Anvisa approves new Covid-19 test that uses innovative biotechnology

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The National Health Surveillance Agency (Anvisa) has approved the use of a new reagent for the Real-Time PCR test, which allows obtaining the genetic material of the new coronavirus through an exclusive process, eliminating previous steps of extraction and allowing it to be carried out directly from the sample.

This is the artus ® SARS-CoV-2 Prep & Amp Kit, a method that uses a liquid-based sample preparation technology, which simplifies and increases the yield of Covid-19 tests.

The kit has been registered for use in markets that accept CE-IVD labeling. In addition, QIAGEN, a German multinational, has applied to the US health authorities for an emergency use authorization for the product.


Product Differentials

According to its manufacturer, the new diagnostic kit identifies the presence or absence of Covid-19 in samples of swab nasopharyngeal and saliva through detection of viral genetic material, saving time, materials and costs.

“This new diagnostic kit can allow greater savings in time, materials and costs, increasing the processing capacity of exams. By decreasing the TAT (turn around time) of the exam, the results can be made available to the attending physician in less than an hour, allowing a quick medical action to be taken, thus generating a direct impact on issues such as social isolation, investigation of contacts, return to work, need for new exams complementary treatments and treatments”, said clinical pathologist Pedro Serrão Morales, columnist for PEBMED, in an interview with the PEBMED News Portal.

Also read – Triple infection: is it possible to have covid-19, flu and dengue at the same time?

syndromic testing

Another technology that has come to facilitate the work of health professionals is syndromic testing, which identifies up to 22 respiratory pathogens of clinical interest, using the technology IQ Astat-Dx.

As several respiratory diseases present a set of similar signs and symptoms (including co-infections), generically characterized by a “flu syndrome”, it is difficult to distinguish them clinically, thus impairing a diagnosis and a specific treatment. This new test can help doctors a lot in this regard.

Another benefit of the technology is the diagnosis of some infections that usually go undetected due to the lack of routine tests available in hospitals.

“In this way, this type of testing can help in the precise identification of the agent causing the respiratory infection, directing the assistant physician to a more specific and appropriate medical procedure”, highlighted the clinical pathologist.

Diagnostics industry sector

Undoubtedly, the diagnostic industry sector has gone through (and overcame) major challenges during the Covid-19 pandemic and has certainly achieved a prominent place and a leading role in this history. In addition, obviously, there is the challenge of developing specific tests for the diagnosis of infection.

“We had to deal with a huge shortage, at a global level, of supplies to carry out the exams. However, it is important to highlight that, in record time, the sector developed and perfected methodologies and diagnostic kits for molecular, antigen and serological tests, which are essential tests to help adequately control the pandemic and formulate public health policies”, he highlighted. Pedro Morales.

In the opinion of QIAGEN Vice President in Latin America, Paulo Gropp, by eliminating diagnostic uncertainties, “these tools are able to provide guidelines for the most appropriate medical management, with the use of the correct medicines and a more responsible approach”. in terms of administration and antibiotic resistance”.

*This article was reviewed by the PEBMED medical team


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