European based rapid PCR-COVID19 home-test company Selfdiagnostics is to submit request for authorisation
TALLINN, Estonia, Dec. 2, 2020 /PRNewswire/ -- European based company Selfdiagnostics (GER, EST) plans to submit request for authorisation of its molecular diagnostic test for home and for point of care use – to detect the coronavirus SARS-CoV-2. Selfdiagnostics rapid PCR is first multifunctional test which allows to detect simultaneously COVID and influenza from one non-invasive nasal swab.
"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," said member of scientific advisory board of Selfdiagnostics PhD, Prof Tamas Bartfai.
CEO and co-founder of Selfdiagnostics Marko Lehes said that home use PCR is revolutionary approach to bring laboratory grade accuracy to endusers hands. "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," said Lehes.
The Selfdiagnotics rapid PCR 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 COVID multitest is confirmative because of running PCR, which cannot be said for antigen tests. The test 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. People 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.
About Selfdiagnostics
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 (http://selfdiagnostics.eu/sdx-multitest/). This unique product paves the way for bigger changes in medicine in regard to patients taking the first steps toward diagnosing illnesses. Doing so Selfdiagnostics has developed a unique molecular diagnostics platform for medical point of care devices. Selfdiagnostics proprietary technology allows different DNA and RNA detection purposes like for respiratory (Covid, Influenza, TB), blood born (HIV, Hepatitis) and urine (CT, NG, MG, TV, Zika) based diseases.
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