COVISTIX™ Limit of Detection is the lowest among comparable antigen tests making it one of the most sensitive tests on the market
Limit of Detection
The Lower the Limit of Detection, the Better
COVISTIXTM Performance vs. PANBIO
Study conducted by an Independent Research Organization INMEGEN (Instituto Nacional de Medicina Genómica, Mexico City, Mexico1)
Study | Sensitivity | Specificity |
|---|---|---|
COVISTIXTM | 96% | 98% |
Shallow Nasal vs. PCR2 (All Comers)3 COVISTIXTM - Sorrento (n=793) PANBIOTM - Abbott (n=2022) |
81% 62% |
96% 99% |
1. medRxiv Preprint: “Analytical Performances of the COVISTIX™ and Panbio™ antigen rapid tests for SARS-CoV-2 detection in an unselected population (all comers) https://www.medrxiv.org/search/covistix
2. PCR is the gold standard that FDA uses as the benchmark for approving rapid tests.
3. Accuracy is critical both for symptomatic and asymptomatic patients. Not everyone who is infected with COVID-19 virus has symptoms of infection (Asymptomatic). Asymptomatic individuals with COVID-19 often have lower viral loads and thus need a more sensitive antigen test. All Comers refers to anyone who comes for testing whether they have symptoms or not.
*Sources: EUA approved antigen tests (visual read lateral flow tests):
BinaxNOWTM https://www.fda.gov/media/141570/download
NIDSTM https://www.fda.gov/media/152464/download
CareStartTM https://www.fda.gov/media/142919/download
StatusTM 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
COVISTIX Data on File