- Rapid lateral flow immunoassay for qualitative detection of SARS-CoV-2 nucleocapsid antigen from direct mid-turbinate nasal swab specimens.
- CLIA-waived (EUA) point-of-care cassette test providing results in 15 minutes with visual readout.
- Each kit includes 40 tests and required components; no specialized instruments or additional reagents needed.
- Intended for testing symptomatic patients within the first 7 days of symptom onset in authorized clinical settings.
- SKU:
- 1232792
- QTY Per Sell:
- 40
- Number of Tests:
- 40 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Direct Mid-Turbinate Nasal Swab Sample
- Key Features:
- CLIA-waived (EUA) rapid test
- Mid-turbinate nasal swab sample
- 15-minute visual results
- Detection Method:
- Lateral flow chromatographic immunoassay
- Target Analyte:
- SARS-CoV-2 nucleocapsid antigen
- Time to Result:
- 15 minutes
- CLIA Complexity:
- Waived (EUA)
- Test Format:
- Single-use cassette
- Storage Conditions:
- Store at 15–30°C (59–86°F); do not freeze
- Intended Use:
- For symptomatic individuals, tested within the first 7 days of symptom onset in authorized clinical settings.
- Performance:
- Positive Percent Agreement: 95.1%
- Negative Percent Agreement: 97.0%
- Country of Origin:
- Made in the USA
- Manufacturer:
- Sekisui Diagnostics, LLC
- Manufacturer Links:
- OSOM COVID-19 Antigen Rapid Test product page: https://sekisuidiagnostics.com/product/osom-covid-19-antigen-rapid-test-eua/
- Regulatory Information:
- Authorized by FDA under an Emergency Use Authorization (EUA); not FDA cleared or approved. For use by authorized laboratories.
- SKU:
- 1232792
- QTY Per Sell:
- 40
- Number of Tests:
- 40 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Direct Mid-Turbinate Nasal Swab Sample
- ic__sync_id:
- 4
- ic__id:
- 7873
- Key Features:
- CLIA-waived (EUA) rapid test
- Mid-turbinate nasal swab sample
- 15-minute visual results
- Detection Method:
- Lateral flow chromatographic immunoassay
- Target Analyte:
- SARS-CoV-2 nucleocapsid antigen
- Time to Result:
- 15 minutes
- CLIA Complexity:
- Waived (EUA)
- Test Format:
- Single-use cassette
- Storage Conditions:
- Store at 15–30°C (59–86°F); do not freeze
- Intended Use:
- For symptomatic individuals, tested within the first 7 days of symptom onset in authorized clinical settings.
- Performance:
- Positive Percent Agreement: 95.1%
- Negative Percent Agreement: 97.0%
- Country of Origin:
- Made in the USA
- Manufacturer:
- Sekisui Diagnostics, LLC
- Manufacturer Links:
- OSOM COVID-19 Antigen Rapid Test product page: https://sekisuidiagnostics.com/product/osom-covid-19-antigen-rapid-test-eua/
- Regulatory Information:
- Authorized by FDA under an Emergency Use Authorization (EUA); not FDA cleared or approved. For use by authorized laboratories.
