Covid Self-Test: How it works in the US and Europe

The recent increase in cases of Covid-19 and the lack of tests in laboratories to carry out the diagnosis have drawn attention to another possibility of detecting the disease not yet available in Brazil: self-tests.

Sold in pharmacies or distributed by the public health system in other countries, self-tests are different from the tests that are already available in some drugstores in Brazil. While the tests already available to Brazilians are collected and interpreted in pharmacies, the self-tests are performed and interpreted by the user himself, who collects his own sample and follows the manufacturer’s instructions.

Self-tests can be purchased in advance and kept at home to use when needed, for example.

According to pathologists, the reliability of the test depends on a number of factors: the person’s ability to follow instructions for sample collection and testing, the viral load at the time of sampling, and the prevalence of disease in a population when the test is performed. .

Available in countries such as the USA, Canada and the United Kingdom, the self-tests still do not have authorization for commercialization in Brazil because their use “needs to be part of a public health policy” that is the responsibility of the government, said Anvisa (Agência de Vigilância Sanitária) in a note last week.

Anvisa states that the “situation of self-tests aimed at notifiable diseases requires linkage to public policies with clearly defined purposes, associated with adequate clinical care and support and, as appropriate, contact tracing to break the chain of transmission.”

“Other countries that have adopted the approach of carrying out in vitro tests for Covid-19 outside the laboratory environment have health criteria aimed at such situations and have established public policies in the perspective of combating the spread of coronavirus”, said the agency.

“The assessment of scenarios, epidemiological context, cultural factors and even the capacity of assistance must be considered in the implementation of measures aimed at improving results.”

Self-tests to detect pregnancy or health conditions such as blood sugar are authorized in Brazil. But a 2015 agency resolution states that tests for the detection of pathogenic (disease-causing) organisms or transmissible agents cannot be performed by self-testing.

However, says Anvisa, it is possible to create exceptions as part of public health policies, as was done with self-tests for HIV detection – which were authorized and made available in the SUS.

After Anvisa’s declaration, the Ministry of Health, responsible for the elaboration of public health policies, sent a document to Anvisa asking for the release of the tests and providing for its “large-scale” use.

The agency is analyzing the request and the expectation is that the result will be released this week.

Next, understand how self-tests work in other countries where their use is already part of public health policies created by governments.

Risk Reduction Measure

In the United States, the CDC (Centers for Disease Control) authorizes the sale of self-tests in pharmacies as part of a policy of population-wide testing — with a series of recommendations for use.

According to the American health organization, the use of self-tests is one of many risk reduction measures adopted or advised by the government, such as vaccination, use of masks and social distancing.

The entity explains that the advantage of self-tests are quick results. “Self-tests are one of several testing options for Covid-19 and may be more convenient than lab tests,” says the CDC.

“You can do the self-test even if you have no symptoms and are fully vaccinated,” says the agency. For example, if you have been in contact with people who have become ill or have been exposed to a risk. “This contributes to making decisions that will help prevent the spread of Covid-19”,

CDC has a series of videos and instructional material for using the resource. The entity points out that, while a positive result means that you need to isolate yourself for at least ten days and warn people with whom you have had contact, a negative result does not necessarily mean that you are free of the disease.

“If you were tested while you had symptoms and followed all instructions carefully, a negative result means your current illness is likely not Covid-19, but that doesn’t completely rule out that possibility.”

“However, it is possible for the test to be negative in people who have Covid-19. This is called a false negative. You can also be negative if your sample was collected very early in your illness. In that case, you may have a positive result later on,” says the CDC.

Pharmacy tests have been used widely in the US, where laboratory tests are expensive and there is no public health care system.

Recently, the increase in Covid-19 cases and the arrival of the omicron variant has led to a shortage of self-tests in the country.

This week, Dr Anthony Fauci, a White House adviser on fighting the pandemic, said the problem will be resolved soon. President Joe Biden announced that the government has purchased 500 million tests to be distributed free to the public.

‘Careful planning and implementation’

Self-tests for Covid are also authorized in Europe, but the ECDC (European Center for Disease Prevention and Control) says that the routine use of pharmacy tests in European Union (EU) countries for the detection of the disease needs to be very “well-known”. planned and carefully implemented”.

In a document addressed to health authorities in EU countries, the health body states that, before implementing self-examinations, health authorities need to analyze the prevalence of the disease (number of cases) and the scenario in which they will be used — such as for testing the general population or for specific groups or situations.

The ECDC says that self-tests can contribute to Covid-19 testing capacity by detecting cases early and reducing transmission, because they allow for rapid self-isolation of infected people.

“However, shifting responsibility for reporting test results from healthcare workers and laboratories to individuals can lead to underreporting and make measures such as contract tracking and quarantine even more challenging,” the ECDC says.

“Current indicators for monitoring the intensity and spread of the Covid-19 pandemic may be (negatively) affected and it may be more difficult to monitor disease trends over time.”

An additional challenge, says the entity, is that the self-test samples will not be available for sequencing and monitoring of worrisome variants of the disease, such as delta and omicron.

The health authority also highlights that there are still few conclusive studies on self-tests as a tool for Covid control.

free distribution

In the United Kingdom, Covid self-tests are distributed by the public health system at no cost, in kits with seven tests. Brits can pick them up at pharmacies or order them online for delivery by post — at no extra charge.

At the end of December, with the advancement of the omni in the UK and an increase in demand for tests, the distribution of these tests was compromised by an imbalance between supply and demand.

After carrying out the self-test, the recommendation of the British government is that users report the results, over the internet, to the public health system.

Other countries, such as Australia and Canada, have also included detection with self-tests in their policies to combat Covid. In both countries, it is also possible to obtain the tests free of charge from the public health system.

In Australia, it is possible to request self-tests from the government and it is mandatory that positive results are reported by users.

The country’s health authorities advise citizens to perform self-tests in situations such as before visiting a place where there is a high risk (such as a nursing home or health facility), before going to a place where there may be crowds, before return to face-to-face work and to reassure yourself if you have no symptoms but are feeling anxious. However, the authorities determine that in the country, if the person has any symptoms of Covid, they need to have a laboratory test.