In relation to the publication of Gazeta Wyborcza of 24 January 2023 concerning antigen tests, I would like to kindly inform you that the Council’s Positions are each time issued taking into account a broad spectrum of health technology assessment criteria relating, inter alia, to the impact on the improvement of citizens’ health, taking into account the incidence, prevalence or mortality rates determined on the basis of current medical knowledge, the effects of the consequences of a disease or a health condition, in particular leading, inter alia, to premature death, as well as the opinions of clinical experts.
Information from the Robert Koch Institute: “Rapid immunochromatographic tests available for the detection of RS virus antigens (mostly based on immunoenzymatic tests) give a result within 20-75 minutes. They are carried out in people up to 18 years of age. Their sensitivity ranges from 50-90% and specificity from 75-100%, with a positive predictive value highly dependent on the age of the patient and the season in which the material is isolated from the affected person. In infants and young children during the season of RSV infection, the diagnostic power of the test is much higher than in older children or tests outside the season. Immunofluorescence (IFT) methods are also used in laboratory diagnosis, which achieve sensitivity and specificity of more than 90%. During the off-season, it is important to confirm the diagnosis by genome detection.” This information refers to the sensitivity and specificity of the antigen test for RSV in individuals aged <18 years. Date of last update of the above information on the Robert Koch Institute website: 06/02/2018.
The excerpt quoted in the Gazeta Wyborcza publication regarding the sensitivity and specificity of the tests refers only to part of the evaluated intervention.
According to the information provided by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), the information provided by the manufacturers in the instructions for use and attached to the registration applications and notifications to the URPL shows that specificity and efficacy are declared by the manufacturers to be above 90%, and the Office has not received any information about tests indicating unacceptable risks with their use.