Industry says it can deliver up to 10 million Covid self-tests per month

Executive President of CBDL (Brazilian Chamber of Laboratory Diagnosis), Carlos Gouvêa estimates that the industry installed in Brazil has the capacity to produce up to 10 million Covid self-tests per month.

Delivery would depend on demand for the exam, which still needs to be regulated by Anvisa (National Health Surveillance Agency) and the federal government.

Still according to the entity’s estimate, which claims to represent 70% of the diagnostic products market, the product should be cheaper than antigen tests, currently supplied in pharmacies and laboratories.

Production capacity was raised in consultation with CBDL and its associates. It also considers the possible manufacture of the product in public laboratories, said Gouvêa.

He projects that the population should look for 20 million to 40 million units in the private market, in 2022, of this exam that can be done at home. Demand in the public network would depend on public policies defined by governments.

Gouvêa says that the production of the self-test is more expensive than that of antigen tests, but that the final product should cost less, as it does not include the price of the test service.

“Today we see values ​​from R$ 70 to R$ 150 (of antigen tests) in pharmacies. The self-test should be from R$ 45 to R$ 70”, says Gouvêa.

Scientific entities demanded this Tuesday (11) a broader testing policy and permission to test at home. The demand for tests soared with the advance of contamination at the turn of the year.

In a note released this Wednesday (12), Abramed (Brazilian Association of Diagnostic Medicine) warned of the risk of lack of necessary supplies in Covid-19 exams. The entity recommended prioritization of exams to patients “according to a severity scale”.

The executive president of CBDL said that the shortage of the product is not widespread and should not be prolonged, as companies have resumed hiring and expanding manufacturing lines.

According to Gouvêa, the market should be able to offer a greater volume of self-tests than required by consumers, but delimiting this demand would still depend on the advancement of the disease. “The self-test comes to complement. The RT-PCR exam itself [considerado ‘padrão-ouro’] continues to play its role,” he said.

The industry representative estimates that the first home-based tests for Covid would hit the market about a month after government regulation of the product. After the rule is released, companies must still register the tests with Anvisa and provide the products.

For Gouvêa, there will be a good supply of self-tests in about three months after the product enters Brazil. He states that national companies already have self-test designs ready to be manufactured.

Testing in Brazil is centered on clinics, pharmacies and public services. Anvisa is waiting for the ministry to propose a public policy to then regulate the self-test.

Health Minister Marcelo Queiroga said that the federal government’s proposal should be delivered to the agency this week.

“It is an initiative that can be added to the efforts of the Ministry of Health, of the public power, in general”, said the minister this Wednesday about the self-test.

One of the doubts in the government is about how to notify the SUS of the diagnosis of Covid obtained by the self-test.

For Gouvêa, an alternative is to provide a QR Code on the device box so that the patient can notify the government if they confirm the infection.

The CBDL president also states that the self-test is complementary, so the notification of the result would not be the main function. “The person tested at home will at least seek confirmation of the infection, probably in the laboratory. He will still stop going out, warn those closest to him. He has already reached the public health objective of cutting the transmission of Covid”, he said.

According to the entity’s consultation with its members, the private market offered about 38 million antigen tests in 2020 in Brazil and 31 million in the following year. The trend, assesses Gouvêa, is for a drop in demand in 2022 in the private market, to 20 million, as the federal government promises to reinforce the distribution of this type of exam in the SUS with the delivery of about 40 million units.

In addition, part of the demand must be supplied by the self-test, says Gouvêa.

According to him, most home testing products are sold in a box with a test available. “Some manufacturers evaluate delivery with two tests per unit. In the United States there are boxes with 5 tests”, he said. The tests are composed of material for collecting the patient’s sample, in addition to diluents and a device to present the result of the analysis.

The person himself collects material (with the aid of a swab, as in a normal PCR) and deposits it on a surface that indicates whether he is infected or not.

The Brazilian industry, in general, assembles the product in Brazil, with imported parts, according to Gouvêa.

Self-testing is not authorized in Brazil because of a 2015 Anvisa resolution, which says that products for the purpose of diagnosing the presence or exposure to a transmissible agent cannot be provided to laypersons, “including agents that cause infectious diseases that can be compulsory notification”.

The same rule establishes that the ban “may be removed” if there are “public policies and strategic actions formally instituted by the Ministry of Health”.

And an exception to this has already occurred. A few years ago, following an initiative by the Ministry of Health, self-tests for HIV were released, which have the support of the WHO (World Health Organization) and PAHO (Pan American Health Organization).

For Gouvêa, there is scope for Brazil to advance on self-testing for other diseases, such as HPV, syphilis and Hepatitis C.