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Seegene får CE-IVD-märkning för användning av Combo Swab, en enhet för självprovtagning med fyra diagnostiska test för COVID-19
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Seegene Inc.

Sep 13, 2021, 03:04 ET

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SEOUL, Sydkorea, 13 september, 2021 /PRNewswire/ -- Seegene Inc. (KQ 096530), Sydkoreas ledande företag inom molekulär diagnostik, meddelade den 20 augusti att man har fått CE-märkning för användning av Combo Swab, en enhet för självprovtagning med fyra diagnostiska analyser.

Combo Swab är en lättanvänd bomullspinne som är utformad för att effektivisera provtagning i stor skala där patienter enkelt tar prover från mun- och näshåla under övervakning av vårdpersonal. Med CE-IVD-märkningen, kan Combo Swab nu användas med Seegenes fyra diagnostiska analyser för COVID-19 inklusive "Allplex™ analys för SARS-CoV-2", "Allplex™ SARS-CoV-2 huvudanalys",Master  "Allplex™ SARS-CoV-2 variant I-analys assay" och "Allplex™ SARS-CoV-2/FluA/FluB/RSV-analys assay". Seegenes mångfaldiga analyser har redan fått ett brett erkännande i hela världen för sin förmåga att upptäcka flera mål i en enstaka kanal. Tillgängligheten på Combo Swab med företagets diagnostiska analyser förväntas öka testeffektiviteten dramatiskt, genom att möjliggöra fortsatt testning av stora grupper människor på betydligt kortare tid.

Combo Swab har många fördelar, samtidigt som den reducerar olika obehagligheter som nasolaryngeala bomullspinnar Nasofarynxprovtagning medför. I jämförelse med nasolaryngeala bomullspinnar som måste stickas långt in i patientens näsrygg tills man stöter på motstånd, kan individer samla in sina egna prov genom att bara ta prover i mun och näsa utan att orsaka något obehag. Tack vare sin enkelhet, behövs det inte vårdpersonal för att ta hand om varje patient, vilket i sin tur, möjliggör effektiv testning av stora grupper människor. Förutom att Combo Swabs drastiskt kan öka testmiljön för storskalig testning, så minskar den även risken för oavsiktlig exponering för viruset för kliniker, då de kan hålla avstånd under testningsförfarandet. Företaget ansökte i juli 2020 om ett patent för en teknik som upptäcker viruset SARS-CoV-2 via prover tagna från mun och näsa. Seegene sade att detta nya testalternativ inte bara kommer att öka tillgängligheten på tester för COVID-19, utan även minimera arbetsbelastningen för vårdpersonal, vilket löser problemet med bristen på kliniker i många länder runtom i världen.

Kliniska data visar att Combo Swabs har en noggrannhet på över 96 %, samma noggrannhet som resultaten för nasolaryngela bomullspinnar. Länder som USA, Storbritannien och Singapore har redan börjat använda enheter för självprovtagning som t.ex. bomullspinnar för mun och näsa för testning i större skala. De flesta tester för självprovtagning, tar dock bara prover från en persons näsa eller mun, medan Seegenes Combo Swab tar prover både från näsa och mun, varpå de resultat som erhålles med Combo Swabs har en högre noggrannhet än andra enheter för självprovtagning.

"Med den snabba spridningen av Delta-varianten, är övervakande testning, nyckeln till att förhindra fortsatt spridning av COVID-19. Med sådana förutsättningar gör Combo Swabs det möjligt att utföra masstestning med dess höga noggrannhet", sade Min-Cheol Lee, Chief Technology Officer hos Seegene. "Seegene äger många olika, unika tekniker som erhållits genom över femtio originalpatent för att upptäcka virusgener i ett enda test. Kombinationen av Combo Swabs och Seegenes många olika tekniker kommer garanterat att bli den optimerade lösningen för att utföra testning för COVID-19 i större skala, och bli ett nödvändigt verktyg när samhällen ska öppna upp igen", tillade han.

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