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Sejoy Auto Test, lateral flow test for coronavirus 19 Sars-CoV-2 (NCoV-2019), sensitivity of 97.5%. -description
Technology: Rapid "lateral flow" test of the presence of antigen in a nasal swab, based on colloidal gold, for the qualitative detection of the Sars-CoV-2 coronavirus of covid19 (nCoV-2019)
Specimen Type: Nasal swab specimens.
Appliance required: None. Everything needed is provided in the box.
Diagnosis time? 10-15 mins
Clinical study result?
Relative sensitivity:
97.5% (93.81%-99.79%) 95% Confidence Intervals
Relative specificity:
99.5%(98.16%-99.99%) 95% Confidence Intervals
Precision:
98.8% (95% CI: 96.48%-99.01%) 95% Confidence Intervals
LOD: 30 TCID50 / mL
No hook effect observed up to a concentration of 4.6 x 10^5 TCID50/mL on inactivated SARS-CoV-2 virus
No cross-reactivity observed on 13 other viruses (detailed table provided in the package leaflet)
Competitive Advantages
very fast result (10-15 minutes),
storage of tests at room temperature (2-30°C),
Simple to use (no need for fancy hardware), quick to learn
more economical than PCR tests
Consumables provided in the kit
Device Certification (CE, FDA, )
EC, compliant with Directive 98/79/EC, and FDA
Medical Device Class: DM Diagnostic In Vitro Class Others
Self-test approved by the ANSM
What's in the box
1 test cassette
1 sterile swab for collection
1 extraction tube with extraction solution
1 dropper cap
Expiry 2027
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