COVID-19 Antigen Rapid Test Pen (Saliva)
WORLD’S FIRST ‘NO-SPIT’ SALIVA ANTIGEN RAPID TEST!
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.
• First and the only no-spit test dedicated to COVID-19 – Its sponge-like pen tip will collect a sufficient volume of specimen in 2 mins without the need to spit and avoiding uncomfortable nasal/throat swabbing.
• ALL IN ONE – No need to waste time setting up a workstation and handle numerous assay components. All you need is one pen that can be used comfortably in any location.
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 conjugated pad. A sample is added to the extraction buffer which is optimized to release the SARS-CoV-2 antigens from specimen. During testing, target antigens, if present in the saliva samples, will be released into the extraction buffer individually packed in the kit. Consequently, the extracted antigens will bind to anti-SARS-CoV-2 antibodies conjugated to coloured particles.
As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies at the test region. Excess coloured particles are captured at the internal control zone. The presence of a coloured band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A coloured band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working.
Sample Type: Oral Fluid / Saliva
Pack Size: 20 pc
Shipping & Working Temp: 2-30°C (Shipping) 15-30°C (Working)
Target: SARS-CoV-2 Nucleoprotein Antigen
LoD (SARS-CoV-2 Virus): 100 TCID50/ml
LoD (rSARS-CoV-2 NP): 0.1 ng/ml
Relative Sensitivity (86 samples): >90.0% (69.9%-97.2%)
Relative Specificity: >97.0% (89.6%-99.2%)
Duration: Results available in 15 minutes.
Test Principle: In vitro immunoassay
Individually-packaged saliva collection pen and extraction buffer cap in the same foil pouch.
Bring devices to room temperature (18-30°C) before use.
1. Open the pouch and remove the Saliva Collection Pen and Extraction Buffer Cap from the packaging. Label the Saliva Collection Pen with patient identification. For best results, the assay should be performed within two hours.
2. Clear throat, then cough deeply four times with mouth closed before collecting the samples.
3. Remove the plastic guard 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 into the Extraction Buffer Cap. Press down to break the seal of the Extraction Buffer Cap, which will release the buffer solution.
6. Start the timer immediately after breaking the seal. Read the results at 15 minutes.