25 Tests
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.
Key Benefits
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.
SAFETY INFORMATION: For professional in vitro diagnostic use only.
Manufactured in Canada. Authorised distributor of
Publications showing value of using saliva over nasopharyngeal swabs
1. Rao M, et al. Comparing nasopharyngeal swab and early morning saliva for the identification of SARS-CoV-2. Clin Infect Dis. 2020 Aug 6:ciaa1156.
2. Wyllie A, L et al. Saliva is more sensitive for SARS-CoV-2 detection in COVID-19 patients than nasopharyngeal swabs. medRxiv. 2020 Apr; 1
3. Azzi L, et al. Saliva is a reliable tool to detect SARS-CoV-2. J Infect. 2020 Jul;81(1): e45-e50
4. World Health Organization. (2020). Transmissions of SARS-CoV-2: Implications for infection prevention precautions, July 9 2020. Scientific Brief. World Health Organization.
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/36-86°F
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)
Storage: Room Temperature or Refrigerated (2-30°C) . DO NOT FREEZE.
1. Unscrew cap of collection tube provided
2. Hold the collection tube close to the lips and let the oral fluid flow into the collection tube. The volume of oral fluid must be between the two black lines (approx. 150-300μl)
3. Twist the tab to open the extraction reagent container
4. Add all the extraction buffer (approx. 300μl) to the specimen collection tube.
5. Screw on the cap of the specimen collection tube and tighten so that it is fully sealed. Shake the specimen collection tube vigorously to mix the oral fluid and the extraction buffer.
6. Hold the specimen collection tube upright and open the cap onto the specimen collection tube.
7. Invert the specimen collection tube and transfer 3 full drops of the extracted specimen (approximately 80 μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). Read the result at 10 minutes. Do not interpret the result after 20 minutes.
Rapid Response COVID-19 Saliva Rapid Antigen Test – Instructions for Use
Rapid Response COVID-19 Saliva Rapid Antigen Test – Fact Sheet
Rapid Response COVID-19 Saliva Rapid Antigen Test – IFU (Multilingual)
Rapid Response COVID-19 Saliva Rapid Antigen Test – Declaration of Conformity
Rapid Response COVID-19 Saliva Rapid Antigen Test – Quick Ref Card
Rapid Response COVID-19 Saliva Rapid Antigen Test – COA
Rapid Response COVID-19 Saliva Antigen Test – MSDS
Publications showing value of using saliva over nasopharyngeal swabs
1. Rao M, et al. Comparing nasopharyngeal swab and early morning saliva for the identification of SARS-CoV-2. Clin Infect Dis. 2020 Aug 6:ciaa1156.
2. Wyllie A, L et al. Saliva is more sensitive for SARS-CoV-2 detection in COVID-19 patients than nasopharyngeal swabs. medRxiv. 2020 Apr; 1
3. Azzi L, et al. Saliva is a reliable tool to detect SARS-CoV-2. J Infect. 2020 Jul;81(1): e45-e50
4. World Health Organization. (2020). Transmissions of SARS-CoV-2: Implications for infection prevention precautions, July 9 2020. Scientific Brief. World Health Organization.