The Health Research Institute (Incliva) of the Hospital Clínico de València has developed a rapid detection kit for COVID-19, now available for use, which allows the presence of the virus to be determined in a very short time.
This kit is based on the results of the project 'Detection and rapid characterization of COVID-19 and the patient', which in April 2020 obtained funding from the Carlos III Health Institute (ISCIII) within the framework of the call for 'Urgent request for expressions of interest for the extraordinary funding of research projects on SARS-COV-2 and the COVID-19 disease '.
The project's main researcher is Felipe Javier Chaves, director of Incliva's Genomics and Diabetes Unit, in collaboration with the Microbiology and Parasitology Service of the Hospital Clínico de València, under the direction of David Navarro.
The Pneumology Service of the same Hospital, led by Jaime Signes Costa, and the JC Group have also participated in the project. Martín-Escudero, from the Internal Medicine Service of the Río Hortega University Hospital in Valladolid.
The main advantages of the developed kit are its high sensitivity (very close to PCR), its specificity of 100% (there are no false positives, no negative cases are detected as positive), which also avoids false negatives, the absence of extraction of RNA (the sample is deposited in a buffer and can be used directly, thus saving costs and time) and its speed (the results are available in 20-30 minutes).
The necessary handling is very simple and without complex equipment that facilitates its use in different areas, such as health centers and emergencies. The sensitivity and specificity obtained is higher than that of antigen tests and somewhat lower than that of PCR, although this kit is much faster and easier to do.
The kits can be used from samples of different origin (nasal exudate, nasopharyngeal sample or buccal scraping) through a very simple procedure with minimal manipulation, both for the processing of the sample and for the analysis of results. Results can be determined with the naked eye.
The kits are based on isothermal amplification of specific regions of the virus and of a human gene that produce a color change in the reaction when the sample is positive. The use of an internal control allows to determine if the samples have been taken and processed correctly, avoiding that samples that have not been taken or preserved well can be interpreted as negative samples.
The project through which this procedure has been developed, over twelve months, has included several activities: determination of the sequences of interest necessary for amplification; development of amplification systems; obtaining samples, developing systems by means of rapid and conventional PCR; development of isothermal amplification systems and their validation.
