Andina

Peruvian molecular test has already passed phase 1, is close to becoming a reality

Edward Malaga-Trillo leads the team which seeks to develop the first rapid molecular test in Peru. Photo: ANDINA/Essalud

Edward Malaga-Trillo leads the team which seeks to develop the first rapid molecular test in Peru. Photo: ANDINA/Essalud

14:29 | Lima, Aug. 17.

Peru is close to having a molecular test produced by national scientists for the better detection of the population infected with COVID-19 —at less cost and time than conventional tests coming from abroad.

Peruvian neurobiologist Edward Malaga-Trillo —who leads the team dedicated to the project at Lima-based Cayetano Heredia University— reported that the test successfully passed phase 1 last Sunday, referring to its analytical validation. The scientist added that they are getting ready to start phase 2, meaning the clinical validation.

"Yesterday at dawn, we successfully passed phase 1. The complete data and analysis will be presented shortly to the National Health Institute (INS). Along with phase 2 data, they will be included in a preprint that we will submit to peer review in an indexed international journal," he wrote on social media on Monday.

The project is supervised by the INS and the General Directorate for Medicines, Supplies and Drugs (Digemid), which are attached to the Ministry of Health (Minsa).

Phase 1 began on July 1 after receiving 100 swab samples from Peruvian patients with COVID-19, previously analyzed by the team using the Gold Standard method (real-time PCR).

"Concerning the clinical validation (phase 2), we are still waiting to obtain a roadmap from Digemid and the INS. After many setbacks, finally —on Friday— we had a meeting with fellow researchers and with both institutions. They showed great willingness and promised to solve the issue as soon as possible," said the project leader, after informing that the next meeting with Minsa authorities will be held this Tuesday.

Both phase 1 and phase 2 are carried out using clinical samples from patients, in order to obtain quantitatively the detection limit of the method and how efficiently it recognizes viral genetic material.

Advantages

The Peruvian scientific community is waiting for the approval of the national molecular test project by Cayetano Heredia University, because it will allow the implementation of epidemiological fences for the control of infections and will offer a series of advantages compared to conventional tests.

First, its cost will not be higher than S/70 (about US$20) per test, almost five times less than the S/300 (about US$100) for a conventional one.

Given its design, the uncomfortable swabbing may no longer be necessary, only a little saliva may be needed, thus avoiding contagion to health personnel.

Also, the result will be obtained in 40 minutes, instead of 48 hours as in the case of conventional tests.

(END) DOP/MVB

Published: 8/17/2020