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COVID-19 Antigen Rapid Test Cassette (Oral Fluid / Saliva)

COV-2C25B
Lateral Flow Test
BTNX
25 tests

DESCRIPTION:
The Rapid Response® COVID-19 Antigen Rapid Test Cassette (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 viral nucleoprotein antigens in Oral Fluid from individuals suspected of COVID-19 infection. In just 10 minutes, the test detects SARS-CoV-2 viral antigens through visual interpretation of colour development.
CE marked for diagnostic use in EU and associated countries

CLINICAL PERFORMANCE:
A clinical evaluation was performed to compare the results obtained by the Rapid Response® COVID-19 Antigen Rapid Test Cassette (Oral Fluid) and a RT-PCR comparator assay. The study included 40 positive specimens and 324 negative specimens.

Relative Sensitivity: 95.0%
Relative Specificity: 100,0%

SAFETY INFORMATION:
For professional in vitro diagnostic use only.

CHARACTERISTICS:
- Sample type: Oral Fluid / Saliva
- Format: Cassette
- Quantity: 25 Tests/Kit
- Sensitivity: 95%
- Specificity: 100%
- Accuracy: 99.5%
- Duration: Results available in 10 minutes
- Storage Condition: 2-30°C
- Test Principle: Chromatographic Immunoassay

Materials Provided:

-25 Test cassettes
- 25 Collection Tubes
- 25 Extraction Reagent Containers (300 ul in each)
- 25 Saliva Sample Collection Wells
- 25 Pipettes
- 1 IFU (+1 quick instruction card)
- 1 Workstation (holds up to 8 collection tubes for the administrator)

HOW IT WORKS:

https://www.youtube.com/watch?v=6M6jhHXR9MU&feature=youtu.be