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AEMPS: Notification about COVID-19 diagnostic

14/05/2020|

Source: Agencia Española de Medicamentos y Productos Sanitarios.

The AEMPS -Spanish Agency for Medicines and Health Products- warns about the risk that products and services for the diagnosis of COVID-19 that do not comply with current legislation may offer in the Spanish market.

The AEMPS has learned of the existence of advertisements offering diagnostic tests for the new coronavirus without requiring the corresponding prescription, indicating that they are self-diagnostic. That is, to be acquired and used autonomously by citizens. These tests have not been certified for this use so they may lack the necessary guarantees of safety, efficacy and quality.

Currently, the tests for the diagnosis of COVID-19 are indicated only for use by healthcare professionals. Only in this way can be guaranteed that the sampling is correct, the products are adequate, the performance of the test does not entail risks for the professional, patients or third parties, and that a correct interpretation of the results and measurements occurs.

The tests for the diagnosis of COVID-19 marketed today have not been developed for use by the general public or for sale in pharmacy offices. Interpreting an analytical result without a clinical context can lead to erroneous decisions.

More information, by clicking here (Spanish .pdf 1,12Mb)

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