In a few days you can take a covid-19 test at home: why it can be a problem

Subsequent Tuesday, July 20, the Council of Ministers will approve the pharmacy sale of fast antigen checks to make use of at house. These checks, not like these for antibodies that have been already available on the market, detect items of SARS-CoV-2 DNA and subsequently point out energetic infections. As Minister Carolina Darias stated this week, the principle focus of those diagnostic checks is on younger individuals from 12 to 29 years previous, who nonetheless have just a few weeks to be vaccinated and who’re presently the largest headache of the authorities as a result of they star within the overwhelming majority of recent instances.

The announcement comes after nearly all Western European international locations (Portugal, Germany, France, Italy, Belgium, Holland, Austria or the Czech Republic) have put this kind of check on sale each in pharmacies and in supermarkets. As could be seen within the incidence map by nation of the final 14 days, the covid-19 house checks they don’t seem to be a definitive weapon —As it’s noticed in Portugal, which in the present day has an identical transmission of the virus—, however they’re undoubtedly helpful, particularly when they’re destined for the unvaccinated inhabitants.

Incidence map for the final 14 days. (ECDC)

As usually occurs with every little thing that surrounds the pandemic, the approval within the subsequent Council of Ministers won’t be written in marble, however will probably be a common framework that the regional administrations should chisel in their very own method. The Neighborhood of Madrid, a pioneer in utilizing antigen checks in our nation, has additionally been essentially the most militant on this regard and has been demanding the Authorities for months to make these self-tests accessible to the general public.

In January of this yr his carried out in pharmacies or dental clinics, however with situations: solely residents summoned by SMS in fundamental well being areas with excessive incidence may entry them. The measure was removed from being a hit, since, as this newspaper revealed in Might, solely 0.5% of the antigen checks within the CAM have been carried out in these institutions.

Questions with out reply

Inside just a few days of the measure taking impact, there are a lot of unanswered questions. For instance, since covid-19 is taken into account a illness of “urgent mandatory declaration“If somebody checks constructive in a house check, they must notify it instantly, however to whom? The corresponding Well being Council or the ministry? In what interval? get a second check, carried out by a healthcare skilled, to endorse the house check? How wouldn’t it be assured that the house check has been carried out with all of the ensures?

The matter turns into much more related after we take into consideration journey. Is it sufficient to take a check at house for a unvaccinated individual can journey to the Canary Islands or the Balearic Islands? Sources from the Ministry of Well being clarify to El Confidencial that this can rely upon the Public Well being departments of the respective autonomous communities.

Photo: The Minister of Health, Carolina Darias.  (EFE)
Well being will give the inexperienced gentle to the sale of self-diagnostic checks with no prescription

Companies

With regard to this matter there are two positions. In international locations corresponding to Germany or Portugal, these checks are legitimate for touring, whereas others such because the Netherlands solely think about them appropriate for self-diagnosis, however do not allow tourists to access their territory if solely considered one of these house checks have been completed, particularly if they arrive from international locations with excessive incidence or the place some fascinating variant corresponding to delta has been detected. It isn’t identified in the meanwhile if Spain will undertake a typical place – essentially the most wise choice – or every territory will agree by itself.

Skilled / House

The explanation for the delay within the implementation of this kind of check, in keeping with Darias, is that till now solely these for skilled use have been accredited, that are distinguished from these that may be bought in pharmacies. For instance, the Abbott Panbio check was the primary for use in our nation in September 2020, but it surely may solely be utilized in a medical or hospital setting. On June 28, the American firm finally received the CE mark —Which permits it to be marketed in Europe— for self-testing.

The expertise is actually the identical, by a bit of saliva or a nasopharyngeal sampling it’s dissolved in a small bottle of liquid after which a drop is placed on a check strip, which provides the outcome after 15 minutes. The primary distinction, within the case of the primary self-tests that have been marketed in the US, was that to acquire the outcome it needed to be checked by an utility on the cell phoneWith a view to test that the check had been carried out accurately, acquire information concerning the consumer and be capable of inform the well being authorities within the occasion of a constructive check.

One individual makes use of the Ellume self-diagnostic check. (Reuters)

Regardless of what it might appear, in keeping with the ECDC evaluation of these devices, there may be not an enormous distinction between the samples being taken by professionals in a clinic or by somebody at house. The primary drawback with these self-tests, along with the communication of the outcomes, is quite within the false negatives.

In contrast to the antigen checks which can be completed in screening, for instance in high-incidence neighborhoods, these are targeted on a inhabitants that’s largely asymptomatic. What does it imply? That he margin of error will increase, notably when figuring out positives. Such a check is usually marketed with a specificity and sensitivity larger than 95%, however that’s not precisely what they just lately discovered within the Irish well being service. A research carried out final month supplied a 52% sensitivity in the case of the Abbott test, and that the topics practiced the gathering of samples beneath the supervision of execs.

In sensible phrases, which means for each 1,000 younger individuals contaminated with COVID-19 who take this check, 480 would have a destructive outcome and they’d exit to drink, dance or journey with complete peace of thoughts. Or to learn Aleksandr Pushkin to the municipal library, which isn’t a query of stigmatizing the lady and, completely, any exercise indoors is prone to trigger contagion.

They promote a sensitivity of 95%, however in actual checks they’ve supplied a sensitivity of 50%

The prediction of a constructive worth shouldn’t be steady, however decreases with incidence. In different phrases, house checks are tremendously helpful when the incidence is excessive, but when it is rather low they might not be very helpful.

“In precept we aren’t in opposition to its dishing out in pharmacies and well being facilities, however there are a lot of features that must be established”, explains Santiago Valor, medical director of Synlab, one of many laboratories that within the final yr and a half has been in control of carry out PCR checks first and antigens or antibodies later. “The sensitivity of antigen checks is restricted and subsequently their use must be indicated in conditions the place PCR can’t be used, primarily in symptomatic individuals who require an instantaneous medical classification “.

The minister identified this week {that a} constructive can solely be thought of “suspicious”, and {that a} PCR will probably be essential to certify contagion.

For Valor, this kind of check “ought to solely be used to detect contaminated people early and act to forestall transmission and supply them with well being care”, however in no case “as a safe-conduct to beat well being obstacles to the unfold of an infection”, whether or not journeys or group conferences corresponding to live shows, “since there isn’t a proof that the choice and the willpower have been made accurately to the indicated particular person.”

Along with these points, there may be that of incorporate the outcomes of those fast antigen checks into databases of well being programs, one thing that might be achieved by way of some kind of expertise, however not if the checks are the most cost effective, corresponding to these which can be being offered in some European international locations.

To this point, along with the Abbott mannequin and one other from the LumiraDx firm, it has transpired that the pharmaceutical firm Cinfa or the distributor PuenteChina will market self-tests of the corporations in our nation. IES Medical or Xiamen Boson Biotech. The costs will probably be between seven and 13 euros per check.

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