Nūhou

I Mei o kēia makahiki, ua paʻi ʻo German PEI i kahi ʻatikala "Comparative sensitivity evaluation for 122 CE-marked SARS-CoV-2 antigen rapid tests", nāna i loiloi i ka naʻau o nā huahana 122 COVID-19 antigen rapid test e loaʻa nei nā palapala hōʻoia CE. kuaiia ma Kelemania..Ma muli o ka hoʻololi ʻana i nā lula hoʻopaʻa inoa EU a me nā kulekele kālā Kelemania, ʻo ke kumu o kēia loiloi hoʻohālikelike e hōʻoia i ka naʻau o nā huahana e kū nei.Hoʻokuʻu ʻia nā hopena loiloi a pau mai ka papa inoa BfArM.Ma ka pūnaewele PEI.Aia ka loiloi he 62 mau hui Kina.

Hoʻomākaukau laʻana: 3 mau ʻanuʻu koʻikoʻi

ʻO ka nui-kiʻekiʻe kiʻekiʻe-PCR CT waiwai 17-25

ʻO ka helu kiʻekiʻe-PCR CT waiwai 25-30

Kūlana haʻahaʻa-PCR CT waiwai 30-36

ʻO ka waiwai CT a me ka lakene hoʻololi kope RNA:

ʻO CT25 ma kahi o 10^6 RNA kope/ml, CT30 ma kahi o 10^4 RNA kope/ml, a ʻo CT36 ma kahi o 10^3 RNA kope/ml.

maʻamau noʻonoʻo liʻiliʻi:

ʻO ka helu coincidence o nā laʻana me ka helu PCR CT <25 he 75%

ʻAʻole nui ka ʻōlelo, e hele wale i ka ʻikepili.

Ka hopena 1: Loaʻa nā huahana 96 i nā koi haʻahaʻa haʻahaʻa, a ʻo 48 nā huahana Kina.No ka maʻalahi o ka hoʻohālikelike ʻana, hoʻokaʻawale ʻia nā hopena o "CT17-36" mai kiʻekiʻe a haʻahaʻa.

Ka hopena 2: ʻAʻole i hoʻokō nā huahana 26 i nā koi haʻahaʻa haʻahaʻa, a ʻo 14 nā huahana Kina.No ka maʻalahi o ka hoʻohālikelike ʻana, hoʻokaʻawale ʻia nā hopena o "CT17-36" mai kiʻekiʻe a haʻahaʻa.

Puna ʻike: medRxiv preprint doi: Https://doi.org/10.1101/2021.05.11.21257016