Translation of VIASURE PCR tests by the company CerTest Biotec

At AbroadLink, we have been translating instructions for use (IFUs) of the company CerTest Biotec since 2016. However, it was only last year during the lockdown that we became very aware of the importance that the translation of in vitro diagnostic (IVD) medical products can have.

At the time, we were glad to have increased the requirements in selecting translators specialised in medical and medical device translation through the implementation of the ISO 13485 quality standard in our company.

Translating IFUs of the various diagnostic tests of CerTest Biotec, especially the diagnostic tests for COVID-19, has been and continues to be a challenge. A challenge that we feel satisfied with and that fulfils us as professionals, given the significant consequences it has for society at this time.

1. What is CerTest Biotec?

CerTest Biotec is an manufacturer of diagnostic tests located in Zaragoza, Spain. The company was founded in 2002 by a pharmacist and a biochemist, Carlos Genzor and Óscar Landeta. CerTest Biotec is an inspiring example of a successful company, having grown exponentially since its creation thanks to its R&D strategy and the internationalisation of its products. The company currently sells its products in more than 130 countries.

In January 2020, they began developing a kit for diagnosing COVID-19. At the time, the virus was still only a problem existing in China for most of the public opinion.

Currently, the company has several diagnostic tests for COVID-19, which also differentiate the variants that have appeared in recent months, such as the British, Brazilian or South African variants, among others.

2. Translation of instructions for use of CerTest Biotec

CerTest Biotec translates the IFUs of many of its products into more than twelve languages. This documentation provides the necessary instructions for laboratory personnel to correctly use the diagnostic tests developed by CerTest Biotec. These IFUs also include information on how to interpret the results obtained as well as the analytical and clinical performance, such as specificity, sensitivity, etc., that each product presents.

Both the aspects related to the preparation of IFUs and their translation, as well as other regulatory requirements, are well established in all the current legislation that you can consult at the Spanish Agency of Medicines and Medical Devices (available in Spanish).

One of the difficulties we encountered while translating IFUs was discerning which names of the different pathogens tested should not be translated. Laboratory personnel performing the tests can better identify the names of different strains of viruses, bacteria, etc., if they are in English or if a nomenclature is used in accordance with previously published standards.

To achieve this goal, AbroadLink project managers identifies all those names that should not be translated. All identified names are entered into a glossary that is confirmed with the Regulatory Affairs department of CerTest Biotec and distributed among the translators assigned to the project.

The requirement to translate IFUs into all the official languages of EU member states is set to significantly increase the demand for translation companies with a scientific-medical specialisation in the coming years.