Izindaba

NgoMeyi walo nyaka, i-PEI yaseJalimane ishicilele indatshana ethi “Ukuhlolwa kokuzwela okuqhathanisayo kokuhlolwa okusheshayo kwe-SARS-CoV-2 okumakwe CE okumakwe nge-SARS-CoV-2”, okuhlole ukuzwela kwemikhiqizo yokuhlola esheshayo eyi-122 COVID-19 antigen njengamanje enezitifiketi ze-CE futhi inezitifiketi ze-CE. idayiswa eJalimane..Ngenxa yezinguquko emithethweni yokubhaliswa kwe-EU kanye nezinqubomgomo zezezimali zaseJalimane, inhloso yalokhu kuhlola okuqhathanisayo iwukuqinisekisa ukuzwela kwemikhiqizo ekhona.Ama-reagents angahlangabezani nezidingo zokuzwela ezincane ayasuswa ohlwini lwe-BfArM, futhi yonke imiphumela yokuhlola iyakhululwa.Ekhasini lewebhu le-PEI.Ukuhlola kufaka izinkampani ezingama-62 zaseChina.

Ukulungiselela isampula: ama-concentration gradients ama-3

I-Ultra-high concentration-PCR CT value 17-25

Ukuhlushwa okuphezulu-PCR CT value 25-30

I-Medium concentration-PCR CT value 30-36

Inani le-CT nesilinganiso sokuguqulwa kwekhophi ye-RNA:

I-CT25 icishe ibe ngu-10^6 amakhophi e-RNA/ml, i-CT30 icishe ibe ngu-10^4 amakhophi e-RNA/ml, futhi i-CT36 icishe ibe ngu-10^3 amakhophi e-RNA/ml.

Isilinganiso esincane sokuzwela:

Izinga lokuqondana kwamasampula anevelu ye-PCR CT<25 ngu-75%

Akukho okuningi ongakusho, vele uye kudatha.

Umphumela 1: Isamba semikhiqizo engama-96 ihlangabezana nezidingo ezincane zokuzwela, ezingama-48 kuzo eziyimikhiqizo yamaShayina.Ukuze kube lula ukuqhathanisa, imiphumela ye-“CT17-36″ ihlelwa ukusuka phezulu ukuya phansi.

Umphumela wesi-2: Isamba semikhiqizo engama-26 ayihlangabezani nezidingo zokuzwela okuncane, okuyi-14 yazo okuyimikhiqizo yamaShayina.Ukuze kube lula ukuqhathanisa, imiphumela ye-“CT17-36″ ihlelwa ukusuka phezulu ukuya phansi.

Umthombo wolwazi: medRxiv preprint doi: Https://doi.org/10.1101/2021.05.11.21257016