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 N501Y mutation 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 sample is received by the test, the conjugated solution from the reagent pad gets dissolved and migrates along with the nasal sample. When the Novel coronavirus is present in the 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 T region.

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.

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) 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.

【REAGENTS】

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..

【STORAGE AND STABILITY】

Store the Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) at room temperature or refrigerated (2-30°C). Do not freeze. All reagents are stable until the expiration dates marked on their outer packaging and buffer vial.

【SPECIMEN COLLECTION AND PREPARATION】

1. Specimen collection:

It is applicable to the diagnosis of the Novel coronavirus from the samples of Nasopharyngeal swab. Using freshly collected samples for optimal test performance. Inadequate sample collection or improper sample handling may yield a false-negative result.

Completely insert the sterilized swab supplied in this kit into the nasal basin, and swab several times to collect the epidermal cells of the mucus.

2. Specimen preparation:

1) Take out 1 bottle of Sample Extraction Buffer, remove the bottle cap, add all the extraction buffer into the extraction tube.

2) Insert the swab into the extraction tube which contains Sample Extraction Buffer. Rotate the swab inside the tube using a circular motion to roll the side of the extraction tube so that liquid is expressed and reabsorbed from the swab, remove the swab. The extracted solution will be used as test sample.

【COMPONENTS OF THE TEST KIT】

· Test Device

· Package Insert

· Sterilized Swab

· Nozzle

· Extraction Tube

· Sample Extraction Buffer

· Tube Stand

【DIRECTIONS FOR USE】

Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C)

prior to testing.

1. Completely insert the sterilized swab supplied in this kit into the nasal basin, and swab several times to collect the epidermal cells of the mucus.

2. Unscrew the whole cap of the specimen collection tube, take out 1 bottle of Sample Extraction Buffer, remove the bottle cap, add all the extraction buffer into the extraction tube.

3.Place the sterilized swab specimen in the sample extraction buffer. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.

4.Remove the sterilized swab while squeezing the sterilized swab head against the inside of Buffer as you remove it to expel as much liquid as possible from the swab. Discard the sterilized swab in accordance with your biohazard waste disposal protocol.

5. Screw on and tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the sample extraction buffer. See illustration 4.

When the sample is ready, take the following procedures to complete the test:

1, 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.

2, Transfer 3 drops of sample into the sample well of test device vertically, start the timer, read the result at 10~20 minutes. Don’t interpret the result after 20 minutes. 

【FEATURES】

• Specimen types: Nasopharyngeal swab
• Testing time: 10-15 minutes
• Sensitivity: 96.17%
• Specificity:> 99.9%

【PACKAGE】