COVISTIX™ Limit Deteksyon se pi ba a nan mitan tès antijèn konparab fè li youn nan pi plis la sansib tès sou mache a
Limit Deteksyon
Pi ba limit la nan deteksyon, pi bon an
COVISTIXTM Pèfòmans kont PANBIO
Etid ki fèt pa yon Òganizasyon Endepandan rechèch INMEGEN (Instituto Nacional de Medicina Genómica, Mexico City, Meksik1)
Etid | Sansiblite | Espesifik |
|---|---|---|
COVISTIXTM | 96% | 98% |
Fon nen vs PCR2 (Tout moun k ap vini yo)3 COVISTIXTM - Sorrento (n=793) PANBIOTM - Abbott (n = 2022) |
81% 62% |
96% 99% |
1. medRxiv Preprint: "Pèfòmans analitik tès rapid antijèn COVISTIX™ ak Panbio™ pou deteksyon SARS-CoV-2 nan yon popilasyon ki pa seleksyone (tout moun) https://www.medrxiv.org/search/covistix
2. PCR se estanda lò ke FDA itilize kòm referans pou apwouve tès rapid yo.
3. Presizyon se kritik tou de pou pasyan sentòm ak asymptomatic. Se pa tout moun ki enfekte ak viris COVID-19 ki gen sentòm enfeksyon (Asymptomatic). Moun ki asymptomatik ak COVID-19 souvan gen pi ba chaj viral epi kidonk bezwen yon tès antijèn ki pi sansib. All Comers refere a nenpòt moun ki vini pou fè tès si yo gen sentòm oswa ou pa.
*Sous: Tès antijèn USA apwouve (vizyèl lekti tès koule lateral):
BinaxNOWTM https://www.fda.gov/media/141570/download
NICHTM https://www.fda.gov/media/152464/download
CareStartTM https://www.fda.gov/media/142919/download
Ki dènye nouvèlTM http://www.pbmc.com/downloads/Status_Cov_Flu_EUA210015_IFU_P-5382.pdf
EllumeTM https://www.fda.gov/media/144592/download
QuickVueTM https://www.fda.gov/media/144668/download
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorization-medical-devices/vitro-diagnostics-euas
Done COVISTIX nan Dosye