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CerTest & Palex, Rapid Tests and PCR for COVID-19 identification

25/09/2020|

CerTest Biotec and Palex Medical: two Spanish companies as an example of excellence in development, production and implementation of rapid tests and PCR for the diagnosis of COVID-19.

At CerTest Biotec, the production of PCR tests for the diagnosis of COVID-19 has not stopped increasing since last February when the company made it available for the health authorities. With Palex Medical, responsible for its implementation throughout the territory, supply to hospitals and diagnostic centers is assured in less than 24 hours. Now, this alliance is reinforced with the new antigen rapid tests developed by CerTest, offering a result in 10 minutes, with PALEX distributing throughout Spain.

The production capacity and coordination of both companies to face the situation of increasing demand since the beginning of the pandemic, allowed more than two and a half million of PCR tests carried out in Spain to be the VIASURE SARS-CoV-2 Real Time PCR Detection Kit CerTest manufactures in its facilities at San Mateo de Gállego (Zaragoza). Thanks to the logistics and technical organization of Palex, which has completely devoted itself to supporting the system health, reaches hospitals, clinics and private laboratories throughout Spain. In the words of Montse Carenys, Manager of Palex Medical, “to have a national manufacturer and a product that can be stored and transported at room temperature, without the need for special conditions, has been crucial to guarantee supply at the most critical moments during these pandemic months”.

CerTest Biotec, S.L., an independent company devoted to the development and manufacture of products for the in vitro diagnosis of infectious diseases, has been doing a significant investment in the production capacity for the PCR diagnostic kits. More than 150,000 PCR tests are manufactured a day.

The VIASURE SARS-CoV-2 Real Time PCR Detection Kit test has been validated and recognized not only at the national level, by the Carlos III Health Institute, but also by international organizations, such as the Therapeutic Goods Administration -TGA- of Australia, the National Drug Administration, Food and Medical Technology of Argentina, or the Foundation for Innovative New Diagnostics (FIND), worldwide recognized.

CerTest’s productive capacity is independent from third parties. Most of the components and reagents needed to manufacture both rapid tests and PCR are also produced inhouse.

The collaboration between CerTest Biotec and Palex Medical has been essential for the hospitals and diagnostic centers to have the required test on time. Palex Medical provides logistics for the test to reach the laboratories at Spain, the specific technical equipment for carrying out the test, as well as the support of the specialists who have been from the beginning accompanying health professionals for the implementation and proper operation of the diagnostic test manufactured by CerTest.

The continuous commitment during these months, and the relevant role of the two Spanish companies since the beginning of the pandemic, is now being reinforced with the new released rapid test for the identification of SARS-CoV-2 antigens in respiratory samples.

The next few months will be crucial in the fight against the virus. Nelson Fernandes, Managing Director of CerTest Biotec believes that “shortly we will have the Flu and Cold season, which will surely bring a great alarm among the population. To have reliable tests which can differentiate the Covid-19 from the Flu or RSV becomes essential to make a screening and follow-up of the initial population, separating positive cases and reducing the need for confirmatory tests, always according to the criteria of health personnel”.

With this possible scenario, the CerTest R&D team has developed different diagnostic tests, both PCR and rapid tests, capable of differentiating SARS-CoV-2, Influenza (Flu causing) and RSV viruses from one patient sample. VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit is the name of the PCR assay. The family of rapid tests to identify the virus is expanded with combos, which allow, from a single patient sample, to differentiate SARSCoV-2, Flu A, Flu B and RSV, offering a result in 10 minutes.

It should be noted both diagnostic techniques must be performed in laboratories by profesional staff, and should always be handled and interpreted under the criteria of healthcare personnel.

Both companies are open to answer any question through their usual contact channels.

September. 2020

 

Download this statement (.pdf file, Spanish language)

Palex Medical, S.A. website

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