A new type of PCR test, introduced in September by scientists from the Palacký University Olomouc Faculty of Medicine and Dentistry, has been certified for professional use in diagnostics and can therefore be used to detect SARS-CoV-2 via nasopharyngeal swabs. The researchers have recently completed a study comparing nasopharyngeal sampling at sampling centres with nasal self-swab tests, and the results suggest high conformity and required sensitivity to SARS-CoV-2 detection.
The test developed by Olomouc researchers can detect the presence of the coronavirus SARS-CoV-2 approximately one hour after sampling as well as detect infection even in asymptomatic individuals in the acute phase of the disease. “Currently, it will be very important to monitor the impact of easing the restrictions imposed to prevent the spread of Covid-19 infection so that we could return to normal life as soon as possible. Despite the hopes for new vaccines, it will be necessary to monitor the spread of the infection in the coming months, detect epicentres, and quickly identify individuals who are in the infectious phase of the disease and who may spread the virus to others. This is the only way to return to normal quickly,” said Milan Raška, Head of the Department of Immunology at the UP Faculty of Medicine and Dentistry and University Hospital Olomouc.
Certified for diagnostic use
Researchers from the Department of Immunology were involved in the development of the PCR test as early as March 2020. They published a description of their work in the August issue of the prestigious academic journal Diagnostics. “This is a sensitive PCR test that allows obtaining results without the demanding RNA isolation. This test is suitable for the acute phase of the disease, which is critical for transmission between individuals. On the contrary, it does not show positive for those individuals who have already had an infection in the past,” said Eva Kriegová, head of the university research team.
The test has now obtained a certificate for professional use in diagnostics (CE IVD), issued by the State Institute for Drug Control (SÚKL). “The test was developed at a Czech university in cooperation with a Czech private company and has parameters meeting international standards and recommendations. We are happy that it has now been certified for professional use in diagnostics,” added Kriegová.
Validation study for self-swabs
To date, the researchers have completed a study comparing nasopharyngeal sampling in sampling centres with nasal self-swabs, and the results suggest strong conformity and comparable sensitivity between the two SARS-CoV-2 detection methods. “A big advantage is the possibility of swabbing by the individuals themselves, as it eliminates the possibility of infecting the sampling staff. The self-swab from the nose is very simple. The swab is inserted successively into both nostrils and then closed in a microtube with a special medium. The virus is then inactivated by heating, so that it loses its ability to infect, and the evaluation is carried out immediately by PCR. The test is very easy to perform for laboratory staff as well as trained students with experience in PCR techniques,” said Regina Fillerová, who participated in the development of the test. "Introducing self-swab tests could significantly contribute to expanding our capacities, which are often limited by the availability of sampling staff equipped with necessary protective equipment.”
“Our current solution will enable fast testing for Covid-19 at a reasonable price, offering an alternative to antigenic tests which have lower sensitivity and require shorter testing intervals than current PCR tests,” explained Petr Kvapil from IAB company, which has been collaborating with Olomouc academics since 2015 when a joint project, OLGEN, was established between the UP Faculty of Medicine and Dentistry and the VSB – Technical University of Ostrava.