——A RAPID TEST FOR THE QUALITATIVE DETECTION OF NOVEL CORONAVIRUS ANTIGENS IN HUMAN SALIVA. For professional In Vitro Diagnostic Use Only.

【SUMMARY】

The novel coronaviruses belong to the βgenus.COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough.Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.Severe acute respiratory syndrome – coronavirus- 2 (SARS-CoV-2) is an enveloped,non-segmented Positive sense rna virus. It is the cause of the Coronavirus-0 disease (COVID-19)common to humans is contagious. SARS-CoV-2 has several structural proteins, including spike(S), envelope (E), membrane (M) and nucleocapsid(N).

At present, there are many variants of the Novel coronavirus (SARS-CoV-2), and the N501Ymutation and its approximate variants have attracted attention because their mutation position is located in the spike glycoprotein’s receptor-binding domain of the virus, thereby changing the virus infected efficiency. In silico analysis demonstrated that the N501Y mutation did not alter the primary and tertiary protein structure of the spike protein RBD domain. Therefore, its antigenicity remains unchanged.

【PRINCIPLE】

The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to Novel coronavirus.The test strip is composed of the following three parts, namely sample pad, reagent pad and reaction membrane. The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coronavirus; the reaction membrane contains the secondary antibodies for Novel coronavirus, and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane.

When the saliva sample is received by the test, the conjugated solution from the reagent padgets dissolved and migrates along with the saliva. When the Novel coronavirus is present in the saliva sample, a complex is formed between the anti-Novel coronavirus conjugate and the virus will be caught / detected by the specific anti- Novel coronavirus monoclonal coated on the Tregion. Whether the sample contains the virus or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates,thereby producing a red line on the region C.

The Novel Coronavirus (SARS-Cov-2) rapid antigen test (saliva) can detect both the SARS-Cov-2 nucleoprotein as well as the SARS-Cov-2 spike protein. By ELISA, we determined that the antibody we use binds to amino acids 511-531 of the SARS Cov-2 spike protein.

The detectability of genetic SARS-CoV-2 variants was tested by examining the sensitivity toward recombinant SARS-Cov-2 spike proteins (319 to 541aa). In these tests, the Novel Coronavirus(SARS-Cov-2) antigen-rapid test achieved the same values when detecting the B.1.1.7 (UK) and B.1.351 (SA) variants as when detecting the standard variant.

【SPECIMEN COLLECTION AND PREPARATION】

1. Specimen collection:

The oral fluid specimen should be collected using the collection tools provided with the kit. Follow the detailed Directions for Use below. No other collection tools should be used with this assay. Oral fluid collected at any time of the day may be used.

2. Specimen preparation:

When the saliva is collected, follow the direction to prepare the specimen with buffer provided with the kit.

【DIRECTIONS FOR USE】

Allow the test device, specimen, extraction buffer to equilibrate to room temperature(15-30°C) prior to testing. Do not place anything in the mouth including food, drink, gum,tobacco, water and mouthwash products for at least 10 minutes prior to collection of oral fluid specimen.

1. Spit enough saliva into the saliva collect cup/bag.

2. Take out an extraction tube and a bottle of extraction buffer, remove the extraction buffer bottle cap, add all the extraction buffer into the extraction tube.

3. Draw enough saliva from the cup with a dropper, make sure the liquid level does not exceed the tunnel between the lower air bag and the plastic pipe, transfer all saliva in the plastic pipe into the extraction tube.

4. Take out a nozzle and close into the extraction tube, gently shake the extraction tube vertically for about 5 seconds to allow saliva mix well with extraction buffer. Fold the used cup/bag in half and discard it into the plastic bag as medical waste in accordance with local regulations.

5. Remove the test device from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch. Put the test device on a clean and flat surface. Transfer 3 drops of sample into the sample well of test device vertically, start the timer.

6.Read the result at 10~20 minutes. Don’t interpret the result after 20 minutes.

【INTERPRETATION OF RESULTS】

POSITIVE: Two red lines appear. One red line appears in the control region(C), and one red line in the test region(T). The shade of color may vary，but it should be considered positive whenever there is even a faint line.

NEGATIVE: Only one red line appears in the control region(C), and no line in the test region(T).

The negative result indicates that there are no Novel coronavirus particles in the sample or the number of viral particles is below the detectable range.

INVALID: No red line appears in the control region(C). The test is invalid even if there is a line ontest region(T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

【FEATURES】

• Specimen type: Saliva
• Testing time: 10 minutes
• Sensitivity: 93.9%
• Specificity:> 99.58%

【PACKAGE】