Good perspectives for a Peruvian rapid molecular test

LIMA, Peru – The development of low-cost rapid molecular tests to diagnose SARS-CoV-2 without RTPCR, held by scientists with Cayetano Heredia Peruvian University and EsSalud, as well as researchers with diverse institutions in Germany, U.S., and Japan, has concluded its validation phase successfully, according to Edward Málaga-Trillo released on his Twitter account.

 

It’s about a molecular tests that leads results in 40 minutes, and that only requires saliva samples without the need to gather fluids through nasopharingeal swap. The Rapid Coronavirus Sensitive Monitoring from Saliva, RCSMS, test consists in a Peruvian adaptation of DETECTR diagnose method, a combination of isothermic RT-LAMP amplification (tool for the virus replication necessary for its location) and the enzymatic detection mediated by Cas12A (genetic edition tool).

 

“The kit validation has used saliva samples from 276 patients of two Lima, Peru hospitals (over a total of 350 samples). The scientific article (pre-print) coming from this Project and that’s already featured on the MedRx digital repository points out that has proven that a low-cost thermo-chemical treatment with TCEP/EDTA is enough for unactivate viral particles and cellular nucleases in saliva, eliminating the need to extract viral RNA with commercial kits, as well as the tricky nasopharyngeal swap procedure and the requirement of level-2 biosecurity laboratories for molecular analysis.”

 

This last aspect makes this development still more relevant as much as its massive use can eventually increase considerably the capability of Peru for processing Covid-19 tests as it doesn’t require  qualified personnel, neither sophisticated facilities.

 

“Our clinic validation shows the RCSMS detects until five viral copies per reaction in 40 min, with sensibility and specificity of 93.8% and 99.0% on the field, respectively, related to RTQPCR […] Also, our field research validates the use of lateralflow bands to view easily the SARS-CoV-2 presence, that flatters the way to implement the RCSMS like an attention point test [that leads results in the same place where the test is taken], in environments with limited access to ultimate generation diagnosis laboratories,” the paper points out.

 

In a statement to el Comercio newspaper, Málaga-Trillo underlines the crew has delivered the correspondent documentation to Bionext, the company that will apply for the authorization to Health Ministry’s Board of Drugs and Supplies (Digemid, as in Spanish)to make and to use.

 

Adding to the contestable fund assigned by the National Council of Science, Technology, and Innovation, the research has been funded by Ac Farma, the Spanish Agency for International Cooperation to the Development, the Peruvian Cock Growers Association, Banco Pichincha, Fuxion, Intercorp, Industrias San Miguel, IBT Peru,  ISA Rep, Minera Poderosa, the National Society of Mining, Petroleum, and energy (SNMPE, as in Spanish), and the National Society of Fishing.