary tools.
Before its launch, a survey was conducted among colleagues from hospitals and biochemists to identify weaknesses during the last dengue outbreak. “Today we can offer the kit to both public and private laboratories. We hope it is well received and meets the needs of biochemists and those who will use it,” García Fabiani concluded.
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