COVID-19 rapid test ImmTek™

for antigensSARS-COV-2nasopharyngeal

Features: -Reliable Performance: 97.53% Accuracy compared with PCR -Expedited Results: Appear in 10 mins (most commercial tests require 15-30 mins) -Easier Interpretation: Dual-colored C/T line (easier-to-distinguish by naked eyes) -Higher Biosafety: Extraction Buffer effectively inactivates coronavirus -Equivalent performance in detecting NP and NS swab specimens. Intended Use ImmTekTM COVID-19 Antigen Rapid Test is an in vitro immunochromatographic assay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal or nasopharyngeal swab specimens from individuals with suspected symptoms within 5 days, as an aid to the rapid diagnosis of SARS-CoV-2 infection. Test results should be interpreted by medical professionals in conjunction with clinical history and symptoms. Specification -Test Principle: Lateral Flow Immunochromatographic Assay -Target Antigen: SARS-CoV-2 Nucleocapsid Protein -Specimen Type: Fresh Nasal or Nasopharyngeal Swab Specimen -Reaction Time: 10 Minutes -Interpretation: Clear and accurate reading of dual-colored C line and T line -Limit of Detection: 313 TCID50 /ml -Cross Reactivity: No cross-reactivity with other viruses and bacteria tested. -Interference: Not affected by the interfering substances tested. -Sensitivity (PPA): 93.48% (95%CI: 82.10%-98.63%) -Specificity (NPA): 99.14% (95%CI: 95.29%-99.98%) -Storage: Room Temperature 15-30°C (59-86°F) CE-marked.