Selfdiagnostics, an European based company, is planning to submit request for authorisation of its molecular diagnostic test for home and for point of care use.
The test can be done to detect the coronavirus SARS-CoV-2. Selfdiagnostics rapid PCR. It is first multifunctional test which allows to detect simultaneously COVID and influenza from one non-invasive nasal swab.
According to member of scientific advisory board of Selfdiagnostics PhD, Prof Tamas Bartfai, “Selfdiagnostics’ instrument free Multitest is based on nucleic acid amplification and has significantly lower false negative results than the serologic test. The test is fully comparable in its sensitivity and specificity to molecular diagnostics home test approved November 20 by FDA as shown by testing of clinical reference samples from COVID 19 patients.”
Co-founder and CEO of Selfdiagnostics Marko Lehes stated that home use PCR is revolutionary approach to bring laboratory grade accuracy to endusers hands.
He added: “Selfdiagnostics has proved its technology with sexually transmitted diseases and now after successful interim clinical study introduces COVID and influenza multitest in current virus season and scales up production in Europe.”
What is it
Selfdiagnostics Covid multitest is confirmative because of running PCR, which cannot be said for antigen tests. It is faster than laboratory PCR – time from sampling to result in only 40 minutes and the test is non-invasive – runs with easy taken nasal swab or/and saliva.
Those who have symptoms or have been in contact with a positive patient, can be tested anywhere and anytime outside of lab – at home, at workplaces, doctors offices, pharmacies etc.
The multitest is based on isothermal PCR which is already approved by FDA for home use and paves the way for tremendous increase of testing cases which is still a key step to stop the pandemics.
Selfdiagnostics Deutschland GmbH brings laboratory-grade precision home medical testing to ordinary users and offers the world’s smallest application of PCR (polymerase chain reaction) technology.
(With inputs from The OnLook News Research Bureau)