Anvisa endorses six new tests for diagnosing the new coronavirus – 03/26/2020 – Balance and Health

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—Anvisa (National Health Surveillance Agency) approved on Thursday (26) six new tests for the diagnosis of infection with the new coronavirus. With this, the total of products already registered in Brazil reaches 17.

The measure is necessary so that companies can offer products on the market – as in laboratories and hospitals. There is no forecast of direct sales to the population.

Of the new tests approved, five use small samples of blood, serum or plasma to detect antibodies against the coronavirus – it is the popular rapid test.

In general, this type of test takes between 10 and 30 minutes to obtain results. Experts, however, have warned of the need to adopt protocols and to check the data of each product before using it on a large scale.

This occurs for two reasons. One of them is the fact that the body takes time to produce antibodies – a period that takes at least five days, according to companies. Thus, a negative result before the recommended period for each test would not exclude an infection by the disease.

The recommendation is that the data be evaluated in conjunction with analysis of symptoms or application of new tests.

Another point is the need to check the sensitivity data – which is the ability to detect positive cases – of these tests for use in Brazil, since most products are imported from other countries and there may be variations.

In addition to the five rapid tests, a sixth approved product uses the PCR technique, which aims to detect the presence of genetic material from the virus in airway samples, such as mucus and saliva.

Anvisa did not provide detailed data on the new products. In a note, the agency says that the supply and production of kits will depend on the capacity of each company.

The records were published in the Federal Official Gazette this Thursday. In the past few days, the agency had already approved 11 tests for diagnosing the new coronavirus, most of them rapid tests.

Currently, the tests used in the country use the PCR technique.

It is a model that has a high degree of precision and is considered a “gold standard” for testing. The analysis time, however, is longer, and takes around four hours (added to other processes, however, the deadline goes up to two days).

This week, the Ministry of Health announced that it plans to expand the offer of tests for coronavirus to 22.9 million in the country.

Of this total, 14.9 million are tests using the PCR technique, used to diagnose patients with severe symptoms, admitted to hospitals.

The others are called rapid tests. The idea of ​​the folder is to start using this second model in health and safety professionals.

The initial protocol foresees that they are applied eight days after the registration of the first signs and symptoms to verify the possibility of returning to work.

In the meantime, professionals would be in isolation at home. At the same time, the government also intends to use the model in flying stations that must be installed to test light cases.

The measure, however, should initially be restricted to cities with more than 500 thousand inhabitants.

The expansion proposal comes at a time when the ministry faces criticism for the decision to concentrate examinations only in serious cases.

On Thursday, the health surveillance secretary, Wanderson Oliveira, again commented on the intention to increase testing. According to him, there is a possibility that the volume offered will exceed 22.9 million during the emergency period.

The increase, however, still depends on negotiations with companies and the supply of inputs for the production of tests in the country.

WHAT TESTS ARE AVAILABLE TODAY TO DIAGNOSE THE NEW CORONAVIRUS

>> RT-PCR LABORATORY TEST

(real-time polymerase chain reaction)
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What it is and what it is for

Called a molecular test, it aims to identify a fragment of the genome of the new coronavirus

How it works

For this, samples of the airways (such as mucus and saliva) are collected using an instrument called a swab, which looks like a cotton swab. This collection is made in health units and sent to laboratories. From there, the genetic material is extracted and analyzed with a test kit using inputs and equipment capable of detecting the virus.

Time in analyze

It takes up to four hours, according to Bio-Manguinhos, a laboratory now responsible for supplying kits. Added collection and other processes, can take days

Benefits and disadvantages

It is considered a method with a high degree of precision, but with a longer analysis time

>> TEST FAST

(such as serological tests)

O what it is and for what it suits

Popularly known as rapid tests, it aims to verify the presence of antibodies or antigens of the virus. You can use two different types of samples: blood, serum and plasma or from the airways, as in the laboratory test.

How it works

Most tests are done with a small drop of blood and consist of a small platform with reagents and a marking line. The material allows to check two types of antibodies (IgM and IgG)

Time to analyze

10 to 30 minutes

Benefits and disadvantages

Despite being faster, it has limitations. One is the fact that the body takes a long time to produce antibodies – in general, IgM appears only after the fifth day after infection; IgG, after the 10th day. It is indicated to be used with specific protocols due to the risk of false negative

SUS SCENARIO

22.9 million is the forecast of tests to be offered, of which which are:

8 million rapid tests
4.9 million PCR tests
10 million PCR theses on automated machines





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