OCU lists 'approved' OTC pharmacy self-diagnosis Covid tests

A LEADING consumer organisation in Spain has warned members of the public to only buy self-diagnosis Covid tests from high-street pharmacies, as these will have been approved by the European Medicines Agency (EMA) and the Spanish Agency for Medicines and Healthcare Products (AEMPS). 

According to the OCU, a number of testing kits are being sold on the internet, with no guarantee that they are officially approved and reliable.

To help consumers identify the ones that are fully licensed for sale and use in Spain, the organisation has listed nine antigen test kits which, if purchased from a pharmacy, are the 'real thing'.

Antigen tests give fast results, in approximately 10 to 15 minutes, meaning they are ideal for people who just want peace of mind or to 'prove' they are negative if they are seeing a friend or family member and want to reassure them, and themselves – they are much cheaper than a PCR test and, according to the OCU, cost between about €6 and €14 from a high-street chemist's.

They are not as accurate as a PCR, however, so if anyone has symptoms compatible with Covid-19 or is known to have been in contact with a 'positive', they should not use an antigen test; a PCR gives much more detail about the nature of the infection and enables it to be treated or monitored correctly.

Eight of the test kits named by the OCU as being 'official' give results from a nasal swab.

These are the SARS-CoV-2 fast-track test, manufactured by Xiamen Boson Biotech; Flowflex antigen SARS-CoV-2, manufactured by Acon Biotech; Diaquick antigen SARS-CoV-2, manufactured by Acon Biotech; 2019-nCov antigen test, manufactured by Guangzhou Wondfo Biotech; antigen SARS-CoV-2 fast-track test, manufactured by Hangzhou Alltest Biotech; Clinitest Rapid Covid-19 antigen self-test, manufactured by Healgen Scientific; SARS-CoV-2 nasal antigen self-test, manufactured by SD Biosensor; and the fast-track self-test antigen SARS-CoV-2 kit, manufactured by Beijing Lepu Medical Technology.

One other self-diagnosis testing kit works with a saliva swab – the fast-track antigen Covid-19 self-test manufactured by Hangzhou Alltest Biotech.

All of these are now available over the counter in pharmacies, without prescription.

The OCU says test kits must have the European Community kitemark and details of the organisation which has approved their sale, complete with a four-digit number.

Although the consumer group has alerted the public about the dangers of buying self-diagnosis tests online, it says there is no problem with using a high-street pharmacy website rather than going to the premises in person, provided the customer is certain this is, in fact, the official page run by the establishment in question.

To check you are buying from a genuine pharmacy via its own website, a list of authorised premises is shown on Distafarma, the OCU explains.

As well as naming the nine approved test types, the OCU stresses the over-the-counter self-diagnosis kits are not valid for travel abroad.

Also, a positive from an antigen test bought from a pharmacy without prescription is considered a 'suspected case' only, pending a PCR or professionally-conducted antigen test by a qualified medical practitioner.

If a pharmacy self-test kit is used and gives a positive, the person should immediately contact a GP surgery or, if out of hours, phone the nearest walk-in clinic or ring the relevant Covid helpline for his or her region, but should stay at home and not go in person to a medical centre.

More information about the types available from local pharmacies, including the antibody tests – which are not valid for travel either – and how to 'read' them can be found in our article on OTC Covid self-test kits.