General information:

Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) is the name given to the new coronavirus that originated in 2019 and is the causative agent of COVID-19 (the disease caused by the SARS-CoV-2 virus). The virus was originally known as the 2019-nCoV nomenclature. SARS-CoV-2 is a new coronavirus strain that has not been previously identified in humans. The genome of these viruses consists of single-stranded RNA protected by two protein coatings - nucleocapsid and capsid. Its genetic characteristics are significantly different from SARS-CoV and MERS-CoV.

WHISTLING TEST 2019-nCoV Ag Saliva EASY TEST is a three-step in vitro diagnostic test (whistle) based on the immunochromatographic assay. It is designed for the qualitative detection of SARS-CoV-2 antigens in saliva specimens of suspected patients up to 7 days after the first symptoms.

• Results in 10 minutes
• Specimen: Saliva
• All necessary reagents provided (individually packed)
• Easy sampling and highest accuracy

Principle of the Test:

WHISTLING TEST 2019-nCoV Ag Saliva EASY TEST uses a double-antibody sandwich to legally detect the antigen of novel coronavirus (2019-nCoV) in saliva samples. During detection, the gold-labeled anti-2019-nCoV monoclonal antibody in the labeling pad binds to the 2019-nCoV antigen in the sample to form a complex, and the reaction complex moves forward along the nitrocellulose membrane under the action of chromatography, it is captured by the anti-2019-nCoV monoclonal antibody pre-coated by the detection zone (T) on the nitrocellulose membrane, and finally a red color reaction line is formed in the T zone. If the sample does not contain 2019-nCoV antigen, a red color reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the quality control area (C).

1. Before test, please read the instructions carefully.
2. Take the cassette to equilibrate to room temperature.
3. Unpack the aluminum foil bag, take out the cassette.
4. Insert the absorber end of the cassette into mouth. Make sure cassette is horizontal statement.
5. Actively swab the inside of the mouth and tongue to collect oral fluid.
6. Remove the absorber end from the mouth when the purple color move across the result window in the center of the test device.
7. Wait for 10 minutes and read the results.

Reagents and materials included:

• 1 Test Casette - individually packed in aluminum bag
• 1 Instructions for use

Performance characteristics:

• Sensitivity 93.91%
• Specificity 99.15%

Video instructions:

• CE-IVD certificated