A test for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human saliva.
The new rapid saliva test offers a non-intrusive alternative to a nasal swab test through detection of the virus that causes Covid-19 (SARS-CoV-2) in a provided saliva sample and is clinically more accurate at detecting the virus than a nasal swab test with a clinical accuracy of 99.5%.

Clinical Sensitivity: 98.26%
Clinical Specificity: >99.99%
Clinical Accuracy: 99.50%

Store the test kit in a cool, dry place between 2-30°C. Keep away from light. Exposure to temperature and / or humidity outside the specified conditions may cause inaccurate results.

• Do not freeze or refrigerate. Use the test kit at temperatures between 15-30°C.
• Use the test kit between 10-90% humidity.
• Do not use the test kit beyond the expiration date (printed on the foil pouch and box).

Note: All expiration dates are printed in Year-Month-Day format.
2022-06-18 indicates June18, 2022.

SARS-CoV-2 antigen test results should not be used as the sole basis for diagnosing or ruling out SARS-CoV-2 infection or for informing about the status of the infection.

• Results from SARS-CoV-2 antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic and or CT should be considered to rule out infection in these individuals.
• Positive results may be due to present infection with SARS-coronavirus strains, see “cross-reactivity” for details. Follow-up testing with a molecular diagnostic and / or CT should be considered to confirm the testing result.
• For in vitro diagnostic use only.
• Not for at-home testing.
• Further molecular diagnostic and / or CT is recommended to identify the actual physical situation.
• Do not open the foil pouch of the test device exposing it to the ambient environment until the test device is ready for immediate use.
• Do not use any damaged test device or material.
• Do not reuse the test device.
• Handle extraction solution with caution, do not contact with eyes or skin. If spilled on eyes or skin, wash thoroughly with water.
• Do not use test kit beyond the expiration date.
• Specific training or guidance is recommended if operators are not experienced with specimen collection and handling procedures.
• Only use saliva as specimen. Follow the package insert to obtain accurate results.
• Wear protective gears such as laboratory coats, disposable gloves, and eye protection when specimens are collected and evaluated.
• Wash hands thoroughly after handling.
• All parts of kit are considered biohazardous and can potentially transmit infectious diseases from blood borne pathogens, even after you have performed cleaning and disinfection. Follow proper precautions and all local regulations when disposing of the used test kits.