The Sienna-Clarity COVID-19 Antigen test is to be performed only using direct nasopharyngeal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within six days of symptom onset.
- Pallet Size: 48 x 40 x 72.
- 9,800 Tests total.
- 392 Kits total.
- 8 Cases total.
- 49 Kits/Case.
- 25 Tests/Kit.
Product Information & Specifications
- Fast and precise results in 10 minutes.
- Nasopharyngeal swab sample.
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- For prescription use only.
- For in vitro diagnostic use only.
- Store between 2 – 30°C (36 – 86°F).
- Clinical sensitivity: 93.80%
- Clinical specificity: 99.20%
- Clinical Accuracy: 98.7%
- Instructions for Use
- FDA Emergency Use Authorization (EUA) Approval Letter