Polymerase chain reaction (PCR) is a routine test for diagnostic and microRNA research that the companies EpiDisease, IMEGEN and Seqplexing have included in their range of services for years. However, the COVID-19 pandemic has given this technique key value as the most effective method for detecting the presence of Sars-CoV-2 virus in humans.

"We have been offering this diagnostic service since May," says Ángela Pérez, CEO of IMEGEN, who adds: "Not only that, but we also manufacture the diagnostic kits to carry them out. In fact, the Valencian company, which has been based at the Universitat de València Science Park for more than a decade, has been selected by the Ministry of Health, through the National Institute of Health Management (INGESA), to supply PCR kits for most of the autonomous communities. "Despite the offer, we are still waiting for the Regional Ministry of Health to count on the services of the Scientific Park companies," he regrets.

Every day at their facilities in Paterna they carry out the analysis of between 100 and 200 samples, to which must be added those carried out at their laboratory in Malaga and which will soon also be carried out at Malaga airport, where they have just been awarded the concession.

"At the moment, we work with companies, whose samples are collected by a nurse at their workplaces, and with individuals who come to us". Out of every 10 PCRs, seven are taken from nasopharyngeal samples. "Saliva samples are taken from children and people who are not easily mobile," explains Greta Carmona, head of COVID-19 test development at IMEGEN.

A new charter of services

EpiDisease has been recognised by the Paterna Ciudad de Empresas Awards as the company that has most significantly transformed and adapted to COVID-19. "The arrival of the pandemic brought an abrupt halt to our research into the development of an in vitro diagnostic kit based on epigenetic markers determined by PCR. Taking advantage of the knowledge and experience we have in this molecular diagnostic technique, we decided to join a consortium of companies - COVID-19 Alliance - for the diagnosis of the new coronavirus, with our laboratory being the nucleus in the Valencia Community," says its scientific director, José Luis García.

Together with the Universitat de València, they have equipped a laboratory in the Science Park with an automated RNA extraction robot and a PCR machine, which allows 1,200 samples to be analysed daily. "The facility is authorised by the Instituto de Salud Carlos III, which depends on the Ministry of Science and Innovation, to provide support to the Valencian Government in the analysis of tests from Valencian hospitals. Furthermore, we are a genetic and microbiological diagnostic centre authorised by the Regional Ministry of Health. All in all, the volume of samples we analyse comes from companies and individuals and averages around 25 a day", explains Eva García, technical manager at EpiDisease.

In this company, the majority of the samples are saliva samples. Trini Alberola, laboratory manager at EpiDisease, stresses that the main advantage of this type of sample is that it does not require the intervention of health personnel, as the person taking the test only has to salivate, deposit it in a sterile bottle - which can be purchased at any pharmacy - and send the sample to the laboratory. However, to ensure greater sensitivity, it should be taken first thing in the morning, on an empty stomach, without drinking water, without smoking and without having used mouthwash.

Strain identification

This is the type of sample that Seqplexing is also working with at the moment. The biotech company was accredited in November as a microbiology laboratory and since then has three professionals on staff dedicated to this PCR service.  "The number of daily samples varies according to the evolution of the wave we are in. While in January we were analysing between 30 and 40 samples a day, we are now working on around 20 a day," says Carmen Ivorra, scientific director. "We are in the process of developing a kit that will also identify whether the strain is the British or South African variant," she says.

The PCR diagnostic test performed by these three companies can detect the presence of a fragment of the Sars-Cov-2 genetic material in the nasopharyngeal or buccal sample on the same day. "If we take the sample before midday, the results are available in the afternoon," say the three biotech companies.

LINKS TO THE PCR SERVICES AT THE SCIENTIFIC PARK OF THE UNIVERSITAT DE VALÈNCIA

IMEGEN: https://imegen.es/paciente/test-covid-19/

EPIDISEASE: testcovid@epidisease.com 

SEQPLEXING: https://seqplexing.com/es/productos/p/COV-PCR-TEST