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Covid, do-it-yourself nasal swabs: where are we?

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During the pandemic there has often been talk about do-it-yourself quick nasal swabs: but where are we? In the US, the Food and Drug Administration (Fda) has already approved some of these tests to be done at home; on this side of the ocean, three of these swabs are authorized in Germany, but in general in Europe – and in Italy – they are used in clinical trials. Meanwhile, the pharmaceutical company Roche recently announced that it has obtained the CE mark (necessary for the marketing of a product) for a less invasive nasal swab that can also be carried out in self-administration, although in the presence of an operator: a way of in short, between a swab carried out by the healthcare staff and a do-it-yourself swab.

Nasal or rhino-pharyngeal swab: what’s the difference?

The idea behind rapid nasal swabs (do-it-yourself or not) is to provide less invasive tools and to reduce the burden and risks of contagion for healthcare professionals. The tampon developed by Roche was also born with this objective, which, according to reports from the pharmaceutical company, should soon arrive on the markets that accept the CE mark. The novelty of the new rapid test is that it reduces the discomfort and makes the procedure easier, for children and the elderly (but not only), since the sample is collected in the anterior area of ​​the nose rather than in the deepest part of the rhino-pharynx. The test is not the only one with these characteristics, given that other do-it-yourself tampons under study and already in use (although still not very widespread) in Italy are nasal and not rhino-pharyngeal, but it could be the first to be able be used on its own, even under the supervision of a healthcare professional. The advantage, in this case, lies in the fact that the physical proximity and therefore the risk of contagion would be reduced for the operator.

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How accurate is the new nasal swab

The doubts of some experts, also exposed in an article in Nature, concern do-it-yourself: the risk could be that of taking the biological material incorrectly, distorting the results. However, a still preliminary study (on 146 symptomatic participants) indicates that the do-it-yourself tampon could be as effective as that performed by healthcare personnel. Another perplexity, which does not only concern the do-it-yourself tests but in general the rapid ones, concerns the lower precision compared to the classic, molecular ones, with longer times. In the case of the Roche test, the company reports high sensitivity and specificity, two measures of the accuracy of the test, even when done independently. In particular, the sensitivity and specificity in a sample of 468 people were respectively 84% and 99.8% in the case of tampons administered independently by the participants. The percentages based on this sample are higher than the minimum requirements indicated by the Ministry of Health (sensitivity equal to or greater than 80% and specificity equal to or greater than 97%).

Do-it-yourself tampon research

The topic has been talked about for some time, since an experimentation on tampons to be done at home started in Veneto last November, which can be purchased in pharmacies for less than 3 euros, based on the diagnostic test developed by the group of microbiologist Roberto Rigoli of Treviso. The investigation is now completed and the results are being evaluated by the Istituto Superiore di Sanità. Currently, rapid diagnostic tests are for the exclusive use of health personnel (in the appropriate centers or pharmacies). Another nasal do-it-yourself kit, called Uffa, was made by the immunology laboratory of the Meyer Hospital in Florence and is currently being validated.

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Among the do-it-yourself tests already available, there is a molecular swab (not rapid), also nasal and less invasive, for self-administration, developed by the startup Testami together with Biogem. Already available online, the kit, certified by the Ministry of Health, is based on the nasal sampling that must be sent by the user to the research laboratories, which in turn will communicate the result.

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