Like many people since antigen test arrived at the pharmacies, Carla (not her real name) decided to buy one before going to a family meal. She always takes all the precautions she can, but she was calmer if she did. However, as soon as he asked for it in the establishment, he detected something strange. The pharmacist told her how to use it, explaining that she should reach down the throat with the. She was surprised, because she had heard that with the self test the sample was collected only from the nose. He didn’t ask, he just decided to take him home and there read the leaflet; but, when I went to check it, there were none. He only found a zip bag with the necessary components to run the test. Among them, there was one inside a container that read: “For professional use only.”
Of course, what happened to Carla It is not something that is happening in pharmacies in a generalized way, but rather something isolated. However, it is important to bear in mind that it is a possible option for us, as consumers, to know how to recognize a true self-diagnostic antigen test.
Not everything goes. Although it may not seem so at first glance, the antigen tests carried out in laboratories and health centers are not the same as those we can use ourselves, so the former cannot be sold to the general population. The consequences, strange as it may seem, they could be dangerous.
How to recognize a self-diagnostic antigen test?
“The pharmacist took from the counter a zip bag with the stick in an individual bag, a small bottle with a liquid and a package in which she explained to me what the test was and a kind of dropper”, Carla tells us.
The self-diagnostic tests are evaluated before they are marketed
Actually what was in that bag was the hyssop with which the sample is taken, the buffer in which it must be introduced before passing it to the test, the cassette, similar to that of a pregnancy test, and the Pasteur pipette with which the sample droplets to be analyzed are taken. Carla thought that this would be a sample they had at the pharmacy to explain to customers how to use the antigen test; But, after the explanation, in which he did not remove any component from its individual packaging, it was that bag that he sold.
That, together with extraction method, was what surprised him the most. It was certainly a sign that what they were selling him was not suitable. But what else should he have noticed?
“To know if a product is of auto diagnosis this indication should be read in the labeling and instructions for use”, Explains to Hipertextual Antonio Blanes, director of technical services of the General Council of Pharmaceutical Colleges. “In addition, both will include the CE marking, followed by the four digits of the notified body that has assessed it”. The latter is important; since, according to the pharmacist, “self-diagnostic tests for SARS-CoV-2 are evaluated before they are marketed by a notified body.” And this is something that does not happen in the case of tests for professional use.
We must, therefore, make sure that what they sell us includes that code and, of course, instructions. If they give us a bag with the components, but the instructions tell us because they are not included in the package, something is wrong.
Of course, the pharmacist can explain to us how it is used. In fact, if we have any questions, he is the right person to inform us. However, this does not exempt the instructions from accompanying the product.
Antigen test acquired by Carla
What does the brand say?
The test that Carla bought was from the brand Global Medical Plus. If we go to its technical sheet, it does not take long to see that sold in large boxes, which include various cassettes, swabs and buffer bottles. And a single instruction manual. Therefore, in this case they were sold separately in a zip bag and the instructions had to be given orally. Because they possibly opened one of these boxes that is supplied to the labs and sold each kit separately. But can that be done?
In Sanivending, a distribution company for this type of product, it is clearly stated that “the sample is taken through a non-superficial nasal swab, so the test must be carried out by a qualified professional in the healthcare field”.
In addition, in the technical sheet of the brand you can read the following:
This is a product classified as “In Vitro Diagnosis”, it is not a “Self Diagnosis” product, therefore it cannot be sold to individuals, but to Companies, Hospitals, Health Centers, Clinics, Laboratories, Nursing Homes, Services Public or Risk Prevention Mutuals, which have health personnel to carry it out and provided that the guidelines established by the Ministerial order published in the BOE of April 14, 2020 are complied with, which establishes that “the performance of diagnostic tests for the detection of COVID-19 in those cases in which there is a previous prescription by a physician and they comply with criteria established by the competent health authority “
Global Médica Plus technical data sheet
It is true that last July a correction was made in the BOE, which added COVID-19 testing to the list of diagnostic tests that can be marketed without a prescription. In it, there were previously those of pregnancy, HIV and self-diagnosis of blood glucose. Therefore, this indication would be somewhat out of date. However, since this is a test that requires a nasopharyngeal sample, it could not be marketed to the non-specialized public as a self-test.
Antigen test acquired by Carla
What can happen when you buy one of these products as if they were self-tests?
Buy a use antigen test A professional believing it to be self-diagnosing can be dangerous on two levels.
On the one hand, if Carla had followed the advice of the pharmacist, she would have had to extract a nasopharyngeal sample, in which the swab is inserted through the nostrils and gently brought into the pharynx. Anyone who has done one of these tests previously would notice that when the toilet is extracted, the sample reaches the throat with the swab. This is not easy and to do it correctly training is necessary. Therefore, the self-diagnostic test are designed to obtain results from a nasal sample, much easier to obtain. If in this case the buyer, without health education or specific training, had heeded the instructions of the pharmacist, it would have been possible to do a lot of damage, as it has well explained to this media Carmen Enter it, PhD in Biology and Technical Director of Lorgen.
“Obviously there is a risk of self-harm that must be avoided using self-diagnostic tests in which the sampling is adapted and avoids this type of damage as long as the manufacturer’s instructions are carefully followed, so I insist on the importance of acquiring these test at the pharmacy and even ask the pharmacist for advice as a healthcare professional. On the part of pharmacists, I think that they should ensure the safety of the client and acquire only those tests that are adapted and validated for self-diagnosis ”.
Carmen Entrala, PhD in Biology and Technical Director of Lorgen
The second problem is precisely the second that Entrala cites. Professional use tests are not validated for self-diagnosis. Therefore, if Carla, who knew that in the self-tests the sample is nasal, had not followed the advice of the pharmacist and had simply inserted the swab in the nose, the result could have been a false negative.
Do not buy antigen tests outside of pharmacies
Both Carmen Entrala and Antonio Blanes insist that we should never buy these products in a place other than the pharmacy. It is the only establishment where we can purchase self-diagnostic tests that have been validated correctly.
We must not stop trusting pharmacists because these types of isolated events occur. They continue to be great professionals who will surely help us with everything we need. But these cases, even being isolated, serve to remind us that Information is power. And, when we risk our health on it, the more information the better.