New Peruvian molecular COVID-19 test advances to request validation

Photo: ANDINA/Diffusion

Photo: ANDINA/Diffusion

12:37 | Lima, Sep. 16.

The team of researchers —who are developing Peruvian molecular tests to detect COVID-19— received the authorization request forms for the use of diagnostic kits intended for validation and local production of those tests, after holding a meeting with officials from the General Directorate of Medicines, Supplies and Drugs (Digemid) run by the Ministry of Health (Minsa).

Neurobiologist Edward Malaga-Trillo —who leads the project at Lima-based Cayetano Heredia University (UPCH)— informed on Tuesday night that, thanks to the prompt response from Digemid Chief Carmen Ponce, they were able to solve the pending issues of regulations linked to the validation of diagnostic tests for SARS-CoV-2, which are currently in phase 2.

In addition to the forms required to start the corresponding authorization process, the researchers also rely on the necessary documents to request the importation of materials and other supplies for production of molecular tests, as well as the criteria for manufacturing.

During the meeting, the health authority clarified the criteria for "exceptional authorization for the production / use of in vitro diagnostic tests at the research stage in situations of urgency or declared emergency."

In the case of new technologies, this procedure can be requested and granted before completing the clinical validation, as long as the preliminary results are subjected to evaluation, without requiring reproducibility tests in national or foreign populations, says the letter shared by the Peruvian scientist.

In addition, considering the prevalence of COVID-19 in Peru and taking as a reference the validation work done by the National Health Institute (INS) —so that LAMP tests start to be used by the Ministry— the researchers concluded that the sample size for clinical (field) validation is less than 400.

The publication of such information by the INS will be very useful as a reference to other projects.

Scientist Malaga-Trillo said that —at the meeting— they made clear the urgency of modifying the biosafety standards and accreditation of diagnostic laboratories as an essential condition to deploy their massive use nationwide, in urban and rural areas that have limited access to technology.


Publicado: 16/9/2020