Iindaba

NgoMeyi walo nyaka, i-PEI yaseJamani yapapasha inqaku elithi "Uvavanyo lokuthelekisa uvakalelo lwe-122 CE-ephawulwe ngovavanyo olukhawulezayo lwe-SARS-CoV-2 ye-antigen", evavanya ubuntununtunu be-122 ye-COVID-19 yeemveliso zovavanyo olukhawulezayo lwe-antigen ngoku ezinezatifikethi ze-CE kwaye ithengiswa eJamani..Ngenxa yotshintsho kwimimiselo yokubhaliswa kwe-EU kunye nemigaqo-nkqubo yezemali yaseJamani, injongo yolu vavanyo lothelekiso kukuqinisekisa uvakalelo lweemveliso ezikhoyo.Ii-reagents ezingahlangabezani nezona mfuno zisezantsi zovakalelo ziyasuswa kuluhlu lwe-BfArM, kwaye zonke iziphumo zovavanyo ziyakhutshwa.Kwiphepha lewebhu le-PEI.Uvavanyo lubandakanya iinkampani ezingama-62 zaseTshayina.

Ukulungiswa kwesampuli: i-3 gradients yoxinaniso

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

Uxinzelelo oluphezulu-ixabiso le-PCR CT 25-30

Uxinzelelo oluphakathi-ixabiso le-PCR CT 30-36

Ixabiso le-CT kunye nomlinganiselo wokuguqulwa kwekopi ye-RNA:

I-CT25 imalunga ne-10^ 6 iikopi ze-RNA / ml, i-CT30 imalunga ne-10^4 iikopi ze-RNA / ml, kunye ne-CT36 malunga ne-10^3 iikopi ze-RNA / ml.

Ubuncinci umgangatho wovakalelo:

Umlinganiselo wokuhambelana kweesampuli kunye nexabiso le-PCR CT <25 yi-75%

Akukho nto ingako yokuthetha, yiya nje kwidatha.

Isiphumo se-1: Iimveliso ze-96 zizonke zihlangabezana neemfuno ezincinci zobuthathaka, apho i-48 yimveliso yaseTshayina.Ukuze kube lula ukuthelekisa, iziphumo ze "CT17-36" zihlelwe ukusuka phezulu ukuya phantsi.

Isiphumo sesi-2: Iyonke yeemveliso ze-26 azihlangabezani neemfuneko zobuntununtunu obuncinci, apho i-14 iyimveliso yaseTshayina.Ukuze kube lula ukuthelekisa, iziphumo ze "CT17-36" zihlelwe ukusuka phezulu ukuya phantsi.

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