Xov xwm

Nyob rau lub Tsib Hlis xyoo no, German PEI tau tshaj tawm ib tsab xov xwm "Kev ntsuam xyuas kev sib piv rau 122 CE-cim SARS-CoV-2 antigen quick tests", uas ntsuas qhov rhiab heev ntawm 122 COVID-19 antigen ceev kuaj cov khoom uas tam sim no muaj daim ntawv pov thawj CE thiab yog muag hauv lub teb chaws Yelemees..Vim muaj kev hloov pauv hauv EU cov cai sau npe thiab German nyiaj txiag txoj cai, lub hom phiaj ntawm qhov kev ntsuas kev sib piv no yog kom paub meej tias qhov rhiab heev ntawm cov khoom uas twb muaj lawm.Cov tshuaj reagents uas tsis ua tau raws li qhov yuav tsum tau muaj kev nkag siab tsawg kawg nkaus raug tshem tawm ntawm BfArM daim ntawv teev npe, thiab txhua qhov kev ntsuam xyuas tau raug tso tawm.PEI webpage.Qhov kev ntsuam xyuas suav nrog 62 lub tuam txhab Suav.

Qauv npaj: 3 concentration gradients

Ultra-high concentration-PCR CT tus nqi 17-25

High concentration-PCR CT tus nqi 25-30

Medium concentration-PCR CT tus nqi 30-36

CT tus nqi thiab RNA daim ntawv hloov pauv piv:

CT25 yog hais txog 10^6 RNA luam / ml, CT30 yog li 10^4 RNA luam / ml, thiab CT36 yog li 10^3 RNA luam / ml.

Yam tsawg kawg nkaus rhiab heev txheem:

Tus nqi sib npaug ntawm cov qauv nrog PCR CT tus nqi <25 yog 75%

Tsis hais ntau, cia li mus rau cov ntaub ntawv.

Qhov tshwm sim 1: Tag nrho ntawm 96 cov khoom ua tau raws li qhov yuav tsum tau muaj kev xav tau yam tsawg kawg nkaus, ntawm 48 yog cov khoom siv hauv Suav teb.Rau qhov yooj yim ntawm kev sib piv, cov txiaj ntsig ntawm "CT17-36" raug txheeb xyuas los ntawm siab mus rau qis.

Qhov tshwm sim 2: Tag nrho ntawm 26 cov khoom lag luam tsis ua raws li qhov xav tau tsawg kawg nkaus, ntawm 14 yog cov khoom lag luam Suav.Rau qhov yooj yim ntawm kev sib piv, cov txiaj ntsig ntawm "CT17-36" raug txheeb xyuas los ntawm siab mus rau qis.

Cov ntaub ntawv qhov chaw: medRxiv preprint doi: Https://doi.org/10.1101/2021.05.11.21257016