The Rapid Response® COVID-19 Antigen Rapid Test Pen (Saliva) is an in vitro immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from saliva samples through visual interpretation of colour development. This test is intended for professional use only.

Key benefits:

• First and only no-spit test dedicated to COVID-19: its sponge-like pen tip will collect a sufficient volume of sample in 2 minutes without spitting and avoiding cumbersome nasal or throat clearing.
• ALL IN ONE – No need to waste time setting up a workstation and managing numerous test components. All you need is a pen that can be used comfortably anywhere.

Test principle

Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated to coloured particles are immobilized on the conjugate pad. A sample is added to the extraction buffer that is optimized to deliver the SARS-CoV-2 antigens from the sample. During the test, the target antigens, if present in the saliva samples, will be released into the extraction buffer individually packaged in the kit. Consequently, the extracted antigens will bind to the anti-SARS-CoV-2 antibodies conjugated with coloured particles.

As the sample migrates along the strip by capillary action and interacts with the reagents on the membrane, anti-SARS-CoV-2 antibodies will capture the complex in the test region. Excess-coloured particles are captured in the internal control zone. The presence of a coloured band in the test region indicates a positive result for SARS-CoV-2 viral antigens, while its absence indicates a negative result. A coloured band in the control region serves as a procedural control, indicating that the proper volume of sample has been added and that the membrane is working.

Specifications 

• Sample type: oral fluid/saliva
• Format: pen
• Pack size: 20 pcs.
• Shipping and working temperature: 2-30°C (shipping) 15-30°C (operating)
• Target: SARS-CoV-2 nucleoprotein antigen
• LoD (SARS-CoV-2 virus): 100 TCID50/ml
• LoD (rSARS-CoV-2 NPs): 0.1ng/mL
• Relative sensitivity: 90%
• Relative specificity: 97%
• Duration: Results available in 15 minutes.
• Test principle: In vitro immunoassay

Materials provided

The saliva collection pen and extraction buffer plug are individually packaged in the same foil bag.

How does it work?

Bring devices to room temperature (18-30°C) before use.

1. Open the bag and remove the saliva collection pen and extraction buffer cap from the packaging. Label the saliva collection pen with the patient’s identification. For best results, the assay should be performed within two hours.

2. Clear your throat, then take four deep coughs with your mouth closed before collecting the samples.

3. Remove the plastic cap from the tip of the Saliva Collection Pen.

4. Place the Saliva Collection Pen in the mouth above the tongue. Hold in place for 2 minutes.

5. Remove the saliva collection pen from the patient’s mouth. Holding the Saliva Collection Pen vertically, place it on the Extraction Damper Cap. Press down to break the seal on the extraction buffer cap, which will release the buffer solution.

6. Start the timer immediately after breaking the seal. Read the results after 15 minutes.