Last December, there was a massive media campaign focused on promoting the product Domácí test na HIV (Home HIV Test); the “faces” of the campaign were sexologist Radim Uzel and a model Agáta Hanychová. The press claimed: “Sixty seconds and you know whether HIV virus is in your body.” Except for various PR articles, also shows of radio and TV stations assured that within several seconds, people at home can check on their own if they are threatened by the fatal AIDS disease. Similar articles appear nowadays as well and their goal is maximal support of sale of the tests. In persons who are informed in an average extent, the information can evoke the impression that after pleasant moments spent in a risky way it is enough just to go and buy a test and in just one minute one can be sure...
It would be great if it was as easy like this, but the reality is different. Because it is offered in free sale in many pharmacies, the promoted diagnostic instrument became subject to control of the CTIA inspectors. After the inspectors found out the major contradiction between the text of the original producer package information in English and its Czech translation, it was obvious that there is a serious problem.
In the original package insert, the producer concretely specifies that the test is to be used only by trained personnel of medical facilities, clinical laboratories, when providing first aid and in medical offices. Further the producer explicitly claims that the test is not for home testing. In the Czech package insert, the original determination was changed into a simple sentence “the test is dedicated to professional single- and quick use” which – in the frame of four-page information typed in minor letters – can easily fall out of attention of a wo/man who bought the product under the influence of advertising and who expects an answer to a very serious question. The fact that the package insert’s text is – with regard to the expected target group – written in professional language is just one side of the problem. The other side, not any less serious, is the practical performance of the test itself. The test composes of overall seven components and for a laic without any medical education its correct use is very difficult. The incorrect performance of the test can bring false results - which is a more harmful variant than uncertainty.
On the grounds of these findings, the Czech Trade Inspection Authority issued a measure of remedy to the controlled company and the remedy was made. This means that the company can continue selling the product if the Czech version of the package insert is in compliance with the English original. In that case every wo/man bears responsibility for purchase and use of products that are not designed for laic use. The same as it is obvious that nobody would operate its own appendix or place filling in their teeth and go to a specialist, it should also be obvious that they will not use a diagnostic which is not designed for self-testing and which is designed to be used by a professional. If it is not legislatively possible to limit sale of particular products, it is necessary to inform about these products in a precise and truthful way so that they are not used incorrectly.
CTIA recommends:
It would be great if it was as easy like this, but the reality is different. Because it is offered in free sale in many pharmacies, the promoted diagnostic instrument became subject to control of the CTIA inspectors. After the inspectors found out the major contradiction between the text of the original producer package information in English and its Czech translation, it was obvious that there is a serious problem.
In the original package insert, the producer concretely specifies that the test is to be used only by trained personnel of medical facilities, clinical laboratories, when providing first aid and in medical offices. Further the producer explicitly claims that the test is not for home testing. In the Czech package insert, the original determination was changed into a simple sentence “the test is dedicated to professional single- and quick use” which – in the frame of four-page information typed in minor letters – can easily fall out of attention of a wo/man who bought the product under the influence of advertising and who expects an answer to a very serious question. The fact that the package insert’s text is – with regard to the expected target group – written in professional language is just one side of the problem. The other side, not any less serious, is the practical performance of the test itself. The test composes of overall seven components and for a laic without any medical education its correct use is very difficult. The incorrect performance of the test can bring false results - which is a more harmful variant than uncertainty.
On the grounds of these findings, the Czech Trade Inspection Authority issued a measure of remedy to the controlled company and the remedy was made. This means that the company can continue selling the product if the Czech version of the package insert is in compliance with the English original. In that case every wo/man bears responsibility for purchase and use of products that are not designed for laic use. The same as it is obvious that nobody would operate its own appendix or place filling in their teeth and go to a specialist, it should also be obvious that they will not use a diagnostic which is not designed for self-testing and which is designed to be used by a professional. If it is not legislatively possible to limit sale of particular products, it is necessary to inform about these products in a precise and truthful way so that they are not used incorrectly.
CTIA recommends:
Concerning diagnostic tools designed for a common user in home background it has to be clearly stated that they are designed for self-testing. These products are tailored in the way that manuals are understandable and products easily usable and results are reliable also after laic use. Diagnostic which misses such marking belongs to the hands of professionals.