Labarai

A watan Mayu na wannan shekara, PEI na Jamusanci ya buga labarin "Kwantar da hankali don gwaje-gwajen sauri na SARS-CoV-2 mai alamar CE 122", wanda ya kimanta ƙwarewar samfuran saurin gwajin 122 na COVID-19 antigen waɗanda ke da takaddun shaida na CE a halin yanzu kuma suna da takaddun shaida na CE. ana sayarwa a Jamus..Saboda sauye-sauye a dokokin rajista na EU da manufofin kuɗi na Jamus, manufar wannan kimantawa ita ce tabbatar da hazakar samfuran da ake da su.An cire reagent waɗanda ba su cika mafi ƙarancin buƙatun hankali ba daga jerin BfArM, kuma ana fitar da duk sakamakon ƙima.A kan shafin yanar gizon PEI.Kiyasin ya hada da kamfanonin kasar Sin 62.

Shirye-shiryen samfurin: 3 maida hankali gradients

Matsanancin babban taro-ƙimar PCR CT 17-25

Babban taro-PCR CT ƙimar 25-30

Matsakaicin maida hankali-PCR CT ƙimar 30-36

Ƙimar CT da rabon kwafin kwafin RNA:

CT25 shine kusan kwafin 10^6 RNA / ml, CT30 shine kusan kwafin RNA 10^4 / ml, kuma CT36 shine kusan kwafin RNA 10^3 / ml.

Mafi ƙarancin ma'aunin hankali:

Adadin daidaituwa na samfuran tare da ƙimar PCR CT <25 shine 75%

Ba abin faɗi da yawa ba, kawai je zuwa bayanan.

Sakamako 1: Jimlar samfuran 96 sun cika mafi ƙarancin buƙatun hankali, wanda 48 samfuran Sinanci ne.Don dacewa da kwatancen, sakamakon "CT17-36" ana jerawa daga babba zuwa ƙasa.

Sakamako 2: Jimlar samfuran 26 ba su cika mafi ƙarancin buƙatun hankali ba, wanda 14 samfuran Sinawa ne.Don dacewa da kwatancen, sakamakon "CT17-36" ana jerawa daga babba zuwa ƙasa.

Tushen bayani: medRxiv preprint doi: Https://doi.org/10.1101/2021.05.11.21257016